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8th edition

Guidelines for the administration of commonly used


anticancer agents and the nursing care of cancer patients
HANDBOOK OF
SYSTEMIC TREATMENTS
FOR CANCER
ALP alkaline phosphatase
ALT alanine aminotransferase
AML acute myeloid leukaemia
ARDS acute respiratory distress
syndrome
AST aspartate aminotransferase
AV atrioventricular
BB bundle branch
BMD bone marrow depression
BP blood pressure
BCRP breast cancer resistance protein
BUN blood urea nitrogen
CHF congestive heart failure
CNS central nervous system
CPK creatine phosphokinase
CSF cerebrospinal fluid
CVA cerebrovascular accident
CVAD central venous access device
D5W dextrose (glucose) 5%
dpm drops per minute
DRESS drug rash with eosinophilia and
systemic symptoms
DS dextrose 4% + sodium chloride
0.18%
DVT deep vein thrombosis
EGFR epidermal growth factor receptor
FBC full blood count
GGT gamma glutamyl transferase
GI gastrointestinal
GORD gastro-oesophageal reflux disease
GvHD graft versus host disease
IA intra-arterial
IBD inflammatory bowel disease
ILD interstitial lung disease
IM intramuscular
INR international normalised ratio
IP intra-peritoneal
IV intravenous
LDH lactate dehydrogenase
LFTs liver function tests
LLN lower limit of normal
LVD left ventricular dysfunction
LVEF left ventricular ejection fraction
MAO monoamine oxidase
MI myocardial infarction
NCI CTCAE National Cancer Institute Common
Terminology Criteria for Adverse
Events
NPSA National Patient Safety Agency
NS sodium chloride 0.9%
P-gp P-glycoprotein
PPE palmar plantar
erythrodysaesthesia syndrome
PPI proton pump inhibitor
PRES posterior reversible
encephalopathy syndrome
RTI respiratory tract infection
SC subcutaneous
SIADH syndrome of inappropriate
antidiuretic hormone secretion
TEN toxic epidermal necrolysis
TIA transient ischaemic attack
TSH thyroid-stimulating hormone
ULN upper limit of normal
UTI urinary tract infection
VEGF vascular endothelial growth factor
VTE venous thromboembolism
WBC white blood cell count
WFI water for injection
Abbreviations
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
1
CONTENTS
Acknowledgments 2
Note from the publisher 3
Preface 4
GENERAL GUIDANCE
Systemic anticancer treatment pathway 5
Suggested 24-hr telephone advice for patients having chemotherapy 9
UKONS oncology/haematology helpline triage tool 10
Recommendations for your safety and protection 12
The management of extravasation 15
Suggested algorithm for the treatment of extravasation 16
Suggested cytotoxic spillage kit 17
References 18
Further resources 19
Nursing implications of drug side effects 20
DRUG MONOGRAPHS
List of drug monographs 30
Drug monographs 31
References for drug monographs 151
APPENDICES
Appendix 1: Glossary 163
Appendix 2: NCI CTCAE v4.0 171
Appendix 3: The cell cycle 174
Appendix 4: Useful formulae 175
February 2014
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ACKNOWLEDGMENTS
Lilly Oncology UK and the publisher, Haymarket Medical, would like to acknowledge the following
healthcare professionals for their contributions to updating the administration and nursing guidelines and
drug monographs for the 8th edition of the handbook.
Authors of the 8th edition (2014)
The Royal Marsden NHS Foundation Trust:
Lisa Dougherty nurse consultant, IV therapy and lead chemotherapy nurse
Anita McWhirter pharmacy clinical services manager
& the clinical pharmacy team
Greater Midlands Cancer Network:
Philippa Jones Macmillan Network lead chemotherapy nurse
Previous editions
We wish to also extend our special thanks to the following past and present members of staff of the
Royal Marsden Hospital, London and Surrey:
Marilyn Marks and Kerry Jennings for the 1st edition
Val Speechley and Tim Root for the 2nd and 3rd editions
Lisa Dougherty, Julie Mycroft and Tim Root for the 4th edition
Stephen Almond, Judith Earl and Lisa Dougherty for the 6th edition
Lisa Dougherty, Lorraine Hyde, Philippa Jones, Caroline Kay, Louise McNamara, Richard Schorstein and
Anita McWhirter for the 7th edition
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
3
Note from the publisher
Welcome to the 8th edition of the Lilly Handbook of Systemic Treatments for Cancer (2014).
The intent of this handbook is to assist healthcare professionals in their day-to-day patient management
by providing concise information and guidelines for the administration of commonly used pharmacological
agents for the treatment of cancer.
The contents of this handbook have been developed collaboratively by nurse and pharmacist teams
at the Royal Marsden NHS Foundation Trust led by Lisa Dougherty and Anita McWhirter, respectively;
in association with the chemotherapy manager and network lead chemotherapy nurse of the Greater
Midlands Cancer Network Philippa Jones, on behalf of Eli Lilly and Company Ltd (Lilly) and the
publisher, Haymarket Medical.
Lillys role, as the sponsor of this handbook, has been limited to checking the factual accuracy of
information on Lilly products and ensuring compliance with the PMCPA Code of Practice for the
Pharmaceutical Industry.
Save for the above, and the compilation of the Appendices section, the updated contents of the handbook
have been developed independently by the authors in collaboration with the publisher.
The monographs in this handbook were compiled from manufacturers summaries of product
characteristics (SPCs) and other established resources. Some of the information presented may reflect
local practice and the clinical expertise of the healthcare professionals involved.
The monographs of the products contained herein are not intended to be a substitute for the
manufacturers SPCs. Only adverse events deemed to be of particular relevance are included.
The publisher has tried to ensure that the information contained in this handbook is accurate and
up-to-date at the time of publication. It is the users responsibility to check for any variation in the
product SPC subsequently. These can be found at www.medicines.org.uk/emc. It is important not to use
copies of the handbook that are out of date or pass on old editions.
The practice guidance presented in this handbook is offered as recommendations, and does not diminish
the requirement for clinical judgment. Readers are strongly advised to check these recommendations
against their local protocols and guidelines and to make their own further enquiries of manufacturers
or specialists in relation to particular drugs, treatments or advice. Lilly, the publisher and the authors
cannot accept liability for errors or omissions, and disclaim any liability arising out of the use of this
handbook in practice.
2014 Lilly Oncology UK.
No part of this publication may be reproduced. Not for resale.
Published by Haymarket Medical, Teddington Studios, Broom Road, Teddington TW11 9BE.
Printed by Cardiff Printing Company, Llantrisant, South Wales.
Date of preparation: February 2014; UKONC00326
Haymarket is certified by BSI to
environmental standard ISO14001
February 2014
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Preface
The range of systemic anticancer therapies has increased dramatically and within the past year over 20
new therapies have become widely available. For the last edition, a change in the title of the handbook
from Cancer Chemotherapy to the Handbook of Systemic Treatments for Cancer, reflected the inclusion
of newer agents that are not purely cytotoxic in nature, such as those targeting specific molecular
receptors and cell signalling pathways.
This handbook is a Lilly initiative to help improve patient care and continues to be used as a definitive
reference and guide to practice by nurses, doctors and pharmacists. The 8th edition updates the existing
84 monographs and includes 24 new drugs. Evidence to support the text has been provided, underpinned
by the principles in the Cancer Services Manual, the requirement of peer review standards and a
comprehensive reference list.
Contributions to this updated edition have been from nursing staff that are involved in the assessment
of patients and the adminstration of chemotherapy on a daily basis, and pharmacists who are involved in
the dispensing and preparation of systemic anticancer therapy, as well as in giving advice to both staff
and patients. It is hoped that all healthcare professionals will find this updated guide useful, and that it
continues to meet their needs in the clinical setting.
Editor
Lisa Dougherty
Nurse consultant, IV therapy and lead chemotherapy nurse, The Royal Marsden NHS Foundation Trust
Ordering additional copies of the handbook
If you would like to order additional copies of the
HANDBOOK OF SYSTEMIC TREATMENTS FOR CANCER
or register your interest to receive future editions, please visit
www.lillyoncology.co.uk
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
5
Systemic anticancer treatment pathway
A number of national reports and guidelines recommend the implementation of key steps in the systemic
anticancer treatment (SACT) pathway to ensure the safe and appropriate delivery of treatment.
The pathway presented here has been developed to reflect the recommendations contained in the following
documents:
1. For better, for worse? National Confidential Enquiry into Patient Outcome and Death, November 2008.
1
2. Chemotherapy Services in England: Ensuring quality and safety. A report from the National
Chemotherapy Advisory Group, 2009.
2
3. Manual for Cancer Services: Chemotherapy Measures (2.0), 2013.
3
Prior to commencing a course of treatment
It is recommended that the key actions shown below are taken prior to commencing a course of treatment
and it is advisable that there is a procedure in place to check that this happens.
2 Physical assessment
1,3
The results of a comprehensive assessment of the patients physical condition and suitability for
treatment should be recorded. This will include a record of the patients performance status at the
time of the decision to treat.
Baseline observations of BP, pulse and respiratory rates should be taken and recorded as per
treatment protocol.
Baseline blood tests should be performed including FBC, urea and electrolytes and renal function.
Treatment- or disease-specific investigations, for example specific tumour markers, should
be performed.
The results of all pre-treatment investigations should be reviewed prior to treatment
administration.
1 Decision to treat, consent and treatment plan
1-3
The decision to initiate the course of SACT should have been made at consultant level unless there
are exceptional circumstances.
There should be a completed standardised consent form that includes reason for and intention of
treatment, as well as common and serious toxicities which have been discussed with the patient.
Patients should be fully involved in decision-making regarding their care and treatment.
Written information should always be provided for the patient and this should be recorded on the
consent form.
There should be a treatment plan for each course of SACT detailing:
Diagnosis and staging according to an internationally recognised staging system
Performance status and co-morbidities
Treatment intent
Tests required pre-SACT
Planned number of cycles
Frequency and method of assessment of response to treatment
Any deviation from protocol and reason for this
This treatment plan should be authorised and signed by a consultant oncologist or
haemato-oncologist.
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4 Prescribing and dispensing
3
Prescribing, prescription verification and dispensing of SACT should only be undertaken by
appropriately trained staff.
All SACT prescriptions should be checked by an oncology pharmacist who has undergone specialist
training, demonstrated appropriate competence and is locally authorised/accredited for the task.
3 The individual assessment by oncology nurses/pharmacists prior to the start of the course of SACT
should include
1
Patient and carer information, education, support and advice.
Each patient should be provided with a card containing key information about the treatment and
contact details of the 24-hr telephone advice service that is available for patients receiving SACT.
The importance of contacting the telephone advice service, if there are worries about symptoms
that may be related to treatment, should be explained clearly.
6 Discharge following administration
The following checks should be performed prior to allowing the patient to go home:
The patient should have all the supportive drugs they are prescribed and understand the
importance of taking them as instructed.
The patient should have an appointment for their next cycle and/or review.
The patient should have a request form for pre-treatment investgations if required.
Reinforce the availability of the 24-hr telephone advice service.
5 Administration of treatment
3,4
Administration should only be undertaken by appropriately trained nurses who have been deemed
competent by their employing organisation.
All SACT should be checked by a second nurse prior to administration.
The prescription should be checked against the patient with the following details confirmed:
patient identity, allergy status, consent, patient understanding of the SACT they are to receive and
their fitness to receive treatment.
The prepared drugs should be checked to ensure they match the prescription for date, dose and
patient details, as well as checking the volume, route of administration, diluent, correct method
(infusion or bolus injection) and expiry date/time.
The patient should have an appropriate vascular access device (VAD) in situ or one should be
inserted by an appropriately trained nurse.
During administration, the nurse should monitor the patient and the VAD site for any side effects
and manage them accordingly.
The nurse should wear appropriate personal protective clothing and dispose of all equipment in
the appropriate sharps bins or clinical waste bags.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
7
Prior to commencing each cycle of treatment
To ensure continued safe and appropriate delivery of SACT, it is vital that the following key actions are taken
prior to commencing each cycle of treament and it is advisable that there is a procedure in place to check
that this happens.
2 Pre-treatment review
Treatment plan are there any changes to the plan, for example dose modifications or alterations
to supportive medications? Have these changes happened?
Assessment of response should the patient have had a senior review and necessary
investigations to assess response to treatment prior to this cycle? Has this been completed?
1 Pre-treatment assessment
1-3
The results of an assessment of the patients physical condition and suitability for treatment should be
recorded, including:
Assessment of toxicity
Clinicians assessing patients for SACT must perform a full assessment of toxicities that the patient may
have experienced at any time since receiving their previous cycle of treatment. This assessment should
be recorded in the patients treatment record and any significant toxicity experienced by the patient
should be discussed with the prescriber prior to treatment administration as there may be a need to
modify the treatment plan. The Manual for Cancer Services: Chemotherapy Measures, recommends the
use of the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE).
3,5
Physical assessment
A review and record of the patients performance status with action taken if deterioration is noted.
The Manual for Cancer Services: Chemotherapy Measures recommends the use of the WHO
system for grading of performance status, but the Eastern Co-operative Oncology Group (ECOG)
system can also be used.
3,6
Observations and recording of BP, pulse and respiratory rates, temperature and body weight,
as indicated
Standard blood tests, including FBC, urea and electrolytes and renal function, should be
performed. The results should be within acceptable/agreed treatment parameters.
Treatment- or disease-specific investigations, such as specific tumour markers, must
be performed.
The results of all pre-treatment investigations should be reviewed prior to treatment administration.
3 Patient and carer information, education, support and advice
3
The provision of information, education and support is an ongoing process and the needs and
requirements of the patient should be assessed regularly throughout treatment. The assessment
and any action arising from it should be recorded in the patients medical record.
The importance of contacting the 24-hr telephone advice service, if the patient is worried about
symptoms that may be related to their treatment, should be reinforced throughout treatment.
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4 Prescribing and dispensing
3
Prescribing, prescription verification and dispensing of SACT should only be undertaken by
appropriately trained staff.
All SACT prescriptions should be checked by an oncology pharmacist, who has undergone
specialist training, demonstrated their appropriate competence and is locally authorised/
accredited for the task.
6 Discharge following administration
The following checks should be performed prior to allowing the patient to go home:
The patient should have all the supportive drugs they are prescribed and understand the
importance of taking them as instructed.
The patient should have an appointment for their next cycle and/or review.
The patient should have a request form for pre-treatment investigations if required.
5 Administration of treatment
3,4
Administration should only be undertaken by appropriately trained nurses who have been deemed
competent by their employing organisation.
All SACT should be checked by a second nurse prior to administration.
The prescription should be checked against the patient to confirm patient identity, allergy status,
consent and fitness to receive treatment.
The prepared drugs must be checked to ensure they match the prescription for date, dose and
patient details as well as volume, route, diluent, correct method (infusion or bolus injection) and
expiry date/time.
The patient should have an appropriate vascular access device (VAD) in situ or one should be
inserted by an appropriately trained nurse.
During administration, the nurse should monitor the patient and the VAD site for any side effects
and manage them accordingly.
The nurse should wear appropriate personal protective clothing and dispose of all equipment in
the appropriate sharps bins or clinical waste bags.
7 End of treatment
3
Following the final cycle of a course of treatment, the patient and their primary care team should be
provided with a plan for further care and informed who will take responsibility for its provision.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
9
Suggested 24-hr telephone advice for patients having chemotherapy
The Manual for Cancer Services: Chemotherapy Measures recommends that cancer networks and
acute trusts ensure that patients receiving SACT who may be experiencing side effects or complications
related to their treatment have access to 24-hr telephone advice on how to obtain help and treatment.
3

The United Kingdom Oncology Nursing Society (UKONS) central west chemotherapy nurses group has
developed a 24-hr triage tool that can be used to risk-assess patients who contact a helpline or present as
an emergency.
7
UKONS recommend that there be a programme of training and assessment of competency
prior to using the tool; however, a brief explanation of the assessment process and a copy of the
assessment tool are included in this book for your information.
The UKONS 24-hr triage tool is a recognised tool that is a simple, reliable, evidence-based process that
grades toxicities according to the significance of presenting symptoms and advises action accordingly.
It identifies patients who require:
Referral to acute oncology teams for urgent assessment
Clinical monitoring or review
The risk assessment process includes a Red Amber Green (RAG) cumulative scoring system to guide
decision-making. It is important that the effects of treatment are not underestimated and that the
significance of the cumulative effects of a number of lower-level toxicities is recognised.
Risk assessment process
It is vitally important that the process is methodical and thorough in order for it to be useful and provide
an accurate triage assessment.
There are a number of questions to ask and information that will need to be collected to make sure that
the correct advice is given.
Step 1
The user moves methodically down the triage assessment tool, asking appropriate questions, for
example, does the patient have any nausea?
If NO, tick green and move on.
If YES, use the questions provided to help you grade the problem and tick either amber or red.
Step 2
Advice is given and action taken according to the guidelines below:
RED any toxicity graded here takes priority and assessment should follow immediately. Red
triage requires face-to-face consultation and assessment by an appropriately trained and qualified
member of the clinical team. This assessment should take place in a suitable area that has access
to investigation and treatment facilities. Patients should be asked to attend as soon as possible for
assessment.
x2 AMBER two or more amber toxicities should be escalated to red. Action and assessment should
follow immediately.
AMBER a single amber toxicity should be reviewed/followed up within 24 hrs. This may be a
telephone consultation or an urgent review clinic appointment. The caller should be instructed to call
back if they continue to have concerns or their condition deteriorates.
GREEN patients should be given reassurance that the problem at present does not give cause for
concern but they should be vigilant and if the situation gets worse or does not improve they should call
back immediately.
Step 3
A record of the assessment and advice given should be made in the patients medical record.
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GRADE GRADE GRADE GRADE
TOXICITY 0 1 2 3 4
Fever and receiving cytotoxic chemotherapy
or immunocompromised
IF TEMP 37.5C or ABOVE or BELOW 36C or GENERALLY UNWELL URGENT Assessment AND MEDICAL REVIEW Follow neutropenia pathway
ALERT Pts on steroids/analgesics or dehydrated may not present with pyrexia but may still have infection (If in doubt do a count)
Chest pain
Onset? What makes it worse?
Radiation? Any cardiac history
STOP CAPECITABINE or INFUSIONAL SFU
None Advise URGENT A&E for medical assessment
Performance Status
Has there been a recent change in performance status?
Asymptomatic Symptomatic but completely
ambulant
Symptomatic, <50% in bed
during the day
Symptomatic,>50% in bed, but
not bed bound
Bed bound
Nausea
How many days? What is the patients oral intake?
Is the patient taking antiemetics as prescribed?
Access patients urinary output
None Able to eat/drink reasonable
intake
Review antiemetics as
prescibed
Can eat/drink but intake
signicantly decreased
Review antiemetics according to
local policy
No signicant intake
Arrange urgent assessment
and review
Vomiting
How many days/episodes?
What is the patients oral intake?
Does the patient have constipation or diarrhoea?
(see specic toxicity)
Assess patients urinary output
None 1 episode in 24 hours
Review antiemetics as
prescibed
2-5 episodeds in 24 hours
Review antiemetics according to
local policy
6-10 episodes in 24 hours
Arrange urgent assessment
and review
>10 episodes in 24 hours
Arrange urgent assessment
and review
Oral/stomatitis
How many days?
Is there evidence of mouth ulcers?
Is there evidence of infection?
Are they able to eat/drink?
Assess patients urinary output
None Painless ulcers, erythema, mild
soreness able to eat/drink
Use mouthwash as
recommended
Painful erythema. oedema or
ulcers but can eat/drink
Continue to use mouthwash,
drink plenty of uids. Use
painkillers either as a tablet or
mouthwash
Painful erythema difculty
with eating and drinking
Arrange urgent assessment
and review
Mucosal necrosis and/or
requires parenteral or enteral
support
Arrange urgent assessment
and review
Diarrhoea
Consider infection!
How many days has this occurred for?
How many times in a 24hr period?
Does the patient have any abdominal pain/discomfort?
For how long? Has the patient taken any medication?
See specic toxicity for pain
NB. If taking CAPECITABINE chemotherapy, follow
specic pathway
None Increase to 2-3 bowel
movements a day over
pre-treatment movements
Drink more uids
Obtain stool sample
?consider regimen specic
antidiarrhoeal
Increase to 4-6 episodes a day or
nocturnal movement/ moderate
cramping
Drink plenty of uids
Obtain stool sample
?obtain regimen specic
antidiarrhoeal
Increase to 7-9 episodes a day
or incontinence
Severe cramping
Arrange urgent assessment
and review
Increase to >10 episodes a day
or grossly bloody diarrhoea or
need for parenteral support
Arrange urgent assessment
and review
Constipation
How long since bowels opened?
What is normal?
Doed the patient have any abdominal pain/vomiting?
Has the patient taken any medication?
None Mild no bowel movement in
last 24 hours
Dietary advice, increase uid
intake, review supportive
medication
Moderate no bowel movement
in last 48 hours
If associated with pain/vomiting
move to red
Review uid and dietary intake
Recommend laxative
Severe no bowel
movement in last 72 hours
Arrange urgent assessment
and review
Paralytic ileum >96 hours
Arrange urgent assessment
and review
Fever NOT receiving chemotherapy Normal n/a >37.5C - 38C
Check in 1 hr and contact again
if still pyrexial see red
>38-40C
Arrange urgent assessment
and review
>40C
Arrange urgent assessment
and review
Infection If Pyrexial see fever toxicity
Has the patient taken their temperature? When?
Has the patient experienced any shivering, chills or shaking
episodes?
None Generally well Generally well
Arrange Review
Severe symptomatic
infection
Arrange urgent assessment
and review
Life threatening sepsis
Arrange urgent assessment
and review
Palmar - plantar syndrome
NB. If taking CAPECITABINE chemotherapy, follow
specic pathway
None Numbness, tingling, painless
erythema and swelling
Advise patient to rest hands
and feet. Use emolient cream
Painful erythema and swelling
? Arrange review(may
require dose reduction or defer
treatment). Advise analgesia
Moist desquamation,
ulceration, blistering and
severe pain
Arrange review (may require
dose reduction or defer
treatment)
Advise analgesia
Fatigue
How many days has this occured for?
Any other associated symptoms?
None Increased fatigue but not
altering normal activities
Rest accompanied with
intermittent mild activity
Moderate or causing difculty
performing some activities
? Arrange review
Severe or loss of ability to
perform some activities
Arrange review
Bedridden or disabling
Arrange urgent assessment
and review
Anorexia
What was their weight before? What is appetite like?
Any contributory factors e.g. dehydration, diarrhoea,
vomiting, mucositus and nausea?
link to specic toxicity
None Loss of appetite without
alteration in eating habits
Dietary advise
Oral intake altered without
signicant weight loss or
malnutrition:
? Arrange review
Oral intake altered in
association with signicant
weight loss/malnutrition
Arrange urgent assessment
and review
Life threatening complications
e.g. collapse
Arrange urgent assessment
and review
Dyspnoea/shortness of breath
Is it a new symptom? Is dyspnoea worsening?
Is there any chest pain? link to specic toxicity
How long for?
What can the patient do? (? alteration in PS)
CONSIDER SVCO/ANAEMIA/PULMONARY EMBOLISM
None No new symptoms Dyspnoea on exertion
? Arrange review
Dyspnoea at normal level
of activity
Will need urgent assessment
and review
Dyspnoea at rest or requiring
ventilatory support
Arrange urgent assessment
and review
Rash
Is it localised or generalised?
How long has it been there?
Any signs of infection? Is it itchy?
HAEMATOLGY FOLLOW LOCAL GUIDANCE
None Macular or papular eruption
or erythema without
associated symptoms
Localised rash, otherwise well
Macular or papular eruption or
erythema with Pruritus or other
associated symptoms
Arrange review
Symptomatic unwell
Arrange urgent assessment
and review
Symptomatic unwell
Arrange urgent assessment
and review
Neurosensory/motor
When did the problem start? Is it continuous?
Is it getting worse? Is it affecting mobility/function
Any constipation or urinary incontinence?
Consider Spinal Cord Compression
None Mild parasthesia, subjective
weakness; no objective
ndings
Monitor and contact
immediately if deteriorates
Mild or moderate sensory loss,
moderate parasthesia, mild
weakness with no loss of function
Immediate contact if deteriorates
Arrange review
Severe sensory loss,
parasthesia or weakness that
interferes with function
Arrange urgent assessment
and review
Paralysis
Arrange urgent assessment
and review
Bleeding
Is it a new problem? Is it continuous? What amount?
Where from? Is the patient on anticoagulants?
HAEMATOLOGY FOLLOW LOCAL POLICY
None Mild self limited controlled by
conservative measures
Gross 1-2 units
Urgent assessment to A&E
Gross 3-4 units per episode
Urgent assessment to A&E
Massive >4 units per episode
Urgent assessment to A&E
Pain
Is it a new? Where is it? How long have you had it?
Have you taken any analgesia?
Consider thrombosis? Any swelling/redness?
None Mild pain
Not interfering with function
Advise/discuss analgesea
Has pain
Pain or analgesea interfering
with function, but not ADL
Arrange review
Severe pain
Pain or Analgesia interfering
ADL
Arrange urgent assessment
and review
Severe pain, disabling!
Arrange urgent assessment
and review
Bruising
Is it a new problem? Is it local/generalised?
Is there any trauma involved?
None Petechia/bruising, localised
Arrange review
Moderate Petechia/purpura
Generalised bruising
Arrange urgent assessment
and review
Generalised petechia/purpura
Arrange urgent assessment
and review
Extravasation
Any problems immediately after administration?
When did the problem start?
Is the problem around the injection site?
Has the patient got a central venous catheter?
Explain the reaction?
Non vesicant
Review next day
Vesicant
Arrange urgent assessment
and review
TRIAGE TOOL ONCOLOGY/HAEMATOLOGY HELPLINE
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GRADE GRADE GRADE GRADE
TOXICITY 0 1 2 3 4
Fever and receiving cytotoxic chemotherapy
or immunocompromised
IF TEMP 37.5C or ABOVE or BELOW 36C or GENERALLY UNWELL URGENT Assessment AND MEDICAL REVIEW Follow neutropenia pathway
ALERT Pts on steroids/analgesics or dehydrated may not present with pyrexia but may still have infection (If in doubt do a count)
Chest pain
Onset? What makes it worse?
Radiation? Any cardiac history
STOP CAPECITABINE or INFUSIONAL SFU
None Advise URGENT A&E for medical assessment
Performance Status
Has there been a recent change in performance status?
Asymptomatic Symptomatic but completely
ambulant
Symptomatic, <50% in bed
during the day
Symptomatic,>50% in bed, but
not bed bound
Bed bound
Nausea
How many days? What is the patients oral intake?
Is the patient taking antiemetics as prescribed?
Access patients urinary output
None Able to eat/drink reasonable
intake
Review antiemetics as
prescibed
Can eat/drink but intake
signicantly decreased
Review antiemetics according to
local policy
No signicant intake
Arrange urgent assessment
and review
Vomiting
How many days/episodes?
What is the patients oral intake?
Does the patient have constipation or diarrhoea?
(see specic toxicity)
Assess patients urinary output
None 1 episode in 24 hours
Review antiemetics as
prescibed
2-5 episodeds in 24 hours
Review antiemetics according to
local policy
6-10 episodes in 24 hours
Arrange urgent assessment
and review
>10 episodes in 24 hours
Arrange urgent assessment
and review
Oral/stomatitis
How many days?
Is there evidence of mouth ulcers?
Is there evidence of infection?
Are they able to eat/drink?
Assess patients urinary output
None Painless ulcers, erythema, mild
soreness able to eat/drink
Use mouthwash as
recommended
Painful erythema. oedema or
ulcers but can eat/drink
Continue to use mouthwash,
drink plenty of uids. Use
painkillers either as a tablet or
mouthwash
Painful erythema difculty
with eating and drinking
Arrange urgent assessment
and review
Mucosal necrosis and/or
requires parenteral or enteral
support
Arrange urgent assessment
and review
Diarrhoea
Consider infection!
How many days has this occurred for?
How many times in a 24hr period?
Does the patient have any abdominal pain/discomfort?
For how long? Has the patient taken any medication?
See specic toxicity for pain
NB. If taking CAPECITABINE chemotherapy, follow
specic pathway
None Increase to 2-3 bowel
movements a day over
pre-treatment movements
Drink more uids
Obtain stool sample
?consider regimen specic
antidiarrhoeal
Increase to 4-6 episodes a day or
nocturnal movement/ moderate
cramping
Drink plenty of uids
Obtain stool sample
?obtain regimen specic
antidiarrhoeal
Increase to 7-9 episodes a day
or incontinence
Severe cramping
Arrange urgent assessment
and review
Increase to >10 episodes a day
or grossly bloody diarrhoea or
need for parenteral support
Arrange urgent assessment
and review
Constipation
How long since bowels opened?
What is normal?
Doed the patient have any abdominal pain/vomiting?
Has the patient taken any medication?
None Mild no bowel movement in
last 24 hours
Dietary advice, increase uid
intake, review supportive
medication
Moderate no bowel movement
in last 48 hours
If associated with pain/vomiting
move to red
Review uid and dietary intake
Recommend laxative
Severe no bowel
movement in last 72 hours
Arrange urgent assessment
and review
Paralytic ileum >96 hours
Arrange urgent assessment
and review
Fever NOT receiving chemotherapy Normal n/a >37.5C - 38C
Check in 1 hr and contact again
if still pyrexial see red
>38-40C
Arrange urgent assessment
and review
>40C
Arrange urgent assessment
and review
Infection If Pyrexial see fever toxicity
Has the patient taken their temperature? When?
Has the patient experienced any shivering, chills or shaking
episodes?
None Generally well Generally well
Arrange Review
Severe symptomatic
infection
Arrange urgent assessment
and review
Life threatening sepsis
Arrange urgent assessment
and review
Palmar - plantar syndrome
NB. If taking CAPECITABINE chemotherapy, follow
specic pathway
None Numbness, tingling, painless
erythema and swelling
Advise patient to rest hands
and feet. Use emolient cream
Painful erythema and swelling
? Arrange review(may
require dose reduction or defer
treatment). Advise analgesia
Moist desquamation,
ulceration, blistering and
severe pain
Arrange review (may require
dose reduction or defer
treatment)
Advise analgesia
Fatigue
How many days has this occured for?
Any other associated symptoms?
None Increased fatigue but not
altering normal activities
Rest accompanied with
intermittent mild activity
Moderate or causing difculty
performing some activities
? Arrange review
Severe or loss of ability to
perform some activities
Arrange review
Bedridden or disabling
Arrange urgent assessment
and review
Anorexia
What was their weight before? What is appetite like?
Any contributory factors e.g. dehydration, diarrhoea,
vomiting, mucositus and nausea?
link to specic toxicity
None Loss of appetite without
alteration in eating habits
Dietary advise
Oral intake altered without
signicant weight loss or
malnutrition:
? Arrange review
Oral intake altered in
association with signicant
weight loss/malnutrition
Arrange urgent assessment
and review
Life threatening complications
e.g. collapse
Arrange urgent assessment
and review
Dyspnoea/shortness of breath
Is it a new symptom? Is dyspnoea worsening?
Is there any chest pain? link to specic toxicity
How long for?
What can the patient do? (? alteration in PS)
CONSIDER SVCO/ANAEMIA/PULMONARY EMBOLISM
None No new symptoms Dyspnoea on exertion
? Arrange review
Dyspnoea at normal level
of activity
Will need urgent assessment
and review
Dyspnoea at rest or requiring
ventilatory support
Arrange urgent assessment
and review
Rash
Is it localised or generalised?
How long has it been there?
Any signs of infection? Is it itchy?
HAEMATOLGY FOLLOW LOCAL GUIDANCE
None Macular or papular eruption
or erythema without
associated symptoms
Localised rash, otherwise well
Macular or papular eruption or
erythema with Pruritus or other
associated symptoms
Arrange review
Symptomatic unwell
Arrange urgent assessment
and review
Symptomatic unwell
Arrange urgent assessment
and review
Neurosensory/motor
When did the problem start? Is it continuous?
Is it getting worse? Is it affecting mobility/function
Any constipation or urinary incontinence?
Consider Spinal Cord Compression
None Mild parasthesia, subjective
weakness; no objective
ndings
Monitor and contact
immediately if deteriorates
Mild or moderate sensory loss,
moderate parasthesia, mild
weakness with no loss of function
Immediate contact if deteriorates
Arrange review
Severe sensory loss,
parasthesia or weakness that
interferes with function
Arrange urgent assessment
and review
Paralysis
Arrange urgent assessment
and review
Bleeding
Is it a new problem? Is it continuous? What amount?
Where from? Is the patient on anticoagulants?
HAEMATOLOGY FOLLOW LOCAL POLICY
None Mild self limited controlled by
conservative measures
Gross 1-2 units
Urgent assessment to A&E
Gross 3-4 units per episode
Urgent assessment to A&E
Massive >4 units per episode
Urgent assessment to A&E
Pain
Is it a new? Where is it? How long have you had it?
Have you taken any analgesia?
Consider thrombosis? Any swelling/redness?
None Mild pain
Not interfering with function
Advise/discuss analgesea
Has pain
Pain or analgesea interfering
with function, but not ADL
Arrange review
Severe pain
Pain or Analgesia interfering
ADL
Arrange urgent assessment
and review
Severe pain, disabling!
Arrange urgent assessment
and review
Bruising
Is it a new problem? Is it local/generalised?
Is there any trauma involved?
None Petechia/bruising, localised
Arrange review
Moderate Petechia/purpura
Generalised bruising
Arrange urgent assessment
and review
Generalised petechia/purpura
Arrange urgent assessment
and review
Extravasation
Any problems immediately after administration?
When did the problem start?
Is the problem around the injection site?
Has the patient got a central venous catheter?
Explain the reaction?
Non vesicant
Review next day
Vesicant
Arrange urgent assessment
and review
TRIAGE TOOL ONCOLOGY/HAEMATOLOGY HELPLINE
4
4 4
P. Jones et al/UKONS/GMCN Endorsed by:
February 2014
12
Recommendations for your safety and protection
The following recommendations concern the safe reconstitution and handling of cytotoxic agents in
order to prevent self contamination. Ideally, all drugs will be reconstituted by trained pharmacy staff in a
microbiological safety cabinet or isolator. Where a nurse may be required to reconstitute a cytotoxic drug
it must be carried out in an isolator that is not on the ward/department or by using a closed reconstitution
device. It should only be carried out when absolutely necessary. Local instructions for isolator use should
be followed.
8,9
The administration of SACT
1 General
1.1 All drugs should be handled with respect, taking great care to avoid spillage.
8
1.2 A pre-treatment assessment should be carried out folowing the steps in the pre-treatment pathway
(pages 5-8). Drug dosage (according to the protocol) should be checked prior to administration of
any SACT.
1,3,8,10
1.3 Strict aseptic technique should be observed at each stage of the procedure, for example, when
adding any drug to an IV solution or via an administration set/injection cap.
10
2 Routes
There are a number of routes for the administration of SACT.
2.1 Oral
The term oral anticancer medicine refers to drugs with direct antitumour activity, administered via
the oral route, including traditional cytotoxic chemotherapy (eg, capecitabine, vinorelbine), small-
molecule treatments (eg, imatinib, erlotinib) and other agents such as thalidomide.
8
2.2 Intravenous
This is the administration of cytotoxic drugs via a peripheral or central vein. It is the most commonly
used route of administration.
8
2.2.1 Vein selection
The vein used should be firm, bouncy, straight and, if possible, previously unused. Bruised
and inflamed areas should be avoided. Ideally the injection or infusion should be given
into a large, easily visible, superficial vein. Any limb with a compromised circulation, for
example, as a result of mastectomy, lymphoedema, thrombophlebitis or trauma, should be
avoided.
11
The antecubital fossa should be avoided, especially when administering vesicant
drugs.
8,11
In everyones interest, it is suggested that a practitioner should have no more than
two attempts at device placement and should then seek the advice of a more experienced
practitioner.
11
Where no suitable veins are available or the patient is to receive regular
administration of highly irritant/vesicant infusions, then consideration should be given to the
placement of a CVAD.
8
2.2.2 Device selection
Cannulae (22 or 24g) should be selected following vein assessment, choosing the smallest
gauge and shortest length appropriate for the type and length of therapy. The smaller the
device, the less trauma to the vein and the better the blood flow around the device. This
increases dilution and rapid removal of the irritant and makes chemical phlebitis less likely.
However, longer cannulae (22 or 20g) may be necessary to reduce the risk of dislodgment or
associated infiltration and extravasation.
8
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
13
2.2.3 Administration
(a) Each device must always be tested with NS before injecting SACT, and similarly flushed
after administration. If several drugs are to be given, the device should be flushed after
each one to prevent possible interactions. This can be accomplished by attaching and
detaching a syringe of NS after each drug or by attaching a compatible infusion to the
device and using one of the following techniques:
10
(i) A fast-running infusion into which the drug is administered simultaneously via
the side arm if the vein can accommodate it or if this method is specified in the
literature. This is useful for highly irritant drugs but may not be necessary when
administering via a CVAD.
(ii) A stop/start flushing technique if the vein is fragile or small and cannot
accommodate a large fluid flow.
(b) Any drug known to be a vesicant should be given first when multiple drugs are
prescribed (but after any pre-medication). It is at this time that the integrity of the vein
is greatest and extravasation is least likely. For practical reasons, drugs to be given by
infusion, for example, dacarbazine, should be administered last.
8,11
(c) A number of cytotoxic drugs are vesicant and will cause extreme tissue damage if
leakage occurs from the vein. Even a very small leak is a serious situation and care
must be taken to ensure that all the drug enters the vein. Consequently, drugs should
be given slowly and the area around the device observed throughout the administration.
8

The practitioner should regularly assess the comfort of the patient, observe the site for
swelling or skin colour changes and check vein patency by checking for blood return.
8
If
the nurse has any doubt about the patency of the device and vein then the administration
should stop and the site should be checked before continuing. If extravasation is
suspected then follow the management of extravasation guidance on page 15.
8,11
(d) Drug solutions that are stored in the refrigerator may cause venospasm and an aching
sensation along the vein. It is important to distinguish between this and the sharp
burning sensation which may indicate the extravasation of a vesicant.
8
(e) With repeated injections of some drugs, veins may become very sensitive. The key is
either to dilute the drug or increase vasodilation. The following may help:
(i) Inject the drug slowly or administer as an infusion.
(ii) Make use of frequent NS flushes.
(iii) Give the injection via a fast-running NS infusion.
(iv) Use the smallest gauge cannula to increase blood flow around the device and
ensure more rapid circulation of the drug.
(v) Apply a heat pack above the cannula site to increase vasodilation.
2.3 Intrathecal
This is the administration of cytotoxic drugs into the CNS via the CSF using a lumbar puncture.
8

SACT administered via this route has the potential to cause great harm and has been associated
with the deaths of at least 13 patients since 1985. Since 2001, all Trusts that administer intrathecal
SACT have been required to comply with the national guidance on safe administration, most
recently updated in 2008.
12,13
Guidance issued by the NPSA means that from 2013, Trusts must
now ensure that all spinal (intrathecal) bolus doses and lumbar punctures are performed using
syringes, needles and other devices with connectors that cannot connect with intravenous Luer
connectors.
14,15

February 2014
14
The key requirements of the 2008 guidance include:
12
Only trained, designated personnel whose names are recorded on the appropriate intrathecal
register are authorised to prescribe, dispense, check or administer intrathecal SACT.
All staff involved in the intrathecal SACT process must undertake a formal competency-based
induction programme and update annually.
In adults, IV drugs must be administered BEFORE intrathecal drugs are issued (or after
IV continuous infusions have been started).
Children receiving intrathecal therapy under general anaesthetic will have their intrathecal
treatment first in theatre. IV drugs (excluding vinca alkaloids) may be given later in day care or on
the ward, but never in theatre.
Intrathecal chemotherapy should always be administered in a designated area, within normal
working hours; out-of-hours administration must only occur in exceptional circumstances.
Checks must be made by medical, nursing and pharmacy staff at relevant stages throughout the
prescribing, preparation and administration process.
This guidance predominantly relates to treatment given intrathecally, by lumbar puncture
(via spinal injection) but is also relevant to intra-ventricular chemotherapy (via injection into the
ventricles of the brain).
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
15
The management of extravasation
Extravasation is the leakage of vesicants (any solution or medication that causes the formation of blisters
with subsequent tissue necrosis and may be DNA- and non-DNA binding) into local tissue. It requires
immediate action if local tissue damage is to be prevented.

If any doubt arises about patency of the vein,
the injection or infusion should be stopped and recommenced in another vein if necessary, preferably in
the other arm. If this is not possible, use of a vein proximal to that already used will prevent leakage from
the earlier puncture site.
8,16
Extravasation should be suspected if:
8
the patient complains of a sharp stinging or burning sensation around the cannula site.
swelling or leakage occurs at the site of the cannula.
no flashback of blood is obtained (but absence of this, seen alone, is not necessarily an indication
of extravasation).
resistance is felt on the plunger of the syringe during bolus administration.
free flow of fluid is absent if an infusion is in progress.
When using a CVAD, blood return must always be established prior to administration.
17
If there is no blood
return, the Trust should have a local policy that describes the steps to be taken by the practitioner in order
to ascertain that the tip of the CVAD is in the correct position.

Prevention is key and nurses should know
which patients are at most risk.
Clinical practice guidelines on the management of extravasation have been issued by the European Society
for Medical Oncology (ESMO) and the European Oncology Nursing Society (EONS); however, guidance may
vary according to local policy.
18,19
The policy detailed here is the current policy of the Royal Marsden NHS
Foundation Trust. It is included for reference only. All staff who administer SACT should ensure that their
Trust or hospital develops its own extravasation policy.
February 2014
16
SUGGESTED ALGORITHM FOR THE TREATMENT OF EXTRAVASATION
SUSPECT EXTRAVASATION IF:
(a) Patient complains of burning or stinging pain OR
(b) There is evidence of swelling, induration, leakage at site OR
(c) There is resistance on plunger of syringe or absence of free flow of infusion OR
(d) There is no blood return (if found in isolation via a peripheral cannula this should not be regarded as an indication
of a non patent vein. However, in the event of no blood return from a CVAD follow algorithm for persistent
withdrawal occlusion)
ELEVATE THE LIMB
Apply hydrocortisone cream to reduce local inflammation. Where appropriate apply dimethyl sulfoxide every 2 hrs for
24 hrs and then 6 hourly for up to 7 days
Document in duplicate one copy in patients notes and one copy to the nurse consultant IV therapy. Complete a clinical
incident form
INFORM THE MEDICAL STAFF
GIVE PATIENT A PATIENT INFORMATION SHEET
CATEGORY A DRUGS
Vinca alkaloids, paclitaxel
Inject 1500 iu hyaluronidase
SC around the site
Apply a warm pack to aid
absorption of hyaluronidase
Warm pack to remain in situ
for 2-4 hrs
STOP THE INJECTION / INFUSION
WITHDRAW AS MUCH OF THE DRUG AS POSSIBLE (INJECTION ONLY)
REMOVE THE PERIPHERAL CANNULA
COLLECT THE EXTRAVASATION PACK
CONSIDER CONTACTING THE EXTRAVASATION TEAM TO PERFORM FLUSH OUT TECHNIQUE
CATEGORY B DRUGS
Dactinomycin, dacarbazine, daunorubicin, doxorubicin,
epirubicin, idarubicin, mitomycin C, streptozocin, trabectedin
Apply cold pack to cause vasoconstriction for
15-20 mins, 3-4 times a day for at least 24 hrs
If extravasation is with any of the following: mitomycin C,
doxorubicin, idarubicin, epirubicin, dactinomycin
Draw around area of extravasation with indelible pen
Put on gloves
Apply thin layer of dimethyl sulfoxide topically to the
marked area using the small plastic spatula in lid of
the bottle
Allow it to dry and apply gauze
This should be applied within 10-25 mins
If extravasation of doxorubicin, idarubicin, epirubicin or
daunorubicin occurs (ie, 3.5ml or more peripherally or
any volume via a CVAD), then stop cold pack, do not apply
dimethyl sulfoxide and contact member of extravasation
team to advise on use of dexrazoxane
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
17
Suggested cytotoxic spillage kit
8
Particulate respirator mask
Plastic apron
Gown
Paper towels
Plastic bucket
Copy of spillage procedure
Essential equipment
Two plastic overshoes
Two disposable armlets
Two clinical waste bags
Two pairs of disposable non-sterile latex or
nitrile gloves
Goggles (non-disposable): EN 166-8
1 Act immediately. Assess the level of exposure of any individual and isolate them from the spill.
2 Collect spillage kit.
3 Put on both pairs of gloves, goggles and a gown and then a disposable plastic apron over the gown.
If there is visible powder spill, put on a good-quality particulate respirator mask.
If spillage is on the floor, put on overshoes.
Procedure
4 Wipe up powder spillage quickly with well dampened paper towels, starting at the outer edge of the spill
area and working in a circular motion towards the middle to contain spill and dispose of them as high-
risk waste.
5 Mop up liquids which have been spilled on a hard surface with paper towels, starting at the outer edge of
the spill area and working in a circular motion towards the middle to contain spill and dispose of them as
high-risk waste.
6 Wash hard surfaces at least twice with copious amounts of cold, soapy water and dry with paper towels.
The floor should then be given a routine clean as soon afterwards as possible. If spillage has occurred on
a carpet it will require cleaning as soon as possible.
If spillage is on clothing, remove it as soon as possible and treat as soiled linen.
If spillage has penetrated clothing, wash contaminated skin liberally with soap and cold water.
If spillage is on bed linen put on gloves and an apron, change it immediately and treat as soiled linen.
If an accident or spillage involving direct skin contact occurs, the area should be washed thoroughly with
soapy water as soon as possible. In the event of a cytotoxic splash to the eye, irrigate thoroughly with NS or
tap water for at least 15 minutes.
Post-procedure
7 Any accident or spillage by nursing staff involving direct skin contact with a cytotoxic drug must be
reported to the occupational health department and manager as soon as possible after the first aid is
performed and appropriate documentation completed.
February 2014
18
References
1. National Confidential Enquiry into Patient Outcome and Death. For better, for worse? A review of the care of patients
who died within 30 days of receiving systemic anti-cancer therapy. London, NCEPOD, 2008. Available from: http://www.
ncepod.org.uk/2008report3/Downloads/SACT_report.pdf (accessed 14 January 2014).
2. National Chemotherapy Advisory Group. Chemotherapy services in England: Ensuring quality and safety. London,
NCAG, 2009. Available from: http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_
consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_104501.pdf (accessed 14 January 2014).
3. National Cancer Peer Review - National Cancer Action Team. National Cancer Peer Review Programme. Manual
for Cancer Services: Chemotherapy Measures, v2.0. London, NCAT, 2013. Available from: http://www.cquins.nhs.
uk/?menu=resources (accessed 14 January 2014).
4. Nursing and Midwifery Council. Standards for medicines management. London, NMC, 2010. Available from:
http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-for-medicines-management.pdf (accessed
14 January 2014).
5. US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Common
Terminology Criteria for Adverse Events (CTCAE) v4.03; June 2010. NIH Publication No.09-5410. Available from: http://
www.eortc.be/services/doc/ctc/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf (accessed accessed 14 January 2014).
6. Oken MM, Creech RH, Tormey DC et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J
Clin Oncol 1982; 5: 649-55.
7. UK Oncology Nursing Society. Oncology/Haematology 24-hour triage rapid assessment and access tool. October 2010.
Available from: http://www.ukons.org/ (accessed 14 January 2014).
8. Hall K, Hyde L, Schorstein R. Chapter 19. Cytotoxic therapy. In: Dougherty L, Lister S (eds). The Royal Marsden Hospital
Manual of Clinical Nursing Procedures. 8th edition. Oxford, Wiley-Blackwell, 2011.
9. Health and Safety Executive. Safe handling of cytotoxic drugs. HSE Information Sheet MISC615. London, HSE, 2003.
Available from: http://www.hse.gov.uk/pubns/misc615.pdf (accessed 14 January 2014).
10. Dougherty L. Chapter 10. Intravenous management. In: Brighton D, Woods M (eds). The Royal Marsden Hospital
Handbook of Cancer Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill
Livingstone, 2005.
11. Dougherty L. Chapter 9. Obtaining peripheral venous access. In: Dougherty L, Lamb J (eds). Intravenous Therapy in
Nursing Practice. 2nd edition. Oxford, Blackwell, 2008.
12. Department of Health. Health Service Circular. HSC 2008/001 Updated national guidance on the safe administration
of intrathecal chemotherapy. London, DH, 2008. Available from: http://webarchive.nationalarchives.gov.
uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/
dh_086844.pdf (accessed 14 January 2014).
13. National Patient Safety Agency. Using Vinca Alkaloid Minibags (Adult/Adolescent Units) NPSA/2008/RRR004. London,
NPSA, 2008. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=59890 (accessed 14 January 2014).
14. National Patient Safety Agency. Safer spinal (intrathecal), epidural and regional devices - Part A: update. NPSA/2011/
PSA001. London, NPSA, 2011. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=94529 (accessed 14
January 2014).
15. National Patient Safety Agency. Safer spinal (intrathecal), epidural and regional devices Part B. NPSA/2009/PSA004B.
London, NPSA, 2009. Available from: http://www.nrls.npsa.nhs.uk/alerts/?entryid45=94529 (accessed 14 January 2014).
16. Dougherty L. IV therapy: recognizing the differences between infiltration and extravasation. Br J Nurs 2008; 17: 896,
898-901.
17. Masoorli S. Extravasation injuries associated with the use of central vascular access devices. JVAD 2003; 8: 21-3.
18. Prez Fidalgo JA, Garca Fabregat L, Cervantes A et al; ESMO Guidelines Working Group. Management of chemotherapy
extravasation: ESMO-EONS Clinical Practice Guidelines. Ann Oncol 2012; 23 Suppl 7: vii167-73.
19. Dougherty L, Oakley C. Advanced practice in the management of extravasation. Cancer Nursing Practice 2011; 10: 16-22.
20. Polovich M, Whitford JM, Olsen M. Chapter VII. Side Effects of Cancer Therapy. In: Polovich M, Whitford JM, Olsen M
(eds). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. 3rd edition. Pittsburgh, Oncology
Nursing Society, 2009.
21. Dolan S. Chapter 21. Anaemia. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook of Cancer
Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
22. Dougherty L. Chapter 23. Alopecia. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook of Cancer
Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
23. Dolan S. Chapter 25. Electrolyte abnormalities. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook
of Cancer Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
24. Wolf L. Chapter 26. Skin and nail changes. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook of
Cancer Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
25. Stephens M. Chapter 29. Pulmonary effects. In: Brighton D, Woods M (eds). The Royal Marsden Hospital Handbook of
Cancer Chemotherapy a guide for the multidisciplinary team. Edinburgh, Elsevier Churchill Livingstone, 2005.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
19
Further resources
British Oncology Pharmacy Association. Position statement on safe practice and the pharmaceutical care of
patients receiving oral anti-cancer chemotherapy. London, BOPA, 2004. Available from: http://www.bopawebsite.org/
publications/docs/position-statements (accessed 29 January 2014).
Department of Health. Reference guide to consent for examination or treatment, second edition 2009. London,
DH, 2009.
El-Saghir N, Otrock Z, Mufarrij A et al. Dexrazoxane for anthracycline extravasation and GM-CSF for skin ulceration and
wound healing. Lancet Oncol 2004; 5: 320-1.
Goodin S. Safe handling of oral chemo agents in community settings. Pharmacy Times 2007 (Sep 1). Available from:
http://www.pharmacytimes.com/publications/issue/2007/2007-09/2007-09-6789 (accessed 29 January 2014).
Griffin E. Safety considerations and safe handling of oral chemotherapy agents. Clin J Oncol Nurs 2003; 7(6 Suppl): 25-9.
Langer SW, Sehested M, Jensen PB. Treatment of anthracycline extravasation with dexrazoxane. Clin Cancer Res 2000;
6: 3680-6.
Nursing and Midwifery Council. The code: Standards of conduct, performance and ethics for nurses and midwives.
London, NMC, 2008.
Rickard CM, Webster J, Wallis MC et al. Routine versus clinically indicated replacement of peripheral intravenous
catheters: a randomised controlled equivalence trial. Lancet 2012; 380: 1066-74.
Royal College of Nursing. Standards for infusion therapy. The RCN IV Therapy Forum. 3rd edition. London, RCN, 2010.
Schulmeister L. Chapter 18. Antineoplastic therapy. In: Infusion Nurses Society, Alexander M, Corrigan A et al (eds).
Infusion Nursing. 3rd Edition. Philadelphia, Saunders Elsevier, 2009.
Sewell G, Summerhayes M, Stanley A. Administration of chemotherapy. In: Allwood M, Stanley A, Wright P (eds). The
Cytotoxics Handbook. 4th edition. Oxford, Radcliffe Medical Press, 2002.
Toft B. External Inquiry into the adverse incident that occurred at Queens Medical Centre, Nottingham, 4th January
2001. London, Department of Health, 2001.
Vidall C, Roe H, Dougherty L et al. Dexrazoxane: a management option for anthracycline extravasations. Br J Nurs 2013;
22: S6 -12.
February 2014
20
Nursing implications of drug side effects
8,20-25
These are ordered to provide the following:
Patient education
Observations/assessment
Monitoring
Action
Haematological toxicity
1 Anaemia
encourage good dietary intake, eg, food high in iron such as liver or broccoli/spinach
observations for pallor, dizziness, shortness of breath
regular FBC
blood transfusion usually packed cells
administer erythropoietin as appropriate
2 Leucopenia
encourage meticulous hand hygiene in staff, patients and carers
teach patient to recognise early signs of infection and report
give chemotherapy alert card to ensure immediate attention at A&E department
prevent exposure to adults or children with known infection
close observation of patient on steroids
take regular swabs and specimens if at risk
regular monitoring of white blood cells
administer prophylactic granulyte colony-stimulating factor (GCSF)
administer antibiotics and GCSF as required
ensure appropriate isolation when WBC very low
3 Thrombocytopenia
warn patient to avoid physical injury
avoid use of razor (use electric)
avoid IM injections
advise use of soft toothbrush
teach patient how to recognise early signs and report
avoid drugs that interfere with platelet function, eg, aspirin, alcohol
observation for bleeding including petechiae, haematuria
regular platelet count
administer platelet transfusion
4 Haemorrhagic tendency
teach patient to watch for signs of bleeding, epistaxis, haematuria, bruising
eliminate other reasons for bleeding, eg, low platelet count
5 Infection/sepsis
explain possibility to patient
give advice about how to prevent infection, recognise signs and symptoms and when to call for advice
give chemotherapy alert card to ensure immediate attention at A&E department
administer antibiotics within 1 hr of assessment
ensure appropriate isolation if required
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
21
Gastrointestinal toxicity
6 Stomatitis
advise patient to avoid extremely hot and cold food, heavy spices and citrus fruits, alcohol and smoking
regular observation of entire mouth using an oral assessment tool where appropriate
check for fungal infections
regular mouth washes, every 2-3 hrs and always after meals
soft diet if severe
administer analgesics and/or antifungals
administer barrier preparation (eg, sucralfate or Gelclair

) for local relief


7 Taste aberration (dysgeusia)
(i) At time of treatment
offer strongly flavoured sweets during injection
(ii) At other times
provide dietary advice
advise sipping drinks/chewing gum/sweets
concentrate on foods that taste good
sharp tasting drinks may be refreshing
8 Anorexia
encourage meals early in the day as better tolerated
advise patient to try small frequent meals
consider how food is presented
determine dietary habits from nursing history
weigh patient regularly
offer food supplements
provide artificial saliva, if due to dry mouth
refer to dietician
9 Dyspepsia
educate patient
administer medications (PPIs, antacids) as indicated
10 Nausea and vomiting
inform patient of what to expect and when
advise patient to try dry crackers for nausea
suggest patient try distraction, meditation, relaxation, acupressure bands or acupuncture
consider patient preference regarding techniques prior to procedure
administer antiemetics prior to chemotherapy and assess effectiveness
for highly emetogenic drugs ensure appropriate antiemetics administered pre-SACT and then
regularly, for at least three days after each course
maintain fluids and observe for electrolyte imbalance
11 Constipation
warn patient of possibility
encourage diet high in fibre
encourage fluids
provide prophylactic laxatives
February 2014
22
12 Diarrhoea
warn patient of possibility
advise a low roughage diet
suggest good perianal hygiene (NB, anal fistulae are more common in immunosuppressed patients)
observe for signs of dehydration and electrolyte imbalance
provide/administer antidiarrhoea agents
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
23
Skin toxicity
13 Venous discolouration
explain possibility to patient
reassure patient it is temporary
14 Venous/injection site pain
administer injection slowly with frequent flushes of NS whenever pain occurs
always distinguish vein pain from extravasation
dilute injection further (if pharmaceutically acceptable)
use local heat to aid vasodilation
suggest CVAD insertion if pain is difficult to tolerate during infusion
15 Nail discolouration and ridging
explain possibility to patient
reassure patient it is temporary
16 Skin pigmentation
explain reason to patient
reassure patient it is temporary
advise against prolonged exposure to bright sunlight
17 Phlebitis
(i) Chemical
administer drugs with NS flushes
administer drugs slowly
use large vein with good blood flow
use small gauge needle
apply local heat or glyceryl trinitrate patch to increase vasodilation
(ii) Thrombophlebitis
inform patient of possibility and that it is temporary
apply symptomatic relief (heat/cold)
use heparinoid or steroid cream
suggest application of anti-inflammatory cream or gel, eg, ibuprofen
18 Flushing
(i) If a local flush along vein in arm at time of administration
advise patient that it is temporary
administer hydrocortisone injection/apply cream
(ii) If body flushing at time of injection
reassure patient that it is temporary
slow drug administration
19 Dermatitis/rash
inform patient of possibility
observe for changes or pain (? shingles)
seek dermatology opinion
administer antihistamine IV or orally as required
apply calamine or similar
February 2014
24
20 Palmar plantar erythrodysaesthesia (PPE)
advise patient to protect skin from sun
encourage and apply greasy emollient to ensure skin is kept supple
observe severity and administer pyridoxine
administer antibiotics as prescribed
21 Pruritis
educate patient
offer antihistamines
22 Erythema multiforme/Stevens-Johnson syndrome/toxic epidermal necrolysis (TEN)
discontinue any medication that could be responsible
correct fluid and electrolyte imbalance and nutritional deficits
provide analgesia, physiotherapy and wound dressings
administer antibiotics for secondary infection
23 Alopecia
explain possibility to patient and advise degree of hair loss
provide patient an opportunity to discuss
reassure patient that hair will grow back
order wig before hair loss
encourage patient to cut long hair to prevent the weight pulling on roots
advise on hair care frequency of washing, use of a neutral pH shampoo, use of brushes and comb
advise against perms and colourants
encourage patient to see own hairdresser for support
use scalp hypothermia where appropriate
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
25
Organ toxicity
24 Hepatic toxicity/abnormal liver function
observe for signs of jaundice
test urine for bilirubin
monitor LFTs
25 Cardiac toxicity/cardiac symptoms (chest pain, palpitations, arrhythmias, change in ECG pattern)
baseline ECG or multiple-gated aquisition (MUGA) scan before treatment and monitor
watch for cumulative effect
check when reaching total cumulative dose of drug
refer to cardiologist
26 Pulmonary toxicity (dyspnoea, cough, pneumonitis, bronchitis)
observe for onset of symptoms shortness of breath, wheezing, etc and report
ensure a baseline chest X-ray prior to starting treatment
check chest X-ray prior to each treatment
advise anaesthetist before surgery
treat infection as required
27 Sexual dysfunction
Female
warn of amenorrhoea normally reversible after treatment stops
advise patient to continue barrier contraception
warn of early menopause/infertility
discuss options for future fertility
Male
discuss pre-treatment sperm banking
warn about possibility of sterility
reassure that changes do not cause impotence
28 Discolouration of urine
inform patient of possibility
reassure patient that it is temporary
29 Haemorrhagic cystitis
if patient is receiving high-dose therapy, test urine for blood
increase fluid intake before and after treatment
measure fluid intake and output (for very high doses of drug, patient should be catheterised to ensure
accurate measurement of output; forced diuresis may be necessary)
mesna given concurrently will protect bladder mucosa from cyclophosphamide and ifosfamide
30 Nephrotoxicity
monitor renal function before treatment and ascertain baseline EDTA or creatinine clearance
test urine for pH alkalinisation may be required during treatment
record fluid intake and output during treatment
ensure adequate hydration; forced diuresis to maintain output may be necessary
February 2014
26
31 Tumour lysis syndrome
observe for signs and symptoms (tachypnoea, tachycardia, hypotension, pulmonary oedema)
monitor and correct electrolyte levels as necessary
administer hydration and monitor fluid balance
administer allopurinol or rasburicase
32 Peripheral nerve toxicity (paraesthesia and peripheral sensory neuropathy)
explain to patient symptoms they might experience such as laryngo- or bronchospasm
encourage patient to wear hat, scarf and gloves in cold weather and avoid cold drinks for 6 hrs after
drugs such as oxaliplatin
observations to determine severity
reassure patient symptoms will usually disappear 4-6 weeks after stopping treatment
change to drug of lesser toxicity
33 CNS toxicity
(i) Observe for signs of problems
neurological assessment
exclude cerebral secondaries
(ii) Mood swings
depression may occur
provide patient an opportunity to talk, along with psychological and emotional support
throughout treatment
34 Pain (headache/myalgia, arthralgia)
warn patient of possibility and advise not to take aspirin-based analgesia
explain need to report any pain that does not resolve
administer analgesia as appropriate
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
27
Sensory toxicity
35 Ototoxicity
observe for patient reports of tinnitus (high frequency hearing loss often first symptom)
ensure baseline audiology testing prior to treatment
refer as appropriate
36 Nasal stuffiness
explain to patient that it is transient
37 Photosensitivity
advise use of sunglasses
advise avoidance of bright lights
reassure patient that it is temporary
38 Eye problems (dry eyes/conjunctivitis/blurred vision)
explain possibility to patient
advise who to contact if it should occur
February 2014
28
Metabolic toxicity
39 Hypo/hyperglycaemia
observation for signs dizziness, pallor, sweating, confusion
monitor for blood glucose levels
provide extra glucose/ensure food available (hypo)
administer insulin as required (hyper)
administer certain infusions slowly
40 Hyperuricaemia
encourage fluid intake
observe urinary output
administration of allopurinol
41 Hypo/hypercalcaemia
observation for increased neural and muscular excitability (hypo)
administration of calcium (unless this is a required effect) (hypo)
observe for complaints of bone/abdominal pain, polyuria, nausea and vomiting, depression and anxiety
(hyper)
administration of hydration, bisphosphonates or calcitonin (hyper)
42 Hypomagnesaemia/hypophosphataemia
observe for signs and symptoms (nervous system excitability, arrhythmia, muscle cramp) (Mg)
administration of magnesium replacements (Mg)
observe for muscle dysfunction and weakness, white cell dysfunction and mental status changes
(Phos)
administration of IV potassium phosphate (Phos)
43 MAO inhibitor
usually only very mild reactions
warn patient to watch for reactions with high tyramine containing foods eg, alcohol, cheese,
Marmite.
44 Hypo/hyperkalaemia
monitor potassium level
observe for signs and symptoms (constipation, fatigue, muscle weakness) (hypo)
administration of potassium replacement (mild = oral; more severe = IV) (hypo)
observe for malaise, palpitations and muscle weakness (hyper)
administration of calcium; may require haemodialysis
45 Hyper/hypothyroidism
observe for signs and symptoms (fatigue, thin brittle hair and dry skin, weakness, unintentional weight
gain) (hypo)
administration of medication, eg, levothyroxine (hypo)
observe for tremors, anxiety, irritability, tachycardia and increased sweating and restlessness (hyper)
administer antithyroid drugs, beta blockers, may require surgery or radioiodine to treat (hyper)
46 Hyperlipidaemia/hypercholesterolaemia
provide dietary advice
monitor levels
may require statins
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
29
Other toxicity
47 Gynaecomastia
explain possibility to patient
48 Tumour pain
reassure patient that effect will pass
administration of analgesia
49 Jaw pain
usually of trigeminal neuralgia type
reassure patient that effect will pass
administer analgesia
50 Carcinogenesis
offer counselling if this occurs or is likely to occur
51 Flu-like symptoms
advise patient of possible symptoms fever, chills, headache
advise patient that it is temporary
administer prophylactic hydrocortisone
52 Hypersensitivity/anaphylaxis
regular nursing observations during drug administration
have appropriate drugs ready if anaphylaxis is a possibility (hydrocortisone, chlorphenamine,
adrenaline)
check sensitivity to drug with test doses (particularly if previous reaction) following a
desensitisation protocol
add hydrocortisone cover to drug regimen
53 Fatigue
inform patient of possibility
explain when it may occur (may be worse when blood cell count is low 10-14 days after SACT) and how
long it might last
advise patient to plan activities and have regular rest periods
encourage family/friend involvement
54 Hypo/hypertension
monitor BP
administer antihypertensive as prescribed if indicated
55 Reactivation of radiation sites
explain possibility to patient
February 2014
30
List of drug monographs
A Afatinib E Epirubicin Panitumumab
Aflibercept Eribulin Pazopanib
Aldesleukin Erlotinib Pemetrexed
Alemtuzumab Estramustine Pentostatin
Arsenic trioxide Etoposide Pertuzumab
Asparaginase Etoposide phosphate Pixantrone
Axitinib Everolimus Pomalidomide
Azacitidine F Fludarabine Ponatinib
B Bendamustine 5-fluorouracil Procarbazine
Bevacizumab Folinic acid R Raltitrexed
Bexarotene G Gefitinib Regorafenib
Bleomycin Gemcitabine Rituximab
Bortezomib H Hydroxycarbamide Ruxolitinib
Bosutinib I Idarubicin S Sorafenib
Brentuximab vedotin Ifosfamide Streptozocin
Busulfan Imatinib Sunitinib
C Cabazitaxel Interferon alfa T Tegafur/gimeracil/oteracil
Capecitabine Ipilimumab Temozolomide
Carboplatin Irinotecan Temsirolimus
Cetuximab L Lapatinib Thalidomide
Chlorambucil Lenalidomide Thiotepa
Cisplatin Lomustine Tioguanine
Cladribine M Melphalan Topotecan
Clofarabine Mercaptopurine Trabectedin
Crizotinib Mesna Trastuzumab
Cyclophosphamide Methotrexate Trastuzumab emtansine
Cytarabine Mifamurtide Treosulfan
D Dacarbazine Mitomycin Tretinoin
Dactinomycin Mitotane V Vandetanib
Dasatinib Mitoxantrone Vemurafenib
Daunorubicin liposomal N Nelarabine Vinblastine
Daunorubicin non-liposomal Nilotinib Vincristine
Decitabine O Ofatumumab Vindesine
Docetaxel Oxaliplatin Vinflunine
Doxorubicin liposomal P Paclitaxel albumin Vinorelbine
Doxorubicin non-liposomal Paclitaxel non-albumin Vismodegib
The Yellow Card Reporting scheme is in place to help the Medicines and Healthcare products Regulatory
Agency (MHRA) monitor the safety of medicines and vaccines in the market.
If you suspect an adverse reaction that may be related to one or more drugs, please complete a Yellow Card.
These can be found in the BNF, MIMS or online at yellowcard.mhra.gov.uk
A
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
31
AFATINIB
Generic name Afatinib
Trade name Giotrif
Drug action EGFR tyrosine kinase inhibitor.
Specific
information
Afatinib is a substrate of P-gp. P-gp inhibitors or inducers could affect exposure to
afatinib and dose adjustments may be required.
Methods of
administration
Oral. Tablets should be taken on an empty stomach. Food should not be consumed
for at least 3 hrs before and at least 1 hr after taking the dose. For patients with
swallowing difficulties, the tablets may be dropped in 100ml of non-carbonated
water and stirred occasionally until dispersed (this may take up to 15 mins), then
drunk immediately. The dispersion can also be administered through a gastric tube.
Side effects Immediate Short-term Long-term
Very common None selected*
Anorexia 8 , stomatitis 6 ,
diarrhoea 12, skin reactions
(rash, dermatitis acneiform,
pruritus, dry skin) 19 21,
epistaxis 4
Paronychia
Common None selected*
Dyspepsia 9 , dysgeusia 7 ,
dehydration, cystitis,
conjunctivitis 38, dry eye 38,
rhinorrhoea, fever, muscle
spasm, cheilitis, increased
ALT and ALP 25,
hypokalaemia 44
PPE 20, renal impairment 30,
weight loss 8
Uncommon None selected* Keratitis
ILD 26
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
32
AFLIBERCEPT
Generic name Aflibercept
Trade name Zaltrap
Drug action Blocks the activation of VEGF receptors, inhibiting the growth of new blood vessels
to the tumour.
Specific
information
Check BP and proteinuria before each dose.
Methods of
administration
IV infusion over 1 hr, using an infusion set containing a 0.2 micron filter.
Side effects Immediate Short-term Long-term
Very common None selected*
Infections 5 , leucopenia 2 ,
neutropenia,
thrombocytopenia 3 ,
headache 34,
hypertension 54,
haemorrhage 4 ,
dyspnoea 26, PPE 20,
proteinuria, diarrhoea 12
Stomatitis 6 , anorexia 8 ,
weight loss, dysphonia,
increased AST and ALT 24,
increased serum creatinine,
asthenia
Common Hypersensitivity Neutropenic infections/
sepsis 5 , UTI,
nasopharyngitis
Fistula, dehydration, arterial
and venous
thromboembolism,
oropharyngeal pain,
rhinorrhoea, skin
hyperpigmentation 16
Uncommon None selected* GI perforation, impaired
wound healing
PRES, nephrotic syndrome,
thrombotic microangiopathy
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
33
ALDESLEUKIN
Generic name Aldesleukin, interleukin-2, IL-2
Trade name Proleukin
Drug action Immunomodulator. Mechanism not completely understood.
Specific
information
May cause potentially fatal capillary leak syndrome which is associated with
hypotension, pulmonary oedema and reduced organ perfusion. Careful monitoring
of circulatory and respiratory function is required. Frequency and severity of these
side effects are lower with SC administration than with IV infusion.
May exacerbate disease symptoms in patients with unrecognised or untreated CNS
metastases.
May exacerbate effusions from serosal surfaces; consider treatment before
initiation of therapy.
Should be discontinued in patients developing severe lethargy or somnolence;
continued administration may result in coma.
Pre-existing bacterial infections should be treated prior to initiation of aldesleukin.
Toxicities associated with aldesleukin may be exacerbated by concurrent bacterial
infections.
Possible disturbances in glucose metabolism; monitor blood glucose.
Perform pre-treatment chest X-rays and ECG.
May exacerbate pre-existing autoimmune disease.
The solution may be slightly yellow.
Methods of
administration
SC injection; or IV infusion in 500ml D5W with 0.1% human albumin solution.
Side effects Immediate Short-term Long-term
Very common
Erythema

19, rash
(including exfoliative
dermatitis)

19,
injection site
reactions

14, fever,
chills, malaise,
asthenia/fatigue

53,
pruritus

21, sweating
Anxiety

33, confusion

33,
depression, insomnia,
headache

34, dizziness,
paraesthesia,
somnolence

33,
dyspnoea

26, cough

26,
nausea and vomiting

10,
diarrhoea

12, anorexia

8 ,
stomatitis

6 ,
hypotension

54, tachycardia;
chest pain (including
angina)

25, oliguria, weight
changes
Anaemia

1 ,
thrombocytopenia

3 ,
increased serum urea and
creatinine,
hypothyroidism

45
Common
(continued on
following page)
Phlebitis

17,
hypothermia
Constipation

11, pulmonary
oedema

26, pleural
effusions, hypoxia,
haemoptysis, epistaxis,
rhinitis, cyanosis,
cardiovascular disorders
(including heart failure),
irritability, agitation,
hallucinations,
musculoskeletal pain

34,
conjunctivitis, dysphagia,
dyspepsia, GI haemorrhage,
ascites, gastritis, RTI

5 ,
acidosis, hyperglycaemia

39,
hypocalcaemia

41,
Leucopenia

2 , eosinophilia,
hypertension

54,
coagulopathy, arrhythmia,
neuropathy, increased LFTs
and LDH, hepatomegaly or
hepatosplenomegaly

24,
haematuria,
hyperthyroidism

45
February 2014
34
Common
(Aldesleukin
side effects
continued from
previous page)
hyperkalaemia

44,
dehydration, neuropathy,
syncope, speech disorders,
ageusia, lethargy,
hypertension

54,
haematuria, renal failure

30,
anuria, alopecia

23,
mucositis

6
Uncommon
Hypersensitivity

52,
thrombosis,
haemorrhage
Hypoglycaemia, coma,
seizures, paralysis,
myasthenia, pancreatitis,
intestinal obstruction, GI
perforation, cholecystitis,
vitiligo, angioedema,
myopathy, myositis
Neutropenia

2 , liver failure
with fatal outcome

24
Rare
Anaphylaxis

52,
pulmonary embolism,
ARDS
Optic nerve disorder,
vesiculobullous rash,
Stevens-Johnson
syndrome

22
Agranulocytosis, diabetes,
activation of Crohns disease
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
35
ALEMTUZUMAB
Generic name Alemtuzumab
Trade name MabCampath
Drug action Monoclonal antibody specific for the CD52 antigen expressed on B and T
lymphocytes.
Specific
information
No longer licensed in the UK but available on a named-patient basis.
Administered in escalating doses during first week: 3mg on day 1, 10mg on day 2
and 30mg on day 3. Standard dose is then 30mg 3 times weekly on alternate days.
If acute moderate to severe adverse reactions occur at either the 3mg or 10mg dose
levels, then those doses should be repeated daily until they are well tolerated before
further dose escalation is attempted.
If therapy is withheld for more than 7 days, gradual dose escalation is necessary.
Patients should be premedicated with oral or IV steroids, an antihistamine and
analgesic 30-60 mins prior to each infusion during dose escalation and as clinically
indicated thereafter. Since prolonged lymphocyte depletion results from treatment,
prophylaxis against Pneumocystis jiroveci pneumonia (eg, twice-daily co-trimoxazole
3 times weekly) and an antiviral should be initiated and continued until CD4+ count
has recovered. Any blood products needed should be irradiated to prevent GvHD.
Methods of
administration
IV infusion over 2 hrs in 100ml NS or D5W.
Side effects Immediate Short-term Long-term
Very common Infusion-related
reactions (fever,
hypotension, chills,
rash) 21
Rash 19 , nausea,
dyspnoea 26, fatigue 53,
CMV infection 5
BMD 1 2 3
Common Hypersensitivity/
anaphylaxis 52
Pruritus 21, vomiting 10,
diarrhoea 12,
constipation 11,
bronchospasm, back pain,
chest pain, stomatitis 6 ,
myalgia 34, headache 34,
confusion 33, anxiety,
somnolence, depression,
insomnia, tremor, dizziness,
GI haemorrhage
Hypertension 54,
tachycardia 25, flushing 18,
palpitations, hyponatraemia,
hypocalcaemia 41,
dehydration
Uncommon None selected*
Ageusia 7 None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
36
ARSENIC TRIOXIDE
Generic name Arsenic trioxide
Trade name Trisenox
Drug action Not completely understood. Induces DNA fragmentation and degradation.
Specific
information
Induction treatment is given daily for a maximum of 50 doses. Consolidation therapy
should begin 3-4 weeks later.
Potentially fatal differentiation syndrome can occur, which is characterised by fever,
dyspnoea, weight gain, lung infiltrates, pleural or pericardial effusions and
leucocytosis. This requires immediate treatment with high-dose steroids
(eg, dexamethasone 10mg IV twice daily).
Can cause QT prolongation and complete AV block.
Caution is advised when coadministered with other drugs known to cause QT
prolongation (eg, macrolide antibiotics, the antipsychotic thioridazine), or those
known to cause hypokalaemia or hypomagnesaemia. Prior to initiating therapy, a
12-lead ECG must be performed and serum electrolytes (potassium, calcium, and
magnesium) and creatinine must be assessed.
Pre-existing electrolyte abnormalities must be corrected and, if possible, drugs that
are known to cause QT prolongation must be discontinued.
Methods of
administration
IV infusion over 1-2 hrs in 100-250ml NS or D5W. May be extended to 4 hrs if
vasomotor reactions (tachycardia) are observed.
Side effects Immediate Short-term Long-term
Very common
Tachycardia 25 Hyperglycaemia 39,
hypokalaemia 44,
hypomagnesaemia

42,
differentiation syndrome
(see Specific information),
dyspnoea 26, fatigue 53,
fever, paraesthesia,
dizziness, headache

34,
nausea and vomiting 10,
diarrhoea 12, pruritus, rash,
myalgia, oedema, pain
ECG abnormalities 25,
increased ALT and AST 24
Common
Hypotension 54 Arthralgia 34, bone pain 34,
pleural effusion

26
BMD 1 2 3 ,
hyperbilirubinaemia, weight
gain
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected*
Pneumonitis

26
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
37
ASPARAGINASE
Generic name Asparaginase, crisantaspase
Trade name Erwinase
Drug action An enzyme that breaks down exogenous asparagine that leukaemic cells depend
upon for survival.
Specific
information
Treatment may be preceded by an intradermal test dose. Asparaginase-induced
pancreatic dysfunction may cause hyperglycaemia which may be detected by urine
or blood glucose monitoring.
Methods of
administration
Given by IV, IM or SC injection.
Avoid froth formation due to excessive or vigorous shaking. The solution should be
rejected if there are any visible particles due to excessive shaking.
The solution should be administered within 15 mins of reconstitution. If a delay of
more than 15 mins between reconstitution and administration is unavoidable, the
solution should be withdrawn into a glass or polypropylene syringe for the period of
the delay. The solution should then be used within 8 hrs.
Daily clotting screen is necessary owing to the potential for clotting derangement.
Side effects Immediate Short-term Long-term
Very common None selected* Coagulation abnormalities None selected*
Common Hypersensitivity (eg,
urticaria, fever,
aches) 52,
dyspnoea 26
Increased serum amylases
and lipase 24
Hepatic impairment
(increased LFTs and
cholesterol, liver toxicity) 24,
acute pancreatitis,
diarrhoea 12, CNS toxicity
(lethargy, depression,
drowsiness, seizures,
coma) 33
Uncommon
Anaphylaxis 52 None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
38
AXITINIB
Generic name Axitinib
Trade name Inlyta
Drug action Selective inhibitor of VEGF receptors 1, 2 and 3.
Specific
information
Axitinib is metabolised in the liver by cytochrome P450 enzymes. Drugs that are
potent inhibitors or inducers of these enzymes should be avoided.
Methods of
administration
Oral. Tablets should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Dysgeusia 7 , headache 34,
haemorrhage 4 ,
dysphonia 35, GI upset
(diarrhoea 12,
nausea and vomiting 10,
constipation 11

), rash/dry
skin 19, stomatitis 6 ,
proteinuria, fatigue 53,
mucositis 6
Hypothyroidism 45,
anorexia/weight loss 8 ,
PPE 20, hypertension 54
Common None selected* Dehydration, dizziness,
tinnitus 35, dyspnoea 26,
cough, dyspepsia 9 ,
flatulence, haemorrhoids,
pruritus 21, erythema 19,
pain (musculoskeletal,
oropharyngeal, extremities,
abdominal) 34
Alopecia 23, increased lipase
and LFTs 24, embolic and
thrombotic events, renal
failure 30, increased TSH,
anaemia 1 ,
thrombocytopenia 3
Uncommon None selected* None selected* Polycythaemia, neutropenia,
leucopenia 2 ,
hyperthyroidism, electrolyte
disturbances, PRES,
hypertensive crisis 54, GI
perforation, anal fistula,
increased creatinine 30
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
39
AZACITIDINE
Generic name Azacitidine
Trade name Vidaza
Drug action Antimetabolite.
Specific
information
Given daily for 7 consecutive days in a 28-day treatment cycle.
Methods of
administration
SC injection into the thigh, arm or abdomen.
Injection sites should be rotated new injections should be given at least 2.5cm
from the previous site and never into areas that are tender, bruised, red or
hardened.
Side effects Immediate Short-term Long-term
Very common Injection site
reactions 14, chest
pain/dyspnoea 25
Constipation 11,
diarrhoea 12, nausea and
vomiting 10, pruritus 21,
rash 19, dizziness,
headache 34, pneumonia,
nasopharyngitis
BMD (nadir 10-17
days) 1 2 3 , anorexia 8 ,
arthralgia
Common None selected*
Fatigue 53, cellulitis, herpes
simplex, UTI, upper RTI,
intracranial and eye
haemorrhage, lethargy,
hypotension/
hypertension

54,
haematoma,
pharyngolaryngeal pain,
dyspepsia, malaise
Hypokalaemia 44, confusion/
anxiety 33, GI and gingival
haemorrhage, alopecia 23,
erythema, musculoskeletal
pain, renal failure, increased
serum creatinine,
haematuria 30, insomnia,
weight loss
Uncommon
Hypersensitivity 52 None selected*
Hepatic failure

24,
progressive hepatic coma,
renal tubular acidosis
Rare None selected*
Tumour lysis syndrome

31,
injection site necrosis, ILD
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
B
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
41
BENDAMUSTINE
Generic name Bendamustine
Trade name Levact
Drug action Alkylating agent that causes DNA crosslinks, preventing replication. Bendamustines
action is non cell-cycle specific.
Specific
information
N/A
Methods of
administration
IV infusion over 30-60 mins in 500ml NS.
Side effects Immediate Short-term Long-term
Very common None selected*
Infections 5 , BMD 1 2 3 ,
nausea and vomiting 10,
mucositis 6 , fatigue 53,
fever, increased creatinine
and urea 30
None selected*
Common
Haemorrhage 4 ,
hypersensitivity 52
Tumour lysis syndrome 31,
increased LFTs 24,
hypokalaemia 44, insomnia,
cardiac impairment
(eg, palpitations, angina,
arrhythmia 25), hypotension/
hypertension 54, pulmonary
impairment 26, diarrhoea 12,
constipation 11,
stomatitis 6 , pain, chills,
dehydration, anorexia 8
Alopecia 23, skin disorders 19,
amenorrhoea 27
Uncommon None selected* Pericardial effusion None selected*
Rare Acute circulatory
failure, anaphylaxis 52
Hyperhidrosis, somnolence,
aphonia, sepsis 5
None selected*
Very rare Tachycardia
Dysgeusia 7 , paraesthesia,
peripheral neuropathy 32,
anticholinergic syndrome,
ataxia, encephalitis, primary
atypical pneumonia 26,
haemolysis, multi-organ
failure, phlebitis 17
MI, cardiac failure 25,
pulmonary fibrosis 26,
infertility 27
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
42
BEVACIZUMAB
Generic name Bevacizumab
Trade name Avastin
Drug action Monoclonal antibody specific for VEGF receptor.
Specific
information
Given once every 14 or 21 days. Doses can be given before or after chemotherapy.
Bevacizumab may delay wound healing, and should not be administered until at
least 28 days after surgery.
Monitoring of proteinuria by dipstick urinalysis is recommended before and during
therapy.
Monitoring of BP is generally recommended during therapy as an increased
incidence of hypertension was observed in bevacizumab-treated patients.
Methods of
administration
IV infusion, initial dose over 90 mins. If well tolerated, the second infusion may be
administered over 60 mins. If the 60-min infusion is well tolerated, all subsequent
infusions may be administered over 30 mins.
The necessary amount of bevacizumab should be withdrawn and diluted to the
required administration volume with NS. The concentration of the final bevacizumab
solution should be within the range 1.4-16.5mg/ml.
Side effects Immediate Short-term Long-term
Very common
Asthenia, fatigue 53 Diarrhoea 12, nausea and
vomiting 10,
pancytopenia 1 2 3 ,
peripheral neuropathy 32,
hypertension 54, anorexia 8 ,
constipation 11,
stomatitis 6 , rectal
haemorrhage, increased
lacrimation, epistaxis, dry
skin, PPE

20, skin
discolouration

16
Ovarian failure

27
Common
Pain 34 Dehydration, proteinuria,
thromboembolism,
anaemia

1 , intestinal
perforation, CHF

25,
supraventricular tachycardia,
CVA, haemorrhage
None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* PRES Necrotising fasciitis,
osteonecrosis of the jaw
Very rare None selected* None selected* None selected*
Unknown None selected* Gallbladder perforation,
fistulae
None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
43
BEXAROTENE
Generic name Bexarotene
Trade name Targretin
Drug action Exact mechanism unknown. Activates retinoid X receptors (transcription factors).
Specific
information
Patients should be advised to limit vitamin A supplements to 15,000 IU/day to avoid
potential additive toxic effects. Patients should also minimise exposure to sunlight
and avoid sun lamps.
Enzyme induction by bexarotene may cause oral contraceptives to fail. Additional
non-hormonal contraception should be used, as the human malformative risk is high.
Caution should be exercised in patients using insulin, sulfonylureas or insulin
sensitisers as bexarotene may enhance the action of these agents.
Methods of
administration
Oral. Capsules should be swallowed whole and taken as a single daily dose with or
after food.
Side effects Immediate Short-term Long-term
Very common
Headache/pain 34,
asthenia
Leucopenia 2 , rash
(including exfoliative
dermatitis) 19, pruritus 21,
hyperlipidaemia 46,
hypercholesterolaemia 46
Thyroid disorders
Common Chills,
hypersensitivity 52
Increased LDH and creatinine,
dizziness 33, hypoaesthesia,
insomnia, dry eyes 38,
diarrhoea 12, nausea and
vomiting 10, anorexia,
abnormal LFTs 24, cheilitis,
dry mouth, constipation 11,
flatulence, abdominal pain,
lymphoma-like reactions,
lymphadenopathy,
hypochromic anaemia 1 ,
weight gain, deafness 35,
peripheral oedema, skin
reactions, alopecia 23,
sweating, musculoskeletal
pain 34, infections
None selected*
Uncommon None selected*
Fever, renal impairment 30,
tachycardia, blood dyscrasia,
purpura, coagulation disorder,
mucous membrane disorder,
cellulitis, albuminuria,
myasthenia, skin
discolouration 16, hair and nail
disorders, hepatic failure 24,
haemorrhage, hypertension 55,
vasodilatation, varicose vein,
eye disorders 38, ataxia,
neuropathy, hyperaesthesia,
depression, agitation, gout
Neoplasms, pancreatitis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
44
BLEOMYCIN
Generic name Bleomycin
Trade name Bleo-Kyowa
Drug action Cytotoxic antibiotic.
Specific
information
Risk of pulmonary fibrosis. Use with caution in patients with impaired respiratory
function or in those who have had previous thoracic radiotherapy. Patients should
have chest X-rays weekly; these should continue for up to 4 weeks after completion
of the course. Lung function tests which use 100% oxygen should not be used in
patients who have been treated with bleomycin.
Methods of
administration
IV bolus or infusion, IM, SC, IA, intra-pleural, IP in NS.
Side effects Immediate Short-term Long-term
Very common Fever, rigors and
malaise 51
Interstitial pneumonia,
anorexia 8 , weight loss,
nausea and vomiting 10,
stomatitis 6 , skin
hypertrophy,
pigmentation 16, alopecia

23,
nail deformation and
discolouration

15
Pulmonary fibrosis 26
Common None selected* Rash and erythroderma
associated with fever 19,
haemorrhage 4 ,
headache 34
None selected*
Uncommon None selected*
Dizziness, diarrhoea

12,
hepatic impairment

24,
oliguria, micturition pain,
polyuria and feeling of
residual urine, tumour pain,
phlebitis

17
Leucopenia

2
Rare Hyperpyrexia and
drug-related deaths
following
intra-cavitary
instillation,
hypotension

54
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* Tenderness and swelling of
fingertips, bulla formation,
sepsis, chest pain,
embolism, thrombosis

25
BMD

1

2

3 , MI, Raynauds
syndrome and digital
ischaemia
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
45
BORTEZOMIB
Generic name Bortezomib
Trade name Velcade
Drug action Proteasome inhibitor.
Specific
information
Blood glucose levels may need close monitoring in patients with diabetes.
Give fluids 1-2 hrs prior to administration to prevent hypotension.
Patients with constipation should be carefully monitored as ileus has been reported.
Herpes zoster antiviral prophylaxis should be considered owing to the risk of
reactivation.
Special care is required when treating patients with risk factors for seizures.
Patients with risk factors for, or existing heart disease, should be closely monitored.
A pre-treatment chest X-ray is recommended to serve as a baseline for potential
post-treatment pulmonary changes.
Methods of
administration
IV bolus over 3-5 secs, followed by a NS flush.
3.5mg powder for solution for injection can be given SC as well as IV.
Side effects Immediate Short-term Long-term
Very common None selected*
Headache 34, herpes zoster,
anorexia 8 , dyspnoea 26,
nausea and vomiting 10,
diarrhoea 12,
constipation 11, rash 19
BMD 1 2 3 , peripheral
neuropathy 32, dysaesthesia,
neuralgia
Common Tachycardia
Myalgia 34, fatigue 53, fever,
postural hypotension 54,
infections (including RTI 26

),
fluid and electrolyte
disturbances, hypoglycaemia/
hyperglycaemia 39,
insomnia, anxiety 33, mood
disorders, loss of
consciousness, dizziness,
dysgeusia 7 , lethargy,
enzyme abnormalities, eye
disorders 38, pruritus 21,
erythema, dermatitis 19,
dry skin
Renal impairment 30,
dysuria
Uncommon Angioedema,
hypersensitivity 52
Hyperthyroidism 45, SIADH,
tumour lysis syndrome 31,
uric acid abnormalities,
hallucination, psychosis,
restlessness, CVA, DVT,
haemorrhage, circulatory
collapse, phlebitis 17,
flushing, vasculitis
Coagulopathy, leucocytosis,
lymphadenopathy,
haemolytic anaemia,
diabetes, hearing
impairment 35, ear
discomfort
Rare
(continued on
following page)
Anaphylaxis 52,
amyloidosis
Neoplasms, Cushings
syndrome, hypothyroidism 45,
vestibular neuronitis, vitamin
B deficiency, gout, increased
appetite, suicidal ideation,
adjustment disorder,
delirium, decreased libido,
brain oedema, TIA, coma,
Visual impairment (including
blindness), coagulation
disorders, thrombocytosis,
hyperviscosity syndrome,
thrombocytopenic purpura,
lymphocytic infiltrates
February 2014
46
Rare
(Bortezomib
side effects
continued from
previous page)
peripheral embolism,
lymphoedema, pallor,
erythromelalgia,
vasodilatation, vein
discolouration 13, venous
insufficiency
Very rare None selected* None selected* Progressive multifocal
leukoencephalopathy
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
47
BOSUTINIB
Generic name Bosutinib
Trade name Bosulif
Drug action Bcr-Abl protein kinase inhibitor.
Specific
information
Bosutinib is mainly metabolised by cytochrome P450 CYP3A4. Drugs that are
inducers or inhibitors of CYP3A4 may interact with bosutinib. Bosutinib should also
be used with caution with drugs that are substrates of P-gp.
Bosutinib should be used with caution in patients with QT prolongation or in patients
taking other drugs that cause QT prolongation. Hypokalaemia or hypomagnesaemia
must be corrected prior to bosutinib administration.
Concurrent treatment with PPIs should be avoided.
Methods of
administration
Oral. Tablets should be taken with food.
Side effects Immediate Short-term Long-term
Very common None selected*
RTI, headache 34, cough 26,
nausea and vomiting 10,
diarrhoea 12, abdominal
pain 34, rash 19, fever,
oedema, fatigue 53
BMD 1 2 3 , anorexia,
arthralgia, abnormal LFTs
Common None selected*
Hypersensitivity 52,
dehydration, dizziness,
dyspnoea 26, gastritis,
pruritus 21, acne, pain
(including chest) 34,
dygeusia 7
Pericardial and pleural
effusion, QT prolongation 25,
hepatotoxicity, renal
failure 30, increased lipase,
creatinine, amylase and
CPK, asthenia,
hyperkalaemia 44,
hypophosphataemia 42,
myalgia 34
Uncommon
Anaphylaxis 52 Acute pancreatitis, GI
haemorrhage, erythema
multiforme, acute
pulmonary oedema
Tinnitus 35, pericarditis 26,
respiratory failure,
pulmonary hypertension
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
48
BRENTUXIMAB VEDOTIN
Generic name Brentuximab vedotin
Trade name Adcetris
Drug action Antibody-drug conjugate (CD30-directed monoclonal antibody + antimicrotubule
agent monomethyl auristatin E).
Specific
information
If patients weight is more than 100kg, the dose calculation should use 100kg.
Co-administration of brentuximab vedotin with strong cytochrome P450 CYP3A4
inhibitors and P-gp inhibitors may increase the risk of neutropenia.
Methods of
administration
Infusion over 30 mins every 3 weeks, through a dedicated IV line.
Side effects Immediate Short-term Long-term
Very common
Diarrhoea 12, nausea
and vomiting 10,
fatigue 53, fever,
infusion-related
reactions 14
Neutropenia 2 ,
infections 5 , alopecia 23,
pruritus 19
Anaemia 1 ,
thrombocytopenia 3 ,
myalgia 34, peripheral
neuropathy 32
Common
Rash 19, chills,
constipation 11
Upper RTI, herpes zoster,
pneumonia 26, cough,
dyspnoea 26, arthralgia,
back pain 34
Hyperglycaemia 39,
dizziness, demyelinating
polyneuropathy
Uncommon Tumour lysis
syndrome 31,
Stevens-Johnson
syndrome 22
Oral candidiasis,
Pneumocystis jiroveci
pneumonia, staphylococcal
bacteraemia, acute
pancreatitis
None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown
Anaphylaxis 52 None selected* Progressive multifocal
leukoencephalopathy
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
49
BUSULFAN
Generic name Busulfan, busulphan
Trade name Busilvex
Drug action Alkylating agent.
Specific
information
Seizures may occur with IV or high-dose oral busulfan, and may be prevented by the
regular use of anticonvulsants.
For obese patients, dosing based on adjusted ideal body weight should be considered.
Caution should be exercised when using paracetamol prior to or concurrently with
busulfan owing to a possible decrease in busulfan metabolism.
Methods of
administration
Oral.
IV infusion over 2 hrs in NS or D5W.
A final concentration of approximately 500 microgram/ml busulfan should be
achieved.
Side effects Immediate Short-term Long-term
Very common
Hypersensitivity

52,
asthenia, chills, fever,
chest pain 55,
oedema, injection site
reactions 14,
mucositis 6 ,
headache 34,
tachycardia 25
Rhinitis, pharyngitis,
BMD 1 2 3 , low blood
electrolytes, anxiety,
depression, insomnia 33,
dizziness, headache,
dyspnoea 26, epistaxis,
cough, hiccup, stomatitis 6 ,
diarrhoea 12, nausea and
vomiting 10, constipation

11,
ascites, anorexia

8 ,
abdominal pain, dyspepsia

9 ,
anal discomfort, hepatomegaly,
jaundice 24, rash 19,
pruritus 21, alopecia 23,
musculoskeletal pain 34,
dysuria, oliguria, hepatic
veno-occlusive disease,
increased LFTs 24, abnormal
breath sounds, increased
creatinine, tachycardia,
hypotension/hypertension

54,
thrombosis, vasodilatation,
hyperglycaemia

39
None selected*
Common None selected* Confusion, hyperventilation,
haematemesis, ileus,
oesophagitis, haematuria,
moderate renal
impairment

30, increased
BUN
Desquamation, erythema,
pigmentation disorder 16,
arrhythmia, cardiomegaly,
pleural and pericardial
effusion, pericarditis

25,
respiratory failure

26, alveolar
haemorrhage, asthma,
atelectasis, decreased LVEF
Uncommon None selected* Delirium, hallucination,
seizure, encephalopathy,
cerebral and GI haemorrhage
None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
C
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
51
CABAZITAXEL
Generic name Cabazitaxel
Trade name Jevtana
Drug action Taxane, inhibitor of mitosis.
Specific
information
Give in combination with 10mg oral prednisone or prednisolone once daily.
The patient must be adequately hydrated throughout treatment to prevent
complications such as renal failure.
Patients should be premedicated with a corticosteroid, an antihistamine and an
H
2
-antagonist at least 30 mins prior to infusion.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV infusion in 250-500ml NS or D5W, over 1 hr or according to protocol, every
3 weeks. Must be administered in a non-PVC container using a non-PVC
administration set with a 0.22 micron filter.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12
Respiratory disorders
(dyspnoea, cough) 26,
constipation and abdominal
pain, BMD 1 2 3
,
fatigue/
asthenia 53, fever,
alopecia 23
Common
Hypersensitivity 52 None selected*
Tinnitus/vertigo 35,
pain (including
musculoskeletal) 34,
peripheral neuropathy 32
Uncommon None selected* None selected* None selected*
Rare None selected* GI haemorrhage and
perforation, intestinal
obstruction
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
52
CAPECITABINE
Generic name Capecitabine
Trade name Xeloda
Drug action Antimetabolite, prodrug of 5-fluorouracil.
Specific
information
Cardiotoxic effects including MI, angina and arrhythmia have been reported.
The effects of warfarin may be potentiated by capecitabine, and the anticoagulant
response should be monitored closely.
Patients should be carefully monitored for opthalmological complications especially
if there is a history of eye disorders.
Methods of
administration
Oral. Take with water within 30 mins after food. Tablets may be dissolved in water
for patients with swallowing difficulties (unlicensed). Ref: NEWT guidelines.
Side effects Immediate Short-term Long-term
Very common None selected*
Diarrhoea 12, nausea and
vomiting 10, stomatitis 6 ,
abdominal pain 34, fatigue 53
PPE 20
Common None selected*
Alopecia 23, rash 19, dry
skin, pruritus 21,
headache 34, dizziness, eye
irritation and
conjunctivitis 38,
dysgeusia 7
BMD 1 2 3 , nail
disorders 15,
hyperbilirubinaemia
Uncommon None selected* None selected* Cardiac disorders (including
MI, angina, arrhythmia) 25
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
53
CARBOPLATIN
Generic name Carboplatin
Trade name N/A
Drug action Platinum compound, that forms crosslinks with DNA, thereby disrupting DNA
synthesis.
Specific
information
IRRITANT.
65% of drug is excreted in the urine within 24 hrs.
Methods of
administration
IV infusion over 60 mins in D5W. Infusion time may vary according to the protocol.
Do not use aluminium-containing needles or IV administration sets.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10 BMD (particularly
thrombocytopenia and
leucopenia; nadir 14-21
days) 1 2 3 ,
nephrotoxicity 30, abnormal
LFTs 24
Common None selected*
Diarrhoea 12

None selected*
Uncommon None selected* None selected* None selected*
Rare Hypersensitivity/
anaphylaxis 52
None selected* None selected*
Very rare None selected* None selected* Worsening of hearing loss
previously induced by
cisplatin 35
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
54
CETUXIMAB
Generic name Cetuximab
Trade name Erbitux
Drug action Monoclonal antibody specific for EGFR.
Specific
information
Determination of serum electrolyte levels is recommended prior to treatment.
Premedication with an antihistamine and a corticosteroid should be given
30-60 mins before each infusion.
Cetuximab is a clear solution, but may contain whitish particles, which do not affect
the quality of the drug.
Patients presenting with signs and symptoms suggestive of keratitis should be
referred promptly to an ophthalmologist.
Methods of
administration
IV infusion via an in-line filter. An infusion time of 2 hrs is recommended for the first
dose, which can subsequently be reduced to 1 hr (maximum rate 10mg/min).
Infusion-related reactions may necessitate a slower infusion rate. Close monitoring
is required during and for at least 1 hr after the end of the infusion.
Side effects Immediate Short-term Long-term
Very common Mild infusion-related
reactions (fever, chills,
dizziness) 52
Skin reactions (dermatitis
acneiform 19, pruritus 21,
dry skin, desquamation),
hypomagnesaemia 42,
mucositis

6
Increased LFTs 24, nail
disorders (paronychia)
Common Severe infusion-
related reactions
(bronchospasm,
urticaria,
BP changes) 52
Hypocalcaemia 41,
headache 34,
conjunctivitis 38,
diarrhoea 12, nausea and
vomiting 10, dehydration,
fatigue

53
Anorexia

8
Uncommon None selected* Blepharitis, keratitis Pulmonary embolism, DVT,
ILD
Rare None selected* None selected* None selected*
Very rare Stevens-Johnson
syndrome/TEN

22
None selected* None selected*
Unknown None selected* Superinfection of skin
lesions
Aseptic meningitis
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
55
CHLORAMBUCIL
Generic name Chlorambucil
Trade name Leukeran
Drug action Alkylating agent.
Specific
information
Risk of irreversible BMD.
Methods of
administration
Oral. Tablets should be taken on an empty stomach.
Side effects Immediate Short-term Long-term
Very common None selected* None selected*
BMD 1 2 3
Common Seizures in children
with nephrotic
syndrome
Nausea and vomiting 10,
diarrhoea 12, stomatitis 6 ,
dysgeusia 7
Secondary haematologic
malignancy
Uncommon Rash None selected* None selected*
Rare
Hypersensitivity

52,
Stevens-Johnson
syndrome/TEN,
seizures

22
Fever
Pulmonary complications 26,
abnormal LFTs 24,
anorexia 8 , hepatotoxicity
Very rare None selected*
Movement disorders, ILD

26 Peripheral neuropathy,
sterile cystitis
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
56
CISPLATIN
Generic name Cisplatin
Trade name N/A
Drug action Platinum compound that forms crosslinks with DNA, thereby disrupting DNA
synthesis.
Specific
information
Pre- and post- treatment hydration with NS or DS required.
Mannitol required to aid diuresis.
Methods of
administration
IV infusion over 6-8 hrs in NS.
May interact with aluminium to form a black precipitate of platinum. Aluminium-
containing IV sets, needles, catheters and syringes should be avoided.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting

10,
hyponatraemia
BMD (nadir 18-23
days) 1 2 3
Common None selected*
Sepsis

5 , arrhythmia

25 None selected*
Uncommon Hypersensitivity/
anaphylaxis 52
Hypomagnesaemia

42 Abnormal
spermatogenesis

27,
ototoxicity

35
Rare None selected*
Convulsion, MI, stomatitis

6 Peripheral neuropathy

32,
leukoencephalopathy, PRES,
acute leukaemia
Very rare None selected* Cardiac arrest None selected*
Unknown None selected*
Tinnitus 35 Nephrotoxicity 30, optic
neuritis, papilloedema and
cortical blindness, blurred
vision 38, hypocalcaemia 41,
hypokalaemia 44,
hyperuricaemia 40,
cardiotoxicity 25,
thromboembolism, CVA
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
57
CLADRIBINE
Generic name Cladribine (2-CdA)
Trade name Leustat, Litak
Drug action Antimetabolite.
Specific
information
Patients with a high tumour burden should receive prophylactic allopurinol for at
least 2 weeks after starting cladribine.
Cladribine can affect the ability to drive and perform skilled tasks.
Methods of
administration
IV infusion in NS (Leustat), SC bolus (Litak).
Leustat must be diluted with the designated diluent prior to administration. Once
diluted if the dose cannot be given immediately, it should be stored in the fridge at
2-8C for no more than 8 hrs and protected from light.
Litak is supplied as a ready-to-use solution for injection. Store in a fridge (2-8C).
Side effects Immediate Short-term Long-term
Very common
Fever, fatigue 53,
injection site reactions
Rash 19, headache 34 None selected*
Common
Contusion 16,
hypersensitivity, septic
shock
Insomnia, anxiety, confusion,
dizziness 33, nausea and
vomiting 10, diarrhoea 12,
constipation 11, flatulence,
hyperhidrosis, ecchymosis,
petechiae, pruritus, pain 34,
asthenia, malaise, chills,
myasthenia, anorexia 8 ,
mucositis 6 , oedema,
cough, dyspnoea

26,
abnormal breath sounds,
lung infiltrates, mildly
increased LFTs 24,
tachycardia, heart murmur,
hypotension 54, epistaxis,
myocardial ischaemia 25,
conjunctivitis
BMD (WBC nadir days 7-14,
recovery days
28-30) 1 2 3 ,
pneumonia 26, infections 5 ,
hypereosinophilia,
myelodysplastic syndrome,
phlebitis 18, primary and
secondary malignancies,
renal failure 30
Uncommon None selected* Paraparesis, somnolence,
paraesthesia 32, lethargy,
neuropathy, ataxia,
pharyngitis, cachexia
Tumour lysis syndrome

31,
Stevens-Johnson
syndrome

22
Rare None selected* None selected* GvHD, ileus, hepatic failure,
apoplexy, impaired speech
and swallowing, cardiac
failure 25, arrhythmia
Very rare None selected* None selected* Amyloidosis, seizures,
depression, blepharitis,
cholecystitis, pulmonary
embolism
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
58
CLOFARABINE
Generic name Clofarabine
Trade name Evoltra
Drug action Purine nucleoside antimetabolite.
Specific
information
N/A
Methods of
administration
IV infusion filtered through a sterile 0.2 micron syringe filter, diluted with 100-250ml
NS as per manufacturers instructions.
Clofarabine must not be mixed with or concomitantly administered using the same
IV set as other medicinal products.
Side effects Immediate Short-term Long-term
Very common None selected*
Anxiety, headache 34,
nausea and vomiting 10,
diarrhoea 12
Febrile neutropenia 5 ,
PPE 20, pruritus 21
Common
Hypersensitivity 52,
flushing 18,
hypotension 54,
respiratory distress,
cough 26
Tumour lysis syndrome 31,
agitation, somnolence,
peripheral neuropathy,
paraesthesia 32, dizziness,
tremor, musculoskeletal and
chest pain 34, weight loss 8 ,
tachycardia
Sepsis 5 , anorexia 8 ,
jaundice, hepatic
veno-occlusive disease
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* Clostridium difficile colitis,
Stevens-Johnson syndrome/
TEN 22
None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
59
CRIZOTINIB
Generic name Crizotinib
Trade name Xalkori
Drug action Inhibitor of receptor tyrosine kinases, including ALK (anaplastic lymphoma kinase)
and hepatocyte growth factor receptor (HGFR; c-Met).
Specific
information
Indicated for ALK-positive disease only.
Crizotinib is metabolised in the liver by cytochrome P450 CYP3A enzymes. Drugs/
foods that are inhibitors or inducers of these enzymes may interact with crizotinib.
It should be administered with caution in patients who have a history of or
predisposition to QT prolongation, or who are taking medicines known to cause
QT prolongation.
Fatal drug-induced hepatotoxicity has occurred with crizotinib.
Methods of
administration
Oral. Capsules should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, increased
ALT 24, anorexia 8 ,
dizziness, dysgeusia 7
Fatigue 53, neutropenia 2 ,
vision disorder 38, oedema,
neuropathy 32
Common None selected* Hypophosphataemia, QT
prolongation 25, increased
AST and ALP, rash 19,
oesophageal disorders and
dyspepsia 9
Leucopenia 2 , lymphopenia,
anaemia, bradycardia,
pneumonitis 26
Uncommon None selected* None selected* Renal cyst
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
60
CYCLOPHOSPHAMIDE
Generic name Cyclophosphamide
Trade name N/A
Drug action Alkylating agent.
Specific
information
Good urinary output will help to prevent chemical cystitis. High IV doses should be
given with concurrent IV/oral mesna to protect the uroepithelium. If mesna is used
to reduce urothelial toxicity, frequent emptying of the bladder should be avoided.
Cyclophosphamide is contraindicated if patient has haemorrhagic cystitis.
Methods of
administration
IV bolus, IV infusion in NS, D5W.
Tablets should be taken on an empty stomach, but if gastric irritation occurs, they
may be taken with meals.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* Stevens-Johnson syndrome/
TEN

22
Unknown
Nasal stuffiness 36 Leucopenia (usually resolves
within 21 days) 2 , nausea
and vomiting 10, anorexia 8 ,
haematuria 30
BMD 1 2 3 , haemorrhagic
cystitis 29, alopecia (with
high doses) 23,
amenorrhoea/azoospermia
(usually reversible) 27, skin
pigmentation (typically
affecting hands and soles of
feet) 16, hepatic toxicity 24,
altered carbohydrate
metabolism, pancreatitis,
macrocytosis,
hypoglycaemia/
hyperglycaemia 39,
SIADH, ILD 26
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
61
CYTARABINE
Generic name Cytarabine, cytosine arabinoside (Ara C)
Trade name DepoCyte (lipid formulation for intrathecal use)
Drug action Antimetabolite.
Specific
information
Ocular toxicity associated with high-dose therapy may be managed prophylactically
using steroid eye drops.
Methods of
administration
DepoCyte: intrathecal or intraventricularly via an Ommaya reservoir.
Other formulations: by IV infusion or injection, or SC injection for cytarabine
20mg/ml or 100mg/ml, compatible in NS and D5W.
100mg/ml injection should not be administered by the intrathecal route owing to the
slight hypertonicity of this formulation.
Prior to use, 100mg/ml vials must be warmed to 55C for 30 mins with adequate
shaking and allowed to cool to room temperature.
Side effects Immediate Short-term Long-term
Very common Arachnoiditis,
headache 34, asthenia
Thrombocytopenia 3 ,
diarrhoea 12, nausea and
vomiting 10, fatigue, oral and
anal inflammation/ulcer,
fever, rash

19, anorexia 8 ,
hepatic impairment

24
None selected*
Common
Pain 34 Confusion 33,
somnolence 33, faecal and
urinary incontinence
Cauda equina syndrome,
seizures 33, cranial nerve
palsies, hypoaesthesia,
myelopathy, paraesthesia,
visual disturbances
(including blindness) 38,
deafness 35
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* Severe spinal cord toxicity,
necrotising encephalopathy
Very rare None selected* Pericarditis None selected*
Unknown Anaphylaxis,
angioedema 52,
thrombophlebitis 17,
skin ulcer, pruritus 21
Pneumonia, sepsis 5 ,
cellulitis at injection site,
dyspnoea, pharyngitis, renal
impairment

30, urinary
retention, chest pain 25,
desquamation, alopecia 23,
neural toxicity, dizziness,
pancreatitis
High-dose therapy:
cerebral and cerebellar
impairment 33 (including
personality change,
peripheral neuropathy 32

),
liver abscess, sepsis

5
Jaundice, freckling
High-dose therapy: corneal
toxicity, conjunctivitis

38,
cardiomyopathy, ARDS,
pulmonary oedema, GI ulcer
and necrosis
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
D
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
63
DACARBAZINE
Generic name Dacarbazine
Trade name N/A
Drug action Alkylating agent.
Specific
information
N/A
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Reconstitute with WFI. Doses up to 200mg/m
2
to be given as slow IV bolus.
For doses 200-850mg/m
2
, dilute further in NS or D5W and give as IV infusion.
Protect from light (especially direct sunlight) by the use of a light-protective
administration set.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected*
Nausea and vomiting 10,
anorexia 8

Alopecia 23, BMD 1 2 3

Uncommon None selected*
Hyperpigmentation 16,
flu-like symptoms 51, visual
impairment 38

None selected*
Rare Pain along course of
vein if given in too
concentrated a
solution or too
rapidly 14, injection
site reactions 14,
hypersensitivity/
anaphylaxis 52,
photosensitivity 37

Diarrhoea 12, headache 34,
confusion 33, lethargy,
seizures, facial paraesthesia,
facial flushing 18, erythema,
rash 19
Hepatic necrosis 24, renal
impairment 30, increased
liver enzymes 24, hepatic
vein occlusion

Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
64
DACTINOMYCIN
Generic name Dactinomycin, actinomycin D
Trade name Cosmegen Lyovac
Drug action Cytotoxic antibiotic with immunosuppressant properties.
Specific
information
Dactinomycin is extremely corrosive to soft tissue.
The dose intensity per 2-week cycle for adults or children should not exceed
15 microgram/kg or 400-600 microgram/m
2
daily for five days. Calculation of the
dosage for obese or oedematous patients should be on the basis of body surface area.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Slow IV bolus or IV infusion added into fast-running infusion of D5W, NS.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Nausea and
vomiting 10
Infections 5 , pharyngitis,
hypocalcaemia 41,
pneumonitis, nausea and
vomiting 10, abdominal
pain 34, diarrhoea 12,
mucositis 6 ,
GI inflammation/ulcer,
cheilitis, dysphagia,
stomatitis 6 , radiation
recall 55, malaise, fatigue
and lethargy 53, skin
reactions (including acne,
Stevens-Johnson syndrome/
TEN) 22
Anorexia, BMD 1 2 3 ,
alopecia 23, liver toxicity
(including abnormal LFTs,
ascites, hepatomegaly,
hepatitis, hepatic failure 24,
hepatic veno-occlusive
disease), myalgia 34,
oedema
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
65
DASATINIB
Generic name Dasatinib
Trade name Sprycel
Drug action Multi-targeted protein kinase inhibitor.
Specific
information
Dasatinib is a substrate and inhibitor of cytochrome P450 CYP3A4. Interactions are
expected with other medicines that are metabolised by or modulate the activity of
this enzyme.
Drugs that cause significant sustained elevation of gastric pH, such as PPIs and
H
2
-antagonists, may reduce plasma concentrations of dasatinib.
Methods of
administration
Oral. Tablets should be taken with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Headache 34, dyspnoea 26,
diarrhoea 12, nausea and
vomiting 10, abdominal pain,
rash 19, musculoskeletal
pain 34, fever, infections

5 ,
cough

26
Haemorrhage 4 , pleural
effusion 26, oedema,
fatigue 53
Common None selected*
Anorexia 8 , dizziness,
dysgeusia 7 , somnolence,
hypertension 54, flushing 18,
febrile neutropenia,
pancytopenia, myasthenia,
asthenia, pain, chills,
contusion, GI disturbances
(including haemorrhage,
dyspepsia 9 ,
constipation 11

)
Depression, insomnia,
neuropathy, visual
disturbances 38, dry eye,
tinnitus 35, cardiac disorders
(including CHF, pericardial
effusion, arrhythmia,
palpitations) 25, alopecia 23,
skin reactions 19,
hyperhidrosis, weight
changes, hyperuricaemia

40,
pulmonary hypertension,
lung infiltrates,
pneumonitis

26
Uncommon Tumour lysis
syndrome

31,
hypersensitivity 52
Rhabdomyolysis, renal
failure 30, urinary frequency,
proteinuria,
gynaecomastia 47, irregular
menstruation 27,
bronchospasm, anxiety,
confusion, conjunctivitis 38,
anal fissure, tendonitis,
myositis, malaise,
temperature intolerance,
increased CPK, Sweets
syndrome
Syncope, tremor, amnesia,
hypotension 54,
thrombophlebitis 17,
pancreatitis, dysphagia,
hepatic impairment 24,
hypoalbuminaemia, affect
lability, decreased libido,
flushing, asthma, upper GI
ulcer, oesophagitis, ascites,
PPE

20, panniculitis, nail
disorders
Rare None selected* Livedo reticularis, ARDS Pure red cell aplasia, CVA,
TIA, seizures, protein-losing
gastroenteropathy, ileus
Very rare None selected* None selected* None selected*
Unknown None selected* Thrombosis/embolism ILD
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
66
DAUNORUBICIN LIPOSOMAL
Generic name Daunorubicin
Trade name DaunoXome
Drug action Anthracycline antibiotic.
Specific
information
Liposomal and non-liposomal (standard) daunorubicin are NOT equivalent or
interchangeable.
Careful monitoring of cardiac function is essential at baseline and regularly
throughout treatment. In addition, LVEF should be measured once a cumulative
dose of 320mg/m of daunorubicin liposomal has been reached, and every
160mg/m thereafter.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV infusion over 30-60 mins in D5W only (incompatible with NS).
Side effects Immediate Short-term Long-term
Very common Red flush flare (local
reactions with higher
doses/sensitive
veins) 18, infusion-
related reactions
(back pain, flushing,
chest tightness,
dyspnoea,
hypotension) 52
Headache 34, nausea and
vomiting 10, diarrhoea 12,
abdominal pain,
dyspnoea 26, stomatitis 6 ,
mucositis, infections 5 ,
asthenia, fatigue 53, chills
BMD (nadir 10-14
days) 1 2 3 , alopecia
(total) 23
Common None selected* Fever (often 2 hrs after
therapy), dizziness, red
urine 28, dehydration
Decreased LVEF 25,
depression
Uncommon None selected*
Sepsis 5 CHF, cardiomyopathy,
fatigue 53
Rare
Anaphylaxis 52 None selected*
Atrial fibrillation, MI 25,
PPE 20
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
67
DAUNORUBICIN NON-LIPOSOMAL
Generic
name
Daunorubicin
Trade name N/A
Drug action Anthracycline antibiotic.
Specific
information
Maximum cumulative dose of 550mg/m
2
should not be exceeded (owing to
cardiotoxicity) in adults. A total cumulative dose of 400mg/m
2
in adults
should only be exceeded with extreme caution in elderly patients, patients with a
history of cardiac disease, arterial hypertension or thoracic irradiation, and patients
previously treated with cardiotoxic drugs.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Slow IV bolus or short infusion, into fast-running infusion of NS.
Facial flushing or erythematous streaking along veins indicates too rapid injection.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown
Local irritation 14 and
phlebitis 17,
anaphylaxis 52,
dehydration, acute
hyperuricaemia

40,
shock, haemorrhage,
flushing, tissue
hypoxia
Nausea and vomiting 10,
mucositis/stomatitis 6 ,
rash 19, pruritus 21,
cardiotoxicity
(cardiomyopathy,
endomyocardial fibrosis,
myocardial ischaemia, MI,
pericarditis/myocarditis,
arrhythmia)

25,
oesophagitis, diarrhoea

12,
abdominal pain, alopecia

23,
radiation recall

55,
erythema, skin and nail
hyperpigmentation

15

16,
nephrotic syndrome, uric
acid nephropathy, red urine
(for 1-2 days), ECG
abnormalities, transiently
increased LFTs
BMD (nadir 8-10
days) 1 2 3 , alopecia
(total) 23, amenorrhoea,
azoospermia

27,
hyperpyrexia, aplasia
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
68
DECITABINE
Generic name Decitabine
Trade name Dacogen
Drug action Prodrug that is converted intracellularly to decitabine triphosphate, which inhibits
DNA methyltransferase.
Specific
information
N/A
Methods of
administration
IV infusion over 1 hr in NS, D5W or Lactated Ringers solution at a concentration of
0.1 to 1mg/ml.
Side effects Immediate Short-term Long-term
Very common Fever
Pneumonia 26, UTI,
BMD 1 2 3 , headache 34,
epistaxis 4 , diarrhoea 12,
nausea and vomiting 10
None selected*
Common Hypersensitivity/
anaphylaxis 52
Sepsis 5 , sinusitis,
stomatitis 6
None selected*
Uncommon None selected* None selected* Sweets syndrome
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
69
DOCETAXEL
Generic name Docetaxel
Trade name Taxotere, Taxceus
Drug action Taxane, inhibitor of mitosis.
Specific
information
For breast, non-small cell lung, gastric and head and neck cancers, premedication
consisting of an oral corticosteroid, such as dexamethasone 16mg per day for three
days starting one day prior to docetaxel administration, is recommended to reduce
the incidence and severity of oedema and hypersensitivity. For prostate cancer, the
premedication is oral dexamethasone 8mg at 12 hrs, 3 hrs and 1 hr before the
docetaxel infusion.
Patients with impaired vision should undergo a prompt and complete
ophthalmologic examination because of the risk of cystoid macular oedema.
Methods of
administration
EXFOLIANT AVOID EXTRAVASATION.
IV infusion over 1 hr or according to protocol in 50-500ml NS or D5W.
Side effects Immediate Short-term Long-term
Very common
Hypersensitivity 52 Nausea and vomiting 10,
diarrhoea 12, dyspnoea 26,
oedema, anorexia 8 ,
asthenia, pain, infections 5 ,
dysgeusia 7
BMD (nadir 7 days) 1 2 3 ,
alopecia 23, stomatitis 6 ,
nail disorders 15, peripheral
neuropathy 32, skin
reactions, myalgia
Common Hypotension/
hypertension 54,
bronchospasm,
flushing 18,
generalised rash/
erythema 19, pain 34
Arrhythmia 25,
haemorrhage 4 ,
constipation 11
Increased LFTs 24, arthralgia
Uncommon None selected* None selected*
Cardiac failure 25,
oesophagitis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
70
DOXORUBICIN LIPOSOMAL
Generic name Doxorubicin
Trade name Caelyx (pegylated liposomal), Myocet (liposome-encapsulated doxorubicin citrate
complex)
Drug action Anthracycline antibiotic.
Specific
information
Liposomal and non-liposomal (standard) doxorubicin are NOT equivalent or
interchangeable.
The liposomal form of doxorubicin is reported to be less cardiotoxic than standard
doxorubicin. It should, however, be used with caution when cumulative lifetime
doses exceed 450mg/m
2
(Caelyx) 550mg/m
2
(Myocet) and regular assessments of
LVEF should be carried out in these patients. This lifetime cumulative dose should
be revised down or used with caution in the event of prior anthracycline/
anthraquinine exposure, mediastinal radiotherapy or concurrent
cyclophosphamide therapy.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Breast cancer, ovarian cancer and multiple myeloma: Caelyx is given by IV infusion
with doses <90mg in 250ml D5W and doses 90mg in 500ml D5W. The initial dose is
administered at a rate no greater 1mg/min with subsequent doses over 1 hr if no
reaction is observed.
AIDS-related Kaposis sarcoma: Caelyx is given by IV infusion in 250ml D5W over
30 mins.
Myocet is given by IV infusion in 100-250ml NS or D5W (at a final concentration of
0.4-1.2mg/ml) over 1 hr.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
alopecia (total) 23,
stomatitis 6 , mucositis 6 ,
red urine 28
PPE 20, BMD (nadir 10-15
days) 1 2 3 , asthenia/
fatigue 53
Common Red flush flare (local
reaction with higher
doses/sensitive
veins) 17 18, aching
along vein 14
Radiation recall 55 Nail and skin
pigmentation 15
Uncommon None selected* None selected* None selected*
Rare None selected* None selected*
Life-threatening CHF 25
Very rare None selected* None selected* Secondary oral neoplasms
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
71
DOXORUBICIN NON-LIPOSOMAL
Generic name Doxorubicin
Trade name N/A
Drug action Anthracycline antibiotic.
Specific
information
Maximum cumulative lifetime dose should not exceed 550mg/m
2
owing to the risk of
cardiotoxicity. This should be revised down or used with caution in the event of prior
anthracycline exposure or mediastinal radiotherapy.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Slow IV bolus over 3-5 mins into fast-running infusion of NS.
IV infusion via CVAD.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
alopecia (total) 23,
stomatitis, mucositis 6 , red
urine 28
PPE (usually mild) 20

Common Red flush flare (local
reaction with higher
doses/sensitive
veins) 18, aching along
vein 14
Radiation recall 55 BMD (nadir 10-15
days) 1 2 3 , nail and skin
pigmentation 15
Uncommon None selected* None selected* None selected*
Rare None selected* None selected*
Life-threatening CHF 25
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
E
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
73
EPIRUBICIN
Generic name Epirubicin
Trade name Pharmorubicin
Drug action Anthracycline antibiotic.
Specific
information
Maximum cumulative lifetime dose should not exceed 900mg/m
2
owing to the risk of
cardiotoxicity. This should be revised down or used with caution in the event of prior
anthracycline exposure or mediastinal radiotherapy.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Slow IV bolus over 3-5 mins into fast-running infusion of NS.
IV infusion in NS or D5W. Intravesicular.
Side effects Immediate Short-term Long-term
Very common Red flush flare (local
reaction with higher
doses/sensitive
veins 18, aching along
vein 14
Red urine (for 1-2 days) 28 BMD (nadir 10-14
days) 1 2 3 , alopecia 23,
nail pigmentation 15
Common Hypersensitivity
(intravesical
administration) 52
Anorexia 8 , dehydration,
radiation recall 55,
infections 5 , hot flushes,
nausea and vomiting 10,
diarrhoea 12, mucositis,
stomatitis 6 , oesophagitis,
hyperpigmentation of the
oral mucosa
None selected*
Uncommon None selected*
Headache 34, phlebitis 17,
erythema, photosensitivity 37
None selected*
Rare
Anaphylaxis 52 Hyperuricaemia 41,
dizziness, dyspnoea,
oedema, rash 19,
amenorrhoea,
azoospermia 27, fever, chills,
malaise, asthenia, altered
transaminase levels
Cardiotoxicity 25,
hepatomegaly 24, ascites,
pulmonary oedema, pleural
effusion 26, arrhythmia
Very rare None selected* None selected* None selected*
Unknown None selected*
Conjunctivitis 38, keratitis Haemorrhage 4 , tissue
hypoxia
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
74
ERIBULIN
Generic name Eribulin
Trade name Halaven
Drug action Non-taxane microtubule dynamics inhibitor belonging to the halichondrin class.
Causes cell-cycle block, disruption of mitotic spindles and apoptotic cell death.
Specific
information
Eribulin mesylate 1.4mg/m
2
equates to eribulin 1.23mg/m
2
.
Methods of
administration
IV infusion over 2-5 mins. May be diluted in up to 100ml of NS (do not use D5W).
Side effects Immediate Short-term Long-term
Very common None selected*
BMD 1 2 , anorexia 8 ,
headache 34, fatigue 53,
fever, peripheral
neuropathy 32, nausea and
vomiting 10, diarrhoea 12,
constipation 11,
musculoskeletal pain
Alopecia 27
Common None selected* UTI, upper RTI,
thrombocytopenia 3 , fluid
and electrolyte
disturbances 42 44,
hyperglycaemia 39,
dizziness, lethargy,
increased lacrimation,
conjunctivitis 38, tachycardia,
hot flushes 18, dyspnoea,
cough 26, epistaxis 4 ,
rhinorrhoea, abdominal
pain/distension 34,
stomatitis 6 , dry mouth,
dyspepsia 7 , GORD, rash 19,
pruritus 21, night sweats,
PPE 20, dry skin, erythema,
pain (extremities,
oropharyngeal, chest),
myasthenia, peripheral
oedema, chills, flu-like
symptoms 51, weight loss 8
Insomnia, depression 33,
neurotoxicity, hyperhidrosis
Uncommon None selected*
Pneumonia 26, neutropenic
sepsis 5 , herpes zoster,
DVT, hyperbilirubinaemia,
dysuria, haematuria 4 ,
proteinuria
Tinnitus 35, pulmonary
embolism 26, ILD,
angioedema, renal failure 30
Rare None selected* None selected* Disseminated intravascular
coagulation, pancreatitis
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
75
ERLOTINIB
Generic name Erlotinib
Trade name Tarceva
Drug action EGFR tyrosine kinase inhibitor.
Specific
information
Erlotinib is metabolised in the liver by cytochrome P450 enzymes. Drugs that are
inhibitors or inducers of these enzymes may interact with erlotinib.
Smokers should be advised to quit, as plasma concentrations of erlotinib are lower
in smokers than non-smokers. The degree of reduction is likely to be clinically
significant.
The absorption of erlotinib is significantly reduced by drugs that increase the
gastric pH. Treatment with PPIs should be avoided and erlotinib should not be
administered at the same time of day as indigestion remedies/antacid preparations.
Methods of
administration
Oral. Tablets should be taken 1 hr before, or 2 hrs after food or other medications.
Side effects Immediate Short-term Long-term
Very common None selected*
Rash 19, dry skin,
diarrhoea 12, abnormal
LFTs 24
None selected*
Common None selected* Nausea and vomiting
(usually mild) 10,
stomatitis 6 , abdominal
pain, dyspnoea, cough 26,
fatigue 53, conjunctivitis 38,
keratitis, pruritus 21,
paronychia, skin fissures,
folliculitis
GI haemorrhage, renal
impairment, ILD
Uncommon None selected* None selected* GI perforation, nephritis,
proteinuria, eyelash/brow
changes, hirsutism,
hyperpigmentation
Rare None selected* None selected*
PPE 20, hepatic failure
Very rare None selected* None selected* Stevens-Johnson syndrome,
corneal ulcer/perforation 22
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
76
ESTRAMUSTINE
Generic name Estramustine
Trade name Estracyt
Drug action Dual mode of action anti-mitotic and anti-gonadotrophic actions.
Specific
information
Absorption of estramustine may be decreased by the presence of calcium in the gut.
Therefore, milk, milk products or drugs containing calcium should not be taken at
the same time of day as estramustine.
Diabetic and hypertensive patients should be carefully monitored during treatment.
Methods of
administration
Oral. Capsules should be swallowed whole no less than 1 hr before, or 2 hrs
after food.
Side effects Immediate Short-term Long-term
Very common None selected* None selected*
Gynaecomastia 47, breast
tenderness, impotence 27,
loss of libido 27, abnormal
LFTs 24
Common None selected*
Nausea and vomiting 10,
diarrhoea 12, oedema
None selected*
Uncommon None selected* None selected* None selected*
Rare None selected*
Myasthenia, confusion 33,
depression, lethargy,
headache 34
CHF 25, ischaemic heart
disease 25, angioedema,
BMD 1 2 3
Very rare None selected* None selected* None selected*
Unknown
Hypersensitivity

52
Hypertension 54,
thromboembolism
None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
77
ETOPOSIDE
Generic name Etoposide
Trade name Eposin, Vepesid
Drug action Anti-mitotic inhibits microtubule assembly.
Specific
information
IRRITANT.
Methods of
administration
IV infusion (Eposin) in 250-1000ml NS over 1 hr according to protocol. Some
protocols infuse over 30 mins or 2 hrs. Maximum concentration if diluted is
400 microgram/ml.
Oral (Vepesid). Capules should be swallowed on an empty stomach.
Etoposide injection can be used to make an oral solution. This is an unlicensed
indication and may be made in some aseptic units. Ref: NEWT guidelines
Side effects Immediate Short-term Long-term
Very common Severe hypotension
if infused in less than
30 mins 54
Nausea and vomiting 10,
anorexia 8
BMD 1 2 3 ,
alopecia (usually total) 23
Common
Anaphylaxis 52 Abdominal pain,
diarrhoea 12, fatigue and
drowsiness 53
Haemorrhage in patients
with severe BMD 4 , hepatic
impairment 24
Uncommon
Arrhythmia and MI 25 None selected* None selected*
Rare None selected* Interstitial pneumonitis or
pulmonary fibrosis 26
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
78
ETOPOSIDE PHOSPHATE
Generic name Etoposide phosphate
Trade name Etopophos
Drug action Anti-mitotic inhibits microtubule assembly.
Specific
information
N/A
Methods of
administration
Slow IV bolus or infusion over 30-60 mins (must not be given rapidly).
Can be given undiluted, or diluted with D5W or NS to a minimum concentration of
100 microgram/ml.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Severe hypotension if
infused in less than
30 mins 54,
anaphylaxis 52
Nausea and vomiting 10,
abdominal pain,
diarrhoea 12,
constipation 11,
mucositis 6 , anorexia 8 ,
dysphagia, dysgeusia 7 ,
anaemia 1 , fatigue and
drowsiness 53, skin
reactions (including
pigmentation 16, rash 19 and
pruritus 21 )
BMD 1 2 3 , alopecia
(usually total) 23
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
79
EVEROLIMUS
Generic name Everolimus
Trade name Afinitor, Votubia
Drug action mTOR (mammalian target of rapamycin) protein kinase inhibitor.
Specific
information
Concomitant treatment with potent cytochrome P450 CYP3A4 inhibitors is not
recommended owing to dramatically increased plasma concentrations.
Everolimus has been associated with serious cases of hepatitis B reactivation,
including fatal outcome. Reactivation can be expected during periods of
immunosuppression.
Methods of
administration
Oral. Tablets should be swallowed whole with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12, stomatitis 6 ,
mucositis, headache 34,
dysgeusia 7 , fatigue 53,
asthenia, peripheral
oedema, fever, infections 5
BMD 1 2 3 , rash 19, dry
skin and pruritus 21, nail
disorders, pneumonitis,
cough 26, epistaxis,
dyspnoea 26,
hyperglycaemia 39,
hypercholesterolaemia 46,
hypertriglyceridaemia,
anorexia 8 , weight loss
Common None selected* Dry mouth, abdominal pain,
oral pain, dysphagia,
dyspepsia 9 , raised ALT
and AST, conjunctivitis 38,
eyelid oedema,
hypophosphataemia 46,
hypokalaemia 44,
hyperlipidaemia 46,
hypocalcaemia 41,
dehydration, insomnia,
haemorrhage, pulmonary
embolism, haemoptysis,
erythema, desquamation,
alopecia (mild) 23, increased
creatinine
Diabetes, renal impairment
(including acute renal
failure) 30, proteinuria,
PPE 20, chest pain 25,
hypertension 54, arthralgia
Uncommon None selected* Ageusia, flushing, DVT,
ARDS, angioedema, impaired
wound healing
CHF 25
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown
Hypersensitivity 52 None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
F
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
81
FLUDARABINE
Generic name Fludarabine
Trade name Fludara
Drug action Antimetabolite.
Methods of
administration
IV bolus, IV infusion over 30 mins in NS.
Oral. Tablets should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12, fever and
malaise 51
BMD 1 2 3
Common None selected*
Visual disturbances 38 Myelodysplastic syndrome
and AML, stomatitis 6 ,
mucositis, peripheral
neuropathy 32
Uncommon
Anaphylaxis 52 Acute pancreatitis,
GI haemorrhage, acute renal
failure 30, erythema
multiforme 22, rash
(including exfoliative) 19,
drug eruption, acute
pulmonary oedema
Tinnitus 35, pericarditis 25,
respiratory failure 26,
pulmonary hypertension,
renal impairment 30
Rare Heart failure and
arrhythmia 25
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
82
5-FLUOROURACIL
Generic name 5-fluorouracil, 5FU, fluorouracil
Trade name N/A
Drug action Antimetabolite.
Specific
information
N/A
Methods of
administration
IV bolus, IV infusion, continuous IV infusion via an infusion device, in NS or D5W.
Volume for infusion depends on regimen and whether there is a CVAD or peripheral
venous access device. Consult individual proforma.
Side effects Immediate Short-term Long-term
Very common None selected*
Infections 5 , nausea and
vomiting 10, diarrhoea

12

,
mucositis 6 , fever,
fatigue 53

BMD 1 2 3 , PPE 20,
alopecia (especially in
women) 23
Common
Chest pain 25,
tachycardia, angina
Conjunctivitis 38

None selected*
Uncommon None selected* Breathing disorders
(including bronchospasm) 26

None selected*
Rare None selected* None selected* Cardiac disorders (including
heart failure, MI)

25
Very rare
Anaphylaxis 52

None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
83
FOLINIC ACID
Generic name Folinic acid, calcium folinate (calcium leucovorin)
Trade name Refolinon, Sodiofolin
Drug action Antidote to folate antagonists. Folinic acid also enhances the cytotoxicity of
5-fluorouracil.
Specific
information
Folinic acid rescue is used following administration of intermediate- or high-dose
methotrexate (generally for methotrexate doses 1000mg/m

).
Methods of
administration
Oral.
IM, IV bolus, IV infusion in NS, D5W. Volume for infusion depends on dose.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* Fever None selected*
Rare None selected* Life-threatening diarrhoea
when used in combination
with 5-fluorouracil 12
None selected*
Very rare Hypersensitivity/
anaphylaxis 52
None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
G
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
85
GEFITINIB
Generic name Gefitinib
Trade name Iressa
Drug action EGFR tyrosine kinase inhibitor.
Specific
information
Gefitinib is metabolised in the liver by cytochrome P450 enzymes. Drugs that are
inhibitors or inducers of these enzymes may interact with gefitinib.
Drugs that cause significant sustained elevation in gastric pH, such as PPIs and
H
2
-antagonists, may reduce plasma concentrations of gefitinib.
Methods of
administration
Oral. Tablets should be taken with or without food.
For patients with swallowing difficulties, the tablet may be dropped in half a glass of
non-carbonated water and swirled occasionally until dispersed (this may take up to
20 mins), then drunk immediately. The glass should be rinsed with half a glass of
water, which should also be drunk. The dispersion can also be administered through
a feeding tube.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12, anorexia 8 ,
stomatitis 6 , asthenia, skin
reactions (mild to
moderate) 19
Abnormal LFTs 24
Common
Fever 5 Conjunctivitis 38,
blepharitis 38, dry eye 38,
haemorrhage, dry mouth,
nail disorders, proteinuria,
cystitis
Increased creatinine,
alopecia 23, ILD 26
Uncommon
Hypersensitivity 52 Keratitis/corneal ulcer,
pancreatitis, GI perforation
Hepatitis 24
Rare None selected* Stevens-Johnson
syndrome/TEN 22, erythema
multiforme 22,
haemorrhagic cystitis 29,
cutaneous vasculitis
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
86
GEMCITABINE
Generic name Gemcitabine
Trade name Gemzar
Drug action Antimetabolite.
Specific
information
Radiosensitiser reduce dose if given with, or within 7 days of radiotherapy.
Methods of
administration
IV infusion over 30 mins in 100ml NS.
Side effects Immediate Short-term Long-term
Very common
Dyspnoea (mild) 26,
rash (mild) 19,
pruritus 21
Nausea and vomiting 10,
flu-like symptoms 51,
anorexia 8 , peripheral/
facial oedema
BMD (mild to
moderate) 1 2 3 , alopecia
(minimal) 23, abnormal
LFTs 24, proteinuria /
haematuria
Common None selected*
Diarrhoea 12,
constipation 11,
stomatitis 6 , headache 34,
insomnia, somnolence,
myalgia 34, back pain 34,
sweating, fever, asthenia,
chills, cough 26, rhinitis
None selected*
Uncommon Bronchospasm
(usually mild, but may
need parenteral
treatment)
None selected* CVA, arrhythmia, heart
failure 25, serious
hepatotoxicity 24, renal
failure 30, haemolytic
uraemic syndrome,
interstitial pneumonitis 26
Rare None selected* Peripheral vasculitis and
gangrene, pulmonary
oedema, ARDS, skin and
injection site reactions,
radiation sensitivity,
increased GGT
Radiation recall 55, MI 25,
hypotension 54
Very rare
Anaphylaxis 52 Ischaemic colitis Stevens-Johnson syndrome/
TEN 22, thrombocytosis,
capillary leak syndrome
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
H
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
87
HYDROXYCARBAMIDE
Generic name Hydroxycarbamide, hydroxyurea
Trade name Hydrea
Drug action Antimetabolite.
Specific
information
Instruct patient to maintain high fluid intake.
Patients should be advised to report skin ulceration as it may necessitate
modification or cessation of therapy.
Skin cancer has been reported in patients receiving long-term hydroxycarbamide
therapy; patients should be advised to protect skin from sun exposure and conduct
self-inspection of the skin and be screened for secondary malignancy during routine
follow-up visits.
Megaloblastosis which does not respond to treatment with folic acid or vitamin B12
may occur.
High doses may cause drowsiness.
Methods of
administration
Oral. If the patient is unable to swallow capsules, contents may be emptied into a
glass of water and taken immediately. The contents of capsules should not be
inhaled or allowed to come into contact with the skin or mucous membranes.
Spillages must be wiped immediately.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected*
Diarrhoea 12, constipation 11 BMD 1 2 3
Uncommon/
rare
(Exact
frequency is
unknown)
Rash 19, erythema,
fever, chills, malaise,
increased LFTs 24,
acute pulmonary
reactions (diffuse
infiltrates, fever,
dyspnoea) 26,
alopecia 23
Nausea and vomiting 10,
transient renal tubular
impairment, tumour lysis
syndrome 31,
hypersensitivity (including
allergic alveolititis) 52
Stomatitis 6 , anorexia 8 ,
dysuria, seizures and
hallucinations 33, skin ulcer
Very rare None selected* None selected*
Renal impairment 30,
dermatomyositis-like skin
changes, skin and nail
pigmentation 16, skin and
nail atrophy, pruritus 21,
actinic keratosis, skin
cancer, violet papules,
desquamation
Unknown None selected* None selected* Secondary leukaemia
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
I
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
89
IDARUBICIN
Generic name Idarubicin
Trade name Zavedos
Drug action Anthracycline antibiotic.
Specific
information
Cumulative dose limits for IV or oral idarubicin have not been defined. However,
idarubicin-related cardiomyopathy was reported in 5% of patients who received
cumulative IV doses of 150 to 290mg/m
2
. Available data on patients treated with oral
idarubicin total cumulative doses up to 400mg/m
2
suggest a low probability of
cardiotoxicity.
Cardiac function monitoring must be particularly strict in patients receiving high
cumulative doses and in those with risk factors (eg, previous anthracycline
exposure).
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Oral. Capsules should be swallowed whole.
IV, slow administration over 5 to 10 mins via the tubing of a freely running IV infusion
of NS.
Side effects Immediate Short-term Long-term
Very common
Fever/chills 51 Nausea/vomiting (severe in
high doses) 10, mucositis,
stomatitis 6 , diarrhoea 12,
abdominal pain,
infections 5 , red urine (for
1-2 days) 28, headache 34
Anorexia 8
,
alopecia,
BMD (nadir 10-15
days) 1 2 3
Common None selected*
Phlebitis 17, haemorrhage
(including GI), rash, pruritus
Increased LFTs 24,
cardiotoxicity (arrhythmia,
decreased LVEF, CHF,
cardiomyopathy) 25,
radiation recall 55
Uncommon Dehydration, shock,
sepsis, oesophagitis,
colitis, ECG
abnormalities 25
MI, skin and nail
hyperpigmentation 15 16,
cellulitis (can be severe),
tissue necrosis,
hyperuricaemia 41,
secondary leukaemia
None selected*
Rare None selected* None selected* Cerebral haemorrhage
Very rare
Anaphylaxis 52, flush
None selected*
Pericarditis, myocarditis 25,
AV and BB block, gastric
erosions, thromboembolism,
PPE 20
Unknown Local reactions,
tumour lysis
syndrome 31
None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
90
IFOSFAMIDE
Generic name Ifosfamide
Trade name N/A
Drug action Alkylating agent (analogue of cyclophosphamide).
Specific
information
Nephrotoxic patient should be well hydrated. Ifosfamide should not be used
without the concurrent administration of mesna to protect against urothelial
damage and resultant haemorrhagic cystitis. Urine should be sent for laboratory
analysis before and at the end of each course of treatment, and the patient should
be monitored for output and evidence of proteinuria and haematuria at regular
intervals throughout treatment period.
Ifosfamide is neurotoxic and can occasionally result in encephalopathy (usually in
the first 3 days after infusion). Signs of CNS toxicity (confusion, dizziness,
somnolence etc) should be reported early to the patients medical team for
investigation.
Methods of
administration
IV infusion, for use as a dilute solution only, usually in 500-1000ml NS (infusion time
is regimen-dependent).
Mesna can be added directly to the infusion bag of ifosfamide during aseptic
preparation.
Side effects Immediate Short-term Long-term
Very common None selected* Nausea and vomiting (often
severe with high doses) 10,
alopecia 23
BMD 1 2 3 , alopecia 23,
nephrotoxicity, dysuria 30,
haemorrhagic cystitis 29
Common
Thrombophlebitis 17 Anorexia 8 , stomatitis 6 ,
CNS effects (including,
lethargy, disorientation,
confusion) 33, agitation,
depressive psychoses,
hallucinations, dermatitis,
impaired gonadal
function 27,
hypersensitivity 52,
polyneuropathy,
pneumonitis, visual
impairment 38, radiation
sensitivity 55
Rash 19
Uncommon None selected*
Hepatic impairment 24,
SIADH
None selected*
Rare None selected* Seizures, tonic-clonic
spasm, motor unrest,
emotional lability, severe
encephalopathy 33, acute
pancreatitis, arrhythmia,
heart failure (very high
doses) 25
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
91
IMATINIB
Generic name Imatinib
Trade name Glivec
Drug action Tyrosine kinase inhibitor.
Specific
information
Imatinib is metabolised in the liver by cytochrome P450 CYP3A4 enzymes. Drugs
that are inhibitors or inducers of these enzymes may interact with imatinib.
TSH levels should be monitored closely in thyroidectomy patients on levothyroxine.
Methods of
administration
Oral. For patients with swallowing difficulties, the tablets may be dispersed in
mineral water or apple juice (50ml for 100mg tablet, 200ml for 400mg tablet).
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12, dyspepsia 9 ,
abdominal pain, headache 34,
rash 19, fatigue 53
BMD 1 2 3 , oedema, skin
reactions, cramp,
musculoskeletal pain 34,
weight gain
Common None selected*
Anorexia 8 , dysgeusia 7 ,
insomnia, dizziness 33,
flushing, dyspnoea 26, chills,
rigors, fever, paraesthesia,
hypoaesthesia, flatulence,
abdominal distension, GORD,
constipation, dry mouth,
gastritis, haemorrhage
Eye disorders (including
conjunctivitis, glaucoma) 38,
epistaxis, cough, increased
LFTs 24, alopecia 23,
photosensitivity 37, night
sweats, joint swelling,
weight loss
Uncommon None selected* Electrolyte disturbances,
infections 5 , migraine,
stomatitis 6 , mucositis 6 ,
eructation, renal pain,
haematuria, acute renal
failure 30, increased urinary
frequency, chest pain,
dehydration
Lymphadenopathy,
thrombocythaemia,
hyperglycaemia 39, anxiety,
depression, somnolence,
syncope, memory impairment,
neuropathy, tremor, restless
legs, tinnitus 35, hearing
loss 35, cardiac disorders,
hypotension/hypertension 54,
Raynauds phenomenon,
gynaecomastia 47, irregular
periods, erectile dysfunction 27,
sciatica, pleural effusion,
ascites, gastric ulcer, cheilitis,
dysphagia, pancreatitis,
hyperuricaemia, 40 hepatitis,
jaundice 24
Rare None selected* Acute generalised
exanthematous pustulosis,
haemorrhagic ovarian cyst,
increased blood amylase
Increased intracranial
pressure, seizures 33, pleuritic
pain, pulmonary fibrosis 26,
IBD, colitis, ileus, tumour
lysis syndrome 31, confusion,
hepatic necrosis, Sweets
syndrome, nail
discolouration 15, angioedema,
Stevens-Johnson syndrome 22,
arthritis, rhabdomyolysis
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* DRESS
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
92
INTERFERON ALFA
Generic name Interferon alfa
Trade name IntronA, Roferon-A
Drug action Not completely understood. Antiproliferative activity against tumour cells by
immunomodulatory mechanisms.
Specific
information
N/A
Methods of
administration
SC, IM, IV (IntronA solution for injection or infusion). For IV infusion, add dose to
50ml NS and infuse over 20 mins.
Side effects Immediate Short-term Long-term
Very common Injection site reactions
Anorexia 8 , GI disturbances
(including nausea 10,
diarrhoea 12),
hypocalcaemia 41, flu-like
symptoms 51, headache 34,
musculoskeletal pain 34,
fatigue 53, increased
sweating, dizziness,
dyspnoea 26, visual
impairment
BMD 1 2 3 , alopecia 23
Common None selected*
Dysgeusia 7 , cyanosis, dry
mouth, oedema,
conjunctivitis 38,
hypertension 54, tremor,
dehydration, somnolence,
psoriasis, hyperuricaemia 40,
epistaxis, rash 19
None selected*
Uncommon None selected* None selected* Psychiatric effects (including
depression and suicidal
ideation) 33, neuropathy 33,
increased LFTs
Rare Hypersensitivity/
anaphylaxis 52
Erectile dysfunction 27,
cardiac disorders (including
MI, CHF) 25, mucosal
dryness
Haemolytic anaemia,
autoimmune disorders, CVA,
seizures, renal
impairment 30, increased
LDH, ischaemic
retinopathy 38
Very rare None selected*
Hypotension 54 Pancreatitis, hepatotoxicity,
pneumonitis,
hyperglycaemia 39
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
93
IPILIMUMAB
Generic name Ipilimumab
Trade name Yervoy
Drug action T-cell potentiator that results in T-cell activation, proliferation, and lymphocyte
infiltration into tumours, leading to tumour cell death.
Specific
information
Ipilimumab is associated with inflammatory adverse reactions resulting from
increased or excessive immune activity.
Methods of
administration
IV over 90 mins in 100ml NS. Use an infusion set and an in-line, sterile, non-
pyrogenic, low protein binding filter (pore size of 0.2-1.2 micron).
Side effects Immediate Short-term Long-term
Very common Injection site
reactions 14
Skin reactions 19 21,
GI disturbances
(eg, diarrhoea 12, nausea
and vomiting 10), anorexia,
fever
Fatigue 53
Common
Hot flushes 18 Tumour pain 48, dehydration,
hypokalaemia 44, confusion,
dizziness, headache 34,
lethargy, blurred vision, eye
pain 38, hypotension 54,
dyspnoea, cough 26, GORD,
abdominal pain 34, hepatic
impairment 24, alopecia 27,
night sweats, chills,
asthenia, oedema, pain
Anaemia 1 , lymphopenia,
hypopituitarism,
hypothyroidism 45,
peripheral neuropathy 32,
GI inflammation,
constipation 11,
GI haemorrhage,
musculoskeletal pain,
muscle spasm
Uncommon
Hypersensitivity 52 UTI, RTI,
thrombocytopenia 3 ,
eosinophilia, neutropenia,
amenorrhoea 27,
infusion-related reactions
14, hyponatraemia, alkalosis,
hypophosphataemia 42,
tumour lysis syndrome 31,
mental status changes,
foreign body sensation in
eyes, conjunctivitis 38,
arrhythmia
Sepsis, adrenal insufficiency,
hyperthyroidism 45,
hypogonadism, Guillain-
Barr syndrome, aseptic
meningitis, syncope, cranial
neuropathy, brain oedema,
ataxia, tremor, myoclonus,
dysarthria, multi-organ
failure, GI ulcer/perforation,
uveitis, vitreous
haemorrhage, peritonitis,
pancreatitis, oesophagitis,
ileus, atrial fibrillation 25,
angiopathy, respiratory
failure 26, ARDS, lung
infiltrates, pneumonitis 26,
hepatic failure, hepatitis,
hepatomegaly 24, TEN,
polymyalgia rheumatica,
arthritis, renal failure 30,
renal tubular acidosis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
94
IRINOTECAN
Generic name Irinotecan
Trade name Campto
Drug action Topoisomerase I inhibitor.
Specific
information
IRRITANT.
Delayed diarrhoea may occur more than 24 hrs after administration and at any time
before the next cycle. This can be life-threatening, especially if the patient is
neutropenic. Fluid and electrolyte replacement must be instigated immediately.
High doses of loperamide must be used, and a prophylactic broad-spectrum
antibiotic should be given if neutropenia is confirmed or suspected. Hospitalisation
is recommended in the presence of fever, or if the diarrhoea persists beyond 48 hrs.
Since irinotecan is partly metabolised by cytochrome P450 CYP3A4, drugs that
inhibit or induce these enzymes may alter the pharmacokinetics of irinotecan and
co-administration should be avoided.
Methods of
administration
IV infusion over 30-90 mins in 250ml NS or D5W.
Side effects Immediate Short-term Long-term
Very common None selected*
Diarrhoea 12 BMD 1 2 3 , alopecia 23
Common Acute cholinergic
syndrome (diarrhoea,
abdominal pain,
conjunctivitis,
hypotension, chills,
malaise, dizziness,
miosis, increased
salivation); treat with
atropine
Nausea and vomiting 10 Increased LFTs 24,
constipation 11, transient
elevation of serum creatinine
Uncommon None selected*
Hypersensitivity 52 None selected*
Rare
Anaphylaxis 52,
hypertension 54
None selected* None selected*
Very rare None selected* None selected* Transient speech disorders
Unknown None selected* None selected*
ILD 26
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
L
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
95
LAPATINIB
Generic name Lapatinib
Trade name Tyverb
Drug action Dual tyrosine kinase inhibitor, inhibiting EGFR (ErbB1) and HER2 (ErbB2).
Specific
information
Cardiac function, including LVEF, should be evaluated prior to initiating lapatinib,
and be monitored throughout treatment. Treatment should be discontinued in
patients with symptoms of decreased LVEF equal to NCI CTCAE grade 3 or above, or
if LVEF drops below the institutions lower limit of normal.
Caution should be taken in patients with conditions that could result in QT
prolongation or if co-administered with other drugs that cause QT prolongation.
Hypokalaemia and hypomagnesaemia should be corrected prior to treatment.
Monitor for symptoms of pulmonary toxicity (dyspnoea, cough, fever) and
discontinue treatment if symptoms are NCI CTCAE grade 3 or greater.
May cause severe diarrhoea, requiring oral and/or IV electrolyte and fluid
replacement. Proactive management with antidiarrhoeals is recommended. Patients
should promptly report changes in bowel patterns. May require dose interruption,
reduction or discontinuation.
Predominantly metabolised by cytochrome P450 CYP3A and therefore interacts with
many drugs affecting these enzymes.
Avoid concomitant treatment with substances that increase gastric pH.
Methods of
administration
Oral, as a single daily dose, at least 1 hr before or 1 hr after food. Administration
time relative to food should be kept the same throughout treatment.
Avoid grapefruit juice.
Side effects Immediate Short-term Long-term
(Note: Many side effects reported when combined with capecitabine, trastuzumab or letrozole)
Very common None selected*
Hot flushes 18, headache,
diarrhoea 12, nausea and
vomiting 10, constipation,
abdominal pain,
dyspepsia 9 , stomatitis 6 ,
epistaxis, cough 26,
dyspnoea
Rash 19, dry skin,
pruritus 21, alopecia 23,
PPE 20, arthralgia, back
pain, pain in extremity 34,
fatigue 53, asthenia,
anorexia 8 , insomnia,
mucositis
Common None selected* None selected*
Decreased LVEF 24,
hyperbilirubinaemia,
hepatotoxicity, nail disorders
(including paronychia) 15,
ILD/pneumonitis 26
Uncommon None selected* None selected* None selected*
Rare Hypersensitivity/
anaphylaxis 52
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
96
LENALIDOMIDE
Generic name Lenalidomide
Trade name Revlimid
Drug action Immunomodulator and angiogenesis inhibitor.
Specific
information
All patients treated must follow the conditions of the Pregnancy Prevention
Programme (except women meeting criteria of non-childbearing potential).
Close monitoring required in patients with cardiac and thromboembolic risk factors.
VTE prophylaxis may be necessary.
Treatment should be discontinued and not resumed in cases of exfoliative or bullous
rash or other suspected severe skin reactions.
Methods of
administration
Oral. The capsules should be swallowed whole, with water, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, flu-like
symptoms 51, infections
(including RTI) 5 ,
dyspnoea 26, epistaxis, rash,
dry skin, pruritus 19,
fatigue 53, oedema,
anorexia 8 ,
hypokalaemia 44, dizziness,
tremor, headache 34
BMD 1 2 3 , VTE, muscle
spasm, pain (bone, muscle
and connective tissue) 34,
blurred vision 38
Common None selected*
Sepsis 5 , abnormal LFTs 24,
hypotension/hypertension
54, dry mouth, stomatitis 6 ,
dyspepsia 9 ,
hyperglycaemia 39, iron
overload
Cataracts 38, deafness/
tinnitus 35,
hypothyroidism 45,
arrhythmia 25, haematuria,
renal failure 30, urinary
incontinence, GI ulcer and
haemorrhage,
hypomagnesaemia 42,
hypocalcaemia 41, chest
pain, lethargy, depression,
confusion, erectile
dysfunction 27,
hyperhidrosis, skin
hyperpigmentation 16, joint
swelling, ataxia
Uncommon None selected*
Hypersensitivity 52, colitis,
hepatic failure 24
Intracranial haemorrhage,
TIA, skin cancer,
photosensitivity 37,
haemolysis, loss of libido 27,
acquired Fanconi syndrome,
blindness
Rare None selected*
Tumour lysis syndrome 31 None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
97
LOMUSTINE
Generic name Lomustine
Trade name N/A
Drug action Alkylating agent; also inhibits nucleic acid synthesis and repair of single-strand
DNA breaks.
Specific
information
Baseline and frequent monitoring of pulmonary function recommended.
Crosses blood-brain barrier.
Methods of
administration
Oral. Capsules should be swallowed whole.
Side effects Immediate Short-term Long-term
Very common None selected*
Rash 19, dry skin,
diarrhoea 12, abnormal
LFTs 24
Thrombocytopenia (nadir
approx 4 weeks) 3 ,
leucopenia (nadir approx 5-6
weeks) 2 ; haematological
toxicity may be cumulative)
Common None selected* None selected* None selected*
Uncommon None selected* None selected*
Anaemia 1
Rare None selected* None selected*
Interstitial pneumonia 26,
lung fibrosis 26,
stomatitis 6 , diarrhoea 12,
alopecia 23
Very rare None selected* None selected* None selected*
Unknown Nausea and
vomiting 10
Anorexia 8 Renal impairment 30,
lung infiltrates 26, abnormal
coordination,
disorientation 33, confusion,
dysarthria, lethargy, visual
impairment 38
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
M
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
99
MELPHALAN
Generic name Melphalan
Trade name N/A
Drug action Alkylating agent.
Specific
information
N/A
Methods of
administration
Slow IV bolus, regional IA perfusion, IV infusion in NS only.
Oral.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10 ,
diarrhoea 12
BMD (delayed onset
2-3 weeks) 1 2 3 ,
stomatitis 6 , alopecia 23
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 Hypersensitivity 52 Pulmonary fibrosis 26,
haemolytic anaemia, hepatic
disorders (abnormal LFTs,
hepatitis, jaundice) 24,
dermatitis 19
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
100
MERCAPTOPURINE
Generic name Mercaptopurine, 6MP
Trade name N/A
Drug action Antimetabolite.
Specific
information
Allopurinol increases mercaptopurine toxicity by inhibiting its metabolism.
Mercaptopurine dose should be lowered if given with allopurinol.
Methods of
administration
Oral.
Side effects Immediate Short-term Long-term
Very common None selected* None selected*
BMD (mild) 1 2 3
Common None selected* Mild nausea and vomiting
(with high doses) 10
Diarrhoea (with high
doses) 12, hepatotoxicity 24
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* Stomatitis (with high
doses) 6 , alopecia 23,
intestinal ulcer
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
101
MESNA
Generic name Mesna
Trade name N/A
Drug action Prevents urothelial toxicity associated with ifosfamide or cyclophosphamide. Exerts
detoxifying effect in efferent urinary tract and bladder.
Specific
information
Increased incidence of pseudoallergic reactions observed in patients with
autoimmune disorders.
Mesna may cause false positive or false negative results in urine dipstick tests for
ketones or erythrocytes.
Methods of
administration
Oral, IV bolus, IV infusion in NS, DS or D5W.
Although mesna tablets are available, the injection formulation can also be taken
orally, added to flavoured drink. Ref: BNF.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, headache,
colic, rash, fatigue 53,
hypotension 54, tachycardia,
limb and joint pain,
depression, irritability
None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
102
METHOTREXATE
Generic name Methotrexate
Trade name Maxtrex (tablets)
Drug action Antimetabolite.
Specific
information
Doses over 100mg/m
2
should not be administered without folinic acid rescue or
assay of serum methotrexate levels 24-48 hrs after dosing.
Methotrexate is extensively protein bound; acidic drugs may increase the risk of
methotrexate toxicity see product literature.
Avoid concomitant use of penicillins, NSAIDs (enhance toxicity of methotrexate by
reducing tubular secretion of methotrexate) and folate antagonists eg, trimethoprim
(severe BMD).
Contraindicated in pre-existing blood dyscrasias, such as bone marrow hypoplasia,
leucopenia, thrombocytopenia or significant anaemia.
Methods of
administration
IV bolus, IV infusion, IM, IA, oral.
Intrathecal refer to national intrathecal guidance.
Diluent: D5W, NS.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
abdominal pain,
stomatitis 6 , anorexia 8 ,
abnormal LFTs
None selected*
Common Diarrhoea Herpes zoster,
BMD 1 2 3 , headache 34,
fatigue 53, drowsiness,
exanthema, erythema,
pruritus 21
Pulmonary complications
due to interstitial
pneumonitis (typical
symptoms dry cough,
dyspnoea, chest pain and
fever; discontinue treatment
and exclude infection) 26
Uncommon None selected* Vertigo, confusion,
depression, seizures 33,
encephalopathy, GI
haemorrhage and ulcer,
pancreatitis
None selected*
Rare None selected* Pericarditis, pericardial
effusion, pericardial
tamponade 25, renal
impairment 30, oliguria,
anuria, visual impairment
Hypotension 54,
thromboembolism, diabetes
Very rare
Anaphylaxis 52 Sepsis 5 , opportunistic
infections 5 ,
lymphadenopathy,
lymphoproliferative
disorders, insomnia,
cognitive impairment, pain,
myasthenia, tumour lysis
syndrome 31
None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
103
MIFAMURTIDE
Generic name Mifamurtide, muramyl tripeptide phosphatidyl ethanolamine (MTP-PE)
Trade name Mepact
Drug action Immunomodulator.
Specific
information
The administration times of mifamurtide and doxorubicin or other lipophilic
medicinal products should be separated.
Mifamurtide acts through stimulation of the immune system; therefore the chronic
or routine use of corticosteroids/ciclosporin/NSAIDs should be avoided during
treatment.
Monitoring of clotting parameters after the first dose and once again after several
doses is recommended.
Methods of
administration
IV infusion over 1 hr. Each vial of mifamurtide should be reconstituted with 50ml NS.
The volume of reconstituted suspension corresponding to the calculated dose is
extracted through the filter provided and further diluted with an additional 50ml NS.
Side effects Immediate Short-term Long-term
Very common
Flu-like symptoms 51,
asthenia, chest pain/
discomfort
Nausea and vomiting 10,
constipation 11,
diarrhoea 12, abdominal
pain, musculoskeletal
stiffness/pain, dyspnoea 26,
cough 26, tachypnoea,
tachycardia, hyperhidrosis,
headache 34, dizziness,
hypotension/hypertension 54
Anorexia/weight loss 8 ,
anaemia 1
Common Infusion site
reactions 14, catheter
site pain, feeling cold,
flushing 18, pallor,
palpitations
Hypokalaemia 44,
paraesthesia, hypoaesthesia,
tremor, somnolence,
lethargy, blurred vision 38,
tinnitus, hearing loss 35,
cyanosis, phlebitis,
dyspepsia 7 , abdominal
distension, rash 19,
pruritus 21, erythema,
muscle spasm, haematuria,
dysuria, pollakiuria, oedema,
mucositis 6
Infections 5 , leucopenia 2 ,
thrombocytopenia 3 ,
dehydration, confusion,
depression, insomnia,
anxiety 33, pleural effusion,
haemoptysis, wheezing,
epistaxis 4 , nasal/sinus
congestion, cancer pain,
pharyngolaryngeal pain, liver
pain, alopecia 23, dry skin,
dysmenorrhoea 27
Uncommon None selected* None selected* None selected*
Rare None selected* Increased blood urea and
creatinine 30
None selected*
Very rare None selected* Subacute thrombosis None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
104
MITOMYCIN
Generic name Mitomycin
Trade name Mitomycin CKyowa
Drug action Cytotoxic antibiotic.
Specific
information
Beware delayed recovery of BMD; toxicity is usually cumulative.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV administration slow IV bolus in WFI or NS, the dose should be given as slowly as
possible and with great care in order to avoid extravasation.
IA; can be given directly into the tumours.
Intravesicular use in bladder cancer usually 20-40mg in 20-40ml WFI or NS is
instilled into the bladder via a urethral catheter. The dose should be retained for a
minimum of 1 hr.
Side effects Immediate Short-term Long-term
Very common Nausea and vomiting
(with high doses) 10
Nausea and vomiting 10,
diarrhoea 12, phlebitis 17
BMD (nadir 4 weeks) 1 2 3 ,
anorexia 8
Common None selected* None selected* Lethargy, asthenia,
fatigue 53, dermatitis 19,
pruritus 21, renal
impairment 30, stomatitis 6 ,
pulmonary disorders
(including pulmonary
oedema, interstitial
pneumonia and pulmonary
fibrosis) 26, weight loss
Uncommon None selected*
Skin reactions, alopecia 23,
haemorrhage, rash 19,
injection site reactions
(vascular pain, erythema,
blisters) 14
Liver and biliary tract
disorders following
administration to the hepatic
artery
Rare Hypersensitivity /
anaphylaxis 52
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected*
Constipation 11 Cystitis and urinary/bladder
disorders following
intravesical administration,
acute leukaemia
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
105
MITOTANE
Generic name Mitotane
Trade name Lysodren
Drug action Antineoplastic agent biochemical mechanism unknown. Adrenal cytotoxic active
substance, also causes adrenal inhibition without cellular destruction.
Specific
information
Plasma levels should be monitored regularly and dose adjustments made in order
to reach therapeutic window with acceptable safety.
Mitotane is an enzyme inducer caution is advised in patients with hepatic
impairment and with concomitant administration of substances metabolised by
cytochrome P450.
Concomitant treatment with spironolactone must be avoided.
Methods of
administration
Oral. Tablets should be taken with water during meals containing food rich in fat.
Daily dose may be divided into 2 or 3 doses.
Advise patients not to use tablets showing signs of deterioration. Caregivers should
wear disposable gloves when handling tablets.
Side effects Immediate Short-term Long-term
Very common None selected*
Mucositis 6 , nausea and
vomiting 10, diarrhoea 12,
epigastric discomfort, ataxia,
paraesthesia, vertigo,
drowsiness, rash 19,
myasthenia, confusion,
leucopenia 2
Increased liver enzymes 24,
anorexia 8 , prolonged
bleeding time,
hypercholesterolemia 46,
hypertriglyceridaemia 46,
adrenal insufficiency ,
gynaecomastia 47
Common Dizziness,
headache 34
None selected*
Anaemia 1 ,
thrombocytopenia 3 , mental
impairment, polyneuropathy,
autoimmune hepatitis
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Hyperpyrexia,
generalised aching,
hypertension 54,
orthostatic
hypotension 54,
flushing 18
Salivary hypersecretion,
dysgeusia 7 , dyspepsia 9 ,
haemorrhagic cystitis 29,
haematuria, proteinuria
Decreased blood uric acid,
maculopathy, eye disorders
(retinal toxicity, diplopia,
lens opacity, visual
impairment) 38, thyroid
impairment, opportunistic
mycosis, liver damage 24
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
106
MITOXANTRONE
Generic name Mitoxantrone, mitozantrone
Trade name N/A
Drug action Anthracycline antibiotic derivative.
Specific
information
Cardiac examinations must be performed in patients who exceed a cumulative dose
of 160mg/m
2
or are at risk of cardiac toxicity.
Methods of
administration
EXFOLIANT AVOID EXTRAVASATION.
IV infusion over at least 3 mins, diluted in at least 50ml NS, D5W or DS.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Anaphylaxis (caused
by sulphites) 52,
phlebitis 17
Blue-green urine (for
24 hrs) 28, anorexia 8 ,
nausea and vomiting 10,
diarrhoea 12,
constipation 11,
stomatitis 6 , mucositis,
GI haemorrhage, abdominal
pain, fever, blue
discolouration of nails, skin
and sclerae 28
Rash, dysgeusia,
somnolence, paraesthesia
(mild), confusion, anxiety,
alopecia, BMD (nadir 10
days) 1 2 3 , pruritus/dry
skin 21, amenorrhoea 27,
increased liver enzymes 24,
creatinine, uric acid and
BUN, cardiac toxicity (CHF,
decreased LVEF, ECG
changes, arrhythmia,
cardiomyopathy) 25
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
N
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
107
NELARABINE
Generic name Nelarabine
Trade name Atriance
Drug action Antimetabolite.
Specific
information
Risk of severe neurological reactions nelarabine must be discontinued at first sign
of neurological events of NCI CTCAE grade 2 or greater.
Patients should receive IV hydration according to standard medical practice for the
management of hyperuricaemia in patients at risk of tumour lysis syndrome. For
patients at risk of hyperuricaemia, the use of allopurinol should be considered.
Methods of
administration
IV infusion. Administer undiluted via a PVC or EVA infusion bag or glass container.
Infuse over 2 hrs in adults or 1 hr in children.
Side effects Immediate Short-term Long-term
Very common
Dyspnoea 26 Diarrhoea 12, nausea and
vomiting 10, constipation 11,
dizziness, headache 34,
cough
Infections (including sepsis,
bacteraemia, pneumonia,
fungal infections) 5 ,
BMD 1 2 3 , fatigue 53,
oedema, pain, peripheral
neuropathy 32, neurotoxicity
(somnolence, paraesthesia
and hypoaesthesia) 33
Common None selected*
Tumour lysis syndrome 31,
hypocalcaemia 41,
hypomagnesaemia 42,
hypokalaemia 44,
anorexia 8 , amnesia,
hypotension 54, pleural
effusion, wheezing,
stomatitis 6 , abdominal
pain 34
Fever 5 , seizures,
confusion, balance disorder,
tremor, dysgeusia 7 ,
blurred vision 38,
musculoskeletal pain,
increased LFTs and
creatinine 24
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
108
NILOTINIB
Generic name Nilotinib
Trade name Tasigna
Drug action BCR-ABL tyrosine kinase inhibitor.
Specific
information
Nilotinib can cause QT prolongation. Baseline ECG and continued monitoring are
recommended as clinically indicated.
Nilotinib is primarily metabolised by hepatic cytochrome P450 CYP3A4 enzymes.
Drugs that are inhibitors or inducers of these enzymes may interact with nilotinib.
Avoid grapefruit juice.
Methods of
administration
Oral. Capsules should be swallowed whole with water. No food should be consumed
for 2 hrs before dose is taken or at least 1 hr after. For patients with swallowing
difficulties, the contents of the capsule can be dispersed in 1 teaspoon of apple
sauce (pureed apple), and taken immediately.
Side effects Immediate Short-term Long-term
Very common None selected*
Headache 34, nausea 10 BMD 1 2 3 ,
hypophosphataemia,
hyperbilirubinaemia,
rash 19, pruritus 21, dry
skin, alopecia, myalgia,
fatigue
Common None selected*
Vomiting 10, diarrhoea 12,
constipation 11, abdominal
pain, dyspepsia 9 ,
dyspnoea, cough 26,
flushing 18, peripheral
oedema
Cardiac disorders
(QT prolongation,
arrhythmia, palpitations) 25,
muscle spasm, arthralgia 34,
pain in extremity, asthenia,
hypokalaemia 44, diabetes,
hypercholesterolaemia 46,
hyperlipidaemia 46,
hyperglycaemia 39,
abnormal LFTs
Uncommon None selected* None selected* Pleural and pericardial
effusions 25 26
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown
Hypersensitivity 52 None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
O
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
109
OFATUMUMAB
Generic name Ofatumumab
Trade name Arzerra
Drug action Monoclonal antibody specific for the CD20 molecule expressed on B-lymphocytes.
Specific
information
Patients should be premedicated with an analgesic, antihistamine and corticosteroid
30-120 mins prior to ofatumumab infusion to reduce the risk of hypersensitivity.
May cause tumour lysis if there is a high tumour burden.
Methods of
administration
IV infusion diluted in 1L NS and administer using the 0.2 micron in-line filter
provided.
First and second infusions: start infusion at 12ml/hr. Double rate every 30 mins to
max 200ml/hr.
Subsequent infusions: start infusion at 25ml/hr. Double rate every 30 mins to max
400ml/hr.
Rates of infusion will be dependent on patient tolerability. If adverse reactions are
observed, infusion should be restarted at 12ml/hr and increased as above if
tolerated.
Side effects Immediate Short-term Long-term
Very common
Hypersensitivity 52 None selected*
RTI 5 , rash, neutropenia 2 ,
anaemia 1
Common
Anaphylaxis 52,
cytokine release
syndrome,
pharyngolaryngeal
pain, cough 26,
hypotension/
hypertension 54
Small bowel obstruction,
diarrhoea 12 , nausea 10
Sepsis 5 , herpes virus
infections 5 , UTI 5 ,
thrombocytopenia 3 ,
leucopenia, back pain
Uncommon None selected*
Tumour lysis syndrome 31 Agranulocytosis,
coagulopathy, red cell
aplasia, lymphopenia
Rare None selected* None selected* Hepatitis B infections and
reactivation
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
110
OXALIPLATIN
Generic name Oxaliplatin
Trade name Eloxatin
Drug action Platinum compound that forms crosslinks with DNA, thereby disrupting DNA
synthesis.
Specific
information
N/A
Methods of
administration
EXFOLIANT AVOID EXTRAVASATION.
IV infusion over 2-6 hrs in D5W. Do NOT dilute with NS or chloride-containing
solutions.
Side effects Immediate Short-term Long-term
Very common Pharyngolaryngeal
dysaesthesia
(dysphagia, dyspnoea,
laryngeal spasm),
acute peripheral
neuropathy (avoid
cold air) 32,
hypersensitivity 52,
anaphylaxis 52
Nausea and vomiting 10,
diarrhoea 12,
constipation 11,
stomatitis 6 , injection site
reactions 14, anorexia 8 ,
epistaxis 4 , alopecia 23,
hypokalaemia 44, fatigue 53,
back pain
BMD 1 2 3 , abnormal
LFTs, dose-cumulative
peripheral neuropathy 32
Common None selected*
Dyspepsia 9 , depression,
insomnia 33,
haemorrhage 4 ,
haematuria, desquamation/
PPE 20, bone pain 34,
arthralgia 34
Nail disorders 15
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
P
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
111
PACLITAXEL ALBUMIN
Generic name Paclitaxel albumin
Trade name Abraxane
Drug action Taxane, inhibitor of mitosis.
Specific
information
Paclitaxel albumin is an albumin-bound nanoparticle formulation of paclitaxel,
which is different to other formulations of paclitaxel. It should NOT be substituted
for or with other paclitaxel formulations.
Methods of
administration
IV infusion over 30 mins.
No diluent in final bag for infusion. The reconstituted paclitaxel albumin (Abraxane)
will appear as a milky suspension.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11,
stomatitis 6 , fever,
fatigue 53, asthenia, rash 19,
alopecia 23
BMD 1 2 3 , anorexia 8 ,
peripheral neuropathy 32,
musculoskeletal pain 34
Common None selected* Abdominal pain and
distension, dyspepsia 9
Infections 5 , headache 34,
dizziness, ataxia,
dehydration, increased
lacrimation, blurred
vision 38, dry eyes 38,
increased appetite,
hypokalaemia 44,
arrhythmia 25, pain in the
extremities 34, muscle
cramps, nail disorders,
pruritus 21, dry skin,
hyperpigmentation,
insomnia, depression,
anxiety, somnolence,
increased liver enzymes 24,
flushing 18, hypertension 54,
lymphoedema, dyspnoea 26,
epistaxis, cough, rhinitis
Uncommon
Hypersensitivity 52 None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
112
PACLITAXEL NON-ALBUMIN
Generic name Paclitaxel
Trade name N/A
Drug action Taxane, inhibitor of mitosis.
Specific
information
Patients should be pre-medicated with a corticosteroid, an antihistamine and an
H
2
-antagonist 30-60 mins prior to infusion.
Contains 49.7% vol ethanol.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Administer paclitaxel first when given in combination with cisplatin.
IV infusion in 250-500ml NS, D5W or DS.
Infuse over 1-3 hrs or according to protocol. Some protocols may infuse over up to
24 hrs.
Must be administered in a non-PVC container using a non-PVC administration set
with 0.22 micron filter (paclitaxel causes leaching of chemicals from PVC).
Excessive shaking or agitation should be avoided.
Inspect prepared solution for precipitation regularly during infusion.
Side effects Immediate Short-term Long-term
Very common Minor hypersensitivity
(mainly flushing and
rash) 52
Nausea and vomiting 10,
diarrhoea 12, mucositis 6 ,
hypotension 54
BMD 1 2 3 , infections
(mainly UTI and upper RTI),
alopecia (total) 23,
musculoskeletal pain 34,
peripheral neuropathy 32
Common Injection site
reactions 14,
bradycadia
Increased liver enzymes 24,
transient and mild nail and
skin changes 15
None selected*
Uncommon Severe
hypersensitivity 52
(urticaria, dyspnoea,
hypotension, chest
pain)
Septic shock
Cardiac disorders 25,
hypertension 54, thrombosis,
thrombophlebitis 17
Rare Anaphylaxis, cardiac
conduction
abnormality 25
None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
113
PANITUMUMAB
Generic name Panitumumab
Trade name Vectibix
Drug action Monoclonal antibody specific for EGFR.
Specific
information
Panitumumab should only be administered to patients that express non-mutated
(wild-type) KRAS gene.
Dose reduction or discontinuation recommended for dermatologic reactions NCI
CTCAE grade 3 or above.
Methods of
administration
Dilute in NS to a final concentration not exceeding 10mg/ml and give via IV infusion
using 0.2 or 0.22 micron in-line filter. On the first cycle, administer over 60 mins. If
tolerated, subsequent cycles can be administered over 30-60 mins. Doses over 1g
should be administered over 90 mins. Infusion set should be flushed with NS before
and after administration.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, abdominal
pain, stomatitis 6 ,
fatigue 53, conjunctivitis 38,
dyspnoea, cough 26, fever,
mucositis 6
Rash 19, acne 17, erythema,
pruritus 21, dry skin,
alopecia 23, paronychia,
anaemia 1 ,
hypomagnesaemia 42,
hypokalaemia 44,
anorexia 8 , insomnia, back
pain 34, peripheral oedema
Common Infusion-related
reactions 52,
hypersensitivity 52,
tachycardia
Cellulitis, folliculitis, anxiety,
headache 34, dizziness,
epistaxis, dyspepsia 9
Leucopenia,
hypocalcaemia 41,
dehydration,
hyperglycaemia 39,
hypophosphataemia 46,
thrombosis, PPE 20,
blepharitis, dry eye 38, eye
pruritus, ocular hyperaemia,
growth of eyelashes, eye
irritation, increased
lacrimation 38
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 None selected* Skin necrosis
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
114
PAZOPANIB
Generic name Pazopanib
Trade name Votrient
Drug action Multi-target tyrosine kinase inhibitor (VEGF receptors 1, 2 and 3,
PDGF receptor /, C-KIT).
Specific
information
BP should be well controlled before initiating pazopanib; frequent monitoring
recommended.
Avoid concomitant treatment with strong inhibitors or inducers of cytochrome
P450 CYP3A4.
Methods of
administration
Oral. Tablets should be taken at least 1 hr before or 2 hrs after a meal.
Avoid grapefruit juice.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
abdominal pain,
diarrhoea 12, dysgeusia 7 ,
hypertension 54,
headache 34
Anorexia 8 , fatigue 53, hair
colour change, alopecia 23,
PPE 20, rash 19, increased
LFTs 24
Common None selected*
Flushing 18, epistaxis,
haemoptysis, dyspnoea 26,
dyspepsia 9 , stomatitis,
flatulence, abdominal
distension
BMD 2 3 , VTE,
paraesthesia 32, dizziness,
lethargy, musculoskeletal
pain, muscle spasm, skin
hypopigmentation,
pruritus 21, hyperhidrosis,
hypothyroidism 45,
proteinuria,
hypophosphataemia 46,
dehydration, insomnia,
blurred vision 38
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
115
PEMETREXED
Generic name Pemetrexed
Trade name Alimta
Drug action Antimetabolite.
Specific
information
Premedication: corticosteroid (dexamethasone 4mg) orally twice daily for 3 days
starting the day before pemetrexed; folic acid 350-1,000 microgram once daily
(5 doses must be given prior to pemetrexed and continued for 21 days after last
dose); vitamin B
12
1g IM in week preceding first dose then once every 3 cycles
thereafter. Subsequent vitamin B
12
injections may be administered on the same day
as pemetrexed.
Caution with other renally excreted drugs including NSAIDs, which should be
omitted for at least 2 days either side of treatment. NSAIDs with long elimination
half-lives (eg, piroxicam) should be interrupted for at least 5 days prior and 2 days
after pemetrexed treatment.
Methods of
administration
IV infusion over 10 mins in 100ml NS.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
diarrhoea 12,
constipation 11, anorexia 8 ,
stomatitis 6 , pharyngitis,
fatigue 53, rash 19,
pruritus 21, alopecia 23
BMD 1 2 3 ,
neuropathy 32, increased
creatinine, decreased
creatinine clearance
Common
Hypersensitivity 52 Fever, dehydration,
conjunctivitis, dysgeusia,
dyspepsia 9
Abnormal LFTs 24
Uncommon None selected*
Nephrotoxicity 30 Peripheral ischaemia
Rare None selected* None selected* None selected*
Very rare
Anaphylaxis 52 Stevens-Johnson syndrome/
TEN 22
None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
116
PENTOSTATIN
Generic name Pentostatin
Trade name Nipent
Drug action Antimetabolite.
Specific
information
Hydration required pre- and post-administration.
Men should not father a child during and up to six months after treatment.
Women of childbearing age must use definitive contraception.
Combination of pentostatin with fludarabine phosphate or high-dose
cyclophosphamide is not recommended owing to the risk of potentially fatal
adverse reactions.
Methods of
administration
Slow IV bolus over 5 mins or infuse over 20-30 mins.
Side effects Immediate Short-term Long-term
Very common None selected* Infections, abdominal pain,
diarrhoea 12, rash 19,
pruritus 21, asthenia 51,
fever 51, chills 51,
headache 34, cough, CNS
toxicity 33
BMD 1 2 3 , hepatic
impairment 24
Common
Flushing 18 Nausea and vomiting 10,
constipation 11,
dyspepsia 9 , fatigue/
malaise 53, mood changes,
anorexia 8 , musculoskeletal
pain, respiratory disorders,
peripheral oedema,
thrombophlebitis 17,
nephrotoxicity (including
dysuria, haematuria) 30, eye
disorders, ear disorders
Cardiac toxicity 25,
neoplasms (including skin
carcinoma)
Uncommon None selected*
Tumour lysis syndrome 31,
haemorrhagic cystitis 29
None selected*
Rare None selected* Oesophageal candidiasis None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
117
PERTUZUMAB
Generic name Pertuzumab
Trade name Perjeta
Drug action Monoclonal antibody specific for EGFR 2 (HER2), mediates antibody-dependent
cell-mediated cytotoxicity. When combined with trastuzumab, which also targets
EGFR 2, antitumour activity is increased.
Specific
information
Observe closely for hypersensitivity for 60 mins after the first infusion then for 30
mins after subsequent infusions.
Decreases in LVEF have been reported. Assess LVEF before and every 3 cycles
during treatment.
Methods of
administration
Initially given as an IV infusion over 1 hr, followed every 3 weeks thereafter by an IV
infusion over 30-60 mins.
Side effects Immediate Short-term Long-term
Very common Hypersensitivity/
anaphylaxis 52,
infusion-related
reactions/cytokine
release syndrome
Upper RTI, BMD 1 2 3 ,
anorexia 8 , peripheral
neuropathy, dysgeusia 7 ,
dizziness, headache 34,
increased lacrimation 38,
dyspnoea, cough 26,
constipation 11, nausea and
vomiting 10, dyspepsia 7 ,
diarrhoea 12, stomatitis 6 ,
rash 19, pain 34, mucositis,
oedema, fever, fatigue 53
Arthritis, myalgia 34,
alopecia 23, dry skin,
insomnia
Common None selected* Chills
Paronychia, LVD, CHF 25,
pleural effusion 26
Uncommon None selected* None selected* ILD
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
118
PIXANTRONE
Generic name Pixantrone
Trade name Pixuvri
Drug action Aza-anthracenedione (anthracycline-related substance).
Specific
information
N/A
Methods of
administration
Slow IV infusion using a 0.2 micron pore size in-line filter over a minimum of 60
mins after dilution with NS to a final volume of 250ml.
Side effects Immediate Short-term Long-term
Very common Asthenia
Nausea and vomiting 10,
skin discolouration 16,
alopecia 23, chromaturia
BMD 1 2 3
Common
Fatigue 53, mucositis,
fever, chest pain 25,
oedema
Dysgeusia 7 , paraesthesia,
headache 34, somnolence,
conjunctivitis, cardiac
disorders 25, dyspnoea,
cough 26, stomatitis 1 ,
diarrhoea 12,
constipation 11, abdominal
pain 34, dry mouth,
dyspepsia 7 , erythema, nail
disorders 15, pruritus 21,
bone pain, proteinuria,
haematuria
Anorexia 8 ,
hypophosphataemia 42
Uncommon
Hypersensitivity 52,
chills, injection site
coldness 14, local
reactions
Anxiety, sleep disorders 33,
dizziness, lethargy, pleural
effusion, pneumonitis 26,
rhinorrhoea, arrhythmia 25,
vascular disorders,
hyperbilirubinaemia,
oliguria, spontaneous
erection 27
Hyperuricaemia 40,
hypocalcaemia 41,
hyponatraemia
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
119
POMALIDOMIDE
Generic name Pomalidomide
Trade name Imnovid
Drug action Has direct anti-myeloma tumouricidal activity, immunomodulatory activities and
inhibits stromal cell support for multiple myeloma tumour cell growth.
Pomalidomide also inhibits angiogenesis by blocking the migration and adhesion of
endothelial cells.
Specific
information
Pomalidomide causes severe and life-threatening birth defects. Both female and
male patients must be enrolled in the Imnovid Pregnancy Prevention Programme
and a Prescription Authorisation Form must be completed with every prescription.
Methods of
administration
Oral. Capsules should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Dyspnoea, cough 26,
diarrhoea 12, nausea 10,
constipation 11, bone pain,
muscle spasm, fatigue 53,
fever, peripheral oedema
Pneumonia 26,
BMD 1 2 3 , anorexia 8
Common None selected* Rash, pruritus
Neutropenic sepsis 5 , RTI,
hyperkalaemia 44,
hyponatraemia, renal
impairment, urinary
retention, pelvic pain,
confusion, reduced
consciousness, peripheral
neuropathy 32, dizziness,
tremor, DVT, pulmonary
embolism, increased ALT
Uncommon None selected* None selected* Hyperbilirubinaemia
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
120
PONATINIB
Generic name Ponatinib
Trade name Iclusig
Drug action Bcr-Abl tyrosine kinase inhibitor.
Specific
information
Caution is advised with concurrent use of moderate/strong inhibitors and strong
inducers of cytochrome P450 CYP3A4. Ponatinib may also increase plasma
concentrations of co-administered substrates of P-gp or BCRP. Products that
elevate gastric pH (such as PPIs, H
2
blockers and antacids) may decrease the
solubility of ponatinib and thus reduce its bioavailability.
Methods of
administration
Oral. Tablets should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Dyspnoea, cough 26,
headache 34, abdominal
pain 34, diarrhoea 12,
nausea and vomiting 10,
constipation 11, increased
lipase and ALT 24,
anorexia 8
BMD 1 2 3 ,
hypertension 54, rash 19, dry
skin, musculoskeletal
pain 34, pain in extremity,
fatigue 53, asthenia,
peripheral oedema, fever
Common None selected*
Blurred vision, dry eye 38,
GORD, dyspepsia, abdominal
distension/discomfort, dry
mouth, insomnia, lethargy,
dizziness, migraine 34, atrial
fibrillation 25, decreased
LVEF 25, hot flushes,
flushing 18, erythema,
pruritus 21, skin pain,
periorbital oedema, chills,
flu-like symptoms 51, chest
pain, pain, mass, face
oedema
Pancreatitis, stomatitis 6 ,
increased blood amylase and
LFTs 24, RTI 26, sepsis,
folliculitis, peripheral
neuropathy, hyperaesthesia,
hypoaesthesia, paraesthesia,
cardiac failure, MI, coronary
artery disease, angina 25,
pericardial and pleural
effusion, DVT, epistaxis 4 ,
dysphonia, fluid and
electrolyte
disturbances 42 44,
hypocalcaemia 41,
hyperglycaemia 39,
hyperuricaemia 40,
hypertriglyceridaemia,
weight loss 8 , alopecia 23,
night sweats, hyperhidrosis,
petechiae, ecchymosis,
muscle spasm, erectile
dysfunction 27
Uncommon None selected*
Tumour lysis syndrome 31,
eyelid oedema
Cerebral infarction, cerebral
artery stenosis, retinal vein
thrombosis, LVD, embolism,
gastric haemorrhage,
hepatotoxicity 24, exfoliative
dermatitis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
121
PROCARBAZINE
Generic name Procarbazine
Trade name N/A
Drug action Cytostatic.
Specific
information
Weak MAO inhibitor properties may interact with certain drugs and foods
containing tyramine.
Intolerance to alcohol (disulfiram-like reaction) may occur.
Methods of
administration
Oral.
A suspension can be made in some aseptic units. This is an unlicensed formulation.
Ref: NEWT guidelines
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
anorexia 8 (all usually
transient)
None selected*
Common None selected* None selected*
BMD 1 2 3
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected*
Hypersensitivity 52
Unknown Mild tyramine
reactions (facial
flushing 18, itchy
rash 19 ), severe
tyramine reactions 43
(sudden headache,
pounding heart, stiff
neck, sweating,
shivering, chills,
sensitivity to light,
nausea and vomiting)
None selected*
Abnormal LFTs 24
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
R
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
123
RALTITREXED
Generic name Raltitrexed
Trade name Tomudex
Drug action Antimetabolite.
Specific
information
Avoid folic acid and folinic acid supplements immediately before and during
administration.
Extreme care should be taken to ensure adequate monitoring of adverse reactions
especially signs of GI toxicity (diarrhoea or mucositis) and BMD (neutropenia,
thrombocytopenia and infections).
Methods of
administration
Short IV infusion in 50-250ml NS or D5W over 15 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
anorexia 8 , diarrhoea 12,
rash 19, pruritus, abdominal
pain, fever, flu-like
symptoms 51
Neutropenia 2 , anaemia 1 ,
arthralgia, hypertonia,
fatigue/malaise 53, asthenia,
increased LFTs 24
Common None selected*
Desquamation, headache 34,
mucositis 6 , infections 5 ,
sweating, cellulitis,
conjunctivitis 38
Thrombocytopenia 3 ,
alopecia 23 , dysgeusia 7
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
124
REGORAFENIB
Generic name Regorafenib
Trade name Stivarga
Drug action Multi-target protein kinase inhibitor with anti-angiogenic and anti-proliferative
activity.
Specific
information
Regorafenib is metabolised by cytochrome P450 CYP3A4 and uridine diphosphate
glucuronosyl transferase UGT1A9. Inducers and inhibitors of these enzymes may
affect the metabolism of regorafenib resulting in decreased or increased effect.
Monitor BP and proteinuria.
Methods of
administration
Oral. Tablets should be swallowed whole after a light meal that contains less than
30% fat.
Side effects Immediate Short-term Long-term
Very common None selected*
Infections 5 ,
thrombocytopenia 3 ,
haemorrhage,
hypertension 54,
headache 34, diarrhoea 12,
PPE 20, rash 19, pain, fever
Anaemia 1 , anorexia 8 ,
stomatitis 6 , mucositis,
dysphonia,
hyperbilirubinaemia,
asthenia/fatigue,
weight loss 8
Common None selected*
Leucopenia 2 ,
hypokalaemia 44,
hypophosphataemia,
hypocalcaemia 41,
hyponatraemia,
hypomagnesaemia 42,
hyperuricaemia, tremor,
dysgeusia, dry mouth, GORD,
gastroenteritis, exfoliative
rash, proteinuria, increased
amylase, lipase and
transaminases 24,
abnormal INR
Hypothyroidism 45, dry skin,
alopecia 23,
nail disorders 15,
musculoskeletal stiffness
Uncommon Hypertensive crisis GI perforation, GI fistula,
erythema multiforme
MI, myocardial ischaemia 25,
severe liver injury
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
125
RITUXIMAB
Generic name Rituximab
Trade name MabThera
Drug action Monoclonal antibody specific for the CD20 antigen on B lymphocytes.
Specific
information
Premedicate with an analgesic, antihistamine and corticosteroid 30-60 mins prior to
infusion if not co-administered as part of chemotherapy. May cause tumour lysis
syndrome if there is a high tumour burden.
Methods of
administration
IV infusion in NS or D5W start first infusion at 50mg/hr then, if well tolerated,
escalate every 30 mins in 50mg/hr increments, to a maximum of 400mg/hr.
Start subsequent infusions at 100mg/hr, and increase every 30 mins in 100mg/hr
increments, to a maximum of 400mg/hr.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea 10, pruritus 21,
rash 19, alopecia 23, fever,
chills, asthenia,
headache 34, infections/
sepsis 5
Leucopenia 2 ,
thrombocytopenia 3
Common None selected*
Vomiting 10, diarrhoea,
hypotension/
hypertension 54,
angioedema, peripheral
oedema, hyperglycaemia,
dizziness, paraesthesia, back
pain 34, abdominal pain 34,
arthralgia 34, cardiac
events 25
Anaemia 1
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected*
Severe skin reactions 22,
progressive multifocal
leukoencephalopathy
None selected*
Unknown Cytokine release
syndrome (dyspnoea,
bronchospasm,
hypoxia) and
infusion-related
reactions 52


interrupt infusion
immediately if severe
None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
126
RUXOLITINIB
Generic name Ruxolitinib
Trade name Jakavi
Drug action Selective inhibitor of the Janus-associated tyrosine kinases JAK1 and JAK2.
Specific
information
Ruxolitinib is metabolised by hepatic cytochrome P450 enzymes. Drugs that are
inhibitors or inducers of these enzymes may interact with ruxolitinib.
Symptoms of myelofibrosis may return over a period of approximately 1 week
following dose interruption/discontinuation. Gradual tapering of the dose may be
considered unless abrupt discontinuation is required, although the utility of the
tapering is unproven.
Methods of
administration
Oral. Tablets can be taken with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
UTI, bruising 4 , dizziness,
headache 34, increased AST
and ALT 24
Weight gain,
hypercholesterolaemia,
BMD 1 2 3 , haemorrhage
(including intracranial
and GI)
Common None selected* Flatulence, herpes zoster None selected*
Uncommon None selected* None selected* Tuberculosis
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
S
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
127
SORAFENIB
Generic name Sorafenib
Trade name Nexavar
Drug action Multi-target tyrosine kinase inhibitor.
Specific
information
N/A
Methods of
administration
Oral. Tablets should be swallowed whole without food or with a low/moderate fat
meal. If the patient intends to have a high fat meal, tablets should be taken at least
1 hr before or 2 hrs after.
Side effects Immediate Short-term Long-term
Very common None selected*
Lymphopenia 2 ,
diarrhoea 12, nausea and
vomiting 10,
hypophosphataemia, PPE 20,
rash 19, pruritus
Hypertension 54,
haemorrhage 4
Common None selected*
BMD 1 2 3 , dry skin,
acne, desquamation,
stomatitis 6 , tinnitus 35,
myalgia/asthenia, fever,
flu-like symptoms 51
Renal impairment 30,
erectile dysfunction 27
Uncommon None selected*
Hypersensitivity 52 Pulmonary complications 27,
abnormal LFTs 24
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
128
STREPTOZOCIN
Generic name Streptozocin
Trade name Zanosar
Drug action Alkylating agent.
Specific
information
No longer licensed in the UK but available on a named-patient basis.
Pancreatic toxicity may cause diabetogenic effect.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV infusion over 30-60 mins in NS or D5W.
Side effects Immediate Short-term Long-term
Very common Burning along vein
during rapid infusion
if extravasated 14,
hypoglycaemia if
infused too rapidly 39
Hypoglycaemia/
hyperglycaemia 39, severe
nausea and vomiting 10,
diarrhoea 12
Nephrotoxicity
(proteinuria, azotaemia,
hypophosphataemia,
glycosuria, renal tubular
acidosis) 30, infertility 27
Common None selected*
Confusion and lethargy 33,
depression 33
Abnormal LFTs 12,
BMD 1 2 3 , alopecia 23,
stomatitis 6 , dysgeusia 7
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
129
SUNITINIB
Generic name Sunitinib
Trade name Sutent
Drug action Multi-target tyrosine kinase inhibitor.
Specific
information
Administration of potent cytochrome P450 CYP3A4 inhibitors/inducers should be
avoided as may increase or decrease sunitinib concentrations.
Yellow discolouration and depigmentation of hair or skin may occur with sunitinib.
Moisturise hands and feet from beginning of treatment.
Methods of
administration
Oral. Capsules should be swallowed whole, with or without food.
Side effects Immediate Short-term Long-term
Very common None selected*
Fatigue 53, diarrhoea 12,
nausea and vomiting 10,
stomatitis 6 , dyspepsia 9 ,
dysgeusia 7 , dry skin,
headache 34, epistaxis
Hypertension 54,
hypothyroidism 45, skin and
hair discolouration 16 23,
PPE 20, neutropenia 2 ,
thrombocytopenia 3
Common None selected* Pulmonary embolism,
tumour haemorrhage,
hypothyroidism 45, dizziness,
cough 26, myalgia, renal
impairment 30, oesophagitis
Peripheral neuropathy 32
Uncommon None selected* None selected* Pancreatitis, hepatic
impairment 54, cardiac
failure/cardiomyopathy 25
Rare None selected* None selected*
QT prolongation 25
Very rare None selected* Stevens-Johnson syndrome/
TEN 22
None selected*
Unknown Angioedema,
hypersensitivity 52
None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
T
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
131
TEGAFUR/GIMERACIL/OTERACIL
Generic name Tegafur/gimeracil/oteracil
Trade name Teysuno
Drug action Tegafur is converted after absorption into the antimetabolite 5-fluorouracil (5-FU),
gimeracil prevents degradation of 5-FU and oteracil decreases the activity of 5-FU in
normal GI mucosa.
Specific
information
Cytochrome P450 CYP2A6 is the major enzyme responsible for the conversion of
tegafur to 5-fluorouracil; therefore, co-administration of CYP2A6 inhibitors should
be avoided.
Methods of
administration
Oral. Capsules should be swallowed whole 1 hr before or 1 hr after a meal. For
patients with swallowing difficulties, try commercial jelly products.
Side effects Immediate Short-term Long-term
Very common None selected*
BMD 1 2 3 , diarrhoea 12,
nausea and vomiting 10,
constipation 11, asthenia
Peripheral neuropathy,
anorexia, fatigue
Common None selected* Lymphopenia, dehydration,
electrolyte imbalance
(including hypokalaemia 44,
hypomagnesaemia 42 ),
insomnia, dizziness,
headache 34,
hypotension 54, DVT,
dyspnoea 26, epistaxis 4 ,
hiccups, cough 26, GI
haemorrhage, stomatitis 6 ,
GI inflammation, flatulence,
abdominal pain/discomfort,
dysphagia, dyspepsia 9 , dry
mouth, mucositis,
dysgeusia 7
Dysgeusia 7 , eye
disorders 38, hearing
impairment 35,
hypertension 54, abnormal
LFTs 24, increased
creatinine, renal
impairment 30, PPE 20,
rash 19, skin
hyperpigmentation 16, dry
skin, pruritus 21,
alopecia 23, weight loss 8 ,
fever, chills
Uncommon Hypersensitivity Infections (including
neutropenic sepsis) 5 ,
altered coagulation,
hyperglycaemia, increased
LDH, hypophosphataemia,
CVA 25, pulmonary
embolism, GI perforation,
multi-organ failure
None selected*
Rare None selected*
Acute hepatic failure 24,
acute pancreatitis,
rhabdomyolysis,
Stevens-Johnson
syndrome/TEN 22,
disseminated intravascular
coagulation
ILD 26, loss of sense of
smell, nail disorders 15,
leukoencephalopathy,
photosensitivity 37
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
132
TEMOZOLOMIDE
Generic name Temozolomide
Trade name Temodal
Drug action Alkylating agent.
Specific
information
If temozolomide is given for 42 days continuously, prophylaxis for Pneumocystis
jiroveci pneumonia should be given. Observe closely for signs of P. jiroveci
pneumonia in patients taking concomitant steroids (regardless of the duration of
temozolomide treatment).
Temozolomide is genotoxic. Men must avoid fathering children during and for
6 months after treatment, and women must use contraception.
Methods of
administration
Oral. Tablets should be swallowed whole on an empty stomach.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10,
constipation 11,
diarrhoea 12, alopecia 23,
rash 19, dry skin,
pruritus 21, erythema
None selected*
Common None selected* Oral candidiasis, dysphagia,
stomatitis 6 , anorexia 8 ,
hyperglycaemia 39,
dysgeusia 7 , cough,
dyspnoea 26,
musculoskeletal pain 34,
myasthenia, fatigue 53,
urinary incontinence,
oedema, DVT, blurred
vision 38, hearing
impairment, tinnitus 35,
anxiety 33, depression 33,
insomnia 33, headache 34,
seizures, dizziness
Thrombocytopenia 3 ,
leucopenia 2 , abnormal
LFTs 24
Uncommon None selected* None selected*
Infertility in men 27,
anaemia 1
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
133
TEMSIROLIMUS
Generic name Temsirolimus
Trade name Torisel
Drug action mTOR (mammalian target of rapamycin) protein kinase inhibitor.
Specific
information
Patients should be premedicated with an antihistamine 30 mins prior
to infusion. Temsirolimus contains ethanol; may be harmful to patients with
alcoholism and impair ability to drive or use machinery (especially doses higher
than 175mg).
Methods of
administration
IV infusion in 250ml NS, over 30-60 mins.
Must be administered in a non-PVC container using a non-PVC administration set
with a 0.2-5 micron filter.
The solution should be protected from excessive room light and sunlight.
Side effects Immediate Short-term Long-term
Very common
Dyspnoea 26 Nausea and vomiting 10,
diarrhoea 12, stomatitis 6 ,
rash 19, pruritus 21,
headache 34
BMD 1 2 3 ,
hypercholesterolaemia 46,
hyperlipidaemia 46,
hyperglycaemia 39, asthenia,
acne, nail disorders 15,
infections (including
cellulitis, herpes zoster,
herpes simplex), anorexia 8 ,
insomnia, increased
creatinine, pneumonia,
hypokalaemia 44,
dysgeusia 7 , fatigue 53,
oedema
Common
Hypersensitivity 52 None selected* Diabetes, increased ALT and
AST, dehydration,
hypocalcaemia 41,
hypophosphataemia 46,
renal impairment 30
Uncommon None selected* None selected* None selected*
Rare None selected* Pneumocystis jiroveci
pneumonia
None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
134
THALIDOMIDE
Generic name Thalidomide
Trade name Thalidomide Celgene
Drug action Immunodulator and angiogenesis inhibitor.
Specific
information
Thalidomide causes severe and life-threatening birth defects. Both female
and male patients must be enrolled in the Thalidomide Celgene Pregnancy
Prevention Programme, and a Prescription Authorisation Form must be
completed with every prescription.
Methods of
administration
Oral. Capsules should be swallowed whole as a single dose at bedtime, with or
without food.
Capsules may be opened and the contents mixed with water to give via a
nasogastric tube, or sprinkled in apple sauce, yoghurt or ice cream. Safe handling
precautions must be used when handling the capsules.
Ref: NEWT Guidelines
Side effects Immediate Short-term Long-term
Very common None selected*
Constipation 11 BMD 1 2 3 , neurological
effects (including peripheral
neuropathy 32 ),
somnolence, fatigue 53,
peripheral oedema
Common None selected*
Vomiting 10, dry mouth,
dyspnoea 26
Confusion, depression, DVT,
pulmonary embolism, ILD,
cardiac disorders 25, severe
rash 19
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
135
THIOTEPA
Generic name Thiotepa
Trade name Tepadina
Drug action Alkylating agent.
Specific
information
IRRITANT.
Methods of
administration
Reconstitute each vial with 10ml WFI, then add to 500ml NS. Administer by IV
infusion via CVAD over 2-4 hrs. If dose higher than 500mg, use 1L NS. For doses
lower than 250mg (eg, in children) use appropriate volume of NS to give final
thiotepa concentration 0.5-1mg/ml.
Side effects Immediate Short-term Long-term
Very common None selected* GvHD, GI disturbances
(nausea and vomiting 10,
diarrhoea 12, dyspepsia 9 ,
enteritis, colitis, abdominal
pain, oesophagitis 6 ,
stomatitis 6 , anorexia 8 ,
hyperglycaemia 39, rash,
pruritus 21, alopecia 23,
blurred vision 38,
conjunctivitis 38,
ototoxicity 35, CNS disorders
(convulsion, encephalopathy,
paraesthesia, dizziness,
headache) 33, arrhythmia 25,
haemorrhagic cystitis 29,
BMD 1 2 3 , infections,
amenorrhoea 27,
azoospermia 27, vaginal
haemorrhage,
lymphoedema,
hypertension 54, idiopathic
pneumonia syndrome,
epistaxis, back pain,
musculoskeletal pain 34
None selected*
Common None selected*
Hypersensitivity 52,
cataracts, intracranial
aneurysm, cerebral
haemorrhage,
tachycardia 25, renal
impairment 30, multi-organ
failure
Secondary malignancy,
hypopituitarism, cardiac
failure 25, haemorrhage 4 ,
embolism, pulmonary
oedema 26, pneumonitis 26,
hepatic disorders
(veno-occlusive liver disease,
hepatomegaly, jaundice,
abnormal LFTs) 24
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected*
Fatigue, asthenia 53 None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
136
TIOGUANINE
Generic name Tioguanine, 6-tioguanine
Trade name N/A
Drug action Antimetabolite.
Specific
information
Unlicensed liquid formulation and 10mg capsules are also available.
Methods of
administration
Oral. Tablets should be taken on an empty stomach.
Side effects Immediate Short-term Long-term
Very common None selected*
Stomatitis 6 , GI intolerance,
nausea 10, diarrhoea 12
BMD 1 2 3 , hepatic
toxicity (including
veno-occlusive disease,
portal hypertension) 24
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* Intestinal necrosis/
perforation
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
137
TOPOTECAN
Generic name Topotecan
Trade name Hycamtin
Drug action Topoisomerase I inhibitor.
Specific
information
Neutropenic colitis should be considered in patients presenting with fever,
neutropenia, and a compatible pattern of abdominal pain.
There have been reports of ILD, some of which have been fatal. Underlying risk
factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to
radiation and use of pneumotoxic drugs and/or colony stimulating factors. Monitor
for symptoms of ILD and discontinue topotecan if ILD is confirmed.
Topotecan is a substrate of P-gp and BCRP; therefore, caution and careful
monitoring is advised when co-administering with drugs that inhibit P-gp or BCRP.
Methods of
administration
EXFOLIANT.
Oral, capsules.
IV infusion in NS/D5W to a concentration of 25-50 microgram/ml over 30 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Alopecia 23, fatigue 53,
asthenia, nausea and
vomiting 10, diarrhoea 12,
constipation 11,
mucositis 6 , abdominal
pain, anorexia 8
BMD 1 2 3 , infections
Common
Hypersensitivity 52,
fever, pruritus 21
Malaise
Sepsis 5 ,
hyperbilirubinaemia 24
Uncommon None selected* None selected* None selected*
Rare
Anaphylaxis 52 None selected* ILD
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* Severe haemorrhage
(associated with
thrombocytopenia)
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
138
TRABECTEDIN
Generic name Trabectedin
Trade name Yondelis
Drug action Cell-cycle inhibitor. Binds to the minor groove of DNA, bending the helix to the major
groove.
Specific
information
Anti-emetic prophylaxis with corticosteroids (eg, dexamethasone) must be
administered to all patients. The dexamethasone additionally has a hepatoprotective
effect.
Trabectedin must not be used in patients with CPK > 2.5 x ULN. Rhabdomyolysis has
been uncommonly reported, usually in association with myelotoxicity, severe LFT
abnormalities and/or renal or multiorgan failure.
Caution should be taken if drugs associated with hepatotoxicity are administered
concomitantly with trabectedin. Alcohol should be avoided during treatment.
Concomitant use of trabectedin with phenytoin may reduce phenytoin absorption
and therefore is not recommended.
Co-administration of trabectedin with potent inhibitors of cytochrome P450 CYP3A4
should be avoided. If this is not possible, close monitoring of toxicities are required
and dose reduction of trabectedin should be considered.
Co-administration of trabectedin with inhibitors of P-gp, eg, verapamil or
ciclosporin, is cautioned.
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Diluted with D5W and given via CVAD.
Soft tissue sarcoma: IV infusion (via an ambulatory pump as an outpatient) over
24 hrs every 3 weeks.
Ovarian cancer: 3-hr IV infusion every 3 weeks.
Side effects Immediate Short-term Long-term
Very common None selected*
Fatigue 53, asthenia 53,
nausea and vomiting 10,
constipation 11,
headache 34, anorexia 8
Increased CPK and
creatinine, decreased blood
albumin, BMD 1 2 3 ,
increased LFTs 24
Common Fever, oedema,
injection site
reactions 14
Dizziness, paraesthesia,
cough, dyspnoea 26,
dehydration, hypotension 54,
flushing 18, diarrhoea 12,
abdominal pain,
dyspepsia 9 , stomatitis 6 ,
weight loss, hypokalaemia 44
Peripheral neuropathy 32,
dysgeusia 7 , alopecia 23,
musculoskeletal pain 34,
infections 5 , insomnia
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
139
TRASTUZUMAB
Generic name Trastuzumab
Trade name Herceptin
Drug action Monoclonal antibody specific for EGFR 2 (HER2).
Specific
information
Patients should be observed for 6 hrs after the start of the first dose and for 2 hrs
after the start of subsequent doses owing to the risk of hypersensitivity.
IV infusion: if a maintenance dose is delayed by more than 1 week, the patient must
be re-loaded.
Methods of
administration
IV infusion in 250ml NS (150mg powder formulation only). Loading/reloading: infuse
over 90 mins. Maintenance: infuse over 30 mins.
SC injection (600mg/5ml solution formulation only). No loading dose required.
Administer over 2-5 mins. Injection site should be alternated between the left and
right thigh. New injections should be given at least 2.5cm from the previous site and
never into areas that are tender, bruised, red or hardened.
Side effects Immediate Short-term Long-term
Very common Injection site
reactions 14,
infusion-related
reactions,
hypersensitivity/
anaphylaxis 52, fever,
BP changes,
arrhythmia 25,
palpitation, wheezing/
dyspnoea, muscle
tightness, tremor,
erythema, rash 19,
pruritus 21, dizziness,
headache 34,
angioedema
Nausea and vomiting 10,
diarrhoea 12, asthenia 53,
fatigue 53, musculoskeletal
pain 34
Reduced LVEF 25
Common None selected*
Constipation 11 Infections 5 , BMD 1 2 3 ,
neutropenic sepsis 5 , CHF
25, cardiomyopathy 25,
oedema, hepatic impairment
24, renal disorders 30,
peripheral neuropathy 32,
paraesthesia, hypertonia,
ataxia, alopecia 23, weight
loss
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Respiratory distress/
failure
Renal impairment 30 None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
140
TRASTUZUMAB EMTANSINE
Generic name Trastuzumab emtansine, TDM-1, ado-trastuzumab emtansine
Trade name Kadcyla
Drug action Antibody-drug conjugate of trastuzumab (human monoclonal antibody specific for
EGFR 2/HER2) and emtansine (inhibitor of mitosis).
Specific
information
Do not substitute trastuzumab emtansine for trastuzumab (Herceptin).
Emtansine is metabolised by hepatic cytochrome P450 enzymes CYP3A4 and (to a
lesser extent) CYP3A5. Drugs that are inhibitors or inducers of these enzymes may
interact with trastuzumab emtansine.
Patients should be observed for 3 hrs after the start of the first infusion and for 1 hr
after the start of subsequent infusions owing to the risk of hypersensitivity.
Evaluation of cardiac function, including baseline LVEF, should be conducted prior to
initiation of treatment and regularly throughout treatment.
Methods of
administration
IV infusion in NS via 0.22 micron in-line non-protein adsorptive filter. Do not shake.
Give first infusion over 90 mins. If first infusion tolerated, give subsequent infusions
over 30 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Diarrhoea 12, fatigue 53,
nausea and vomiting 10,
musculoskeletal pain,
headache 34, constipation 11
Increased transaminases 24,
thrombocytopenia 3 ,
anaemia 1
Common None selected*
Mucositis 6 Hypokalaemia 44,
neutropenia 2 , PPE 20,
reduced LVEF 25, pulmonary
toxicity (ILD,
pneumonitis) 26, peripheral
neuropathy 32
Uncommon Hypersensitivity/
anaphylaxis 52
None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
141
TREOSULFAN
Generic name Treosulfan
Trade name N/A
Drug action Alkylating agent.
Specific
information
N/A
Methods of
administration
VESICANT AVOID EXTRAVASATION.
Oral.
IP.
IV bolus (max dose 3g/m
2
).
IV infusion (doses >3g/m
2
) at a rate of 3g/m
2
every 5-10 mins.
Doses of 8g/m
2
over 30 mins.
Side effects Immediate Short-term Long-term
Very common None selected*
Nausea and vomiting 10 BMD 1 2 3 , alopecia 23,
bronze skin pigmentation 16
Common None selected* None selected* None selected*
Uncommon None selected* None selected* Treatment-related secondary
malignancy
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown
Hypersensitivity 52 Hypoglycaemia 39,
haemorrhagic cystitis 29
None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
142
TRETINOIN
Generic name Tretinoin, all-trans retinoic acid (ATRA)
Trade name Vesanoid
Drug action Not completely understood. Induces cellular differentiation and decreases the
proliferation of acute promyelocytic leukemia cells.
Specific
information
Avoid supplements containing vitamin A because of the potential for additive toxicity.
Tretinoin causes serious birth defects when taken during pregnancy.
Avoid pregnancy during treatment and for 1 month after cessation of treatment.
Pregnancy tests must be performed at monthly intervals during treatment.
The progesterone-only contraceptive (mini pill) is an inadequate form of
contraception for patients taking tretinoin, and alternative methods should be used.
Potentially fatal differentiation syndrome can occur, which is characterised by fever,
dyspnoea, weight gain, lung infiltrates, pleural or pericardial effusions and
leucocytosis. This requires immediate treatment with high-dose steroids
(eg, dexamethasone 10mg IV twice daily).
Patients must not be treated with tetracyclines and tretinoin at the same time owing
to the risk of increased intracranial pressure.
Methods of
administration
Oral, in 2 divided doses. Capsules should be swallowed whole with or just after
a meal.
Side effects Immediate Short-term Long-term
Very common None selected* Differentiation syndrome
(see Specific information),
anorexia 8 , headache 34,
confusion, anxiety,
depression, insomnia 33,
paraesthesia, visual
disturbances 38,
conjunctivitis 38, malaise,
increased serum creatinine,
flushing 18, erythema,
pruritus 21, nausea and
vomiting 10, diarrhoea 12,
constipation 11, alopecia 23,
pain (bone, chest and
abdominal) 34
Hearing impairment 35,
arrhythmia 25, pancreatitis
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected*
Abnormal LFTs 24,
thrombosis,
hypercalcaemia 41, CVA, MI
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
V
Guide to frequency of side effects
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare (<1/10,000)
Unknown (cannot be estimated from the available data spontaneous reports)
Some (but not all) of the adverse events experienced with the drugs over time are listed
in the monographs. Please consult individual SPCs for full details.
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
143
VANDETANIB
Generic name Vandetanib
Trade name Caprelsa
Drug action Potent inhibitor of VEGF receptor 2, EGFR and RET tyrosine kinases and
sub-micromolar inhibitor of VEGF receptor 3.
Specific
information
Vandetanib is associated with a substantial and concentration-dependent
QT prolongation. ECG monitoring should be carried out before treatment, 1, 3, 6 and
12 weeks after starting treatment and following dose adjustment or interruption,
then every 3 months for at least 1 year. Administration of vandetanib with
substances known to cause QT prolongation is contraindicated or not recommended.
Patients without RET mutations may have a decreased benefit from vandetanib
treatment and thus a different benefit/risk balance.
The concomitant use of vandetanib with strong cytochrome P450 CYP3A4 inducers
should be avoided.
Methods of
administration
Oral. Tablets should be taken with or without food. For patients who have difficulty
swallowing, tablets may be dropped in half a glass of non-carbonated water, without
crushing, stirred until dispersed (approximately 10 mins) and the resultant
dispersion swallowed immediately. Any residues in the glass are to be mixed with
half a glass of water and swallowed. The liquid can also be administered through
nasogastric or gastrostomy tubes.
Side effects Immediate Short-term Long-term
Very common None selected*
QT prolongation 25,
GI disturbances,
photosensitivity 37, skin
reactions, nail disorders 15,
upper RTI 26, anorexia 8 ,
hypocalcaemia 41,
headache 34, paraesthesia,
dysaesthesia, dizziness,
hypertension 54, asthenia,
fatigue 53, pain, oedema,
proteinuria
Insomnia, depression 33,
UTI, visual impairment 38,
corneal structural
change 38, renal
impairment 30,
nephrolithiasis
Common None selected* Anxiety, electrolyte
disturbances,
hyperglycaemia 39,
dehydration, colitis, dry
mouth, dry eye 38,
stomatitis 6 , dysphagia,
constipation, PPE 20,
hypothyroidism, increased
AST and ALT 24, weight loss 8 ,
increased blood creatinine
Conjunctivitis 38,
alopecia 23, fever, dysuria,
haematuria, infections 5 ,
GI haemorrhage,
pyelonephritis, gastritis,
epistaxis 4 , haemoptysis,
pneumonitis, lethargy,
dysgeusia 7
Uncommon None selected* None selected* Seizures, clonus, cataract,
heart failure, arrhythmia 25,
ILD 26, pancreatitis,
peritonitis, ileus, intestinal
perforation, anuria, impaired
healing
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
144
VEMURAFENIB
Generic name Vemurafenib
Trade name Zelboraf
Drug action Selective inhibitor of the activated form of BRAF kinase commonly found in
metastatic melanoma.
Specific
information
Before taking vemurafenib, patients must have BRAF V600 mutation-positive
tumour status confirmed by a validated test.
Methods of
administration
Oral. Tablets must be swallowed whole, with or without food, but consistent intake of
both daily doses on an empty stomach should be avoided.
Side effects Immediate Short-term Long-term
Very common None selected*
Anorexia 8 , headache 34,
dysgeusia 7 , cough 26,
diarrhoea 12, nausea and
vomiting 10, constipation 11,
photosensitivity 37, actinic
keratosis, rash 19,
pruritus 21, hyperkeratosis,
erythema, alopecia 23, dry
skin, sunburn, fatigue 53,
fever, increased GGT
Pain in extremity,
musculoskeletal pain 34,
skin papilloma, peripheral
oedema, asthenia, cutaneous
squamous cell carcinoma
Common None selected* 7th nerve paralysis,
dizziness, folliculitis, uveitis,
PPE 20, erythema nodosum,
increased ALT, ALP and
bilirubin 24, weight loss 8 ,
QT prolongation 25
Basal cell carcinoma,
arthritis, keratosis pilaris
Uncommon None selected* Increased AST Non-cutaneous squamous
cell carcinoma, peripheral
neuropathy, retinal vein
occlusion, vasculitis,
Stevens-Johnson syndrome/
TEN 22
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
145
VINBLASTINE
Generic name Vinblastine
Trade name N/A
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Dosage increase may be continued until the dose which reduces WBC to
approximately 3000 cells/mm
3
is reached, but must not exceed 18.5mg/m
2
for adults
or 12.5 mg/m
2
for children.
Methods of
administration
IV USE ONLY. FATAL IF GIVEN BY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
NPSA recommendation:
Adult IV infusion in 50ml NS. Paediatric IV bolus in 20ml NS.
Note that this differs to the SPC which recommends IV bolus.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected*
Hypoaesthesia 32,
paraesthesia 32, peripheral
neuritis 32, loss of deep
tendon reflexes 32
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown Cold sensation/ache
along vein during
injection 14
Tumour pain 48, nausea and
vomiting 10, vesiculation of
the mouth and skin,
diarrhoea 12, anorexia 8 ,
abdominal pain, pharyngitis,
GI haemorrhage,
headache 34, seizures,
asthenia, dizziness 33
Leucopenia 2 ,
constipation 11, jaw pain 49,
depression, malaise,
alopecia 23,
amenorrhoea 27,
azoospermia 27
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
146
VINCRISTINE
Generic name Vincristine
Trade name N/A
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Maximum weekly dose of 2mg for adults.
In general, adverse reactions are reversible and are related to dosage size
and cumulative dosage. The use of small amounts of vincristine daily for long
periods is not advised.
Methods of
administration
IV USE ONLY. FATAL IF GIVEN BY ANY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
NPSA recommendation:
Adult IV infusion in 50ml NS. Paediatric IV bolus in 20ml NS.
Note that this differs from the SPC which recommends IV bolus.
Side effects Immediate Short-term Long-term
Very common None selected* None selected* None selected*
Common None selected* None selected* None selected*
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* SIADH, damage to the 8th
cranial nerve resulting in
deafness, difficulty with
balance, dizziness,
nystagmus and vertigo 33
Very rare None selected* None selected* None selected*
Unknown Cold sensation along
vein 14, anaphylaxis 52
Jaw pain 49, nausea and
vomiting 10, diarrhoea 12,
constipation 11, abdominal
pain, stomatitis 6 ,
anorexia 8
Neurotoxicity and peripheral
neuritis 32, polyuria 30,
dysuria and urinary
retention 30, alopecia 23,
leucopenia 2
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
147
VINDESINE
Generic name Vindesine
Trade name N/A
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Patients with demyelinating Charcot-Marie-Tooth disease (an inherited neuropathic
disorder) should not be given vindesine.
Methods of
administration
IV USE ONLY FATAL IF GIVEN BY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
NPSA recommendation:
Paediatric IV bolus over 5-10 mins in 10-20ml NS.
Note that this differs to the SPC which recommends IV bolus.
To reduce the risk of thrombosis, avoid administering into extremities where blood
circulation is impaired (eg, owing to invading cancer, phlebitis, varicose veins).
Side effects Immediate Short-term Long-term
Very common Injection site reactions
(erythema, burning
pain 14, vein
discolouration 13 and
phlebitis 17

)
Nausea and vomiting 10 Stomatitis 6 , constipation
(mild to moderate) 11,
diarrhoea 12, anorexia, BMD
(nadir days 3-5) 1 2 3 ,
transiently increased
LFTs 24, hypoaesthesia and
paraesthesia 32
Common None selected*
Transient jaw pain 49,
generalised musculoskeletal
pain 34
Alopecia (mild) 23,
fatigue 53, fever
Uncommon
Dyspnoea 52,
bronchospasm 52
None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
148
VINFLUNINE
Generic name Vinflunine
Trade name Javlor
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
In order to prevent constipation, laxatives and dietary measures including oral
hydration are recommended from day 1 to day 5 or 7 after each infusion.
Concomitant use of potent inhibitors or inducers of cytochrome P450 CYP3A4 should
be avoided.
Methods of
administration
IV USE ONLY FATAL IF GIVEN BY OTHER ROUTES.
VESICANT AVOID EXTRAVASATION.
Venous access should be established for a 500ml bag of NS or D5W in the upper part
of the forearm or central venous arm. The IV infusion should be started with half of
the 500ml bag of NS or D5W at a free flowing rate to flush the vein. The vinflunine
solution should be piggy-backed to the side injection port closest to the 500ml bag
to further dilute the drug. Vinflunine should be infused over 20 mins. Patency should
be assessed frequently and extravasation precautions should be maintained
throughout the infusion. After the infusion is completed, the remaining NS or D5W
should be run at a flow rate of 300ml/hr. In order to flush the vein, administration of
vinflunine should always be followed by at least an equal volume of either NS
or D5W.
Side effects Immediate Short-term Long-term
Very common Injection site
reactions 14, fever
Asthenia/fatigue 53,
constipation 11, abdominal
pain 34, nausea and
vomiting 10, diarrhoea 12
BMD 1 2 3 ,
hyponatraemia,
stomatitis 6 , anorexia 8 ,
alopecia 23, myalgia 34,
weight loss 8
Common
Tachycardia 25,
hypersensitivity 52,
chest pain 25, chills,
pain, oedema,
hypotension/
hypertension 54,
phlebitis 17, dyspnoea,
cough 26
Insomnia, headache 34,
dizziness, syncope,
dysphagia, dyspepsia 9 ,
rash 19, pruritus 21,
hyperhidrosis
Infections, ear pain,
dehydration, neuralgia,
dysgeusia 7 , neuropathy,
vein thrombosis, ileus,
buccal disorders,
myasthenia, jaw pain 49,
pain in extremity,
musculoskeletal pain
Uncommon None selected* ARDS
Neutropenic sepsis 5 ,
gastric disorders,
oesophagitis, gingival
disorders 6 , visual
disturbances 38, tinnitus 35,
myocardial ischaemia, MI 25,
pharyngolaryngeal pain,
SIADH, dry skin, erythema,
renal impairment 30,
increased transaminases,
weight gain
Rare None selected* None selected* PRES
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* Tumour pain
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
149
VINORELBINE
Generic name Vinorelbine
Trade name Navelbine
Drug action Vinca alkaloid, inhibitor of mitosis.
Specific
information
Maximum adult IV dose 60mg.
Maximum adult oral dose of 120mg or 160mg depending on the dose and
clinical unit (60mg/m
2
or 80mg/m
2
).
Methods of
administration
VESICANT AVOID EXTRAVASATION.
IV: ACCIDENTAL INTRATHECAL INJECTION IS LIKELY TO BE FATAL.
NPSA recommendation:
Adult IV infusion in 50ml NS. Paediatric IV bolus in 20ml NS.
Note that this differs to the SPC.
Flush with NS following administration.
Oral. Capsules should be swallowed whole and taken with food.
Side effects Immediate Short-term Long-term
Very common Injection site reactions
(erythema, burning
pain 14, vein
discolouration 13,
phlebitis 17

)
Nausea and vomiting 10 Stomatitis 6 , constipation
(mild to moderate) 11, BMD
(leucopenia, neutropenia and
anaemia; nadir-days
5-7) 1 2 , transiently
increased LFTs 24, alopecia
(mild) 23, peripheral
neuropathy 32
Common None selected* Diarrhoea (mild to
moderate) 12
Thrombocytopenia 3 , jaw
pain 49, fatigue 53, fever,
asthenia, pain 34
Uncommon Dyspnoea and
bronchospasm 52
None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
February 2014
150
VISMODEGIB
Generic name Vismodegib
Trade name Erivedge
Drug action Inhibitor of the Hedgehog cell signalling pathway.
Specific
information
Owing to the risk of embryo-foetal death or severe birth defects, women taking
vismodegib must not be pregnant or become pregnant during treatment and for 24
months after the final dose. Women of childbearing potential must comply with
contraceptive measures specified by the SPC.
Vismodegib passes into semen and male patients must comply with contraceptive
measures while taking vismodegib and for 2 months after the final dose, as
specified by the SPC.
An appointed healthcare professional must educate patients so they understand and
acknowledge all the conditions of the Erivedge Pregnancy Prevention Programme.
Medicinal products that alter the pH of the upper GI tract (eg, PPIs, H
2
-receptor
antagonists, and antacids) may reduce vismodegib bioavailability.
Vismodegib is primarily metabolised by the liver. Medicinal products that inhibit or
induce P-gp or cytochrome P450 enzymes may interact with vismodegib.
Methods of
administration
Oral. Capsules must be swallowed whole, with or without food. The capsules must
not be opened, to avoid unintended exposure to patients and health care providers.
Side effects Immediate Short-term Long-term
Very common Nausea and
vomiting 10,
diarrhoea 12,
constipation 11
Anorexia 8 , dysgeusia 7 ,
weight loss 8 , fatigue 53,
pruritus 19
Alopecia 23, muscle spasm,
amenorrhoea 27, ageusia
Common
Rash 19 Increased liver enzymes 24,
dehydration, hyponatraemia,
dyspepsia 9 , abdominal
pain, pain in extremity,
musculoskeletal pain, flank
pain 34
Madarosis, abnormal hair
growth, asthenia, hypogeusia
Uncommon None selected* None selected* None selected*
Rare None selected* None selected* None selected*
Very rare None selected* None selected* None selected*
Unknown None selected* None selected* None selected*
Nursing implications ( 1

2

3

etc) see pages 20-29. *None selected for the purposes of this handbook
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
151
References for drug monographs
Afatinib
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Aflibercept
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Aldesleukin
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Alemtuzumab
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Arsenic trioxide
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14/06/2013; accessed 17 January 2014. Available at: http://www.medicines.org.uk/EMC/medicine/17692/SPC/
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Asparaginase
EUSA Pharma (Europe) Limited. Erwinase, 10,000 Unit/vial, lyophilisate for solution for injection SPC. Last
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Axitinib
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Azacitidine
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Bendamustine
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Bevacizumab
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Bexarotene
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Bleomycin
ProStrakan. Bleo-Kyowa powder for solution for injection SPC. Last updated on the eMC 17/08/2012; accessed
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Bortezomib
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solution+for+injection/
Bosutinib
Pfizer Limited. Bosulif 100mg and 500mg tablets SPC. Last updated on the eMC 07/06/2013; accessed 17 January
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Brentuximab vedotin
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Busulfan
Pierre Fabre Limited. Busilvex 6 mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
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Busilvex+6+mg+ml+concentrate+for+solution+for+infusion/Aspen.
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Cabazitaxel
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Roche Products Limited. Xeloda 150mg and 500mg film-coated tablets SPC. Last updated on the eMC
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Xeloda+150mg+and+500mg+Film-coated+Tablets/
Smyth JA, ed. The NEWT guidelines for administration of medication to patients with enteral feeding tubes or
swallowing difficulties (2nd ed). North East Wales NHS Trust, 2010. Capecitabine (p70).
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Cetuximab
Merck Serono. Erbitux 5mg/ml solution for infusion SPC. Last updated on the eMC 21/03/2013; accessed
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Chlorambucil
Aspen. Chlorambucil 2mg tablets SPC. Last updated on the eMC 13/02/2013; accessed 17 January 2014. Available
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Cisplatin
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Cladribine
Janssen-Cilag Ltd. Leustat Injection SPC. Last updated on the eMC 25/07/2013; accessed 17 January 2014.
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LIPOMED GmbH. Litak 2mg/ml solution for injection SPC. Last updated on the eMC 16/06/2010; accessed
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Clofarabine
Sanofi. Evoltra 1mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 03/12/2013; accessed
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Crizotinib
Pfizer Limited. Xalkori 200mg and 250mg hard capsule SPC. Last updated on the eMC 03/12/2013; accessed
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Cyclophosphamide
Pharmacia Limited. Cyclophosphamide 50 tablets SPC. Last updated on the eMC 26/03/2012; accessed 17 January
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Cytarabine
Napp Pharmaceuticals Limited. DepoCyte 50mg suspension for injection SPC. Last updated on the eMC
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Hospira UK Ltd. Cytarabine injection solution 20mg/ml SPC. Last updated on the eMC 19/11/2010; accessed
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Hospira UK Ltd. Cytarabine injection solution 100mg/ml SPC. Last updated on the eMC 26/11/2010; accessed 17
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Pharmacia Limited. Cytarabine Injection Solution 100mg/ml SPC. Last updated on the eMC 01/10/2013; accessed
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Dacarbazine
medac GmbH. Dacarbazine 100mg, 200mg, 500mg, 1000mg SPC. Last updated on the eMC 1/06/2011; accessed
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Dactinomycin
Lundbeck Pharmaceuticals Ireland Limited. Cosmegen Lyovac 500 micrograms powder for solution for injection
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Dasatinib
Bristol-Myers Squibb Pharmaceutical Limited. Sprycel 20mg, 50mg, 80mg, 100mg and 140mg film coated tablets
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Daunorubicin liposomal
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Daunorubicin non-liposomal
Zentiva. Daunorubicin 20mg powder for injection SPC. Last updated on the eMC 18/11/2013; accessed 17 January
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Decitabine
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Docetaxel
Sanofi-Aventis. Taxotere 20mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 05/07/2013;
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Sanofi-Aventis. Taxotere 80mg/4ml concentrate for solution for infusion SPC. Last updated on the eMC 08/07/2013;
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Sanofi-Aventis. Taxotere 160mg/8ml concentrate for solution for infusion SPC. Last updated on the eMC
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medac GmbH. Taxceus 20mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 05/07/2013;
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Hospira UK Ltd. Docetaxel Hospira 10mg/ml concentrate for solution for infusion SPC. Last updated on the eMC
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Doxorubicin liposomal
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Cephalon (UK) Limited. Myocet SPC. Last updated on the eMC 14/06/2013; accessed 17 January 2014. Available at:
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Doxorubicin non-liposomal
medac GmbH. Doxorubicin hydrochloride 2mg/ml solution for infusion SPC. Last updated on the eMC 06/03/2012;
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Epirubicin
Pharmacia Limited. Pharmorubicin SPC. Last updated on the eMC 06/11/2012; accessed 17 January 2014.
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Actavis UK Ltd. Epirubicin hydrochloride 2mg/ml solution for injection SPC. Last updated on the eMC 10/06/2013;
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Eribulin
Eisai Ltd. Halaven 0.44mg/ml solution for injection SPC. Last updated on the eMC 06/08/2013; accessed 17 January
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Erlotinib
Roche Products Limited. Tarceva 25mg, 100mg and 150mg film-coated tablets SPC. Last updated on the eMC
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Pfizer Limited. Estracyt Capsules SPC. Last updated on the eMC 12/08/2013; accessed 17 January 2014. Available
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Etoposide
Bristol-Myers Squibb Holdings Limited. Vepesid Soft Capsules 50mg and 100mg SPC. Last updated on the eMC
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medac GmbH. Eposin concentrate for solution for infusion 20mg/ml SPC. Last updated on the eMC 05/12/2011;
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Smyth JA, editor. The NEWT guidelines for administration of medication to patients with enteral feeding tubes or
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Etoposide phosphate
Bristol-Myers Squibb Pharmaceuticals Limited. Etopophos 100mg powder for solution for injection SPC. Last
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Everolimus
Novartis Pharmaceuticals UK Ltd. Afinitor tablets SPC. Last updated on the eMC 02/12/2013; accessed 17 January
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Novartis Pharmaceuticals UK Ltd. Votubia 5mg tablets SPC. Last updated on the eMC 10/12/2013; accessed
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Fludarabine
Sanofi. Fludara 50mg powder for solution for injection or infusion SPC. Last updated on the eMC 13/04/2011;
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Sanofi. Fludara oral 10mg film-coated tablet SPC. Last updated on the eMC 23/08/2011; accessed 17 January 2014.
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5-fluorouracil
medac GmbH. Fluorouracil injection, 25mg/ml, solution for injection SPC. Last updated on the eMC 26/02/2010;
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Folinic acid
medac GmbH. Sodiofolin 50mg/ml, solution for injection SPC. Last updated on the eMC 17/10/2012; accessed
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Pfizer Limited. Refolinon injection 3mg/ml SPC. Last updated on the eMC 20/08/2013; accessed 17 January 2014.
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Pfizer Limited. Refolinon tablets SPC. Last updated on the eMC 15/09/2009; accessed 17 January 2014. Available
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Gefitinib
AstraZeneca UK Ltd. Iressa 250mg film-coated tablets SPC. last updated on the eMC 20/08/2013;
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Gemcitabine
Eli Lilly and Company Ltd. Gemzar 200mg powder for solution for infusion, Gemzar 1000mg powder for solution for
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Hydroxycarbamide
E. R. Squibb & Sons Limited. Hydrea 500mg hard capsules SPC. Last updated on the eMC 01/06/2012;
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Idarubicin
Pharmacia Limited. Zavedos 5mg powder for solution for injection SPC. Last updated on the eMC 06/11/2012;
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Pharmacia Limited. Zavedos 10mg capsules SPC. Last updated on the eMC 06/11/2012; accessed 17 January 2014.
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Ifosfamide
Baxter Healthcare Ltd. Ifosfamide injection 1g SPC. Last updated 10/07/2012; accessed 17 January 2014.
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Baxter Healthcare Ltd. Ifosfamide injection 2g SPC. Last updated 10/07/2012; accessed 17 January 2014.
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Imatinib
Novartis Pharmaceuticals UK Ltd. Glivec tablets SPC. Last updated on the eMC 28/11/2013; accessed
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Interferon alfa
Merck Sharp & Dohme Limited. IntronA 18, 30 and 60 million IU solution for injection, multidose pen SPC. Last
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Roche Products Limited. Roferon-A 18MIU/0.6ml Cartridge SPC. Last updated on the eMC 29/07/2013;
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Roche Products Limited. Roferon-A Pre-Filled Syringe SPC. Last updated on the eMC 25/07/2013;
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Ipilimumab
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Irinotecan
Pfizer Limited. Campto 20mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 30/04/2013;
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Lapatinib
GlaxoSmithKline UK. Tyverb SPC. Last updated 12/08/2013; accessed 17 January 2014. Available at:
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Lenalidomide
Celgene Ltd. Revlimid SPC. Last updated 06/12/2013; accessed 17 January 2013. Available at: http://www.
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Lomustine
medac GmbH. Lomustine medac 40mg SPC. Last updated on the eMC 14/03/2013; accessed 17 January 2014.
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Melphalan
Aspen. Melphalan 2mg tablets SPC. Last updated on the eMC 07/02/2013; accessed 17 January 2014. Available at:
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Aspen. Melphalan 50mg powder and solvent for solution for injection/infusion SPC. Last updated on the eMC
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Mercaptopurine
Aspen. Mercaptopurine 50mg tablets SPC. Last updated on the eMC 17/04/2013; accessed 17 January 2014.
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Mesna
Baxter Healthcare Ltd. Mesna tablets 400mg SPC. Last updated 06/04/2009; accessed 17 January 2014.
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Methotrexate
Pharmacia Limited. Maxtrex tablets 10mg SPC. Last updated on the eMC 15/11/2013; accessed 17 January 2014.
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Hospira UK Ltd. Methotrexate 100mg/ml injection SPC. Last updated on the eMC 30/01/2009; accessed 17 January
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Accord Healthcare Limited. Methotrexate 25mg/ml solution for injection SPC. Last updated on the eMC 12/11/2013;
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Mifamurtide
Takeda UK Ltd. Mepact 4mg powder for suspension for infusion SPC. Last updated on the eMC 04/10/2013;
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Mitomycin
ProStrakan. Mitomycin C SPC. Last updated on the eMC 31/05/2013; accessed 17 January 2014. Available at:
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Mitotane
HRA Pharma UK and Ireland Limited. Lysodren 500mg tablets SPC. Last updated on the eMC 04/07/2013; accessed
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Mitoxantrone
Hospira UK Ltd. Mitoxantrone (Mitozantrone) 2mg/ml sterile concentrate SPC. Last updated on the eMC
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Nelarabine
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Nilotinib
Novartis Pharmaceuticals UK Ltd. Tasigna 150mg hard capsules SPC. Last updated on the eMC 09/09/2013;
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Ofatumumab
GlaxoSmithKline UK. Arzerra (acetate formulation) SPC. Last updated on the eMC 27/11/2013; accessed 17 January
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Oxaliplatin
Sanofi. Eloxatin 5mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 03/02/2012; accessed
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Actavis UK Ltd. Oxaliplatin 5mg/ml powder for solution for infusion SPC. Last updated on the eMC 06/01/2011;
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Paclitaxel albumin
Celgene Ltd. Abraxane 5mg/ml powder for suspension for infusion SPC. Last updated on the eMC 23/08/2013;
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Paclitaxel non-albumin
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Actavis UK Ltd. Paclitaxel 6mg/ml concentrate for solution for infusion SPC. Last updated on the eMC 18/07/2013;
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Panitumumab
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Pazopanib
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Pemetrexed
Eli Lilly and Company Limited. Alimta 100mg/500mg powder for concentrate for solution for infusion SPC. Last
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Pentostatin
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Pertuzumab
Roche Products Limited. Perjeta 420mg concentrate for solution for infusion SPC. Last updated on the eMC
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Pixantrone
CTI Life Sciences Limited. Pixuvri 29mg powder for concentrate for solution for infusion SPC. Last updated
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Pomalidomide
Celgene Ltd. Imnovid SPC. Last updated on the eMC 30/09/2013; accessed 17 January 2014. Available at:
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Ponatinib
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Procarbazine
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Topotecan
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Appendix 1
Glossary
absolute risk
A measure of the risk of a certain event happening. In cancer research, it is the likelihood that a
person who is free of a specific type of cancer at a given age will develop that cancer over a certain
period of time. For example, a woman 35 years of age, with no known risk factors for breast cancer,
has an absolute risk of getting breast cancer.
alkylating agent
A type of drug that is used in the treatment of cancer. It interferes with the cells DNA and inhibits
cancer cell growth.
angiogenesis
Blood vessel formation. Tumour angiogenesis is the growth of new blood vessels that tumours need
to grow. This process is caused by the release of chemicals by the tumour and by host cells near
the tumour.
angiogenesis inhibitor
A drug or substance that keeps new blood vessels from forming. In cancer treatment, angiogenesis
inhibitors may prevent the growth of new blood vessels that tumours need to grow.
anthracycline
A type of antibiotic that comes from certain types of Streptomyces bacteria. Anthracyclines are used
to treat many types of cancer. Anthracyclines damage the DNA in cancer cells, causing them to die.
Daunorubicin, doxorubicin and epirubicin are anthracyclines.
antibody-dependent cell-mediated cytotoxicity (ADCC)
A type of immune reaction in which a target cell or microbe is coated with antibodies and killed
by certain types of white blood cells. The white blood cells bind to the antibodies and release
substances that kill the target cells or microbes. Also called antibody-dependent cellular
cytotoxicity.
antigen
Any substance that causes the body to make a specific immune response.
antimetabolite
A drug that is very similar to natural chemicals involved in a normal biochemical reaction in cells
but different enough to interfere with the normal division and functions of cells.
antisense DNA
Small pieces of DNA that can bind to specific molecules of RNA and block the cells ability to use the
RNA to make a protein or work in other ways. Antisense DNA may be used to block the production
of proteins needed for cell growth. It is being studied in the treatment of many types of cancer.
anti-VEGFR monoclonal antibody
A monoclonal antibody being studied in the treatment of some types of cancer. Monoclonal
antibodies are made in the laboratory and can locate and bind to substances in the body, including
cancer cells. Anti-VEGFR monoclonal antibodies bind to receptors for vascular endothelial growth
factor (VEGF) and keep VEGF from binding to them. This may stop the growth of new blood vessels
that tumours need to grow. They act as antiangiogenesis agents.
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apoptosis
A type of cell death in which a series of molecular steps in a cell lead to its death. This is one
method the body uses to get rid of unneeded or abnormal cells. The process of apoptosis may be
blocked in cancer cells. Also called programmed cell death.
B cell
A type of white blood cell that makes antibodies. B cells are part of the immune system and develop
from stem cells in the bone marrow. Also called B lymphocyte.
Bcr-Abl fusion protein
A protein made from pieces of two genes that get joined together. It is found in most patients with
chronic myelogenous leukaemia, and in some patients with acute lymphoblastic leukaemia or acute
myelogenous leukaemia. Inside the leukaemia cells, the Abl gene from chromosome 9 joins to the
Bcr gene on chromosome 22 to form the Bcr-Abl fusion gene, which makes the Bcr-Abl fusion protein.
blood-brain barrier (BBB)
A network of blood vessels and tissue that is made up of closely spaced cells and helps keep
harmful substances from reaching the brain. The blood-brain barrier lets some substances, such
as water, oxygen, carbon dioxide and general anaesthetics, pass into the brain. It also keeps out
bacteria and other substances, including many anticancer drugs.
brachytherapy
A type of radiation therapy in which radioactive material sealed in needles, seeds, wires or
catheters is placed directly into or near a tumour. Also called implant radiation therapy, internal
radiation therapy and radiation brachytherapy.
bronchoscopy
A procedure that uses a bronchoscope to examine the inside of the trachea, bronchi (air passages
that lead to the lungs) and lungs. A bronchoscope is a thin, tube-like instrument with a light and
a lens for viewing. It may also have a tool to remove tissue to be checked under a microscope for
signs of disease. The bronchoscope is inserted through the nose or mouth. Bronchoscopy may be
used to detect cancer or to perform some treatment procedures.
carcinogen
Any substance that causes cancer.
carcinoma in situ
A group of abnormal cells that remain in the place where they first formed. They have not spread.
These abnormal cells may become cancer and spread into nearby normal tissue. Also called
stage 0 disease.
cell-cell signalling
The transfer of information from one cell to another. Cells signal to each other by direct contact
or by the release of a substance from one cell that is taken up by another cell. Cell-cell signalling
is important for cells to grow and work normally. Cells that lose the ability to respond to signals
from other cells may become cancer cells. Also called cell-to-cell signalling and intercellular
communication.
cell-cycle regulation
Any process that controls the series of events by which a cell goes through the cell cycle. During
the cell cycle, a cell makes a copy of its DNA and other contents, and divides in two. When cell cycle
regulation doesnt happen correctly, cells may divide in an uncontrolled way and diseases such as
cancer can occur.
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central venous access catheter
A thin, flexible tube that is inserted into a vein in the upper arm, thigh or neck or below the
collarbone. It is guided (threaded) into a large vein near the heart called the vena cava or into the
right atrium of the heart. It is used to give intravenous fluids, blood transfusions and chemotherapy
and other drugs, and for taking blood samples. It reduces the need for repeated injections.
chemoradiation
Treatment that combines chemotherapy with radiation therapy. Also called chemoradiotherapy.
DNA
The molecules inside cells that carry genetic information and pass it from one generation to the
next. Also called deoxyribonucleic acid.
DNA methyltransferase
An enzyme that attaches methyl groups to DNA. A methyl group is a chemical group containing one
carbon and three hydrogen atoms. Also called DNA methylase.
epidermal growth factor receptor (EGFR)
The protein found on the surface of some cells to which epidermal growth factor binds, causing the
cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so
these cells may divide excessively in the presence of epidermal growth factor. Also called ErbB1
and HER1.
febrile neutropenia
A condition marked by fever and a lower-than-normal number of neutrophils in the blood. A
neutrophil is a type of white blood cell that helps fight infection. Having too few neutrophils
increases the risk of infection.
fusion gene
A gene made by joining parts of two different genes. Fusion genes may occur naturally in the body
by transfer of DNA between chromosomes. For example, the BCR-ABL gene found in some types of
leukaemia is a fusion gene. Fusion genes can also be made in the laboratory by combining genes or
parts of genes from the same or different organisms.
genomic profile
Information about all the genes in an organism, including variations, gene expression and the way
those genes interact with each other and with the environment. A genomic profile may be used to
discover why some people get certain diseases while other people do not, or why people respond
differently to the same drug.
hazard ratio
A measure of how often a particular event happens in one group compared to how often it happens
in another group, over time. In cancer research, hazard ratios are often used in clinical trials
to measure survival at any point in time in a group of patients who have been given a specific
treatment compared to a control group given another treatment or a placebo. A hazard ratio of one
means that there is no difference in survival between the two groups. A hazard ratio of greater than
one or less than one means that survival was better in one of the groups.
Karnofsky Performance Status (KPS)
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky
Performance scores range from 0 to 100. A higher score means the patient is better able to carry
out daily activities. KPS may be used to determine a patients prognosis, to measure changes in a
patients ability to function, or to decide if a patient could be included in a clinical trial.
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mean survival
The average length of time from either the date of diagnosis or the start of treatment for a disease,
such as cancer, for which the patient is alive. In a clinical trial, measuring mean survival is one way
to see how well a new treatment works.
measurable disease
A tumour that can be accurately measured in size. This information can be used to judge response
to treatment.
meiosis
A special form of cell division in which each daughter cell receives half the amount of DNA as the
parent cell. Meiosis occurs during formation of egg and sperm cells in mammals.
metastasis
The spread of cancer from one part of the body to another. A tumour formed by cells that have
spread is called a metastatic tumour or a metastasis. The metastatic tumour contains cells that
are like those in the original (primary) tumour. The plural form of metastasis is metastases.
micrometastasis
Small numbers of cancer cells that have spread from the primary tumour to other parts of the body
and are too few to be picked up in a screening or diagnostic test.
mitosis
The process by which a single parent cell divides to make two new daughter cells. Each daughter
cell receives a complete set of chromosomes from the parent cell. This process allows the body to
grow and replace cells.
mitotic inhibitor
A type of drug that blocks cell growth by stopping mitosis (cell division). Mitotic inhibitors are used
to treat cancer. Also called antimitotic agent.
molecular marker
A biological molecule found in blood, other body fluids or tissues that is a sign of a normal or
abnormal process, or of a condition or disease. A molecular marker may be used to see how
well the body responds to a treatment for a disease or condition. Also called biomarker and
signature molecule.
monoclonal antibody
A type of protein made in the laboratory that can bind to substances in the body, including cancer
cells. There are many kinds of monoclonal antibodies. A monoclonal antibody is made so that it
binds to only one substance. Monoclonal antibodies are being used to treat some types of cancer.
They can be used alone or to carry drugs, toxins or radioactive substances directly to cancer cells.
oestrogen receptor (ER)
A protein found inside the cells of the female reproductive tissue, some other types of tissue and
some cancer cells. The hormone oestrogen will bind to the receptors inside the cells and may cause
the cells to grow.
oncogene
A mutated (changed) form of a gene involved in normal cell growth. Oncogenes may cause the
growth of cancer cells. Mutations in genes that become oncogenes can be inherited or caused by
being exposed to substances in the environment that cause cancer.
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phlebitis
Inflammation (redness, swelling, pain and heat) of a vein, usually in the legs. Phlebitis may be
caused by infection, injury or irritation.
phototoxicity
A condition in which the skin or eyes become very sensitive to sunlight or other forms of light. It can
be caused by taking certain drugs or rubbing certain essential oils (scented liquid taken from plants)
or other topical agents into the skin. Phototoxicity causes sunburn, blisters and other skin problems.
predictive factor
A condition or finding that can be used to help predict whether a persons cancer will respond
to a specific treatment. The term may also describe something that increases a persons risk of
developing a condition or disease.
progesterone receptor (PR)
A protein found inside the cells of the female reproductive tissue, some other types of tissue and
some cancer cells. The hormone progesterone binds to the receptors inside the cells and may
cause the cells to grow.
prognostic factor
A situation or condition, or a characteristic of a patient, that can be used to estimate the chance of
recovery from a disease or the chance of the disease recurring (coming back).
progression-free survival
The length of time during and after treatment for which a patient is living with a disease that does
not get worse. Progression-free survival may be measured in a clinical study or trial to help find out
how well a new treatment works.
protein expression
Refers to the production of protein by cells. The study of protein expression in cancer cells may give
information about a specific type of cancer, the best treatment to use and how well a treatment works.
proto-oncogene
A gene involved in normal cell growth. Mutations (changes) in a proto-oncogene may cause it to
become an oncogene, which can cause the growth of cancer cells.
prostate-specific antigen (PSA)
A protein made by the prostate gland and found in the blood. PSA blood levels may be higher
than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH) or infection or
inflammation of the prostate gland.
quality of life
The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on
quality of life. These studies measure aspects of an individuals sense of wellbeing and ability to
carry out various activities.
reactive oxygen species
A type of unstable molecule that contains oxygen and that easily reacts with other molecules in a
cell. A build up of reactive oxygen species in cells may cause damage to DNA, RNA and proteins,
and may cause cell death. Reactive oxygen species are free radicals. Also called oxygen radical.
salvage therapy
Treatment that is given after the cancer has not responded to other treatments.
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signal transduction inhibitor
A substance that blocks signals passed from one molecule to another inside a cell. Blocking these
signals can affect many functions of the cell, including cell division and cell death, and may kill
cancer cells. Certain signal transduction inhibitors are being studied in the treatment of cancer.
signalling pathway
Describes a group of molecules in a cell that work together to control one or more cell functions, such
as cell division or cell death. After the first molecule in a pathway receives a signal, it activates another
molecule. This process is repeated until the last molecule is activated and the cell function is carried out.
Abnormal activation of signalling pathways can lead to cancer, and drugs are being developed to
block these pathways. These drugs may help block cancer cell growth and kill cancer cells.
stable disease
Cancer that is neither decreasing nor increasing in extent or severity.
stage
The extent of a cancer in the body. Staging is usually based on the size of the tumour, whether
lymph nodes contain cancer and whether the cancer has spread from the original site to other parts
of the body.
stem cell
A cell from which other types of cells develop. For example, blood cells develop from blood-forming
stem cells.
stereotactic body radiation therapy
A type of external radiation therapy that uses special equipment to position a patient and precisely
deliver radiation to tumours in the body (except the brain). The total dose of radiation is divided into
smaller doses given over several days. This type of radiation therapy helps spare normal tissue.
survivorship
In cancer, survivorship focuses on the health and life of a person with cancer post treatment until
the end of life. It covers the physical, psychosocial and economic issues of cancer, beyond the
diagnosis and treatment phases. Survivorship includes issues related to the ability to obtain health
care and follow-up treatment, late effects of treatment, second cancers and quality of life. Family
members, friends and caregivers are also considered part of the survivorship experience.
synergistic
In medicine, describes the interaction of two or more drugs when their combined effect is greater
than the sum of the effects seen when each drug is given alone.
T cell
A type of white blood cell. T cells are part of the immune system and develop from stem cells in the
bone marrow. They help protect the body from infection and may help fight cancer. Also called T
lymphocyte and thymocyte.
targeted therapy
A type of treatment that uses drugs or other substances to identify and attack specific types
of cancer cells with less harm to normal cells. Some targeted therapies block the action of
certain enzymes, proteins or other molecules involved in the growth and spread of cancer cells.
Other types of targeted therapies help the immune system kill cancer cells or deliver toxic
substances directly to cancer cells and kill them. Targeted therapy may have fewer side effects
than other types of cancer treatment. Most targeted therapies are either small molecule drugs or
monoclonal antibodies.
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taxane
A type of drug that blocks cell growth by stopping mitosis (cell division). Taxanes interfere with
microtubules (cellular structures that help move chromosomes during mitosis). They are used to
treat cancer. A taxane is a type of mitotic inhibitor and a type of antimicrotubule agent.
telomerase
An enzyme in cells that helps keep them alive by adding DNA to telomeres (the ends of
chromosomes). Each time a cell divides, the telomeres lose a small amount of DNA and become
shorter. Over time, the chromosomes become damaged and the cells die. Telomerase helps keep
this from happening. Cancer cells usually have more telomerase than most normal cells.
thrombolysis
The process of breaking up a thrombus (blood clot) that is blocking blood flow. The blood clot may
be dissolved using drugs delivered through a catheter (tube) into the clot.
thrombophlebitis
Inflammation of a vein that occurs when a blood clot forms.
thymidylate synthase
An enzyme involved in making and repairing DNA. High levels of thymidylate synthase may be
involved in how certain types of cancer form and respond to treatment.
time to progression (TTP)
The length of time from the date of diagnosis or the start of treatment for a disease until the
disease starts to get worse or spread to other parts of the body. In a clinical trial, measuring the
time to progression is one way to see how well a new treatment works.
TNM staging system
A system to describe the amount and spread of cancer in a patients body. T describes the size of
the tumour and any spread of cancer into nearby tissue; N describes the spread of cancer to
nearby lymph nodes; and M describes metastasis (spread of cancer to other parts of the body).
This system was created and is updated by the American Joint Committee on Cancer (AJCC) and
the International Union Against Cancer (UICC). The TNM staging system is used to describe most
types of cancer.
topoisomerase inhibitor
A substance that blocks topoisomerase (enzymes that break and rejoin DNA strands and are
needed for cells to divide and grow). Blocking these enzymes may kill cancer cells. Certain
topoisomerase inhibitors are being studied in the treatment of cancer.
total parenteral nutrition (TPN)
A form of nutrition that is delivered into a vein. Total parenteral nutrition does not use the digestive
system. It may be given to people who are unable to absorb nutrients through the intestinal tract
because of persistent vomiting, severe diarrhoea or intestinal disease. It may also be given to those
undergoing high-dose chemotherapy or radiation and bone marrow transplantation. It is possible
to give all of the protein, calories, vitamins and minerals a person needs using total parenteral
nutrition. Also called hyperalimentation and parenteral nutrition.
transcription
In biology, the process by which a cell makes an RNA copy of a gene (sequence of DNA).
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tumour lysis syndrome
A condition that can occur after treatment of a fast-growing cancer, especially certain leukaemias
and lymphomas (cancers of the blood). As tumour cells die, they break apart and release their
contents into the blood. This causes a change in certain chemicals in the blood, which may cause
damage to organs, including the kidneys, heart and liver.
tumour necrosis factor (TNF)
A protein made by white blood cells in response to an antigen or infection. TNF can also be made in
the laboratory. It may boost a persons immune response, and also may cause necrosis (cell death)
of some types of tumour cells. TNF is being studied in the treatment of some types of cancer. It is a
type of cytokine.
tumour suppressor gene
A type of gene that makes a protein called a tumour suppressor protein that helps control cell
growth. Mutations (changes in DNA) in tumour suppressor genes may lead to cancer. Also called
antioncogene.
tyrosine kinase inhibitor
A substance that blocks the action of enzymes called tyrosine kinases. Tyrosine kinases are involved
in many cell functions, including cell signalling, growth and division. These enzymes may be too
active or found at high levels in some types of cancer cells, and blocking them may help keep
cancer cells from growing. Some tyrosine kinase inhibitors are used to treat cancer. They are a type
of targeted therapy.
vascular endothelial growth factor (VEGF)
A substance made by cells that stimulates new blood vessel formation.
whole-brain radiation therapy (WBRT)
A type of external radiation therapy used to treat patients who have cancer in the brain. It is often
used to treat patients whose cancer has spread to the brain, or who have more than one tumour or
tumours that cannot be removed by surgery. Radiation is given to the whole brain over a period of
many weeks. Also called whole-brain radiotherapy.
wedge resection
Surgery to remove a triangle-shaped slice of tissue. It may be used to remove a tumour and a small
amount of normal tissue around it.


Reference
National Cancer Institute at the National Institutes of Health. NCI Dictionary of Cancer Terms. Available from:
http://www.cancer.gov/dictionary (accessed 14 January 2014).
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
171
Appendix 2
NCI CTCAE v4.0
This is an abbreviated adaption from the original publication by the US National Cancer Institute.
Please refer to the original publication at: http://evs.nci.nih.gov/ftp1/CTCAE/About.html
Grade 1 Grade 2 Grade 3 Grade 4
Blood and lymphatic system disorders
Anaemia
Haemoglobin
(Hgb)
<LLN10.0g/dL;
<LLN6.2mmol/L;
<LLN100g/L
<10.08.0g/dL;
<6.24.9mmol/L;
<10080g/L
<8.0g/dL;
<4.9mmol/L;
<80g/L;
transfusion indicated
Life-threatening;
urgent intervention
indicated
Febrile
neutropenia
Absolute
neutrophil count
(ANC)
<100/mm
3
with a
single temperature
of >38.3C or
a sustained
temperature of
38C for more than
1 hr
Life-threatening;
urgent intervention
indicated
Ear and labyrinth disorders
Ear pain Mild pain Moderate pain Severe pain
Tinnitus Mild symptoms Moderate symptoms Severe symptoms
Eye disorders
Conjunctivitis Asymptomatic or
mild symptoms
Symptomatic;
topical intervention
indicated
Limiting self care
activities of daily
living

Gastrointestinal disorders
Dry mouth Dry or thick saliva
without significant
dietary alteration
Oral intake alteration
(eg, copious water,
other lubricants, diet
limited to purees
and/or soft, moist
foods)
Inability to
adequately aliment
orally; tube feeding
or TPN indicated

Dyspepsia Mild symptoms Moderate symptoms Severe symptoms


Dysphagia Symptomatic,
tolerates regular diet
Symptomatic and
altered eating/
swallowing
Severe; tube
feeding or TPN
or hospitalisation
indicated
Life-threatening;
urgent intervention
indicated
Oesophagitis Asymptomatic;
intervention not
indicated
Symptomatic;
altered eating/
swallowing; oral
supplements
indicated
Severe; tube
feeding, TPN or
hospitalisation
indicated
Life-threatening;
urgent intervention
indicated
Vomiting 12 episodes in
24 hrs
35 episodes in
24 hrs
6 episodes; tube
feeding, TPN or
hospitalisation
indicated
Life-threatening;
urgent intervention
indicated
February 2014
172
Grade 1 Grade 2 Grade 3 Grade 4
General disorders and administration site conditions
Fatigue Fatigue relieved by
rest
Fatigue not relieved
by rest; limiting
instrumental
activities of daily
living
Fatigue not relieved
by rest; limiting self
care activities of
daily living

Fever 38.039.0C >39.040.0C >40.0C for 24 hrs >40.0C for >24 hrs
Flu-like
symptoms
Mild flu-like
symptoms present
Moderate symptoms;
limiting instrumental
activities of daily
living
Severe symptoms;
limiting self care
activities of daily
living

Infusion-related
reaction
Mild; infusion
interruption not
indicated
Therapy or infusion
interruption
indicated but
responds promptly
to antihistamines,
NSAIDs, narcotics,
IV fluids; prophylactic
medications
indicated for 24 hrs
Prolonged
recurrence of
symptoms following
initial improvement;
hospitalisation
indicated
Life-threatening;
urgent intervention
indicated
Infusion site
extravasation
Erythema with
associated
symptoms (eg,
oedema, pain,
induration, phlebitis)
Ulceration or
necrosis; severe
tissue damage;
operative
intervention
indicated
Life-threatening;
urgent intervention
indicated
Injection site
reaction
Tenderness with or
without associated
symptoms (eg,
warmth, erythema,
pruritus)
Pain; lipodystrophy;
oedema, phlebitis
Ulceration or
necrosis; severe
tissue damage;
operative
intervention
indicated
Life-threatening;
urgent intervention
indicated
Investigations
Alkaline
phosphatase
increased
>ULN2.5 x ULN >2.55.0 x ULN >5.020.0 x ULN >20.0 x ULN
Blood bilirubin
increased
>ULN1.5 x ULN >1.53.0 x ULN >3.010.0 x ULN >10.0 x ULN
Creatinine
increased
>11.5 x baseline;
>ULN1.5 x ULN
>1.53.0 x baseline;
>1.53.0 x ULN
>3.0 baseline;
>3.06.0 x ULN
>6.0 x ULN
Lymphocyte
count decreased
<LLN800/mm
3
;
<LLLN0.8 x 10
9
/L
<800500/mm
3
;
<0.80.5 x 10
9
/L
<500200/mm
3
;
<0.50.2 x 10
9
/L
<200/mm
3
;
<0.2 x 10
9
/L
Lymphocyte
count increased
>400020,000/mm
3
>20,000/mm
3

Neutrophil count
decreased
<LLN1,500/mm
3
;
<LLN1.5 x 10
9
/L
<1,5001,000/mm
3
;
<1.51.0 x 10
9
/L
<1,000500/mm
3
;
<1.00.5 x 10
9
/L
<500/mm
3
;
<0.5 x 10
9
/L
Platelet count
decreased
<LLN75,000/mm
3
;
<LLN75.0 x 10
9
/L
<75,00050,000/mm
3
;
<75.050.0 x 10
9
/L
<50.00025,000/mm
3
;
<50.025.0 x 10
9
/L
<25.000/mm
3
;
<25.0 x 10
9
/L
Serum amylase
increased
>ULN1.5 x ULN >1.52.0 x ULN >2.05.0 x ULN >5.0 x ULN
Urine output
decreased
Oliguria
(<80ml in 8 hrs)
Anuria
(<240ml in 24 hrs)
Weight gain 5<10% from
baseline
10<20% from
baseline
20% from baseline
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
173
Grade 1 Grade 2 Grade 3 Grade 4
Investigations continued
Weight loss 5<10% from
baseline;
intervention not
indicated
10<20% from
baseline; nutritional
support indicated
20% from baseline;
tube feeding or TPN
indicated

White blood cell


decreased
<LLN3,000/mm
3
;
<LLN3.0 x 10
9
/L
<3,0002,000/mm
3
;
<3.02.0 x 10
9
/L
<2,0001,000/mm
3
;
<2.01.0 x 10
9
/L

Nervous system disorders


Peripheral
sensory
neuropathy
Asymptomatic;
loss of deep
tendon reflexes or
paraesthesia
Moderate; limiting
instrumental
activities of daily
living
Severe; limiting self
care activities of
daily living
Life-threatening;
urgent intervention
indicated
Renal and urinary disorders
Haematuria Asymptomatic;
intervention not
indicated
Symptomatic;
urinary catheter or
bladder irrigation
indicated; limiting
instrumental
activities of daily
living
Gross haematuria;
transfusion,
IV medications or
hospitalisation;
or operative
intervention
indicated; limiting
self care activities of
daily living
Life-threatening;
urgent intervention
indicated
Proteinuria 1+ proteinuria;
urinary protein
<1.0g/24 hrs
2+ proteinuria;
urinary protein
1.03.4g/24 hrs
Urinary protein
3.5g/24 hrs

Skin and subcutaneous tissue disorders


Alopecia Hair loss <50% of
normal for that
individual that is
not obvious from a
distance but only on
close inspection
Hair loss 50%
normal for that
individual that is
readily apparent
to others; wig
indicated;
psychosocial impact

Pruritus Mild or localised;
topical intervention
indicated
Intense or
widespread;
intermittent; skin
changes from
scratching (eg,
oedema, papulation,
excoriations,
lichenification,
oozing/crusts);
oral intervention
indicated; limiting
instrumental
activities of daily
living
Intense or
widespread;
constant; limiting
self care activities of
daily living or sleep;
oral corticosteroid or
immunosuppressive
therapy indicated

Rash -
maculopapular
Macules/papules
covering <10% BSA
with or without
symptoms (eg,
pruritus, burning,
tightness)
Macules/papules
covering 1030%
BSA +/- symptoms;
limiting instrumental
activities of daily
living
Macules/papules
covering >30% BSA
+/- symptoms;
limiting self care
activities of daily
living

February 2014
174
Appendix 3
The cell cycle
M PHASE = MITOSIS
R = RESTRICTION POINT
(Cell commits to cell division and
enters S-phase)
Prophase
Chromosomes
(containing DNA)
form identical pairs
(called chromatids)
and move towards
the centre of the
cell
Metaphase
Spindle fibres
attach to
chromosomes;
chromatids begin to
separate
Anaphase
Two sets of new
single-stranded
chromosomes move
to opposite ends of
the cell
Telephase
A nuclear
membrane forms
around each set of
chromosomes; a
membrane divides
the cell in two
S-PHASE =
SYNTHESIS PHASE
(DNA replication)
G2 PHASE =
SECOND GAP PHASE
(Preparation for mitosis)
G1 PHASE =
FIRST GAP PHASE
(Metabolic changes occur to
prepare cell for division)
G0 = CELL CYCLE
ARREST
INTERPHASE = G1 + S + G2
(Period between mitotic divisions)
Lilly Handbook of Systemic Treatments for Cancer 8th Edition
175
Creatinine clearance
Determines an estimate of glomerular filtration rate using age and serum creatinine concentration.
Calculate estimated creatinine clearance using the Cockcroft and Gault
1
formula:
Estimated creatinine
Clearance (ml/min) =
(140 age) x weight x sex-dependent constant
serum creatinine
Age (years); weight (kg); serum creatinine (micromol/L)
Sex-dependent constant
Male = 1.23
Female = 1.04
Body surface area (BSA)
The Mosteller
2
formula
BSA (m
2
) =
height (cm) x weight (kg)
3600
Appendix 4
Useful formulae
Please note that these formulae are examples of the various published formulae for calculating,
for example, body surface area. These are presented as a guide and it is the responsibility of the
practitioner to refer to local protocols and/or guidelines.
February 2014
176
Calverts formula for carboplatin dosing
The systemic drug exposure produced by any dose of carboplatin in a patient can be reasonably
estimated on the basis of his or her renal function. Calverts formula
3
of delivering a calculated dose
in terms of target carboplatin area under the time-concentration curve (AUC) and a measured or
estimated glomerular filtration rate (GFR) has been widely used.
Please refer to your local protocol or the relevant SPC for the recommended target AUC.
Note: with the Calvert formula, the total dose of carboplatin is calculated in mg, not mg/m
2
.
Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
References
1. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41.
2. Mosteller RD. Simplified calculation of body surface area. N Engl J Med 1987; 317: 1098.
3. Calvert AH, Newell DR, Gumbrell LA et al. Carboplatin dosage: prospective evaluation of a simple formula
based on renal function. J Clin Oncol 1987; 7: 1748-56.
A Medical Education Goods and Services item by Lilly Oncology UK
UKONC00326 February 2014