Bendamus tine H yd rochlorid e 100mg Pow der fo r Injectio n TajPhar ma : U s es , Side Effects , Interac tions , Pictures , W arni ngs

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Rx  chronic lymphocytic leukaemia in cases

where fludarabine combination
Bendamustine hydrochloride chemotherapy is not appropriate for you
 non-Hodgkin’s lymphomas, which had not,
for Injection 100mg Taj or only shortly, responded to prior rituximab
Pharma treatment
 multiple myeloma in cases where high-dose
(Bendamustine hydrochloride)
chemotherapy with autologous stem cell
Package leaflet: Information for the user transplantation, thalidomide or bortezomib
Read all of this leaflet carefully before you containing therapy is not appropriate for
start using this medicine because it contains you.
important information for you.
2. WHAT YOU NEED TO KNOW
 Keep this leaflet. You may need to read it BEFORE YOU USE
again.
 If you have any further questions, ask your BENDAMUSTINE
doctor or pharmacist. HYDROCHLORIDE
 If you get any side effects, talk to your Do not use Bendamustine hydrochloride
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.  if you are allergic to bendamustine
See section 4. hydrochloride or any of the other ingredients
of this medicine (listed in section 6)
What is in this leaflet  while breastfeeding, if treatment with
1. What Bendamustine hydrochloride is and Bendamustine hydrochloride is necessary
what it is used for during lactation you must discontinue
2. What you need to know before you use breastfeeding (see section warnings and
Bendamustine hydrochloride precautions on breastfeeding)
3. How to use Bendamustine hydrochloride  if you have severe liver dysfunction
4. Possible side effects (damage to the functional cells of the liver)
5. How to store Bendamustine hydrochloride  if you have yellowing of the skin or whites
6. Contents of the pack and other information of the eyes caused by liver or blood
problems (jaundice)
 if you have severely disturbed bone marrow
1. WHAT BENDAMUSTINE function (bone marrow depression) and
HYDROCHLORIDE IS AND serious changes in your number of white
blood cells and platelets in the blood
WHAT IT IS USED FOR
 if you have had major surgical operations
Bendamustine hydrochloride is a medicine less than 30 days before starting treatment
which is used for the treatment of certain types  if you have an infection, especially one
of cancer (cytotoxic medicine). accompanied by a reduction in white blood
Bendamustine hydrochloride is used alone cells (leucocytopenia)
(monotherapy) or in combination with other  in combination with yellow fever vaccines.
medicines for the treatment of the following
forms of cancer: Warnings and precautions
Talk to your doctor or nurse before using
Bendamustine hydrochoride
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 in case of reduced capability of the bone Other medicines and Bendamustine

marrow to replace blood cells. You should hydrochloride
have your number of white blood cells and Tell your doctor or pharmacist if you are
platelets in the blood checked before starting taking, have recently taken or might take any
treatment with Bendamustine hydrochloride other medicines.
before each subsequent course of treatment
and in the intervals between courses of If Bendamustine hydrochloride is used in
treatment combination with medicines which inhibit the
 in case of infections. You should contact formation of blood in the bone marrow, the
your doctor if you have signs of infection, effect on the bone marrow may be intensified.
including fever or lung symptoms If Bendamustine hydrochloride is used in
 in cases of existing heart disease (e.g. heart combination with medicines which alter your
attack, chest pain, severely disturbed heart immune response, this effect may be intensified.
rhythms). Cytostatic medicines may diminish the
effectiveness of live-virus vaccination.
Talk to your doctor or nurse during use of Additionally cytostatic medicines increase the
Bendamustine hydrochloride risk of an infection after vaccination with live
vaccines (e.g. viral vaccination).
 in case you notice any pain in your side, Pregnancy, breastfeeding and fertility
blood in your urine or reduced amount of
urine. When your disease is very severe, If you are pregnant or breastfeeding, think you
your body may not be able to clear all the may be pregnant or are planning to have a baby,
waste products from the dying cancer cells. ask your doctor or pharmacist for advice before
This is called tumour lysis syndrome and using this medicine.
can cause kidney failure and heart problems Pregnancy
within 48 hours of the first dose of Bendamustine hydrochloride can cause genetic
Bendamustine hydrochloride. Your doctor damage and has caused malformations in animal
may ensure you are adequately hydrated and studies. You should not use Bendamustine
give you other medicines to help prevent it hydrochloride during pregnancy unless certainly
 in case of reactions on your skin during indicated by your doctor. In case of treatment
treatment with Bendamustine hydrochloride. you should have medical consultation about the
The reactions may increase in severity risk of potential adverse effects of your therapy
 in case of painful red or purplish rash that for the unborn child and genetic consultation is
spreads and blisters and/or other lesions recommended.
begin to appear in the mucous membrane
(e.g. mouth and lips), in particular if you had If you are a woman of childbearing potential you
before light sensitivity, infections of the must use an effective method of contraception
respiratory system (e.g. bronchitis) and/or both before and during treatment with
fever Bendamustine hydrochloride. If pregnancy
 in case of severe allergic or occurs during your treatment with Bendamustine
hypersensitivity reactions. You should pay hydrochloride you must immediately inform
attention to infusion reactions after your first your doctor and should have genetic
cycle of therapy. consultation.
If you are a man, you should avoid fathering a
Children and adolescents child during treatment with Bendamustine
hydrochloride and for up to 6 months after
There is no experience in children and
treatment has stopped. There is a risk that
adolescents with bendamustine hydrochloride.
treatment with Bendamustine hydrochloride will
 Bendamus tine H yd rochlorid e 100mg Pow der fo r Injectio n TajPhar ma : U s es , Side Effects , Interac tions , Pictures , W arni ngs , Bendamus ti ne H ydrochlori de Dos age & Rx Info | B endamus ti ne H ydrochlori de U s es , Side Effects - Anticancer, Bendam us tine H ydrochlo ride : Indicati ons , Side Effects , W arnings , Ben damus tine H ydr ochloride - Dr ug Info rmati on - TajPha rma, Be ndamus tin e H ydrochlori de dos e Taj phar maceuticals Bendam us tine H ydrochlo ride inte ractions , Taj Pha rmaceutical Ben damus tine H ydr ochloride con train dications , Benda mus tine H ydrochl oride p rice, Benda mus ti ne H ydrochlo ride TajPh arma Benda mus tine H ydrochl oride Pow der fo r Injecti on PIL - TajPha rma Stay connec ted to all up dated o n Benda mus tine H ydrochlo ride Taj Pha rmaceuticals Taj pha rmaceuticals Mu mbai. Patien t Inf orma tion Leaflets , PIL.

lead to infertility and you may wish to seek Bendamustine hydrochloride 120 mg per square
advice on conservation of sperm before metre of your body surface area (based on your
treatment starts. height and weight) on Days 1+2
Breastfeeding Repeat the cycle after 3 weeks at least 6 times
Bendamustine hydrochloride must not be Multiple myeloma
administered during breastfeeding. If treatment Bendamustine hydrochloride 120-150 mg per
with Bendamustine hydrochloride is necessary square metre of your body surface area (based
during lactation you must discontinue on your height and weight) on Days 1+2
breastfeeding. Ask your doctor or pharmacist for
advice before taking any medicine. Prednisone 60 mg per square metre of your body
surface area (based on your height and weight)
Fertility i.v. or per os. on Days 1–4
Men receiving treatment with Bendamustine Repeat the cycle after 4 weeks at least 3 times
hydrochloride are advised not to conceive a
child during treatment and for up to 6 months Treatment should be terminated if white blood
afterwards. Before starting treatment, you should cell (leukocyte) and/or platelet values drop to
seek advice on storing sperm because of the determined levels. Treatment can be continued
possibility of permanent infertility. after white blood cell values have increased.
Driving and using machines Impaired liver or kidney function
No studies on the effects on the ability to drive Dependent on the degree of impairment of your
and to use machines have been performed. liver function it may be necessary to adjust your
dose (by 30% in case of moderate liver
Do not drive or operate machines if you dysfunction). No dose adjustment is necessary in
experience side effects, such as dizziness or lack case of impairment of kidney function. Your
of coordination. attending doctor will decide whether a dosage
adjustment is necessary.
3. HOW TO USE How it is administered
BENDAMUSTINE Treatment with Bendamustine hydrochloride
should be undertaken only by doctors
HYDROCHLORIDE experienced in tumour therapy. Your doctor will
Bendamustine hydrochloride is administered give you the exact dose of Bendamustine
into a vein over 30-60 minutes in various hydrochloride and use the necessary precautions.
dosages, either alone (monotherapy) or in
Your attending doctor will administer the
combination with other medicines.
solution for infusion after preparation as
Treatment should not be started if your white prescribed. The solution is administered into a
blood cells (leukocytes) have fallen to counts vein as a short-term infusion over 30-60
below determined levels. minutes.
Your doctor will determine these values at Duration of use
regular intervals.
There is no time limit laid down as a general
Chronic lymphocytic leukaemia rule for treatment with Bendamustine
Bendamustine hydrochloride 100 mg per square hydrochloride. Duration of treatment depends on
metre of your body surface area (based on your disease and response to treatment.
height and weight) on Days 1+2 If you are at all worried or have any questions
Repeat the cycle after 4 weeks up to 6 times regarding treatment with Bendamustine
hydrochloride, please speak to your doctor or
Non-Hodgkin’s lymphomas
nurse.
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If you forget to use Bendamustine  feeling sick (nausea)

hydrochloride  vomiting
If a dose of Bendamustine hydrochloride has  mucosal inflammation
been forgotten, your doctor will usually retain  headache
the normal dosage schedule.  increased blood level of creatinine (a
chemical waste product that is produced by
If you stop using Bendamustine your muscle)
hydrochloride  increased blood level of urea (a chemical
The doctor treating you will decide whether to waste product)
interrupt the treatment or to change over to a  fever
different preparation.  fatigue.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist. Common side effects (may affect up to 1 in 10
people)

4. POSSIBLE SIDE EFFECTS  bleeding (haemorrhage)

Like all medicines, this medicine can cause side  disturbed metabolism caused by dying
effects, although not everybody gets them. cancer cells releasing their contents into the
blood stream
Some of the findings listed below may be found  reduction in red blood cells which can make
after tests performed by your doctor. the skin pale and cause weakness or
Tissue decay (necrosis) has been observed very breathlessness (anaemia)
rarely following leakage of Bendamustine  low counts of neutrophils (a common type
hydrochloride into the tissue outside the blood of white blood cell important to fighting off
vessels (extravascular). A burning sensation infections)
where the infusion needle is inserted may be a  hypersensitivity reactions such as allergic
sign of leakage outside the blood vessels. The inflammation of the skin (dermatitis), nettle
consequence can be pain and poorly healing skin rash (urticaria)
defects.  a rise in liver enzymes AST/ALT (which
The dose-limiting side-effect of Bendamustine may indicate inflammation or damage to
hydrochloride is impaired bone-marrow cells in the liver)
function, which usually returns to normal after  a rise in the enzyme alkaline phosphatase
treatment. Suppressed bone marrow function (an enzyme made mostly in the liver and
may lead to low blood cells, which in turn may bones)
lead to an increased risk of infection, anaemia or  a rise in bile pigment (a substance made
a heightened risk of bleeding. during the normal breakdown of red blood
cells)
Very common side effects (may affect more  low potassium blood levels (a nutrient that is
than 1 in 10 people) necessary for the function of nerve and
muscle cells, including those in your heart)
 low counts of white blood cells (disease-  disturbed function (dysfunction) of the heart
fighting cells in your blood) (palpitations, angina pectoris)
 decrease in the red pigment of the blood  disturbed heart rhythms (arrhythmia)
(haemoglobin: a protein in red blood cells  low or high blood pressure (hypotension or
that carries oxygen throughout the body) hypertension)
 low counts of platelets (colourless blood  disturbed lung function
cells that help blood clot)  diarrhoea
 infections  constipation
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 sore mouth (stomatitis) Very rare side effects (may affect up to 1 in

 loss of appetite 10,000 people)
 hair loss
 skin changes  primary atypical inflammation of the lungs
 missed periods (amenorrhoea) (pneumonia)
 pain  break-down of red blood cells
 insomnia  rapid decrease in blood pressure sometimes
 chills with skin reactions or rash (anaphylactic
 dehydration shock)
 dizziness  disturbed sense of taste
 itchy rash (urticaria).  altered sensations (paraesthesia)
 malaise and pain in the limbs (peripheral
Uncommon side effects (may affect up to 1 in neuropathy)
100 people)  serious condition resulting in the blockade
of specific receptor in the nervous systems
 accumulation of fluid in the heart sac  disorders of the nervous system
(escape of fluid into the pericardial space)  lack of coordination (ataxia)
 ineffective production of all blood cells  inflammation of the brain (encephalitis)
(myelodysplastic syndrome)  increased heart rate (tachycardia)
 acute leukemia  inflammation of the veins (phlebitis)
 heart attack, chest pain (myocardial infarct)  formation of tissue in the lungs (fibrosis of
 heart failure. the lungs)
 bleeding inflammation of the gullet
Rare side effects (may affect up to 1 in 1,000 (haemorrhagic oesophagitis)
people)  bleeding of stomach or gut
 infertility
 infection of the blood (sepsis)  multiple organ failure.
 severe allergic hypersensitivity reactions
(anaphylactic reactions) Not known side effects (cannot be estimated
 reduction in your bone marrow function, from the available data)
which may make you feel unwell or show up
in your blood tests  liver failure
 signs similar to anaphylactic reactions  renal failure
(anaphylactoid reactions)  irregular and often rapid heart rate (atrial
 drowsiness fibrillation)
 loss of voice (aphonia)  painful red or purplish rash that spreads and
 acute circulatory collapse (failure of blood blisters and/or other lesions begin to appear
circulation mainly from a cardiac origin with in the mucous membrane (e.g. mouth and
failure to maintain the supply of oxygen and lips), in particular if you had before light
other nutrients to the tissues and removing sensitivity, infections of the respiratory
toxins) system (e.g. bronchitis) and/or fever
 reddening of the skin (erythema)  pneumonitis
 inflammation of the skin (dermatitis)  bleeding from the lungs.
 itching (pruritus)
 skin rash (macular exanthema) There have been reports of tumours
 excessive sweating (hyperhidrosis). (myelodysplastic syndrome, acute myeloid
leukaemia (AML), bronchial carcinoma)
following treatment with Bendamustine
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hydrochloride. No clear relationship with After reconstitution and dilution, chemical and
Bendamustine hydrochloride could be physical stability has been demonstrated for 3.5
determined. hours at 25°C/60% RH and 2 days at 2°C to 8°C
Contact your doctor or seek medical attention in polyethylene bags.
immediately if you notice any of the following From a microbiological point of view, the
side effects (frequency not known): product should be used immediately. If not used
immediately, in-use storage times and conditions
 serious skin rashes including Stevens- prior to use are the responsibility of the user and
Johnson syndrome and toxic epidermal would normally not be longer than 24 hours at
necrolysis. These can appear as reddish 2° to 8°C, unless reconstitution/dilution (etc) has
target-like macules or circular patches often taken place in controlled and validated aseptic
with central blisters on the trunk, skin conditions.
peeling, ulcers of mouth, throat, nose, Do not throw away any medicines via
genitals and eyes and can be preceded by wastewater or household waste. Ask your
fever and flu-like symptoms pharmacist how to throw away medicines you no
 widespread rash, high body temperature, longer use. These measures will help protect the
enlarged lymph nodes and other body organs environment.
involvement (Drug Reaction with
Eosinophilia and Systemic Symptoms which
is also known as DRESS or drug 6. CONTENTS OF THE PACK
hypersensitivity syndrome). AND OTHER INFORMATION
Reporting of side effects What Bendamustine hydrochloride contains
If you get any side effects, talk to your doctor or The active substance is bendamustine
nurse. This includes any possible side effects not hydrochloride.
listed in this leaflet. Each lyophilized vial contains:
Bendamustine Hydrochloride 100mg
Excipients q.s.
5. HOW TO STORE The other ingredients are Butylhydroxytoluene,
BENDAMUSTINE Macrogol, Mannitol.
HYDROCHLORIDE What Bendamustine hydrochloride looks like
Keep this medicine out of the sight and reach of and contents of the pack
children. Packed in glass vial with rubber stopper.
Do not use this medicine after the expiry date Pack sizes of 1,4, or 5 vials.
which is stated on the carton label and the vial Not all pack sizes may be marketed.
after ‘EXP’. The first two digits indicate the
month and the last four digits indicate the year. 7.Manufactured in India By:
The expiry date refers to the last day of that TAJ PHARMACEUTICALS LIMITED
month. at SURVEY NO.188/1 TO 189/1,190/1 TO 4,
Keep the container in the outer carton to protect ATHIYAWAD, DABHEL, DAMAN- 396210
the content from light. (INDIA).
Note on shelf-life after opening or preparing
the solution
Bendamustine hydrochloride contains no
preservatives.