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Peak Development for ...

Medication Administration

Vol. 17 Issue 2
February 2016

Overview: New Drugs of 2015

Peak Development Resources
P.O. Box 13267
Richmond, VA 23225
Phone: (804) 233-3707
Fax: (804) 233-3705

Peak Development for Medication

Administration and Competency
Assessment Tool for Medication
Administration are components of
a site license for the Peak
Development Resources
Competency Assessment System
for Medication Administration
and may be reproduced for this
individual facility only. Sharing
of these components with any
other freestanding facility within
or outside the licensees corporate
entity is expressly prohibited.

The information contained in

Peak Development for Medication
Administration is intended only as
a guide for the practice of
licensed nursing personnel who
administer medications. Every
effort has been made to verify the
accuracy of the information
herein. Because of rapid changes
in the field of drug therapy, the
reader is advised to consult the
package insert, facility pharmacist
or patients physician for relevant
information. This is particularly
important for new or seldom used
drugs. Use of professional
judgment is required in all patient
care situations. It is the readers
responsibility to understand and
adhere to policies and procedures
set forth by the employing
institution. The editor and
publisher of this newsletter
disclaim any liability resulting
from use or misuse of
information contained herein.
Copyright 2016

After completion the learner should be able to:

1. Identify newly-approved drugs, their
indications, actions and adverse effects.
2. Discuss nursing responsibilities related to
new medications.
According to the US Food and Drug
Administration (FDA), 45 new drugs were
approved in 2015. This is the largest number of
novel drugs approved annually since 1996. Of
these new approvals, 36% were first in class
drugs, meaning they represent development of
a new drug that works to treat a condition in a
novel and innovative way. Also, approximately
47% of approvals were for orphan drugs, used
to treat rare conditions for which treatment
options are usually limited. This is the highest
number of orphan drugs ever approved by the
FDA in a year. This is notable, since, due to the
small number of potential users, usually fewer
than 200,000, these drugs may not be
commercially successful for the company,
which decreases the likelihood of their
development. Unique drug approvals for 2015
include the first 3-D printed drug, Spritam
(levetiracetam), used to treat seizures, and
Addyi (flibanserin), the first drug for treatment of
decreased sexual desire in women. Selected
prescription drug approvals for 2015 include:
- Addyi (flibanserin), oral drug approved
August 18: Addyi is indicated for treatment of
low sexual desire in premenopausal women. It
interacts with serotonin receptors, but the
mechanism of action is unknown. Addyi carries
a boxed warning regarding the risk of severe
hypotension if used with alcohol or drugs that
inhibit CYP3A4 enzymes, or in patients with
liver impairment. It is available only under a
restricted program. Adverse effects include
dizziness, drowsiness, fatigue and nausea.
- Aristada (aripiprazole lauroxil), IM drug
approved October 6: This is a long-acting,

atypical antipsychotic agent indicated for

treatment of schizophrenia. Its action is thought
to result from effects on dopamine and
serotonin receptors. A boxed warning states
there is increased risk of death in elderly
patients with dementia-related psychosis; the
drug should not be used in these patients.
Adverse effects include orthostatic hypotension,
hyperglycemia, weight gain, decreased WBC
count and tardive dyskinesia. It is administered
monthly by a healthcare professional.
- Bridion (sugammadex), IV drug approved
December 15: A first-in-class drug, Bridion is
used to reverse neuromuscular blockade due to
use of anesthetic agents rocuronium and
vecuronium during surgery. It acts by binding
with the anesthetic agents to reduce their effect
on receptor sites. Adverse effects include
bradycardia and anaphylaxis.
- Corlanor (ivabradine), oral drug approved
April 15: This is a first-in-class cardiac drug
used to reduce the risk of hospitalization in
patients with chronic heart failure. Corlanor
blocks a specific channel regulating heart rate,
resulting in reduced heart rate. Adverse effects
include bradycardia, atrial fibrillation and
- Cosentyx (secukinumab), sub-q drug
approved January 21: Cosentyx is a first-inclass drug, indicated for the treatment of
moderate to severe plaque psoriasis, psoriatic
arthritis and ankylosing spondylitis. This
monoclonal antibody reduces inflammation and
modifies immune response. Adverse effects
include risk of infection, hypersensitivity
reactions and inflammatory bowel disease.
- Entresto (sacubitril/valsartan), oral drug
approved July 7: This first-in-class cardiac drug
is indicated to reduce the risk of hospitalization
and death in patients with chronic heart failure.
Sacubitril inhibits an enzyme that breaks down
certain peptides helpful for cardiac function.

Valsartan is an existing angiotensin II receptor blocker (ARB),

commonly used to treat hypertension and heart failure.
Entresto carries a boxed warning due to the risk of fetal
toxicity. Adverse effects include hypotension, impaired renal
function and hyperkalemia.
- Kengreal (cangrelor), IV drug approved June 22: This
platelet inhibitor is used to prevent MI and thrombosis during
percutaneous coronary intervention (angioplasty and/or stent).
It acts by blocking platelet activation and aggregation. There is
risk of bleeding and anaphylaxis.
- Praluent (alirocumab), sub-q drug approved July 24: This
first-in-class drug is used to lower LDL cholesterol levels in
patients with heterozygous familial hypercholesterolemia or
clinical atherosclerotic cardiovascular disease. It is used in
conjunction with diet, statins and other treatment, and is
administered every 2 weeks. Adverse effects include influenza,
upper respiratory tract infection and hypersensitivity reactions.
Another drug in this class, Repatha (evolocumab), was
approved August 27.
- Praxbind (idarucizumab), IV drug approved October 16:
This first-in-class drug is indicated to reverse bleeding due to
use of the anticoagulant dabigatran (Pradaxa). It binds to
dabigatran, preventing anticoagulation. Adverse effects include
risk of thromboembolic events due to the underlying condition,
recurrence of bleeding and hypersensitivity reactions.
- Rexulti (brexpiprazole), oral drug approved July 10: This
atypical antipsychotic agent is indicated for treatment of
schizophrenia and as adjunct therapy, with antidepressants, in
treatment of depression. Its action is believed to result from
effects on dopamine and serotonin receptors. Rexulti carries a
boxed warning due to risk of death in elderly patients with
dementia-related psychosis; the drug should not be used in
these patients. The warning also includes risk of suicide when
administered with antidepressants to those age 24 and
younger. Adverse effects include orthostatic hypotension,
hyperglycemia, weight gain, decreased WBC count and tardive
dyskinesia. Another oral atypical antipsychotic drug, Vraylar
(cariprazine), was approved on September 17 for treatment of
schizophrenia and bipolar disorder in adults.
- Savaysa (edoxaban), oral drug approved January 8: This
anticoagulant agent is used to reduce the risk of stroke and
embolism in patients with non-valvular atrial fibrillation, and for
treatment of deep vein thrombosis and pulmonary embolus
after treatment with a parenteral anticoagulant. It acts by
inhibiting factor Xa to prevent thrombus formation. A boxed
warning includes reduced effectiveness in A-fib patients with
creatinine clearance >95 ml/min, increased risk of clot
formation with premature discontinuation of drug, and risk of

spinal/epidural hematoma during lumbar puncture or neuraxial

anesthesia. Adverse effects include bleeding, anemia, rash
and abnormal liver function tests.
- Tresiba (insulin degludec), sub-q drug approved
September 25: Tresiba is a novel, ultra-long acting human
insulin analog, indicated for treatment of type 1 and type 2
diabetes in adults. It is injected once daily, at any time, by use
of the pre-filled pen. Adverse effects include hypoglycemia,
hypersensitivity reactions, lipodystrophy at injection site,
edema and hypokalemia.
- Varubi (rolapitant), oral drug approved September 1: Varubi
is indicated, along with other antiemetic drugs, for the
prevention of delayed nausea and vomiting associated with
cancer chemotherapy in adults. It acts by blocking stimulation
of neurokinin-1 receptors. Adverse effects include neutropenia,
decreased appetite, dizziness and hiccups.
In addition, several new drugs were developed to treat
selected advanced cancers: Ibrance (palbociclib) for breast
cancer, Portrazza (necitumumab) for lung cancer, Cotellic
(cobimetinib) for melanoma, Odomzo (sonidigib) for basal cell
and Lonsurf (trifluridine and lipiracil) for colorectal cancer.
Working with New DrugsRole of the Nurse
The pharmaceutical field is constantly changing, with the
development of new drugs, approval of currently-marketed
drugs for different indications, and classification of some
prescription drugs to OTC status. Therefore, the nurses drug
knowledge base must remain current in order to provide safe
care. This is especially important when newly-approved or
unfamiliar drugs are being administered. For any drugs
administered, the nurse must be knowledgeable regarding the
indications, recommended dosage, route, therapeutic and side
effects, and precautions/contraindications. When administering
newly-approved drugs, the nurse must be particularly watchful
for possible adverse effects, since all of these may not have
been apparent during clinical trials. The FDA has set up the
MedWatch program to encourage the voluntary reporting of
serious adverse effects caused by drugs or medical devices
once they are FDA-approved and in general use. Health
professionals are encouraged to report any suspected effects
that result in death, disability, birth defects, life-threatening
events, or hospitalization. If the FDA determines that the drug
or device is unsafe, it may be removed from the market. Any
confusing or unclear packaging should also be reported.
Nurses play an important role in the process of new drug
development by assisting with research, following the
development of new drugs, maintaining a current knowledge
base, and reporting serious adverse reactions.

Peak Development for Medication Administration

Overview: New Drugs of 2015

Page 2

Peak Development for ...

Medication Administration
Competency Assessment Tool

Vol. 16 Issue 2
February 2016

Overview: New Drugs of 2015




Directions: Place the letter of the one best answer in the space provided.
_____1. In 2015, more new drugs were approved by the FDA than in any year since 1996.
A. True
B. False
_____2. Unique drug approvals for 2015 include the first-ever:
A. opioid using a self-injector pen
B. 3-D printed drug
C. oral drug on a dissolvable film
D. medication for treatment of tardive dyskinesia
_____3. Which of the following women is at highest risk for adverse effects of Addyi (flibanserin):
A. Carol, who is premenopausal
B. Barbara, who has type 2 diabetes
C. Rachel, who had a hysterectomy 2 years ago
D. Gayle, who has 3-4 alcoholic drinks daily
_____4. A significant benefit of the new atypical antipsychotic drug, Aristada (aripiprazole laureate),
is that it is:
A. approved for use in dementia-related psychosis
B. safer than similar drugs, and does not cause effects such as weight gain or hypotension
C. long-acting and is administered monthly
D. available as a quick-dissolving oral tablet
_____5. Corlanor (ivabradine) and Entresto (sacubitril/valsartan) are new drugs approved to treat:
A. heart failure
B. hypertension
C. pulmonary hypertension
D. all of the above

_____6. Which of the following new drugs is most likely to cause bleeding as an adverse effect:
A. Cosentyx (secukinumab)
B. Bridion (sugammadex)
C. Praluent (alirocumab)
D. Kengreal (cangrelor)
_____7. Praxbind (idarucizumab) is a first-in-class drug approved to reverse the anticoagulant
effects of:
A. warfarin
B. apixaban
C. enoxaparin
D. dabigatran
_____8. Tresiba (insulin degludec) is a novel insulin that:
A. can be taken orally
B. is ultra-long acting
C. is approved for treatment of type 2 diabetes only
D. must be taken immediately prior to a meal
_____9. The nurse determines that treatment with Varubi (rolapitant) is effective when the patient
taking it states:
A. I dont feel like I have to run to the bathroom to urinate every hour.
B. Im having a soft, formed bowel movement every day.
C. I havent had any nausea or vomiting.
D. I dont have much of an appetite.
____10. Which of the following is an FDA program set up specifically to encourage the voluntary
reporting of serious adverse effects of medications or devices:
A. Center for Drug Evaluation and Research
B. Sentinel Events
C. MedWatch
D. Report NOW

Competency Assessment Tool

Overview: New Drugs of 2015

Page 2

Peak Development for ...

Medication Administration

Month: February 2016

Overview: New Drugs of 2015

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