Download Script Notes - AmeriHealth Caritas Pennsylvania

Script Notes
The Pharmacy and Therapeutics Newsletter for AmeriHealth Caritas Pennsylvania Participating Providers
Q2 2014
In this issue
Safety alerts...................................................................................................1
Product updates..........................................................................................2
Formulary additions..................................................................................3
Food and Drug Administration (FDA) Alerts
Onglyza and Kombiglyze
XR (saxagliptin): Drug safety
communication — FDA to review
heart failure risk with these
medications
Issue: The FDA is requesting clinical trial
data from the manufacturer of saxagliptin to
investigate a possible association with heart
failure. A study published in the New England
Journal of Medicine in October 2013 noted
an increased rate of hospitalizations for heart
failure in the saxagliptin group compared to
placebo.
Recommendation: The FDA considers the
findings from the initial trial to be preliminary
and does not recommend any prescribing
changes to the medication at this time. The
requested data will be provided to the FDA in
early March 2014, and an investigation will
take place at that time.
Approved testosterone products:
Drug safety announcement — FDA
is evaluating the risk of stroke,
heart attack and death with these
medications
Issue: One study published in the Journal
of the American Medical Association in
November 2013 suggested a 30 percent
increase of stroke, heart attack and death in
subjects who were prescribed testosterone.
Another study found the risk of heart attack
doubled in men over age 65 in the first 90
days after filling a testosterone product
prescription. For men below age 65 who also
had a pre-existing history of cardiac disease,
the risk was increased two- to three-fold.
Recommendation: The FDA does not
recommend patients stop taking their
prescribed therapies at this time, and is
AmeriHealth Caritas Pennsylvania
currently further investigating the risks
associated with testosterone therapy. The
FDA urges health care professionals to
carefully weigh the risks and benefits of
testosterone therapy before prescribing it for
patients. Testosterone therapy is only FDAapproved for low testosterone associated with
a medical condition.
Agila Specialties Private Limited
etomidate 2 mg/mL, 10 mL and
20 mL vials: Drug recall — particles
identified
Issue: A voluntary recall is issued nationwide
on 10 lots of etomidate 2 mg/mL 10 mL and
20 mL injection vials from Agila Specialties
Private Limited, a subsidiary of PA-Mylan
Inc. There was a risk of small black particles,
which were parts of paper shipping labels,
to be present in individual vials. No adverse
reports have been filed but the particulates
could lead to impairment of microcirculation,
phlebitis, infection, embolism and subsequent
infarction.
Only the lots below are affected:
Lot # 5000927, expiration date 06/2014 (20 mL).
Lot # 5000931, expiration date 06/2014 (20 mL).
Lot # 5000936, expiration date 06/2014 (20 mL).
Lot # 5000942, expiration date 06/2014 (20 mL).
Lot # 5001012, expiration date 09/2014 (20 mL).
Lot # 5001040, expiration date 09/2014 (20 mL).
FDA warns of possible harm
from exceeding recommended
dose of over-the-counter sodium
phosphate products to treat
constipation
Issue: The FDA is issuing a warning stating
that using more than one dose in 24 hours of
over-the-counter sodium phosphate drugs,
including both oral solutions and rectal
enemas, to treat constipation can cause rare
but serious harm to the kidneys and heart,
and even death. Reports of severe dehydration
and changes in serum electrolytes, including
calcium, sodium and phosphate, have been
seen. These cases typically occurred when
using a larger-than-recommended single dose
or more than one dose in a day. Patients at
particular risk include young children, adults
over age 55, and patients who are dehydrated,
who have kidney disease, bowel obstruction
or inflammation of the bowel, and/or who are
taking drugs that can affect kidney function.
Recommendation: Patients should not
exceed the recommended dosing and
duration on the labeling of these products.
Children below age 5 should not receive these
oral products unless the parent/guardian
first consults with a health care professional.
Rectal forms of these products should never
be given to children below 2 years of age.
Lot # 5001071, expiration date 10/2014 (20 mL).
Lot # 5000983, expiration date 08/2014 (10 mL).
Lot # 5000986, expiration date 08/2014 (10 mL).
Lot # 5001023, expiration date 09/2014 (10 mL).
Recommendation: Distributors, retailers,
hospitals, pharmacies and clinics that have the
product being recalled should stop use and
discontinue distribution.
Script Notes Q2 2014 | 1
Product Updates
Mechanism of action
(MOA)
Usual dose
DM type 2: Sodium-glucose cotransporter 2 (SGLT2) inhibitor as an
adjunct to diet and exercise.
Dapagliflozin is an inhibitor of SGLT2. By
inhibiting SGLT2, dapagliflozin reduces
reabsorption of filtered glucose, thereby
increasing urinary glucose excretion.
5 mg once daily, taken in the morning,
with or without food.
Tablet: 5 mg and 10 mg
Treatment of orthostatic dizziness, or
lightheadedness in adult patients with
symptomatic neurogenic orthostatic
hypotension (NOH) caused by primary
autonomic failure [Parkinson’s disease
(PD), multiple system atrophy and pure
autonomic failure], dopamine betahydroxylase deficiency, and nondiabetic
autonomic neuropathy.
The exact mechanism of action of
Northera in the treatment of neurogenic
orthostatic hypotension is unknown.
100 mg three times daily — upon arising
in the morning, at midday and in the late
afternoon at least 3 hours prior to bedtime
— with or without food.
Capsule: 100 mg, 200 mg,
300 mg
Tivorbex®
(Indomethacin)
Treatment of mild to moderate acute pain
in adults.
The mechanism of action of Tivorbex is
not completely understood but involves
inhibition of cyclooxygenase (COX-1 and
COX-2).
20 mg orally three times daily or 40 mg
orally two or three times daily.
Capsule: 20 mg and 40 mg
Vimizim®
(Elosulfase alfa)
Vimizim is a hydrolytic lysosomal
glycosaminoglycan (GAG)-specific
enzyme indicated for patients with
mucopolysaccharidosis type IVA (MPS
IVA; Morquio A syndrome).
Vimizim is intended to provide
the exogenous enzyme
N-acetylgalactosamine-6-sulfatase that
will be taken up into the lysosomes and
increase the catabolism of the GAGs KS
and C6S.
2 mg per kg body weight administered
once every week as an intravenous
infusion over a minimum of 3.5 to 4.5
hours, based on infusion volume.
Injection: 5 mg/5 mL (1 mg/mL) in
single-use vials
Hetlioz is a melatonin receptor agonist
indicated for the treatment of non-24hour sleep-wake disorder.
The precise mechanism by which
tasimelteon exerts its therapeutic effect
in patients with non-24-hour sleep-wake
disorder is not known. Tasimelteon is
an agonist at melatonin MT1 and MT2
receptors. These receptors are thought
to be involved in the control of circadian
rhythms.
20 mg prior to bedtime, at the same
time every night without food.
Capsule: 20 mg
Imbruvica®
(Ibrutinib)
Indicated for the treatment of patients with
mantle cell lymphoma (MCL) who have
received at least one prior therapy, and
chronic lymphocytic leukemia (CLL) who
have received at least one prior therapy.
Ibrutinib is a small-molecule inhibitor of
BTK enzymatic activity. BTK is a signaling
molecule of the B-cell antigen receptor
(BCR) and cytokine receptor pathways.
BTK’s role in signaling through the B-cell
surface receptors results in activation of
pathways necessary for B-cell trafficking,
chemotaxis and adhesion.
MCL: 560 mg taken orally once daily (four
140 mg capsules once daily) (2.2).
CLL: 420 mg taken orally once daily (three
140 mg capsules once daily) (2.2).
Capsules should be taken orally with a
glass of water. Do not open, break or
chew the capsules.
Capsule: 140 mg
Impavido®
(Miltefosine)
Impavido is an anti-leishmanial drug
indicated in adults and adolescents
≥ 12 years of age weighing ≥ 30
kg (66 lbs) for treatment of: visceral
leishmaniasis due to Leishmania
donovani, cutaneous leishmaniasis due
to Leishmania braziliensis, Leishmania
guyanensis, and Leishmania panamensis
and mucosal leishmaniasis due to
Leishmania braziliensis.
The specific mode of action of miltefosine
against the Leishmania species is
unknown. The mechanism of action of
miltefosine is likely to involve interaction
with lipids including membrane lipids,
inhibition of cytochrome c oxidase
(mitochondrial function) and apoptosislike cell death.
Treatment duration: 28 consecutive days.
30 kg to 44 kg: one 50 mg capsule twice
daily with food.
45 kg or greater: One 50 mg capsule three
times daily with food.
Capsule: 50 mg
Drug
Farxiga®
(Dapagliflozin)
Northera®
(Droxidopa)
Hetlioz®
(Tasimelteon)
Indication
References:
1. Farxiga® prescribing information, Bristol-Myers Squibb, January 2014.
2. Northera® prescribing information, Chelesea Therapeutics Inc., February 2014.
3. Tivorbex® prescribing information, Iroko Pharmaceuticals LLC, February 2014.
4. Vimizim® prescribing information, BioMarin Pharmaceutical Inc., January 2014.
AmeriHealth Caritas Pennsylvania
Dosage forms
and strength
5. Hetlioz® prescribing information, Vanda Pharmaceuticals Inc., January 2014.
6. Imbruvica® prescribing information, Janseen Biotech Inc., February 2014.
7. Impavido® prescribing information, Paladin Therapeutics Inc., March 2014.
Script Notes Q2 2014 | 2
Formulary Update Additions
Drug
Linzess® (linaclotide)
Namenda XR® (memantine HCl)
Tudorza PressAir® Inhaler
(aclidinium bromide)
Eliquis® (apixaban)
Lialda® DR (mesalamine)
Indication
Mechanism of action
(MOA)
Adult treatment of IBS with constipation
and chronic idiopathic constipation.
Linaclotide is a guanylate cyclase-C (GCC) agonist, which increases intracellular
and extracellular cGMP levels. Elevation
in intracellular cGMP stimulates secretion
of chloride and bicarbonate into the
intestinal lumen. Increased extracellular
cGMP was shown to decrease the activity
of pain-sensing nerves.
Treatment of moderate to severe dementia
of the Alzheimer’s type.
Memantine is postulated to exert its
therapeutic effect through its action as a
low to moderate affinity uncompetitive
(open-channel) NMDA receptor
antagonist which binds preferentially
to the NMDA receptor-operated cation
channels.
Long-term maintenance treatment
of bronchospasm associated with
COPD, including chronic bronchitis and
emphysema.
To reduce the risk of stroke and systemic
embolism in patients with nonvalvular
atrial fibrillation.
Induction of remission in adults with
active, mild to moderate ulcerative colitis.
Maintenance of remission of ulcerative
colitis.
Capsules: 145 mcg, 290 mcg
CIC: 145 mcg PO daily on empty stomach,
30 minutes prior to first meal of the day.
XR capsules: 7 mg, 14 mg, 21 mg, 28 mg
Maintenance dose: 28 mg once daily.
Titration pack
Long-acting antimuscarinic agent that
exhibits pharmacological effects through
inhibition of M3 receptor at the smooth
muscle leading to bronchodilation in the
airways.
One inhalation twice daily.
Dry powder inhaler, 400 mcg per
inhalation
Reversible and selective active site
inhibitor of Factor Xa. Apixaban
inhibits free and clot-bound FXa, and
prothrombinase activity. Apixaban
indirectly inhibits platelet aggregation
induced by thrombin. Apixaban decreases
thrombin generation and thrombus
development.
The recommended dose for most patients
is 5 mg taken orally twice daily.
Tablets: 2.5 mg, 5 mg
Mesalamine has a topical antiinflammatory effect on colonic epithelial
cells. Mesalamine can inhibit the
activation of NF-kB, and consequently
the production of pro-inflammatory
cytokines. Mesalamine also directly
activates PPARy receptors in colonic/
rectal epithelium, which were found to be
deficient in ulcerative colitis.
Fosrenol® (lanthanum carbonate)
To reduce serum phosphate in patients
with end-stage renal disease (ESRD).
Zostavax® (zoster vaccine live)
Prevention of herpes zoster (shingles) in
individuals 50 years of age and older.
Boosts VZV-specific immunity, which
is thought to be the mechanism by
which it protects against zoster and its
complications.
AmeriHealth Caritas Pennsylvania
IBS-C: 290 mcg PO daily on empty
stomach, 30 minutes prior to first meal
of the day.
Initial dose: 7 mg once daily.
Phosphate binder that reduces the
absorption of phosphate by forming
insoluble lanthanum phosphate
complexes that pass through the GI tract
unabsorbed.
References:
1. Linzess® prescribing information, Merck & Co. Inc., February 2014.
2. Namenda XR® prescribing information, Forest Pharmaceuticals Inc., April 2013.
3. Tudorza PressAir® prescribing information, Forest Pharmaceuticals Inc., June 2013.
4. Eliquis® prescribing information, Bristol-Myers Squibb Company, January 2014.
Dosage forms
and strength
Usual dose
Induction of remission: Two to four 1.2 g
tablets once daily with a meal.
Tablets: 1.2 g
Maintenance of remission: Two 1.2 g
tablets once daily with a meal.
Initial total daily dose is 1500 mg, titrated
every 2 – 3 weeks.
Chewable tablets: 500 mg, 750 mg,
1000 mg
Single 0.65 mL subcutaneous injection.
Single-dose vials with not less than 19,
400 plaque-forming units (PFUs) per
0.65 mL dose when reconstituted to a
suspension
5. Lialda® DR prescribing information, Shire US Inc., September 2013.
6. Fosrenol® prescribing information, Shire LLC, October 2012.
7. Zostavax® prescribing information, Merck and Co. Inc., 2006.
Script Notes Q2 2014 | 3
Script Notes
Steven Feinstein, M.D.
P&T Committee Chair
Editor
Norbert Becker, R.Ph.
Clinical Pharmacist,
Formulary/DUR
Contributing editors
Christine Carter, Pharm.D.
Director, Clinical Client Services
Angela Guldin, Pharm.D.
Clinical Pharmacist,
Formulary/DUR
John Vellutato, Pharm.D.
Clinical Pharmacist,
Formulary/DUR
William Bell, R.Ph.
Clinical Pharmacist,
Formulary/DUR
Jamila J. Jorden,
Pharm.D., M.B.A.
Clinical Pharmacist,
Formulary/DUR
Nicole Campese, Pharm.D.
Clinical Pharmacist,
Formulary/DUR
Noel Ortiz, Pharm.D.
Clinical Pharmacist,
Formulary/DUR
Roberta Savo, Pharm.D.
Clinical Pharmacist,
Formulary/DUR
Patrick DeHoratius, Pharm.D.
Clinical Pharmacist,
Formulary/DUR
Jenna Marks, Pharm.D.
Pharmacy Resident
We welcome your thoughts, comments and/
or suggestions. Do you have an idea for a
story? Is there information we can provide
to help you?
All correspondence concerning Script Notes
should be sent to:
Norbert Becker, R.Ph.
Contact with any questions: 1-215-863-5670.
Maribel DaCosta, Pharm.D.
Clinical Pharmacist,
Formulary/DUR
Formulary
Website Access
Access the AmeriHealth Caritas Pennsylvania website 24 hours/7 days a
week at http://www.amerihealthcaritaspa.com/apps/formulary/index.aspx.
The formulary is updated quarterly. We recommend adding this link as a
favorite in your computer’s Web browser for easy access.
8040 Carlson Drive
Suite 500
Harrisburg, PA 17112
PRX-1422-26
Andrew Maiorini, Pharm.D.
Vice President,
Clinical Outcomes
The Pharmacy and Therapeutics Newsletter for
AmeriHealth Caritas Pennsylvania Participating Providers