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Samford University Global Drug Information Service
Editor: Terri M. Wensel, Pharm.D., BCPS Associate Editor: Temeka Borden, Pharm.D.
Samford University Global Drug Information Service, Birmingham, AL 35229 Telephone: (205) 726-2659
http://pharmacy.samford.edu/dic/default.aspx FAX: (205) 726-4012
___________________________________________________________________________________________________ Samford University is an Equal Opportunity Institution and welcomes applications for employment and educational programs from all
individuals regardless of race, color, sex, disability, or national or ethnic origin.
PHARMACY
PRÉCIS
Précis: a concise summary of essential points, statements or facts
Volume 28 (Issue 1) February 2010
NEW MOLECULAR ENTITIES OF 2009
The new molecular entities approved during 2009 (including indication, approval date, and comments)
are presented in this issue of Pharmacy Précis. An explanation of the FDA classification of the new
drugs also is included. If you need any additional information regarding these agents, please call the
Samford University Global Drug Information Service at (205) 726-2659.
Current FDA classification for newly approved drugs is based on chemical classification and is outlined
below.
FDA CLASSIFICATIONS CHEMICAL CLASSIFICATION THERAPEUTIC
CLASSIFICATION
ADDITIONAL
CLASSIFICATION
1. New molecular entity - drug
not marketed in U.S. by any
manufacturer
2. New salt - active moiety is
marketed in the U.S., but this
particular salt, ester, or
derivative is not
3. New formulation - drug
marketed in the U.S., but this
particular formulation is not
4. New combination - two or
more ingredients in
combination not marketed in
the U.S.
5. New manufacturer - already
marketed by another firm;
duplicated salt, formulation or
combination
6. New indication - already
marketed by same firm but
used primarily for new
indications
7. Marketed without an
approved NDA
8. OTC Switch
S = Standard review - assigned
to drugs that appear to have
therapeutic qualities similar to
drugs already approved
P = Priority review - assigned
to drugs that appear to have
therapeutic gain over drugs
currently available
O = Orphan designation -
Pursuant to Section 526 of the
Orphan Drug Act (Public Law
97-414 as amended).
1. Providing effective therapy
or diagnosis for a disease
not adequately treated or
diagnosed by any marketed
drug
2. Providing improved
treatment or greater
effectiveness or safety
3. Having a modest, but real
advantage over
convenience, elimination of
troublesome side-effects, or
treatment of a specific sub-
population of patients
AA = AIDS drugs (always
classified as P)
E = Drugs that treat life-
threatening or severely
debilitating diseases
F = Possible fraudulently
submitted data
G = Data from a type F
classification is
validated
N = Nonprescription drug
V = Designated orphan
drug
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1P
Dronedarone
(Multaq)
Sanofi-Aventis Antiarrhythmic drug indicated to
reduce the risk of cardiovascular
hospitalization in patients with
paroxysmal or persistent atrial
fibrillation (AF) or atrial flutter (AFL),
with a recent episode of AF/AFL
and associated cardiovascular risk
factors (i.e., age >70, hypertension,
diabetes, prior cerebrovascular
accident, left atrial diameter ≥50 mm
or left ventricular ejection fraction
[LVEF] <40%), who are in sinus
rhythm or who will be cardioverted.
7/01/2009 Black box warning: Dronedarone is contraindicated in patients
with NYHA Class IV heart failure or NYHA Class II - III heart
failure with a recent decompensation requiring hospitalization
or referral to a specialized heart failure clinic.
Initial dose is 400 mg twice a day with morning and evening
meals. Most common adverse reactions (≥2%) are diarrhea,
nausea, abdominal pain, vomiting, and asthenia. Dronedarone
is metabolized by CYP 3A and is a moderate inhibitor of CYP
3A and CYP 2D6 and has potentially important
pharmacodynamic interactions.
Everolimus
(Afinitor)
Novartis
Pharmaceuticals
Corporation
Kinase inhibitor indicated for the
treatment of patients with advanced
renal cell carcinoma after failure of
treatment with sunitinib or sorafenib.
3/30/2009 Initial dosing of 10 mg once daily with or without food.
Treatment interruption and/or dose reduction to 5 mg once
daily may be needed to manage adverse drug reactions. For
patients with Child-Pugh class B hepatic impairment, reduce
dose to 5 mg once daily.
If strong inducers of CYP3A4 are required, increase
everolimus dose in 5 mg increments to a maximum of 20 mg
once daily. Most common adverse reactions (incidence ≥30%)
are stomatitis, infections, asthenia, fatigue, cough, and
diarrhea.
Avoid live vaccines and close contact with those who have
received live vaccines. Fetal harm can occur when
administered to a pregnant woman.
Pralatrexate
(Folotyn)
Allos Folate analogue inhibitor indicated
for relapsed or refractory peripheral
T-cell lymphoma (PTCL)
9/24/2009 Recommended dose is 30 mg/m2 administered as an
intravenous push over 3-5 minutes once weekly for 6 weeks in
a 7-week cycle.
Patients should be supplemented with B12 every 8-10 weeks
and 1-1.25 mg of folic acid daily.
Pralatrexate is available in a 20 mg/mL concentration in 1 mL
and 2 mL vial sizes.
The most common adverse effects include mucositis,
thrombocytopenia, nausea, and fatigue.
Prasugrel
(Effient)
Eli Lilly and
Company
P2Y12 platelet inhibitor indicated
for the reduction of thrombotic
cardiovascular events (including
stent thrombosis) in patients with
acute coronary syndrome who are
07/10/2009 Black box warning for bleeding risk. Do not use prasugrel in
patients with active pathological bleeding or a history of
transient ischemic attack or stroke. In patients ≥ 75 years of
age, prasugrel is generally not recommended because of the
increased risk of fatal and intracranial bleeding and uncertain
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1P
to be managed with PCI as follows:
Patients with unstable angina or,
non-ST-elevation myocardial
infarction (NSTEMI).
Patients with ST-elevation
myocardial infarction (STEMI) when
managed with either primary or
delayed PCI
benefit, except in high-risk patients (diabetes or prior MI),
where its effect appears to be greater and its use may be
considered.
Do not start prasugrel in patients likely to undergo urgent
coronary artery bypass graft surgery (CABG). When possible,
discontinue prasugrel at least 7 days prior to any surgery.
Additional risk factors for bleeding include:
• body weight < 60 kg
• propensity to bleed
• concomitant use of medications that increase the risk
of bleeding.
Initiate treatment with a single 60 mg oral loading dose.
Continue at 10 mg once daily with or without food. Consider 5
mg once daily for patients < 60 kg. Patients should also take
aspirin (75 mg to 325 mg) daily. Bleeding, including life-
threatening and fatal bleeding, is the most commonly reported
adverse reaction.
Vigabatrin
(Sabril)
Lundbeck Inc. Vigabatrin is an anticonvulsant
indicated for the treatment of
infantile spasms and refractory
complex partial seizures in adults.
08/21/09 Black box warning: Vigabatrin can cause permanent vision loss
in infants, children, and adults. Patients who fail to show
substantial clinical benefit within a short period of time should
be taken off vigabatrin because of the risk of permanent vision
loss.
Vigabatrin should be used as adjunctive therapy in patients
who have failed other anticonvulsant treatments. Initial starting
dose is 500 mg twice daily and titrate to a recommended dose
of 1500 mg twice daily. For infantile spasms, the
recommended initial dose is 50 mg/kg/day may titrate by 25-50
mg/kg/day every 3 days to a maximum of 150 mg/kg/day.
Dosage tapering per package insert should be implemented in
order to avoid withdrawal seizures.
Common adverse reactions (≥5% change in placebo) are
vision loss, fatigue, somnolence, nystagmus, tremor, vision
blurring, memory impairment, weight gain, arthralgia, abnormal
coordination, and confusional state.
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1P,O
Artemether/
Lumefantrine
(Coartem)
Novartis Fixed combination of artemether
and lumefantrine which acts as a
blood schizontocide. It is indicated
for treatment of acute,
uncomplicated malaria infections
due to Plasmodium falciparum in
patients >5kg.
4/07/2009 Tablets for oral administration. The dose should be taken with
food or drinks rich in fat such as milk. Patients should be
encouraged to resume normal eating as soon as food can be
tolerated since this improves absorption of artemether and
lumefantrine. In the event of vomiting within 1 hour of
administration a repeat dose should be taken. A standard 3
days treatment schedule with a total of 6 doses is
recommended as follows. Four tablets as a single dose at the
time of initial diagnosis, again 4 tablets after 8 hours and then
4 tablets twice daily (morning and evening) on each of the
following two days (total course comprises 24 tablets).
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1S
Asenapine
(Saphris)
Schering-Plough Atypical antipsychotic indicated for
the acute treatment of
schizophrenia in adults and acute
treatment of manic or mixed
episodes associated with bipolar I
disorder in adults.
8/13/2009 Black box warning for elderly patients with dementia-related
psychosis treated with antipsychotic drugs is at an increased risk
of death.
Schizophrenia: The recommended starting and target dose of
asenapine is 5 mg sublingually twice daily.
Bipolar Disorder: The recommended starting dose of asenapine is
10 mg sublingually twice daily. The dose can be decreased to 5
mg twice daily if there are adverse effects.
Administration: Do not swallow tablet. Asenapine sublingual
tablets should be placed under the tongue and left to dissolve
completely. The tablet will dissolve in saliva within seconds. Eating
and drinking should be avoided for 10 minutes after
administration.
Warnings include: cerebrovascular adverse, neuroleptic malignant
syndrome, tardive dyskinesia, hyperglycemia, orthostatic
hypotension, syncope, leukopenia, neutropenia, agranulocytosis,
QT prolongation, seizures, potential for cognitive and motor
impairment, and suicide.
Commonly observed adverse reactions (incidence ≥5% and at
least twice that for placebo) were:
Patients with Schizophrenia: akathisia, oral hypoesthesia, and
somnolence.
Patients with Bipolar Disorder: somnolence, dizziness,
extrapyramidal symptoms other than akathisia, and weight
increased.
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1S
Benzyl alcohol
(Ulesfia)
Sciele
Pharmaceuticals
Inc
Pediculicide indicated for the topical
treatment of head lice infestation in
patients 6 months of age and older.
4/09/2009 Apply benzyl alcohol to dry hair, using enough to completely
saturate the scalp and hair. Rinse off with water after 10
minutes. Repeat treatment in 7 days.
Warnings and precaution:
Neonatal toxicity: Risk of gasping syndrome if benzyl alcohol is
used in neonates.
Eye irritation: Avoid eye exposure. Flush immediately with
water if benzyl alcohol comes into contact with eyes.
Contact dermatitis: May occur with benzyl alcohol.
Use in children: benzyl alcohol should only be used on children
under the direct supervision of an adult.
Most common adverse reactions (> 1% and more common than
with placebo): ocular irritation, application site irritation, and
application site anesthesia and hypoesthesia.
Bepotastine
besilate
(Bepreve)
ISTA
Pharmaceuticals,
Inc.
H1 receptor antagonist indicated for
the treatment of itching associated
with allergic conjunctivitis.
9/08/2009 Bepotastine is available as a 1.5% eye drop formulation.
Patients are to instill one drop into affected eye(s) twice daily.
Contact lenses should be removed prior to instillation of eye
drops. Most common adverse drug reaction (25% incidence)
was a mild taste after instillation. Other adverse reactions (2-
5% incidence) were eye irritation, headache, and
nasopharyngitis.
Besifloxacin
(Besivance)
Bausch and Lomb Quinolone antimicrobial indicated
for the treatment of bacterial
conjunctivitis caused by susceptible
bacteria.
5/28/2009 Instill one drop in the affected eye(s) 3 times a day,
four to twelve hours apart for 7 days. The most common
adverse event reported in 2% of patients treated with
besifloxacin was conjunctival redness.
Isolates the following bacteria: CDC coryneform group G,
Corynebacterium pseudodiphtheriticum*, Corynebacterium
striatum*, Haemophilus influenzae, Moraxella lacunata*,
Staphylococcus aureus, Staphylococcus epidermidis,
Staphylococcus hominis*, Staphylococcus lugdunensis*,
Streptococcus mitis group, Streptococcus oralis, Streptococcus
pneumoniae, Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10
infections.
Febuxostat
(Uloric)
Takeda Xanthine oxidase (XO) inhibitor
indicated for the chronic
management of hyperuricemia in
patients with gout.
Febuxostat is not recommended for
the treatment of asymptomatic
2/13/2009 The recommended starting dose of febuxostat is 40 mg once
daily. For patients who do not achieve a serum uric acid (sUA)
less than 6 mg per dL after 2 weeks with 40 mg, febuxostat 80
mg is recommended. Febuxostat can be administered without
regard to food or antacid use. Concomitant administration of
febuxostat with XO substrate drugs, azathioprine,
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1S
hyperuricemia. mercaptopurine, or theophylline could increase plasma
concentrations of these drugs resulting in severe toxicity.
Warnings include: gout flare, cardiovascular events, and liver
enzyme elevation. Adverse reactions occurring in at least 1%
of febuxostat-treated patients, and, at least 0.5% greater than
placebo, are liver function abnormalities, nausea, arthralgia,
and rash.
Iloperidone
(Fanapt)
Vanda
Pharmaceuticals
Atypical antipsychotic agent
indicated for the acute treatment of
schizophrenia in adults.
5/06/2009 Black box warning for elderly patients with dementia-related
psychosis treated with antipsychotic drugs is at an increased
risk of death. In choosing among treatments, prescribers
should consider the ability of iloperidone to prolong the QT
interval and the use of other drugs first.
The recommended target dosage is 12 to 24 mg/day
administered twice daily. This target dosage range is achieved
by daily dosage adjustments, alerting patients to symptoms of
orthostatic hypotension, starting at a dose of 1 mg twice daily,
then moving to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg
twice daily on days 2, 3, 4, 5, 6, and 7 respectively, to reach
the 12 mg/day to 24 mg/day dose range. Iloperidone can be
administered without regard to meals.
Milnacipran
(Savella)
Forest Laboratories
Inc.
Selective serotonin and
norepinephrine reuptake inhibitor
(SNRI) indicated for the
management of fibromyalgia.
1/14/2009 Increased risk of suicidal ideation, thinking and behavior in
children, adolescents, and young adults taking antidepressants
for major depressive disorder (MDD) and other psychiatric
disorders. Milnacipran is not approved for use in pediatric
patients. The most frequently occurring adverse reactions (≥
5% and greater than placebo) were nausea, headache,
constipation, dizziness, insomnia, hot flush, hyperhidrosis,
vomiting, palpitations, heart rate increased, dry mouth, and
hypertension. Administer milnacipran in two divided doses per
day; begin dosing at 12.5 mg on the first day and increase to
100 mg/day over a 1-week period. Recommended dose is 100
mg/day, may be increased to 200 mg/day based on individual
patient response. Dose should be adjusted in patients with
severe renal impairment.
Pitavastatin
(Livalo)
Kowa
Pharmaceutical
America Inc
HMG-CoA reductase inhibitor
indicated for treatment of primary
hyperlipidemia and mixed
hyperlipidemia in adjunct with diet
8/03/09 The recommended dose range for pitavastatin is 1-4 mg once
daily at anytime with or without food. The recommended
starting dose is 2 mg with a maximum dose of 4 mg. Dosing in
moderate renal impairment and patients with end-stage renal
disease on dialysis the recommended starting dose is 1 mg
with a maximum dose of 2 mg. It comes available as a tablet
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1S
with strengths of 1 mg, 2 mg, and 4 mg. The most frequent
adverse reactions associated with pitavastatin (≥2%) were
myalgia, back pain, diarrhea, constipation, and pain in
extremities.
Romidepsin
(Istodax)
Gloucester
Pharmaceuticals
Histone deacetylase inhibitor
indicated for treatment of cutaneous
T-cell lymphoma in patients who
have received at least one prior
systemic therapy.
11/05/2009 The recommended dose is 14 mg/m² intravenously over four
hours on days 1, 8, 15, of a 28 day cycle. Cycles are to be
repeated every 28 days if clinical benefit occurs. Romidepsin
is available as a 10 mg/2mL diluent vial. Romidepsin has been
associated with hematologic issues such as anemia,
thrombocytopenia, and leucopenia. Monitoring of potassium
and magnesium levels is required because romidepsin has
been shown to increase the risk of QT prolongation. Common
adverse reactions were nausea, fatigue, infection, vomiting,
anorexia, ECG T-wave changes, thrombocytopenia,
neutropenia, and anemia. Close monitoring of INR is warranted
when using concomitantly with warfarin. In addition,
concomitant use with strong CYP 3A4 inhibitors and inducers
should be avoided.
Saxagliptin
(Onglyza)
Bristol-Myers
Squibb
Dipeptidyl peptidase-4 inhibitor
indicated as an adjunct to diet and
exercise to improve glycemic
control in adults with type 2
diabetes mellitus.
Should not be used for the
treatment of type 1 diabetes mellitus
or diabetic ketoacidosis.
Has not been studied in
combination with insulin.
7/31/2009 The recommended dose is 2.5 mg or 5 mg once daily taken
regardless of meals. 2.5 mg daily is recommended for patients
with moderate or severe renal impairment, or end-stage renal
disease (CrCl ≤50 mL/min). Assess renal function prior to
initiation of saxagliptin and periodically thereafter. 2.5 mg daily
is recommended for patients also taking strong cytochrome
P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole).
Adverse reactions reported in ≥5% of patients treated with
saxagliptin and more commonly than in patients treated with
placebo are: upper respiratory tract infection, urinary tract
infection, and headache. When used with an insulin
secretagogue (e.g., sulfonylurea), a lower dose of the insulin
secretagogue may be required to reduce the risk of
hypoglycemia.
Telavancin
hydrochloride
(Vibativ)
Theravance Inc. Lipoglycopeptide antibacterial
indicated for the treatment of
complicate skin and skin structure
infections caused by susceptible
gram positive bacteria.
9/11/2009 The dose for telavancin is 10 mg/kg over 60 minutes once daily
for 7-14 days. Renal adjustments include dose reduction with
CrCl 30-50 mL/min administer 7.5 mg/kg every 24 hours, with
CrCl 10-30 mL/min administer 10 mg/kg every 48 hours.
Dosages available are 250 mg and 750 mg single dose vials.
Telavancin has shown decreased efficacy with CrCl ≤50
mL/min, potential for QTc prolongation, coagulation test
interference, infusion-related reactions, and clostridium
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
1S
difficile-associated disease. Common adverse reactions
(≥10% of patients) were taste disturbance, nausea, vomiting,
and foamy urine.
Based on animal studies telavancin has shown propensity to
cause fetal harm and efficacy has not demonstrated in pediatric
patients.
Tolvaptan
(Samsca)
Otsuka
Pharmaceutical
Group
Selective vasopressin V2-receptor
antagonist indicated for the
treatment of clinically significant
hypervolemic and euvolemic
hyponatremia [serum sodium < 125
mEq/L or less marked hyponatremia
that is symptomatic and has
resisted correction with fluid
restriction], including patients with
heart failure, cirrhosis, and
Syndrome of Inappropriate
Antidiuretic Hormone (SIADH).
5/19/2009 Black box warnings states tolvaptan should be initiated and re-
initiated in patients only in a hospital where serum sodium can
be monitored closely. Too rapid correction of hyponatremia
(e.g., >12 mEq/L/24 hours) can cause osmotic demyelination
resulting in dysarthria, mutism, dysphagia, lethargy, affective
changes, spastic quadriparesis, seizures, coma and death. In
susceptible patients, including those with severe malnutrition,
alcoholism or advanced liver disease, slower rates of
correction may be advisable.
Should be initiated and re-initiated in a hospital. The
recommended starting dose is 15 mg once daily. Dosage may
be increased at intervals ≥ 24 hr to 30 mg once daily, and to a
maximum of 60 mg once daily as needed to raise serum
sodium. Monitor serum sodium and volume status. The most
common adverse reactions (≥ 5% placebo) are thirst, dry
mouth, asthenia, constipation, pollakiuria or polyuria, and
hyperglycemia.
Treprostinil
(Tyvaso)
United
Therapeutics
Corporation
Prostacyclin vasodilator indicated
for the treatment of pulmonary
arterial hypertension (WHO Group
I) in patients with NYHA Class III
symptoms, to increase walk
distance.
7/30/2009 Administer undiluted, as supplied. A single breath delivers
approximately 6 mcg of treprostinil. Administer in 4 separate
treatment sessions each day approximately four hours apart,
during waking hours. Initial dosage: 3 breaths [18 mcg] per
treatment session. If 3 breaths are not tolerated, reduce to 1 or
2 breaths. Dosage should be increased by an additional 3
breaths at approximately 1-2 week intervals, if tolerated.
Titrate to target maintenance dosage of 9 breaths or 54 mcg
per treatment session as tolerated. Most common adverse
reactions (≥ 10%) are cough, headache, nausea dizziness,
flushing, throat irritation, pharyngolaryngeal pain and diarrhea.
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3O
Sotalol
hydrochloride
(Sotalol)
Academic
Pharmaceuticals
Sotalol hydrochloride for
intravenous use is an antiarrhythmic
agent indicated for: substitution for
oral sotalol in patients who are
unable to take sotalol orally
7/02/2009 Black box warning: Sotalol can cause life threatening
ventricular tachycardia associated with QT interval
prolongation. Do not initiate sotalol therapy if the baseline
QTc is longer than 450 ms. If the QT interval prolongs to 500
ms or greater, the dose must be reduced, the duration of the
infusion prolonged or the drug discontinued. Patient should be
hospitalized in a facility that can provide cardiac resuscitation
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
2S
Dexlansoprazole
(Kapidex)
Takeda
Pharmaceutical
Company
Proton pump inhibitor (PPI)
indicated for healing of all grades of
erosive esophagitis, (EE)
maintaining healing of EE, treating
heartburn associated with non-
erosive gastroesophageal reflux
disease.
1/30/2009 Most commonly reported adverse reactions (≥2%): diarrhea,
abdominal pain, nausea, upper respiratory tract infection,
vomiting, and flatulence. Dexlansoprazole is available in two
dosage strengths: 30 mg and 60 mg, per capsule. Each
capsule contains enteric-coated granules consisting of
dexlansoprazole.
Ferumoxytol
(Feraheme)
AMAG
Pharmaceuticals,
Inc.
Iron replacement product indicated
for the treatment of iron deficiency
anemia in adult patients with
chronic kidney disease (CKD).
6/30/2009 The recommended dose is an initial 510 mg intravenous
injection followed by a second 510 mg intravenous injection 3
to 8 days later. Administer ferumoxytol as an undiluted
intravenous injection delivered at a rate of up to 1 mL/sec (30
mg/sec). The recommended ferumoxytol dose may be
readministered to patients with persistent or recurrent iron
deficiency anemia. The most common adverse reactions (≥
2%) following the administration of ferumoxytol are diarrhea,
nausea, dizziness, hypotension, constipation, and peripheral
edema.
Ganciclovir
(Zirgan)
Sirion
Therapeutics, Inc.
Topical ophthalmic antiviral
indicated for treatment of acute
herpetic keratitis.
9/15/2009 Black box warning: Granulocytopenia, anemia, and
thrombocytopenia. Animal studies have carcinogenic,
teratogenic, and inhibition of spermatogenesis. Indicated only
for treatment of CMV retinitis in immunocompromised patients.
Ganciclovir is available in a 0.15% ophthalmic gel. The
recommended dose is instillation of one drop in the affected
eye(s) five times daily until corneal ulcer heals, and then instill
one drop three times daily for seven days. Patients are
instructed not to wear contact lenses during the course of
ganciclovir therapy. Common adverse reactions were eye
irritation (20%), blurred vision (60%), punctate keratitis (5%),
and conjunctival hyperemia (5%).
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3O
and continuous electrocardiographic monitoring. Adjust the
dosing interval based on creatinine clearance.
Intravenous sotalol must be diluted. Appropriate diluents are
saline, 5% dextrose in water (D5W), or ringer‟s lactate.
Intravenous sotalol is administered by a volumetric infusion
pump over 5 hours at a constant infusion rate.
The intravenous dose is approximately equal to the oral dose
and administered at the same dosing frequency; 75 mg of
intravenous sotalol is approximately equal to 80 mg of oral
sotalol.
Starting adult dose is 75 mg administered twice daily. If
creatinine clearance is between 60 and 40 mL/min, administer
once daily, if less than 40 mg/mL, sotalol is not recommended
The dose can be up-titrated to maximal dose of 150 mg twice
daily under close ECG and QT interval monitoring. Intravenous
Sotalol is available in 10 mL vial (15 mg/mL) (Must be diluted
prior to use).
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3P
Dexamethasone
(Ozurdex)
Allergan Glucocorticoid indicated for the
treatment of macular edema
following branch retinal vein
occlusion (BRVO) or central retinal
vein occlusion (CRVO).
6/17/2009 For ophthalmic intravitreal injection only. The intravitreal
injection procedure should be carried out under controlled
aseptic conditions. Following the intravitreal injection, patients
should be monitored for elevation in intraocular pressure and
for endophthalmitis.
Intravitreal implant containing dexamethasone 0.7 mg in the
Novadur solid polymer drug delivery system. Intravitreal
injections have been associated with endophthalmitis, eye
inflammation, increased intraocular pressure, and retinal
detachments. Patients should be monitored following the
injection. Use of corticosteroids may produce posterior
subcapsular cataracts, increased intraocular pressure,
glaucoma, and may enhance the establishment of secondary
ocular infections due to bacteria, fungi, or viruses.
Corticosteroids should be used cautiously in patients with a
history of ocular herpes simplex. The most common adverse
reactions reported by ≥20% of patients included increased
intraocular pressure and conjunctival hemorrhage.
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3P
Tranexamic Acid
(Lysteda)
Xanodyne Pharm Treatment of heavy menstrual
bleeding.
11/13/2009 Concomitant use with hormonal contraceptives may increase
the risk of blood clots, stroke, or myocardial infarction.
Visual or ocular adverse effects may occur; discontinue use if
these happen.
Tranexamic acid is available as a 650 mg tablet.
Tranexamic acid should be taken as 2 tablets three times a
day for a maximum of 5 days during monthly mensuration.
The most common adverse reactions include headache, sinus
and nasal symptoms, back pain, abdominal pain,
musculoskeletal pain, joint pain, muscle cramps, migraine,
anemia, and fatigue.
Valganciclovir
(Valcyte)
Roche
Laboratories, Inc.
Cytomegalovirus (CMV) nucleoside
analogue DNA polymerase inhibitor
treatment of CMV retinitis in AIDS
patients, prevention in adults of
CMV in kidney, heart, kidney-
pancreas transplant patients at high
risk. CMV prevention in pediatric
heart and kidney transplant
patients.
8/28/2009 Black box warning for dose or therapy-limiting
granulocytopenia, anemia, and/or thrombocytopenia and also
for propensity to be teratogenic, carcinogenic, and cause
aspermatogenesis.
Valganciclovir is no longer indicated for use in adult or
pediatric liver transplant patients. Valganciclovir is available in
450 mg tablet and a new 50 mg/mL oral solution. The oral
solution and tablet formulation should be taken with food.
Valganciclovir solution is not recommended for adult use.
Common adverse reactions (≥20% of patients) include
diarrhea, pyrexia, hypertension, upper respiratory infection,
vomiting, anemia, neutropenia, constipation, nausea, and
cough.
Colesevelam
hydrochloride
(Welchol)
Daiichi Sankyo Bile acid sequestrant indicated as
an adjunct to diet and exercise in
the treatment of hyperlipidemia and
to improve glycemic control in
adults with type II diabetes.
10/02/2009 Colesevelam is now available in a new oral suspension of 3.75
g and 1.875 g packets. The recommended dose is a 3.75 g
packet once daily or a 1.875 g packet twice daily and the dose
should be taken with a meal. Colesevelam is not to be used in
improving glycemic control in type I diabetic patients.
Contraindications include history of bowel obstruction,
triglycerides ≥500 mg/dL, or patients with a history of
hypertriglyceridemia induced pancreatitis. Common adverse
reactions (≥2% incidence compared to placebo) were
constipation, dyspepsia, nausea. Post-marketing reports have
showed decreased levels of warfarin and phenytoin when give
concomitantly with colesevelam and administration of either of
these agents should be four hours prior to taking colesevelam.
Colesevelam has also shown through post-marketing reports to
increase levels of thyroid stimulating hormone; therefore,
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(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
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3P
administration of thyroid hormones should be four hours prior
to administration of colesevelam. Diclofenac sodium
(Pennsaid)
Nuvo Research Non-steroidal anti-inflammatory
(NSAID) for the treatment of signs
and symptoms of osteoarthritis of
the knee.
11/04/2009 Black box warning: NSAIDs are associated with increased risk
of adverse cardiovascular thrombotic events, gastrointestinal
irritation, ulceration, inflammation, bleeding, and perforation.
NSAIDs are also contraindicated for peri-operative pain
concerning coronary artery bypass graft surgery.
Diclofenac is available in a new 1.5% topical solution. The
recommended dose is forty drops on each drop each painful
knee four times daily. Diclofenac topical solution is to be
applied to clean, dry skin and allowed to dry completely before
covering with any articles of clothing or any other substances.
Patients must be sure to wash hands after application. The
most common adverse reactions associated with this topical
formulation were application site reactions.
Diclofenac
(Cambia)
Kowa
Pharmaceuticals
NSAID indicated for the acute
treatment of migraine attacks with
or without aura in adults 18 years of
age or older.
6/17/2009
Black box warnings:
NSAIDs may increase the risk of serious cardiovascular (CV)
thrombotic events, myocardial infarction, and stroke, which can
be fatal. Risk may increase with duration of use. Diclofenac is
contraindicated for the treatment of peri-operative pain in the
setting of coronary artery bypass graft (CABG) surgery.
NSAIDs increase the risk of serious gastrointestinal (GI)
adverse events including bleeding, ulceration, and perforation
of the stomach or intestines, which can be fatal. Events can
occur at any time without warning symptoms. Elderly patients
are at greater risk. Diclofenac is not indicated for the
prophylactic therapy of migraine. Safety and effectiveness of
diclofenac not established for cluster headache, which is
present in an older, predominantly male population.
Single 50 mg dose; mix single packet contents with 1 to 2
ounces (30 to 60 mL) of water prior to administration. Each
packet contains buffered diclofenac potassium 50 mg in a
soluble powder. Most common adverse reactions (≥1% and
>placebo) were nausea and dizziness.
Diclofenac
potassium
(Zipsor)
Xanodyne
Pharmaceuticals
NSAID indicated for relief of mild to
moderate acute pain.
6/16/2009 Black box warnings:
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial infarction, and stroke, which can
be fatal. This risk may increase with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular
disease may be at greater risk. Diclofenac is contraindicated
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3P
for the treatment of perioperative pain in the setting of coronary
artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal
adverse events including, bleeding, ulceration, and perforation
of the stomach or intestines, which can be fatal. These events
can occur at any time during use and without warning
symptoms. Elderly patients are at greater risk for serious
gastrointestinal events.
Most common adverse reactions (incidence ≥ 1% of diclofenac
25 mg treated subjects) are gastrointestinal experiences
including abdominal pain, constipation, diarrhea, dyspepsia,
nausea, vomiting, dizziness, headache, somnolence, pruritus,
and increased sweating.
Fentanyl buccal
soluble film
(Onsolis)
Biodelivery
Sciences
Opioid analgesic indicated only for
the management of breakthrough
pain in patients with cancer, 18
years of age and older, who are
already receiving and who are
tolerant to opioid therapy for their
underlying persistent cancer pain.
7/16/2009 Black box warning:
Contains fentanyl, a Schedule II controlled substance with
abuse liability similar to other opioid analgesics. Must only be
used in opioid tolerant patients. Life-threatening respiratory
depression could occur in patients not taking chronic opiates.
Contraindicated in management of acute or postoperative pain.
Do not substitute for any other fentanyl products. Contains
fentanyl in an amount that can be fatal to a child. Keep out of
reach of children and dispose of unneeded films properly. Use
with CYP3A4 inhibitors may cause potentially fatal respiratory
depression. Fentanyl buccal soluble film is available only
through a restricted distribution program called the FOCUS
Program and requires prescriber, pharmacy, and patient
enrollment.
Initial starting dose of 200 mcg in all patients. Titrate using
200 mcg fentanyl film increments (up to a maximum of four 200
mcg films or a single 1200 mcg film) to adequate analgesia
without undue side effects. Maximum is one dose per episode;
no more than four doses per day; separate by at least 2 hours.
Most common adverse reactions (frequency ≥10%): nausea,
vomiting, dizziness, dehydration, dyspnea, and somnolence.
Guanfacine
hydrochloride
(Intuniv)
Shire
Pharmaceuticals,
Inc.
Alpha-2 adrenergic receptor agonist
indicated for the treatment of
ADHD.
9/02/2009 The new formulation of guanfacine is an extended-release
tablet that should not be crushed, chewed, or broken before
swallowing. Guanfacine should be administered once daily and
in the absence of a high fat meal because of delayed gastric
emptying. Immediate and extended-release tablets are not
exchangeable on a mg-per-mg basis. Extended release tablets
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(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3P
are available as 1 mg, 2 mg, 3 mg, and 4 mg strengths. The
maintenance dose of guanfacine is 1-4 mg per day depending
upon clinical response and tolerability. When discontinuing
guanfacine, taper the dose in increments of no less than 1 mg
every 3 to 7 days. Common adverse reactions included
somnolence, abdominal pain, dizziness, hypotension, dry
mouth, and constipation. Monitor carefully when concomitantly
using CYP 3A4 inhibitors/inducers, anti-hypertensives, and
CNS depressants.
Lamotrigine XR
(Lamictal XR)
GlaxoSmithKline Antiepileptic drug (AED) indicated
as adjunctive therapy for partial
onset seizures with or without
secondary generalization in patients
≥13 years of age.
5/29/2009 Black box warning includes: Cases of life-threatening serious
rashes, including Stevens-Johnson syndrome, toxic-epidermal
necrolysis, and/or rash-related death, have been caused by
lamotrigine. The rate of serious rash is greater in pediatric
patients than in adults. Additional factors that may increase the
risk of rash include: coadministration with valproate, exceeding
recommended initial dose of lamotrigine XR, and exceeding
recommended dose escalation of lamotrigine XR. Benign
rashes are also caused by lamotrigine; however, it is not
possible to predict which rashes will prove to be serious or life-
threatening. Lamotrigine XR should be discontinued at the first
sign of rash unless the rash is clearly not drug-related.
Doses are administered once daily. Dose escalation and
maintenance doses are based on concomitant medications. To
avoid an increased risk of rash, the recommended initial dose
and subsequent dose escalations should not be exceeded.
Lamotrigine XR Patient Titration Kits are available for the first 5
weeks of treatment. Most common adverse reactions
(treatment difference ≥4%, Lamotrigine XR -Placebo) are
dizziness, tremor/intention tremor, cerebellar coordination/
balance disorder, nausea, asthenic conditions (asthenia,
fatigue, and malaise), vertigo/positional vertigo, and diplopia.
Levonorgestrel
(Plan B One-Step)
Duramed Progestin only emergency
contraceptive indicated for the
prevention of pregnancy.
7/10/2009 Levonorgestrel is now available in a one dose package that
contains only one tablet. Patients are to take the one tablet as
soon as possible and within 72 hours of unprotected sex.
Magnesium
Hydroxide /
Omeprazole /
Sodium
Bicarbonate
Santarus Proton pump inhibitor indicated for
the treatment of duodenal ulcer,
gastric ulcer, gastroesophageal
reflux disease (GERD), and the
maintenance healing of erosive
12/4/2009 Should not be administered to patients unable to take
magnesium.
The most common adverse effects are headache, abdominal
pain, nausea, diarrhea, vomiting, and flatulence.
This product is available as 750 mg sodium bicarbonate and
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(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3P
esophagitis 343 mg magnesium hydroxide with either 20- or 40-mg of
omeprazole.
The recommended dose for the treatment of duodenal ulcer is
20 mg daily for 4 weeks; gastric ulcer 40 mg daily for 4 weeks;
GERD 20 mg for 4-8 weeks; maintenance healing 20 mg daily.
Metformin
HCL/Pioglitazone
(ACTOplus Met
XR)
Takeda Global Biguanide and thiazolidinedione
combination product indicated for
the treatment of type II diabetes
mellitus.
5/12/2009 Metformin/pioglitazone is now available in a new extended-
release formulation. It is available in strengths of 15 mg
(pioglitazone)/ 1000 mg (metformin) and 30 mg
(pioglitazone)/1000 mg (metformin).
Black box warning: Pioglitazone has a warning for the
causation or exacerbation of heart failure and metformin has a
warning for causation of lactic acidosis.
Metoclopramide
(Metozolv ODT)
Salix Pharms Dopamine receptor antagonist used
for the relief of gastroesophageal
reflux symptoms and diabetic
gastroparesis
9/4/2009 Treatment may cause extrapyramidal symptoms and treatment
should last no longer than 12 weeks.
Commonly reported adverse effects include headache, nausea,
vomiting, fatigue, and somnolence.
Metoclopramide ODT is available in 5- and 10-mg tablets.
The dose for reflux related symptoms is 10mg to 15 mg up to
four times a day at least 30 minutes before eating and at
bedtime. For diabetic gastroparesis, the dose is 10 mg four
times daily at least 30 minutes before eating and at bedtime for
2-8 weeks.
Oxybutynin
Chloride Gel 10%
(Gelnique)
Watson
Pharmaceuticals,
Inc.
Antimuscarinic agent indicated for
the treatment of overactive bladder
with symptoms of urge, urinary
incontinence, urgency, and
frequency.
1/27/2009 Use caution in patients with clinically significant bladder
outflow obstruction because of the risk of urinary retention.
Use caution in patients with gastrointestinal obstructive
disorders or decreased intestinal motility. Discontinue
oxybutynin in patients with skin hypersensitivity. Advise
patients to cover the application site with clothing if skin-to-skin
contact at the application site is anticipated. Wash hands
immediately after product application. Contains alcohol-based
gel, avoid open fire or smoking until the gel has dried. Apply
contents of one sachet of oxybutynin once daily to dry, intact
skin on the abdomen, upper arms/shoulders, or thighs. Rotate
application sites, avoiding use of the same site on consecutive
days. oxybutynin is for topical application and should not be
ingested.
Sevelamer
carbonate
(Renvela)
Genzyme Phosphate binder indicated for the
control of serum phosphate in
patients with chronic kidney disease
8/12/2009 The new formulation for sevelamer is 800 mg and 1600 mg
packet for oral suspension. The starting dose is either 800 mg
or 1600 mg packet for oral administration three times daily with
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3P
on dialysis. meals. Titrate by 800 mg in two week intervals until desired
serum phosphorous target is reached. Sevelamer is
contraindicated in patients with bowel obstruction. Safety and
efficacy have not been established in patients with dysphagia,
swallowing disorders, impaired GI motility, or major GI tract
surgery. The most frequently observed adverse reactions were
nausea and vomiting. Cases of fecal impaction and bowel
perforation have been reported. Administer other oral
medications at least one hour before or three hours after
sevelamer administration.
Sumatriptan
injection
(Sumavel
Dosepro)
Zogenix Inc. 5-HT1B/1D receptor agonist
(triptan) indicated for:
The acute treatment of migraine
attacks, with or without aura.
The acute treatment of cluster
headache episodes.
Important limitations:
Use only after a clear diagnosis of
migraine or cluster headache has
been established.
Not intended for the prophylactic
therapy of migraine.
7/15/2009 For subcutaneous use only. Single 6 mg dose administered to
the abdomen or thigh. Do not administer to the arm or other
areas of the body. The maximum recommended dose that may
be given in 24 hours is two doses separated by at least 1 hour.
Benefit of second dose in patients who have failed to respond
to a first dose has not been established.
The most common adverse reactions (≥ 2% and > placebo)
were injection site reactions, tingling, warm/hot sensation,
burning sensation, feeling of heaviness, pressure sensation,
feeling of tightness, numbness, feeling strange, tight feeling in
head, flushing, tightness in chest, discomfort in nasal
cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/
sedation, and headache.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3S
Telbivudine
(Tyzeka)
Novartis HBV nucleoside analogue reverse
transcriptase inhibitor indicated for
the treatment of chronic hepatitis B
in adult patients with evidence of
viral replication and either evidence
of persistent elevations in serum
aminotransferases (ALT or AST) or
histologically active disease.
4/28/2009 Black box warning includes: Lactic acidosis and severe
hepatomegaly with steatosis, including fatal cases, have been
reported with the use of nucleoside analogues. Severe acute
exacerbations of hepatitis B have been reported in patients
who discontinued anti-hepatitis B therapy, including
telbivudine. Hepatic function should be monitored closely in
patients who discontinue therapy. Resumption of anti-hepatitis
B therapy may be warranted.
Dosing for adults and adolescents (≥16 years of age): 600 mg
once daily, taken orally, with or without food. Dose adjustment
required in patients with creatinine clearance < 50 mL/min.
The new label includes a warning for peripheral neuropathy,
increased when used in combination with pegylated interferon
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3S
alfa-2a. Avoid concomitant use of pegylated interferon alfa-2a
or other interferons.
Temozolomide
(Temodar)
Schering-Plough Alkylating drug indicated for the
treatment of adult patients with
newly diagnosed glioblastoma
multiforme concomitantly with
radiotherapy and then as
maintenance treatment and for
refractory anaplastic astrocytoma,
patients who have experienced
disease progression on a drug
regimen containing nitrosourea and
procarbazine.
2/27/2009 Newly diagnosed glioblastoma multiforme: 75 mg/m2
for 42
days concomitant with focal radiotherapy followed by initial
maintenance dose of 150 mg/m2
once daily for days 1-5 of a
28-day cycle of Temodar for 6 cycles.
Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m2
once daily for 5 consecutive days per 28-day treatment cycle.
The recommended dose for temozolomide as an intravenous
infusion over 90 minutes is the same as the dose for the oral
capsule formulation. Bioequivalence has been established only
when injection was given over 90 minutes. The most common
adverse reactions (≥ 10% incidence) are: alopecia, fatigue,
nausea, vomiting, headache, constipation, anorexia,
convulsions, rash, hemiparesis, diarrhea, asthenia, fever,
dizziness, coordination abnormal, viral infection, amnesia, and
insomnia.
Tobramycin /
dexamethasone
(TobraDex
ST)
Alcon Topical antibiotic and corticosteroid
combination for steroid-responsive
inflammatory ocular conditions for
which a corticosteroid is indicated
and where superficial bacterial
ocular infection or a risk of bacterial
ocular infection exists.
2/13/2009 Instill one drop into the conjunctival sac(s) every 4 to 6 hours.
During the initial 24 to 48 hours, dosage may be increased to
one drop every 2 hours. Frequency should be decreased
gradually as warranted by improvement in clinical signs, but
care should be taken not to discontinue therapy prematurely.
Most common adverse reactions to topical ocular tobramycin
are hypersensitivity and localized ocular toxicity, including eye
pain, eyelids pruritus, eyelid edema, and conjunctival
hyperemia. The reactions due to the steroid component are
increases in intraocular pressure with possible development of
glaucoma.
Zolpidem
(Edluar)
Orexo Indicated for the short-term
treatment of insomnia characterized
by difficulties with sleep initiation.
3/13/2009 Adult dose: 10 mg once daily immediately before bedtime.
Sublingual tablet should be placed under the tongue, where it
will disintegrate. Elderly/debilitated patients/hepatic
impairment: 5 mg once daily immediately before bedtime.
Downward dosage adjustment may be necessary when used
with CNS depressants. Zolpidem should not be administered
with or immediately after a meal. Most commonly observed
adverse events using zolpidem tartrate were: -Short-term (<10
nights): Drowsiness, dizziness and diarrhea; -Long-term (28-35
nights): Dizziness and drugged feelings. Reevaluate if
insomnia persists after 7 to 10 days of use. Abnormal thinking,
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(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3S
behavior changes and complex behaviors: May include “sleep
driving” and hallucinations. Prescribe the least amount
feasible. Use can impair alertness and motor coordination. If
used in combination with other CNS depressants, dose
reductions may be needed due to additive effects. Do not use
with alcohol.
Bromocriptine
mesylate
(Cycloset)
VeroScience LLC Dopamine receptor agonist
indicated as an adjunct to diet and
exercise to improve glycemic
control in adults with type 2
diabetes.
Important Limitations of Use:
Should not be used to treat type 1
diabetes or diabetic ketoacidosis.
Limited efficacy data in combination
with thiazolidinediones.
Efficacy has not been confirmed in
combination with insulin.
5/05/2009 Adverse reactions reported in ≥ 5% of patients included
nausea, fatigue, dizziness, vomiting, and headache.
Postmarketing reports with higher doses of bromocriptine used
for other indications include psychotic disorders,
hallucinations, and fibrotic complications. May increase the
unbound fraction of highly protein-bound therapies, altering
their effectiveness and safety profiles. May increase ergot-
related side effects or reduce ergot effectiveness for migraines
if co-administered within 6 hours of ergot-related drugs.
Extensively metabolized by CYP3A4. Use caution when
coadministering strong inhibitors, inducers, or substrates for
CYP3A4. Calcitrol
(Vectical)
Galderma
Laboratories
Vitamin D analog indicated for the
topical treatment of mild to
moderate plaque psoriasis in adults
18 years and older.
1/23/2009 Apply ointment to affected areas of the body twice daily. This
product is not for oral, ophthalmic, or intravaginal use. The
maximum weekly dose should not exceed 200 grams. Each
gram of ointment contains 3 micrograms of calcitriol. Avoid
excessive exposure of calcitrol ointment treated areas to either
natural or artificial sunlight. Most common adverse reactions
(incidence >3%) were lab test abnormality, urine abnormality,
psoriasis, hypercalciuria, and pruritus.
Ciprofloxacin
(Cetraxal)
WraSer
Pharmaceuticals
Quinolone antimicrobial indicated
for the treatment of acute otitis
externa due to susceptible isolates
of Pseudomonas aeruginosa or
Staphylococcus aureus.
5/01/2009 This is a sterile, preservative-free otic solution of ciprofloxacin
hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25
mL) in each single use container. Contents of one single use
container should be instilled into the affected ear twice daily
(approximately 12 hours apart) for 7 days. This product is for
otic use only. Use of ciprofloxacin otic solution may result in
overgrowth of nonsusceptible organisms. The most common
adverse reactions reported in 2-3% of patients treated with
ciprofloxacin otic solution were application site pain, ear
pruritus, fungal ear superinfection, and headache.
Clonidine
hydrochloride
(Jenloga)
Addrenex
Pharmaceuticals,
Inc.
Centrally acting alpha-2 agonist
indicated for the treatment of
hypertension.
9/29/2009 This product is a modified-release formulation of clonidine that
is not directly interchangeable with the immediate release
dosage formulation. The initial dose for clonidine is 0.1 mg at
bedtime which can be titrated by 0.1 mg at weekly intervals up
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
3S
to 0.6 mg daily in divided doses. When discontinuing
clonidine, taper the dose over 2 to 4 days gradually to prevent
rebound hypertension. Common adverse reactions include
(≥5% incidence) dry mouth, fatigue, dizziness, headache,
nausea, somnolence, and insomnia.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
4P
Aliskiren
hemifurate /
valsartan
(Valturna)
Novartis Direct rennin inhibitor and
angiotensin receptor blocker
combination indicated for the
treatment of hypertension.
9/16/2009 Black box warning: aliskiren/valsartan can cause injury or
death to the fetus when used in the 2nd
and 3rd
trimester and
should not be used in pregnancy.
Aliskiren/valsartan is available as a tablet in
150(aliskiren)/160(valsartan) mg and 300/320 mg strengths.
The maximum dose is 300/320 mg. Common adverse drug
reactions include (≥1.5% incidence more common than
placebo) were fatigue and nasopharyngitis. Aliskiren/valsartan
can be utilized in patients not adequately controlled on
monotherapy, initially in patients suspected not to obtain
control with a single agent, or as a substitute for the titrated
components once patient is stabilized.
Amlodipine
besylate /
telmisartan
(Twynsta)
Boehringer
Ingelheim
Angiotensin receptor blocker and
non-dihydropyridine calcium
channel blocker combination
indicated for the treatment of
hypertension.
10/16/2009 Black box warning: Drugs that affect the angiotensin system
have been shown to injury and death in infants in the 2nd
and
3rd
trimester and use should be avoided in pregnancy.
Initial starting dose is 40mg/5mg (telmisartan/amlodipine) or
80mg/5mg. Available strengths are 40mg/5mg, 40mg/10mg,
80mg/5mg, and 80mg/10mg tablets. Amlodipine/telmisartan
can be used in combination with other antihypertensives or as
monotherapy. It can also act as a substitute therapy for
patients stabilized on each active ingredient independently.
Most common reasons for discontinuation (≤5% of patients) of
amlodipine/telmisartan were peripheral edema, hypotension,
and dizziness. Common adverse reactions were (≥2% higher
incidence compared to placebo) peripheral edema, dizziness,
orthostatic hypotension, and back pain.
Amlodipine/
Valsartan/ Hydrochlorothiazide
(Exforge HCT)
Novartis Combination calcium channel
blocker, angiotensin receptor
blocker, and thiazide diuretic.
Indicated for the treatment of
4/30/2009 Black box warning: When pregnancy is detected, discontinue
amlodipine/valsartan/hydrochlorothiazide as soon as possible.
Drugs that act directly on the renin-angiotensin system can
cause injury or death to the developing fetus.
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
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4P
hypertension. Amlodipine/valsartan/hydrochlorothiazide may be used as add-
on/switch therapy for patients not adequately controlled on any
two of the following antihypertensive classes: calcium channel
blockers, angiotensin receptor blockers, and diuretics. The full
blood pressure lowering effect was achieved 2 weeks after
being on the maximal dose. Available in tablets:
(amlodipine/valsartan/ hydrochlorothiazide mg) 5/160/12.5
10/160/12.5 5/160/25 10/160/25 10/320/25.
Most common adverse events (≥2% incidence) are dizziness,
peripheral edema, headache, dyspepsia, fatigue, muscle
spasms, back pain, nausea and nasopharyngitis.
Morphine
Sulfate/Naltrexone
HCL
(Embeda)
Alpharma King Indicated for moderate to severe
pain when continuous scheduled
analgesia is needed for an
extended period of time.
8/13/2009 Black box warnings: avoidance of alcoholic beverages while
taking morphine or naltrexone due to risk of increased plasma
morphine levels, for use only in opioid-tolerant patients, not
intended for use as PRN analgesic, chewing, crushing, or
dissolving capsules will release naltrexone which may
precipitate withdrawal in opioid-tolerant patients.
Morphine/naltrexone capsules are to be swallowed whole or
sprinkled in applesauce and swallowed. The dosage strengths
are 20 mg/ 0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg,
80 mg/3.2 mg, 100 mg/ 4 mg. Morphine/naltrexone can be
give once to twice daily. The most common adverse drug
reactions were constipation, nausea, and somnolence.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
5P
Ibuprofen
(Caldolor)
Cumberland
Pharmaceuticals
NSAID indicated in adults for the
management of mild to moderate
pain, management of moderate to
severe pain as an adjunct to opioid
analgesics, and reduction of fever
6/11/2009 Black box warning‟s:
Cardiovascular Risk: NSAIDs may increase the risk of serious
CV thrombotic events, myocardial infarction, and stroke, which
can be fatal. Risk may increase with duration of use.
Gastrointestinal Risk: NSAIDs increase the risk of serious
gastrointestinal (GI) adverse events including bleeding,
ulceration, and perforation of the stomach or intestines, which
can be fatal. Events can occur at any time without warning
symptoms. Elderly patients are at greater risk.
The most common adverse reactions are nausea, flatulence,
vomiting, headache, hemorrhage and dizziness.
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
5P
Trypan blue
(MembraneBlue)
Dutch
Ophthalmic
An acid di-azo group dye. For use
as an aid in ophthalmic posterior
surgery, used for facilitating
removal of epiretinal tissue.
2/20/2009 Prior to injection of trypan blue 0.15% perform a „fluid-air
exchange‟. Carefully apply trypan blue 0.15% to epiretinal
membranes using a blunt cannula. Remove all excess dye.
OR
Inject trypan blue 0.15% directly in a BSS filled vitreous cavity,
wait 30 seconds, remove all excess dye.
Warning includes excessive staining. Trypan blue 0.15%
should be removed from the eye immediately after staining.
Adverse reactions include: discoloration of high water content
hydrogen intraocular lenses, and inadvertent staining of the
posterior lens capsule and vitreous face.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
5S
Fenofibric acid
(Fibricor)
AR Scientific, Inc. Peroxisome proliferator receptor
alpha activator indicated for
hypertriglyceridemia, primary
hyperlipidemia, and mixed
dyslipidemia.
8/14/2009 Fenofibric acid comes in a 35 mg and 105 mg tablet.
Fenofibric acid dosing for hypertriglyceridemia is 35 mg to 105
mg, and the dose should be adjusted based on patient
response, where as for hyperlipidemia or mixed dyslipidemia,
the dose should be 105 mg. In renal impairment (CrCl 30-80
ml/min) the dose should be 35 mg. Fenofibric acid can be
taken without regard to meals. Fenofibric acid is
contraindicated in patients with severe renal dysfunction such
as those on dialysis, active liver disease, gallbladder disease,
and nursing mothers. The most common adverse reactions
observed with fenofibric acid were increased liver enzymes,
back pain, abdominal pain, and headache. Monitoring
parameters include CBC with differential, creatine
phosphokinase, liver function tests, serum bilirubin serum
cholesterol and triglycerides.
Ketorolac
tromethamine
ophthalmic solution
(Acuvail)
Allergan NSAID indicated for the treatment
of pain and inflammation following
cataract surgery
7/22/2009 One drop of ketorolac should be applied by the patient to the
affected eye twice daily beginning 1 day prior to cataract
surgery, and continued through the first 2 weeks of the
postoperative period. Available as a 4.5 mg/mL ketorolac
tromethamine solution in a single-use vial. Warnings include:
delayed healing, potential for cross-sensitivity, increased
bleeding time due to interference with thrombocyte aggregation
and corneal effects including keratitis. Most common adverse
reactions occurring in 1-6% of patients were increased
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
5S
intraocular pressure, conjunctival hemorrhage, and vision
blurred.
Nicotine polacrilex
(Nicorette)
GlaxoSmithKline Naturally occurring alkaloid indicate
for the treatment of nicotine
withdrawal
5/18/2009 Nicotine polacrilex has a new manufacturer which is
GlaxoSmithKline and it comes available in a 2 mg and 4 mg
troche.
Oxaliplatin
(Eloxatin)
Teva Parenteral Non-cell cycle specific, alkylating
antineoplastic agent that inhibits
DNA synthesis indicated for
colorectal cancer, gastric cancer,
ovarian cancer, breast cancer, non-
Hodgkin‟s lymphoma, head and
neck cancer, pancreatic cancer,
biliary tract cancer, testicular
cancer, and malignant
mesothelioma.
8/07/2009 Black box warning for anaphylactic reactions which may occur
within minutes of oxaliplatin administration, and symptoms may
be managed with epinephrine, corticosteroids, and
antihistamines.
This update is regarding a new manufacturer for Oxaliplatin.
Oxaliplatin has a wide range of dosage options depending on
the particular cancer being treated. The dose range is from 85
mg/m² to a maximum dose of 130 mg/m² IV. There is no
specific adjustment for renal impairment; however, area under
the curve increased significantly in patients with CrCl<80
ml/min. Oxaliplatin is usually used in combination with other
drugs in order to target cancerous cell division at multiple
stages. Monitoring parameters include CBC with differential,
liver function tests, and serum creatinine. This drug is
associated with hematologic adverse events (i.e.
thrombocytopenia, leucopenia), gastrointestinal effects (i.e.
nausea/vomiting, ulceration, diarrhea), infusion site reactions,
peripheral neuropathy, and elevated liver enzymes.
Oxaliplatin is available as an injectable preparation with 50
mg/10ml, 100 mg/20ml, and 200mg/40ml strengths.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
6P
Lansoprazole
(Prevacid)
Novartis Proton pump inhibitor indicated for
gastroesophageal reflux disease
5/18/2009 This is the new over-the-counter lansoprazole manufactured by
Novartis. The past manufacturer was Takeda Pharmaceuticals.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
6S
Azelastine
hydrochloride
MEDA
Pharmaceuticals
H1 receptor antagonists indicated
for the relief of the symptoms of
8/31/2009 Azelastine comes in two strengths 0.1% and 0.15% and the
usual dosage is 1-2 sprays twice daily for using in children 12
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
6S
(Astepro) seasonal and perennial allergic
rhinitis. Also indicated for
vasomotor rhinitis, ocular pruritus,
and allergic conjunctivitis.
years or older and adults. Azelastine must be primed before
initial use and when not used for longer than 3 or more days.
Common adverse reactions (≥2% incidence) include bitter
taste, nasal discomfort, epistaxis, headache, fatigue,
somnolence, and sneezing.
Exenatide
(Byetta)
Amylin
Pharmaceuticals
Glucagon-like peptide receptor
agonist indicated as an adjunct to
diet and exercise to improve
glycemic control in type II diabetes.
10/30/2009 Exenatide now is indicated for treatment of type II diabetes as
monotherapy whereas before it was only indicated as an
adjunct along with other diabetic medications. However, the
use of exenatide in patients with type I diabetes or on insulin is
not recommended. Exenatide is injected subcutaneously twice
daily prior to morning or evening meals at least six hours apart.
Initial dose is recommended to start at 5 mcg twice daily and
increased to 10 mcg twice daily after one month based on
clinical response. Exenatide is not recommended in patients
with CrCl less than 30 mL/min.
Common adverse reactions (≥5%) were nausea,
hypoglycemia, vomiting, diarrhea, jitteriness, dizziness,
headache, and dyspepsia. Post-marketing issues have been
increased INR with warfarin and non-fatal and fatal necrotizing
pancreatitis.
Sildenafil
(Avastin)
Pfizer Phosphodiesterase 5 (PDE5)
inhibitor indicated for the treatment
of pulmonary arterial hypertension
(WHO Group I) to improve exercise
ability and delay clinical worsening.
5/07/2009 Initial dose of 20 mg three times a day, approximately 4-6
hours apart, with or without food. Doses above 20 mg TID not
recommended. Most common adverse reactions (≥ 3% and
more frequent than placebo) include epistaxis, headache,
dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis.
Limitation of use: The efficacy has not been adequately
evaluated in patients taking bosentan concurrently.
Tadalafil
(Adcirca)
Eli Lilly and
Company
PDE5 inhibitor indicated for the
treatment of pulmonary arterial
hypertension (WHO Group I) to
improve exercise ability.
5/22/2009 Initial dose is 40 mg once daily, with or without food. Dividing
the dose (40 mg) over the course of the day is not
recommended. Use with ritonavir requires dosage adjustments
The most common adverse reaction is headache.
Renal Impairment dose adjustment:
Mild or moderate: Start with 20 mg once daily.
Severe: Avoid use of tadalafil.
Hepatic Impairment dose adjustment:
Mild or moderate: Consider starting dose of 20 mg once daily.
Severe: Avoid use of tadalafil.
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
7P
Pancrelipase
(Creon)
Solvay
Pharmaceuticals
Combination of porcine-derived
lipases, proteases, and amylases
indicated for the treatment of
exocrine pancreatic insufficiency
due to cystic fibrosis or other
conditions.
4/30/2009 Should be swallowed whole. For infants or patients unable to
swallow intact capsules, the contents may be administered
without crushing or chewing, followed by fluid to ensure
complete ingestion. Dosing should not exceed the
recommended maximum dosage set forth by the Cystic
Fibrosis Foundation Consensus Conferences Guidelines.
Treatment-emergent adverse events occurring in at least 2
patients (greater than or equal to 6%) receiving pancrelipase
or placebo is abdominal pain, abdominal pain upper, abnormal
feces, cough, dizziness, flatulence, headache, and weight
decreased.
Pancrelipase
(Zenpep)
Eurand Combination of porcine-derived
lipases, proteases, and amylases
indicated for the treatment of
exocrine pancreatic insufficiency
due to cystic fibrosis or other
conditions.
8/27/2009 There are 4 different strengths with pancrelipase, all of which
are capsules. The most common adverse drug reactions (≥6%
of patients) observed were abdominal pain, flatulence,
headache, cough, decreased weight, early satiety, and
confusion. This product in not interchangeable with other
pancreatic insufficiency medications. Take oral capsule right
before or with meals or snacks followed by a glass of water or
juice. Dosages should not exceed recommended maximum
dosages provided by the Cystic Fibrosis Foundation
Consensus Conferences Guidelines.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
7S
Capsaicin (Qutenza) Neurogesx TRPV1 channel agonist used for the
treatment of neuropathic pain
associated with postherpetic
neuralgia
11/16/2009 Airborne inhalation may cause coughing or sneezing to occur.
Transient increases in blood pressure may occur; monitor
patients during and after treatment.
Capsaicin is available as a patch containing 8% capsaicin (640
mcg/m2). Each patch contains a total of 179 mg capsaicin.
Capsaicin is to applied to the most painful area for 60 minutes
at a time. Up to 4 patches may be applied. Treatment should
be repeated every 3 months or as warranted by return of pain.
Topical anesthetic must be applied prior to use.
Application site reactions are the most commonly reported
adverse effects.
Codeine Sulfate Roxane Opioid analgesic indicated for the 7/16/2009 Codeine sulfate is now available in a tablet formulation with
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
7S
relief of mild to moderately severe
pain.
strengths of 15 mg, 30 mg, and 60 mg. Prior to this new
formulation codeine was only available as an oral solution or
injection in the phosphate form.
Colchicine
(Colcrys)
Mutual
Pharmaceutical
Company
Alkaloid indicated for prophylaxis
and treatment of gout flares in
adults and for the treatment of
Familial Mediterranean fever in
adults and children four years or
older.
10/16/2009 Prevention of gout flares requires a dose of 0.6 mg once to
twice daily in patients sixteen years or older with a maximum
dose of 1.2 mg/day. For treatment of gout flares the
recommended dose is 1.2 mg at first sign of a gout flare and
the 0.6 mg an hour later. For treatment of Familial
Mediterranean fever the dose recommendations range from
1.2 to 2.4 mg(>12 years old), 0.9 mg to 1.8 mg(6 to 12 year
old), and 0.3 mg to 1.8 mg(4 to 6 years old) in divided doses.
Patients with hepatic or renal impairment should not receive
colchicine in conjunction with P-gp and CYP 3A4 inhibitors.
Common adverse reactions seen in treatment of gout were
diarrhea and pharyngolaryngeal pain. Common adverse
reactions (up to 20%) seen in treatment of Familial
Mediterranean fever were abdominal pain, diarrhea, nausea,
and vomiting.
Golimumab
(Simponi)
Centocor Ortho
Biotech, Inc
Tumor necrosis factor (TNF) blocker
indicated for the treatment of:
Moderately to severely active
rheumatoid arthritis (RA) in adults,
in combination with methotrexate
and
active psoriatic arthritis (PsA) in
adults, alone or in combination with
methotrexate, and active ankylosing
spondylitis in adults (AS)
4/24/2009 Black box warning for serious infections leading to
hospitalization or death including tuberculosis (TB), bacterial
sepsis, and invasive fungal and other opportunistic infections
has occurred. Golimumab should be discontinued if a patient
develops a serious infection or sepsis. Perform test for latent
TB; if positive, start treatment for TB prior to starting
golimumab. Monitor all patients for active TB during treatment,
even if initial latent TB test is negative. The dose for
rheumatoid arthritis, psoriatic arthritis, and ankylosing
spondylitis is 50 mg administered by subcutaneous injection
once a month. Most common adverse reactions (incidence >
5%): upper respiratory tract infection, nasopharyngitis.
GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
BIOLOGICS
Antithrombin
(recombinant)
(ATryn)
GTC
Biotherapeutics
Inc
ATryn is a recombinant antithrombin
indicated for the prevention of peri-
operative and peri-partum
thromboembolic events in
2/6/2009 Most common adverse reactions reported in clinical trials at a
frequency of ≥ 5% were hemorrhage and infusion site reaction.
Anaphylaxis and severe hypersensitivity reactions are
possible. The anticoagulant effect of drugs that use
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
BIOLOGICS
hereditary antithrombin deficient
patients
antithrombin to exert their anticoagulation may be altered when
antithrombin is added or withdrawn. To avoid excessive or
insufficient anticoagulation, regularly perform coagulation tests
suitable for the anticoagulant used, at close intervals,
especially in the first hours following the start or withdrawal of
antithrombin and monitor patients for bleeding or thrombosis.
The dosage of antithrombin is individualized for each patient.
Treatment goal is to restore and maintain functional
antithrombin (AT) activity levels between 80% - 120% (0.8 - 1.2
IU/mL) of normal. Administer loading dose as a 15-minute
intravenous infusion immediately followed by continuous
infusion of the maintenance dose.
Canakinumab
(Ilaris)
Novartis
Pharmaceuticals
Interleukin-1β blocker indicated for
the treatment of Cryopyrin-
Associated Periodic Syndromes
(CAPS), in adults and children 4
years of age and older including:
Familial Cold Autoinflammatory
Syndrome (FCAS) and Muckle-
Wells Syndrome (MWS).
7/17/2009 Dosing is 150 mg for CAPS patients with body weight greater
than 40 kg, and 2 mg/kg for CAPS patients with body weight
greater than or equal to 15 kg and less than or equal to 40 kg;
for children 15 to 40 kg with an inadequate response, the dose
can be increased to 3 mg/kg.
Interleukin-1 blockade may interfere with immune response to
infections. Treatment with medications that work through
inhibition of IL-1 has been associated with an increased risk of
serious infections. Ilaris has been associated with an increased
incidence of serious infections. Live vaccines should not be
given concurrently with canakinumab. Prior to initiation of
therapy, patients should receive all recommended
vaccinations. The most common adverse reactions reported
by patients are nasopharyngitis, diarrhea, influenza, headache
and nausea.
C1 Esterase Inhibitor
(Human) (Berinet)
CSL Behring Acute abdominal or facial attacks of
hereditary angioedema (HAE) in
adults and adolescents
10/9/2009 Hypersensitivity may occur and epinephrine should be
immediately available. Use of off-label high doses has
resulted in thrombotic events.
C1 esterase inhibitor is available as 500 units lyophilized
concentrate in a single-use vial for reconstitution with 10 mL of
diluent (sterile water). The dose of C1 esterase inhibitor is 20
units/kg administered at a rate of 4 mL/minute.
The most common adverse effects are subsequent HAE
attacks, headache, abdominal pain, nausea, muscle spasm,
pain, diarrhea, and vomiting. An increase in severity of pain is
the most severe reaction reported to date.
Fibrinogen CSL Behring Fibrinogen is a physiological 1/16/2009 Monitor patients for early signs of allergic or hypersensitivity
Samford University Global Drug Information Service
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
BIOLOGICS
concentrate (human)
(RiaSTAP)
substrate of three enzymes:
thrombin, factor XIIIa, and plasmin.
Indicated for the treatment of acute
bleeding episodes in patients with
congenital fibrinogen deficiency,
including afibrinogenemia and
hypofibrinogenemia.
reactions and if necessary, discontinue administration and
institute appropriate treatment. Thrombotic events have been
reported in patients receiving fibrinogen. The most serious
adverse reactions observed are thrombotic episodes
(pulmonary embolism, myocardial infarction, deep vein
thrombosis) and anaphylactic reactions. The most common
adverse reactions observed in clinical studies were fever and
headache. Dose (mg/kg body weight) =
[Target level (mg/dL) - measured level (mg/dL)]
1.7 (mg/dL per mg/kg body weight). Fibrinogen is available as
a single-use vial containing 900 mg to 1300 mg lyophilized
fibrinogen concentrated powder for reconstitution.
Haemophilus b
Conjugate Vaccine
(Tetanus Toxoid
Conjugate) (Hiberix)
GlaxoSmithKline Active immunization booster dose
for the prevention of disease
caused by Haemophilus influenzae
type b in children 15 months
through 4 years of age (prior to 5th
birthday).
8/19/2009 If a patient experienced Guillain-Barre syndrome within 6
weeks of receiving another tetanus toxoid containing vaccine,
weigh risk and benefit before administering the vaccine.
Haemophilus b conjugate vaccine is supplied in vials of
lyophilized vaccine to be reconstituted with the provided saline
diluent. After reconstitution, a single dose of 0.5 mL should be
given intramuscularly.
Injection site reactions, fever, fussiness, loss of appetite, and
restlessness are the most commonly reported adverse effects.
Human
Papillomavirus
Bivalent Types 16
and 18 Recombinant
Vaccine (Cervarix)
GlaxoSmithKline Prevention of cervical neoplasms
caused by oncogenic human
papillomavirus types 16 and 18 in
females 10-25 years of age
10/16/2009 Observe patients for syncope for 15 minutes after
administration. The prefilled syringe should not be used in
patients with latex allergies.
This vaccine is available in 0.5 mL suspension for injection in a
single-dose vial or pre-filled syringe.
Patients should receive a total of three 0.5 mL doses at 0-, 1-,
and 6-months.
Injection site reactions, fatigue, headache, myalgia,
gastrointestinal symptoms, and arthralgia are the most
common adverse effects.
Immune Globulin
Intravenous (Human)
(Gammaplex)
BioProducts
Laboratoy
Treatment of patients with primary
humoral immunodeficiency (PI)
9/17/2009 Renal dysfunction, acute renal failure, osmotic nephropathy,
and death may occur in patients predisposed to these
conditions. This formulation of immune globulin does not
contain sucrose and should be administered at the minimum
rate possible.
This immune globulin is available as a liquid solution
containing 5% IgG (50 mg/mL).
The dose should be 300-800 mg/kg every 3-4 weeks. Initial
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GENERIC NAME
(BRAND NAME) SPONSOR CLASSIFICATION & INDICATION/USE
APPROVAL
DATE COMMENTS
BIOLOGICS
infusion rate should be 0.5 mg/kg/min (0.01 mL/kg/min) for 15
minutes. If tolerated, the maintenance rate should be
increased to 4 mg/kg/min (0.08 mL/kg/min).
Headache, fatigue, nausea, pyrexia, hypertension, myalgia,
pain, and vomiting are the most commonly reported adverse
effects.
Influenza Virus
Vaccine (Agriflu)
Novartis Active immunization of adults ≥ 18
years against influenza disease
caused by virus subtypes A and B
which are present in the vaccine
11/27/2009 This flu vaccine should not be administered to patients with
sensitivities to egg proteins, kanamycin, or neomycin.
This vaccine is available in 0.5 mL single dose, pre-filled
syringes with no preservatives.
Injection site reactions, headache, myalgia, and malaise are
the most common adverse effects.
Japanese
Encephalitis Vaccine,
Inactivated (Ixiaro)
Intercell
Biomedical
Prevention of disease caused by
Japanese encephalitis virus in
patients ≥ 17 years
3/30/2009 The Japanese encephalitis vaccine contains protamine sulfate
and may cause hypersensitivity reactions in some patients.
The vaccine is supplied as 0.5 mL single dose pre-filled
syringe for injection.
Headache, myalgia, and injection site reactions are the most
commonly reported adverse effects.
von Willebrand
Factor / Coagulation
Factor VIII Complex
(Human) (Wilate)
Octapharma Spontaneous or trauma-induced
bleeding episodes in patients with
von Willebrand disease (VWD) and
in patients with VWD in which
desmopression is either ineffective
or contraindicated
12/4/2009 For minor bleeds, the loading dose of VWF:RCo is 20-40 IU/kg
and the maintenance dose is 20-30 IU/kg every 12-24 hours.
Treat to a goal of VWF:RCo and FVIII activity trough levels of
>30%.
For major bleeds, the loading dose of VWF:RCo is 40-60 IU/kg
and the maintenance dose is 20-40 IU/kg every 12-24 hours.
Treat to a goal of VWF:RCo and FVIII activity trough levels of
>50%.
Urticara and dizziness are the most commonly reported
adverse effects.
VWF:RCo is available as a sterile lyophilized powder for
reconstitution for intravenous use in 450 IU VWF:RCo and
FVIII activities in 5mL and 900 IU VWF:RCo and FVIII activities
in 10 mL
****************************************************************************************************************************************************************************************
Prepared by: John Mark Rolling, Pharm.D. Candidate Reviewed by: Peter J. Hughes, Pharm.D.
Chris Welch, Pharm.D. Candidate Terri M. Wensel, Pharm.D., BCPS
Temeka Borden, Pharm.D.
Maisha Kelly Freeman, Pharm.D., BCPS
****************************************************************************************************************************************************************************************