Samford University Global Drug Information Service …

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


2

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


3

GENERIC NAME


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.


4

GENERIC NAME


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


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.


5

GENERIC NAME


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,


6

GENERIC NAME


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


7

GENERIC NAME


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


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


8

GENERIC NAME


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.


9

GENERIC NAME


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


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%).


10

GENERIC NAME


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


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.


11

GENERIC NAME


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,


12

GENERIC NAME


APPROVAL

DATE COMMENTS

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


13

GENERIC NAME


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


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


14

GENERIC NAME


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


15

GENERIC NAME


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


16

GENERIC NAME


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


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


17

GENERIC NAME


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,


18

GENERIC NAME


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


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


19

GENERIC NAME


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


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


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.


20

GENERIC NAME


APPROVAL

DATE COMMENTS

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


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.


21

GENERIC NAME


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


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


22

GENERIC NAME


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


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


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


23

GENERIC NAME


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.


24

GENERIC NAME


APPROVAL

DATE COMMENTS

7P

Pancrelipase

(Creon)

Solvay

Pharmaceuticals

Combination of porcine-derived

lipases, proteases, and amylases


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


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


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


25

GENERIC NAME


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


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


26

GENERIC NAME


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


27

GENERIC NAME


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


28

GENERIC NAME


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

****************************************************************************************************************************************************************************************

Samford University Global Drug Information Service …

Documents