Expanded indications/Labeling changes for May 2009

[chantell.reagan]

Expanded indications:

Avastin (bevacizumab) by Genentech
Expanded indication: For treatment of glioblastoma, as a single agent for patients with progressive disease following prior therapy

•Link to Genentech press release 5/09
•Link to prescribing information

Azor (amlodipine/olmesartan)
Expanded indications: treatment of hypertension, alone or with other antihypertensive agents AND as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals

•Link to prescribing information

Cimzia (certolizumab pegol)
Expanded indication: treatment of adult patients with moderately to severely active rheumatoid arthritis (RA)
•1st available pegylated anti-TNF agent for RA; can be dosed at 400 mg initially and at weeks 2/4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered.

•Link to UCB press release 5/09
•Link to prescribing information

Prograf (tacrolimus)
Expanded indication: use with mycophenolate mofetil (MMF) for the prophylaxis of organ rejection in allogenic kidney transplantation

•Link to FDA letter
•Link to prescribing information

Revatio (sildenafil)
Expanded indication: the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening.

•Link to FDA letter
•Link to prescribing information

Risperdal Consta (risperidone)
Expanded indication: both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of Bipolar I Disorder

•Link to FDA letter

New dosage forms/regimens:

ACTOplus met XR (pioglitazone HCl and metformin HCl) tablets by Takeda
Approval: once daily as an adjunct to diet and exercise for the treatment of type 2 diabetes
•available late 2009

•Link to press release 5/09

Lamictal ODT (lamotrigine 25mg, 50mg, 100mg, 200mg orally disintegrating tablets) by GlaxoSmithKline
Approval: long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in adults 18 years or older who have been treated for mood episodes with other medicine and as an antiseizure treatment for epilepsy
•should be available in pharmacies by early July 2009

•Link to FDA letter

Sprycel (dasatinib) tablets by BMS
Labeling changes (indications and dosage): treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib AND treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
•Dosage and administration: Chronic phase CML: 100 mg once daily, Accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL: 140 mg once daily

•Link to prescribing information

Tyzeka (telbivudine) oral solution by Novartis
Approval: treatment of chronic hepatitis B (CHB) in adult patients with evidence of viral replication and active liver inflammation and CHB patients with renal impairment who may require a dose reduction

•Link to FDA letter

Safety concerns

Botulism toxins (Botox, Dysport, Myobloc)
Safety issue: boxed warning and REMS program, due to reports that the effects may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision, and drooping eyelids.

•Link to news article 5/09

Tarceva (erlotinib)
Warnings and precautions update: information about 3 disorders has been added: gastrointestinal perforation; bullous, blistering, and exfoliative skin conditions; and ocular disorders

•Link to news article 5/09

Testosterone gels (Androgel, Testim)
Safety issue: boxed warning about the dangers of secondary exposure to children, due to 8 adverse event reports causing "inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior"

•Link to news article 5/09

Sources:
U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER