Rx Product News

Author:

HOT Rx

Benlysta

Marketed by:

GlaxoSmithKline (Research Triangle Park, NC) and Human Genome Sciences (Rockville, MD)

Indication:

The FDA approved Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erthematosus who are receiving standard therapy. Benlysta is the first of a new class of drugs called B-lymphocyte stimulator (BLyS)–specific inhibitors. Belimumab blocks the binding of soluble BLyS, a B cell survival factor, to its receptors on B cells. It does not bind B cells directly, but belimumab inhibits the survival of B cells and reduces the differentiation of B cells into immunoglobulin-producing plasma cells by binding with BLyS. The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus or in combination with other biologics or intravenous cyclophosphamide.

Dosage Form:

Single-use vials of belimumab lyophilized powder: 120 and 400 mg/vial

For More Information:

www.benlysta.com

IntunIv 

Marketed by:

Shire plc (Philadelphia, PA)

Indication:

Shire plc announced that Intuniv (guanfacine) extendedrelease tablets were approved by the FDA for use as adjunctive therapy to stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. Intuniv, a nonstimulant and selective alpha 2A agonist, is the only once-daily ADHD medication approved for administration as an adjunctive therapy to stimulants. Intuniv was previously approved as monotherapy for ADHD. Tablets should not be crushed, chewed, or broken before swallowing and should not be administered with meals high in fat. The effectiveness of Intuniv for more than 9 weeks has not been systematically evaluated. Patients requiring longer-term treatment should be periodically reassessed.

Dosage Form:

Extended-release tablets: 1, 2, 3, and 4 mg 50 n 04.11 

For More Information:

www.intuniv.com

Zyclara Cream 3.75%

Marketed by:

Graceway Pharmaceuticals (Bristol, TN)

Indication:

Zyclara (imiquimod) Cream 3.75% was approved by the FDA for the treatment of external genital and perianal warts in patients 12 years and older. Zyclara Cream was developed as a once-daily treatment regimen for up to 8 weeks to help improve adherence for patients with external genital and perianal warts. Zyclara Cream may weaken condoms and diaphragms, and sexual contact should be avoided while the cream is on the skin. Zyclara Cream is also indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses of the full face or balding scalp in immunocompetent adults.

Dosage Form:

Cream: imiquimod 3.75%

For More Information:

www.zyclaracream.com

Makena

Marketed by:

Ther-Rx, a subsidiary of KV Pharmaceuticals (St. Louis, MO)

Indication:

The FDA approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm birth, defined as delivery before 37 weeks of pregnancy, in women with a singleton pregnancy with a history of at least 1 spontaneous singleton preterm birth. Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth. Makena is administered by intramuscular injection at a dose of 250 mg/mL once weekly. Treatment may begin between 16 weeks, 0 days and 20 weeks, 6 days gestation and continue until week 37 of gestation or delivery, whichever occurs first.

Dosage Form:

5-mL multidose vial (250 mg/mL) containing 1250 mg hydroxyprogesterone caproate

For More Information:

www.makena.com


Zostavax

Marketed by:

Merck (Whitehouse Station, NJ)

Indication:

The FDA approved an expanded indication for Zostavax (Zoster Vaccine Live) for the prevention of herpes zoster, or shingles, in adults 50 years and older. According to the Centers for Disease Control and Prevention, approximately 1 in 3 individuals will experience shingles in their lifetime. The incidence and severity of shingles increase with age. Zostavax is not indicated for the treatment of shingles or postherpetic neuralgia or for the prevention of chicken pox. Zostavax is the only shingles vaccine licensed for use in the United States.

Dosage Form:

Single-dose vials for subcutaneous injection: 0.65 mL

For More Information:

www.zostavax.com

Yervoy

Marketed by:

Bristol-Myers Squibb (Princeton, NJ)

Indication:

Yervoy (ipilimumab) was approved by the FDA for the treatment of unresectable or metastatic melanoma. Melanoma is the leading cause of death from skin disease. According to the National Cancer Institute, 68,130 new cases of melanoma were diagnosed in the United States in 2010. Yervoy is a monoclonal antibody that blocks human cytotoxic T-lymphocyte antigen 4, which may play a role in slowing down or turning off the body’s immune system, hindering its ability to fight off cancerous cells. Yervoy is administered intravenously over 90 minutes every 3 weeks for a total of 4 doses.

Dosage Form:

Single-use vials for intravenous administration: 50 mg/10 mL (5 mg/L) and 200 mg/40 mL (5 mg/L)

For More Information:

www.yervoy.com

Zemplar

Marketed by:

Abbott (Abbott Park, IL)

Indication:

Zemplar (paricalcitrol) Injection, which is indicated for the prevention and treatment of secondary hyperparathyroidism associated with stage 5 chronic kidney disease, is now available in a 10-mcg multidose vial. The 10-mcg multidose vial will replace the existing 10-mcg single-use vial, and can be used for multiple doses up to 7 days after its initial use. Zemplar Injection is the first and only active vitamin D that is available in a multidose vial. It is also available in 2- and 5-mcg single-use vials.

Dosage Form:

Multidose vial: 10 mcg; single-use vials: 2 and 5 mcg

For More Information:

www.abbott.com

AbIlIfy

Marketed by:

Bristol-Myers Squibb Co (Princeton, NJ) and Otsuka Pharmaceutical Co Ltd (Tokyo, Japan)

Indication:

Abilify has received FDA approval as an adjunct to the mood stabilizers lithium or valproate for the maintenance treatment of bipolar I disorder. Abilify was previously approved as an adjunct to lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder, and for the maintenance treatment of bipolar I disorder.

Dosage Forms:

Tablets: 2, 5, 10, 15, 20, and 30 mg; orally disintegrating tablets: 10 and 15 mg; oral solution: 1 mg/mL; single-dose vial for injection: 9.75 mg/1.3 mL

For More Information:

www.abilify.com