Rx Product News

Published Online: Monday, December 12, 2011
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Accu-Chek Aviva Plus Test Strips

Marketed by: Roche Diagnostics (Indianapolis, IN)

Indication: Roche announced FDA clearance of ACCU-CHEK Aviva Plus test strips for use in measuring blood glucose levels in patients with type 1 and type 2 diabetes. The ACCU-CHEK Aviva Plus test strip is free from maltose interference and offers improved accuracy as tested against a 23% tighter accuracy specification based on the current ISO 15197: 2003 standard. It is designed for use with the ACCU-CHEK Aviva meter, so patients currently using that system will not need to change meters.

How Supplied: Available in boxes of 50 or 100 test strips

For More Information: www.accu-chek.com; 800-858-8072


Acanya Gel 1.2%/2.5%

Marketed by: Coria Laboratories (Bridgewater, NJ)

Indication: Coria Laboratories announced the availability of Acanya (clindamycin phosphate and benzoyl peroxide) Gel 1.2%/2.5% in a ready-to-use pump. Indicated for the topical treatment of acne vulgaris in patients 12 years and older, Acanya Gel is the only FDAapproved once-daily antibiotic/benzoyl peroxide combination product for both inflammatory and noninflammatory acne. Designed to minimize mess, the pump dispenses a premixed amount of gel, and has a shelf life of 10 weeks at room temperature. Acanya is a water-based and fragrance-free gel, and is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. Patients should minimize sun exposure after application.

Dosage Form: Gel: each g of product contains 10 mg clindamycin phosphate and 25 mg benzoyl peroxide

For More Information: www.acanyagel.com/hcp/index.html


Nexplanon 68 mg

Marketed by: Merck & Co, Inc (Whitehouse Station, NJ)

Indication: Merck announced that Nexplanon (etonogestrel impant) 68 mg is now available in the United States. Nexplanon is a progestin-only contraception that is approved for the prevention of pregnancy for up to 3 years. Made of a soft, flexible medical polymer, it is inserted under the skin of a woman’s upper forearm by a trained health care professional. Etonogestrel prevents pregnancy by altering the endometrium, thickening cervical mucus, and inhibiting ovulation. It may be less effective in women who are very overweight over time, and in women who take medications that induce liver enzymes.

Dosage Form: Implant: each radiopaque, rod-shaped implant contains etonogestrel 68 mg preloaded in the needle of a disposable applicator

For More Information: www.nexplanon-usa.com/en/hcp/index.asp


Exparel

Marketed by: Pacira Pharmaceuticals (Parsippany, NJ)

Indication: The FDA approved Exparel (bupivacaine liposome injectable suspension) for single-dose infiltration into surgical sites to produce postsurgical analgesia. Exparel uses DepoFoam technology to provide pain relief over time. The recommended dosage of Exparel, which is slowly injected into soft tissue via infiltration, is dependent upon the surgical site and the volume required to cover the surgical area. The product is contraindicated for obstetrical paracervical block anesthesia. Although it should not be administered with lidocaine or other non–bupivacaine-based local anesthetics, Exparel may be used after at least 20 minutes have elapsed following the local administration of lidocaine.

Dosage Form: Injectable suspension: 10- and 20-mL single-use vials containing 13.3 mg bupivacaine liposome per mL

For More Information: www.exparel.com


Jakafi

Marketed by: Incyte Corporation (Wilmington, DE)

Indication: The FDA approved Jakafi (ruxolitinib) tablets for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF. Jakafi is the first Janus kinase inhibitor to be approved for any indication. A complete blood count must be performed before initiating therapy with Jakafi and then every 2 to 4 weeks until the dosage is stabilized. The starting dose is 20 mg orally twice daily for patients with a platelet count greater than 200 X 10 9 /L and 15 mg twice daily for patients with a platelet count between 100 X 10 9 /L and 200 X 10 9 /L. The dose may be increased based on response to a maximum of 25 mg twice daily.

Dosage Form: Tablets: 5, 10, 15, 20, and 25 mg

For More Information: www.jakafi.com


Erwinaze

Marketed by: EUSA Pharma USA (Langhorne, PA)

Indication: The orphan drug Erwinaze (asparaginase Erwinia chysanthemi) was approved by the FDA as a component of a multiagent chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) in patients who have developed hypersensitivity to Escherichia coli–derived asparaginase. ALL is the most common form of childhood cancer, and is also one of the most curable. Erwinaze depletes blood levels of asparagine, an amino acid that is essential for the growth of cells, including the cells associated with ALL. Patients should be monitored for serious hypersensitivity reactions, including anaphylaxis, glucose intolerance, thrombosis, and hemorrhage.

Dosage Form: Intramuscular injection: lyophilized powder, 10,000 IU per vial

For More Information: www.erwinaze.com


Complera

Marketed by: Gilead Sciences Inc (Foster City, CA)

Indication: Complera (emtricitabine/ rilpivirine/tenofovir disoproxil fumarate) is approved by the FDA as a single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults. Complera contains 3 antiretroviral medications, combining Gilead’s Truvada (a fixed-dose combination of the nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate) with Janssen Therapeutics’ Edurant (the non-nucleoside reverse transcriptase inhibitor rilpivirine). The recommended dose of Complera is 1 tablet taken once daily with a meal. The product should not be administered in patients with a creatinine clearance less than 50 mL/min and is not recommended in patients younger than 18 years.

Dosage Form: Tablets: each tablet contains 200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate

For More Information: www.complera.com


Onfi

Marketed by: Lundbeck Inc (Deerfield, IL)

Indication: The FDA approved Onfi (clobazam) tablets as an adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years and older. LGS is a severe and rare form of epilepsy that involves multiple kinds of seizures that are often frequent. Although typically diagnosed in childhood, it can persist into adulthood. Onfi is classified as a C-IV controlled substance. In patients weighing 30 kg or less, Onfi should be started at 5 mg daily and titrated up as tolerated to 20 mg daily. In patients weighing more than 30 kg, therapy should be started at 10 mg daily and titrated up as tolerated to 40 mg daily. All doses larger than 5 mg should be administered in 2 divided doses. Onfi tablets can be administered whole or crushed and mixed with applesauce.

Dosage Form: Tablets: 5, 10, and 20 mg

For More Information: https://www.onfi.com/selection



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