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Rx Product News

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Prevnar 13

Marketed by: Pfizer Inc (New York, NY)

Indication: The FDA approved the use of Pfizer Inc’s Prevar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) for single-dose use in adults 50 years and older for active immunization for the prevention of pneumonia and invasive disease caused by 13 different serotypes of Streptococcus pneumoniae. Prevnar 13 is also indicated for use as a 4-dose immunization series in children aged 6 weeks through 5 years. In adults, antibody responses to Prevnar 13 were diminished when given with inactivated influenza virus vaccine.

Dosage Form: Intramuscular injection: 0.5-mL suspension supplied in a single-dose prefilled syringe

For More Information: www.prevnar.com

 

Picato

Marketed by: LEO Pharma, Inc (Parsippany, NJ)

Indication: Picato (ingenol mebutate) gel (0.015% or 0.05%) was approved by the FDA for the topical treatment of actinic keratosis. Actinic keratosis is a precancerous condition characterized by dry, scaly, roughtextured patches or lesions that form on the outermost layers of skin and has the potential to progress to squamous cell carcinoma. Picato 0.015% gel is used once daily on the face and scalp for 3 consecutive days, and Picato 0.05% gel is used once daily on the trunk or extremities for 2 consecutive days.

Dosage Form: Gel: ingenol mebutate, 0.015% or 0.05%

For More Information: www.picato.com

B-nexa

Marketed by: Upsher-Smith Laboratories, Inc (Maple Grove, MN)

Indication: Upsher-Smith Laboratories announced the launch of B-Nexa tablets, a prescription prenatal vitamin indicated to provide B-vitamin supplementation that contains ginger to help calm pregnancy-related nausea and vomiting. Each tablet contains 40 mg of vitamin B 6 ; 1.2 mg of folic acid, USP; 124.1 mg of calcium (as dicalcium phosphate and tricalcium phosphate); and 100 mg of ginger root powder extract. B-Nexa does not contain antihistamines. Patients can take 1 or 2 B-Nexa tablets daily, in divided doses, or as directed by a physician.

How Supplied: Tablets: 60-count bottles

For More Information: www.b-nexa.com

Jentadueto

Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc (Ridgefield, CT) and Eli Lilly and Co (Indianapolis, IN)

Indication: The FDA approved Jentadueto (linagliptin/metformin HCl) tablets, a dipeptidyl peptidase-4 inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with linagliptin and metformin is appropriate. Jentadueto is not indicated for patients with type 1 diabetes or diabetic ketoacidosis, and has not been studied in conjunction with insulin. The maximum dose is 2.5 mg linagliptin/1000 mg metformin twice daily.

Dosage Form: Tablets (linagliptin/metformin HCl): 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg

For More Information: www.jentadueto.com

Janumet xr

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

Indication: Janumet XR (sitagliptin and metformin HCl extended-release) tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with sitagliptin and metformin is appropriate. Janumet XR is not indicated for type 1 diabetes or diabetic ketoacidosis, and it has not been studied in patients with a history of pancreatitis. Tablets should be swallowed whole and not split, crushed, or chewed. The maximum daily dose is 100 mg sitagliptin/2000 mg metformin extended release.

Dosage Form: Tablets (sitagliptin/metformin HCl extended release): 100 mg/1000 mg, 50 mg/500 mg, and 50 mg/1000 mg

For More Information: www.januvia.com/sitagliptin/januvia/ hcp/janumetxr/index.jsp

Kalydeco

Marketed by: Vertex Pharmaceuticals (Cambridge, MA)

Indication: After priority review, the FDA announced the approval of Kalydeco (ivacaftor) tablets for the treatment of cystic fibrosis (CF) in patient 6 years and older who have a G551D mutation in the CFTR gene. The G551D mutation is found in approximately 4% of patients with CF. When a a patient’s genotype is unknown, the presence of the G551D mutation should be confirmed by an FDAcleared CF mutation test. Adults and children 6 years and older should take one 150-mg tablet orally every 12 hours with food that contains fat.

Dosage Form: Tablets: 150 mg

For More Information: www.kalydeco.com