Rx Product News (April 2015)

Actavis

Indication: The FDA has approved Avycaz—a combination of ceftazidime (a cephalosporin antibiotic) and avibactam (a beta-lactamase inhibitor)—for the treatment of (1) complicated intra-abdominal infections, in combination with metronidazole, and (2) complicated urinary tract infections, including pyelonephritis, in adults. Each dose should be administered intravenously over 2 hours, with the strength and frequency dependent on the patient’s estimated creatinine clearance.

Dosage Form: Injection: 2/0.5 g in a single-use vial

For More Information: www.avycaz.com

CresembaMarketed by: Astellas Pharma

Indication: The FDA has approved Cresemba (isavuconazonium sulfate), an azole antifungal, for the treatment of invasive aspergillosis and invasive mucormycosis. The recommended loading dose is 372 mg orally (2 capsules) or intravenously (1 reconstituted vial) every 8 hours for 48 hours, while the recommended maintenance dose is 372 mg orally or intravenously once daily, starting 12 to 24 hours after the last loading dose.

Dosage Form: Capsules: 186 mg; Injection: 372 mg in a single-use vial

For More Information: www.cresemba.com

PrestaliaMarketed by: Symplmed Pharmaceuticals

Indication: The FDA has approved Prestalia, a combination of perindopril arginine (an angiotensinconverting enzyme inhibitor) and amlodipine (a dihydropyridine calcium channel blocker), for the treatment of hypertension in patients not adequately controlled with monotherapy, and as an initial therapy in patients likely to need multiple drugs to control their blood pressure. The recommended starting dose is 3.5/2.5 mg orally once daily. The dose should be adjusted according to the patient’s blood pressure goals, with 1 to 2 weeks between titration steps.

Dosage Form: Tablets: 3.5/2.5, 7/5, and 14/10 mg

For More Information: www.symplmed.com/symplmed_ products_prestalia

OpdivoMarketed by: Bristol-Myers Squibb

Indication: The FDA has approved Opdivo (nivolumab), a programmed death receptor-1 blocking antibody, for the treatment of patients with metastatic squamous non—small cell lung cancer with progression on or after platinum-based chemotherapy. The recommended dose is 3 mg/kg administered intravenously over 60 minutes every 2 weeks.

Dosage Form: Injection: 40 mg/4 mL and 100 mg/10 mL in a single-use vial

For More Information: www.opdivo.com