Rx Product News (June 2015)

Novo Nordisk

Indication: The FDA has approved Saxenda (liraglutide [rDNA origin] injection), a glucagon-like peptide-1 receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients. The prescribing information includes a black box warning for risk of thyroid c-cell tumors. The recommended dose of Saxenda is 3 mg daily, administered at any time of day, without regard to meals.

Dosage Form: Solution for subcutaneous injection: prefilled, multidose pen that delivers doses of 0.6, 1.2, 1.8, 2.4, or 3 mg (6 mg/mL, 3 mL)

For More Information: www.saxenda.com

NatparaMarketed by: NPS Pharmaceuticals, Inc

Indication: The FDA has approved Natpara, a parathyroid hormone, as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The dose of Natpara should be individualized to achieve a serum calcium level in the lower half of the normal range. Before Natpara is started, vitamin D stores must be sufficient and the serum calcium level above 7.5 mg/ dL. The starting dose of Natpara is 50 mcg injected once daily in the thigh. When Natpara is started, the dose of active vitamin D should be decreased by 50% if the serum calcium level is above 7.5 mg/dL.

Dosage Form: Injection: 25, 50, 75, or 100 mcg

For More Information: http://natpara.com

BotoxMarketed by: Allergan, Inc

Indication: The FDA has expanded the use of Botox (onabotulinumtoxinA) to treat upper limb spasticity in adults. The dose should be selected based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history. Electromyographic guidance is recommended.

Dosage Form: Injection: single-use, sterile 100 units or 200 units vacuum- dried powder for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection USP prior to injection

For More Information: www.botoxuls.com

SavaysaMarketed by: Daiichi Sankyo, Inc

Indication: The FDA has approved Savaysa (edoxaban), a factor Xa inhibitor, to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The recommended dose is 60 mg once daily in patients with a creatinine clearance (CrCl) >50 to ≤ 95 mL/ min; Savaysa should not be used in patients with a CrCl >95 mL/min. The dose should be reduced to 30 mg once daily in patients with a CrCl of 15 to 50 mL/min. Savaysa already had FDA approval for the treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial therapy with a parenteral anticoagulant.

Dosage Form: Tablets: 60, 30, and 15 mg

For More Information: http://savaysa.com