Rx Product News (October 2015)

UnituxinMarketed by: United Therapeutics

Indication: The FDA has approved Unituxin (dinutuximab)—a GD2- binding monoclonal antibody indicated in combination with granulocytemacrophage colony-stimulating factor, interleukin-2, and 13-cis-retinoic acid—for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multi-agent, multimodality therapy. The recommended dosage is 17.5 mg/m²/day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles.

Dosage Form: Injection: 17.5 mg/5 mL (3.5 mg/mL) in a single-use vial

For More Information: www.unituxin.com

PromactaMarketed by: Novartis

Indication: The FDA has approved an expanded use for Promacta (eltrombopag) to include children 1 year and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. For chronic ITP, the dosage is initiated at 25 mg once daily for pediatric patients aged 1 to 5 years. The updated label includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA in June 2015 for children 6 years and older and in 2008 for use in adult patients.

Dosage Form: Tablets: 12.5, 25, 50, 75, and 100 mg; oral suspension: 25 mg

For More Information: www.promacta.com

RepathaMarketed by: Amgen, Inc

Indication: The FDA has approved Repatha (a proprotein convertase subtilisin kexin type 9 inhibitor antibody) as an adjunct to diet and (1) maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol (LDL-C); or (2) other LDL-lowering therapies (eg, statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia who require additional lowering of LDL-C. For the recommended dosing guidelines, see the full prescribing information.

Dosage Form: Injection: 140 mg/mL in a single-use prefilled (1) syringe or (2) SureClick autoinjector

For More Information: www.repathahcp.com

SynjardyMarketed by: Boehringer Ingelheim Pharmaceuticals, Inc

Indication: The FDA has approved Synjardy (empagliflozin and metformin hydrochloride) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin. The starting dose should be individualized based on the patient’s current regimen. The maximum recommended dose is 12.5 mg empagliflozin/ 1000 mg metformin twice daily.

Dosage Form: Tablets: 5 mg/500 mg, 5 mg/1000 mg, and 12.5 mg/500 mg, and 12.5 mg/1000 mg

For More Information: www.boehringer-ingelheim.com