Rx Product News (January 2016)

GlaxoSmithKline

Indication: The FDA has approved Nucala (mepolizumab), an interleukin- 5 antagonist monoclonal antibody, for add-on maintenance treatment of patients 12 years or older with severe asthma and with an eosinophilic phenotype. The recommended dosage is 100 mg subcutaneously once every 4 weeks.

Dosage Form: Injection: 100 mg of lyophilized powder in a single-dose vial for reconstitution

For More Information: gsksource.com

Dyanavel XRMarketed by: Tris Pharma

Indication: The FDA has approved Dyanavel XR, a central nervous system stimulant, for the treatment of attention-deficit/hyperactivity disorder in children 6 years or older. The recommended starting dose is 2.5 or 5 mg once daily in the morning. The dosage may be increased in increments of 2.5 to 10 mg per day every 4 to 7 days until an optimal response is obtained.

Dosage Form: Extended-release oral suspension containing 2.5 mg of amphetamine base per mL

For More Information: trispharma.com

PraxbindMarketed by: Boehringer Ingelheim Pharmaceuticals, Inc

Indication: The FDA has approved Praxbind (idarucizumab), a humanized monoclonal antibody fragment, for patients treated with Pradaxa (dabigatran) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/ urgent procedures or for life-threatening or uncontrolled bleeding. The recommended dose of Praxbind is 5 g, provided as 2 separate vials, each containing 2.5 g/50 mL of idarucizumab.

Dosage Form: Injection: 2.5 g/50 mL solution in a single-use vial

For More Information: boehringer-ingelheim.com

AristadaMarketed by: Alkermes

Indication: The FDA has approved Aristada (aripiprazole lauroxil) extended-release injectable suspension, an atypical antipsychotic, for the treatment of schizophrenia in adults. Aristada must be administered by intramuscular injection in the deltoid (441-mg dose only) or gluteal (441 mg, 662 mg, or 882 mg) muscle by a health care professional.

Dosage Form: Extended-release injectable suspension: 441-, 662-, or 882-mg single-use, prefilled syringe

For More Information: aristada.com