Rx Product News (July 2015)

GlaxoSmithKline and Theravance, Inc

Indication: The FDA has expanded the indication of Breo Ellipta (fluticasone furoate/vilanterol), approving it for the once-daily treatment of asthma in patients 18 years and older. The recommended dose is 1 inhalation of Breo Ellipta 100 mcg/25 mcg or 200 mcg/25 mcg once daily. Breo Ellipta previously received FDA approval for long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

Dosage Form: Inhalation powder (fluticasone furoate/ vilanterol): 100 mcg/25 mcg or 200 mcg/25 mcg

For More Information: www.gsksource.com/pharma/content/gsk/source/us/en/brands/breo.html

Tuzistra XRMarketed by: Vernalis Therapeutics, Inc, and Tris Pharma, Inc

Indication: The FDA has approved Tuzistra XR—a combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine1-receptor antagonist—for relief of cough and symptoms associated with upper respiratory allergies or the common cold. Tuzistra XR is not indicated for patients younger than 18 years. The recommended dose in adults 18 years and older is 10 mL every 12 hours, not to exceed 2 doses (20 mL) in 24 hours.

Dosage Form: Extended-release oral suspension: an antitussive—codeine polistirex, which contains 14.7 mg of codeine, and an antihistamine– chlorpheniramine polistirex, which contains 2.8 mg of chlorpheniramine per 5 mL

For More Information: www.vernalis.com/development-2/commercial-pipeline/coughcold/tuzistra-xr

LenvimaMarketed by: Eisai, Inc

Indication: The FDA has approved Lenvima, a kinase inhibitor, for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine—refractory differentiated thyroid cancer. The recommended dose is 24 mg by mouth once daily. In patients with severe renal or hepatic impairment, the dose is 14 mg by mouth once daily. Because of the potential for serious adverse reactions in nursing infants, women should be advised to discontinue breast-feeding during treatment with Lenvima.

Dosage Form: Capsules: 4 and 10 mg

For More Information: www.lenvima.com

Stiolto RespimatMarketed by: Boehringer Ingelheim Pharmaceuticals, Inc

Indication: The FDA has approved Stiolto Respimat, a combination of tiotropium (an anticholinergic) and olodaterol (a long-acting beta2-adrenergic agonist), for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. The recommended dose is 2 inhalations of Stiolto Respimat once daily, at the same time of day.

Dosage Form: Inhalation spray: each actuation from the mouthpiece contains 3.124 mcg of tiotropium bromide monohydrate (equivalent to 2.5 mcg of tiotropium) and 2.736 mcg of olodaterol hydrochloride (equivalent to 2.5 mcg of olodaterol).

For More Information: www.stiolto.com