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Takeda Type 2 Diabetes Therapies, NESINA (alogliptin), KAZANO (alogliptin and metformin HCl) and OSENI (alogliptin and pioglitazone) Now Available in Pharmacies in the United States
Date:6/17/2013

an adjunct to diet and exercise. Metformin HCl is a biguanide, a widely used anti-diabetes medication that acts primarily by reducing the amount of glucose produced by the liver.

OSENI is an FDC therapy which combines alogliptin and pioglitazone in a single tablet, for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise. Pioglitazone is a TZD that decreases insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise. An NDA for alogliptin and pioglitazone was approved in July 2011 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name LIOVEL in Japan.

Indication

Indications for NESINA (alogliptin) 6.25 mg, 12.5 mg, and 25 mg Tablets; KAZANO (alogliptin and metformin HCl) 12.5 mg/500 mg and 12.5 mg/1000 mg Tablets; and OSENI (alogliptin and pioglitazone) 25 mg/15 mg, 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/15 mg, 12.5 mg/30 mg, and 12.5 mg/45 mg Tablets

NESINA, KAZANO, and OSENI are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

NESINA, KAZANO, and OSENI are not for treatment of type 1 diabetes or diabetic ketoacidosis.

Important Safety Information

WARNING: CONGESTIVE HEART FAILURE—for OSENI

Thiazolidinediones, including pioglitazone, which is a component of OSENI, cause or exacerbate congestive heart failure in some patients. After initiation of OSENI, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone in OSENI
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