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Takeda Receives FDA Approval for Three New Type 2 Diabetes Therapies, NESINA (alogliptin) and Fixed-Dose Combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl)
Date:1/25/2013

s with liver disease.

Hypoglycemia: Insulin and insulin secretagogues are known to cause hypoglycemia. A lower dose of the insulin or insulin secretagogue may be required to minimize the risk when used in combination with NESINA, KAZANO, or OSENI.

Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with NESINA, KAZANO, OSENI, or any other anti-diabetic drug.

Adverse Reactions

Most common adverse reactions (greater than or equal to 4% of patients treated with NESINA 25 mg and more frequently than in patients who received placebo) were nasopharyngitis (4.4%), headache (4.2%), and upper respiratory tract infection (4.2%).

Most common adverse reactions (greater than or equal to 4% of patients treated with co-administration of alogliptin and metformin) were upper respiratory tract infection (8%), nasopharyngitis (6.8%), diarrhea (5.5%), hypertension (5.5%), headache (5.3%), back pain (4.3%), and urinary tract infection (4.2%).

Most common adverse reactions (greater than or equal to 4% of patients treated with co-administration of alogliptin and pioglitazone) were nasopharyngitis (4.9%), back pain (4.2%), and upper respiratory tract infection (4.1%).

Drug Interactions

Use of OSENI with CYP2C8 strong inhibitors (e.g., gemfibrozil) will, or inducers (e.g., rifampin) may, require dose adjustment.

Cationic drugs eliminated by renal tubular secretion should be used with caution if taken with KAZANO.

Please see accompanying Full Prescribing Information, including Medication Guide, for NESINA.

Please see accompanying Full Prescribing Information, inc
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SOURCE Takeda Pharmaceutical Company Limited
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