Bristol-Myers Squibb Company and AstraZeneca announced that type 2 diabetes drug Kombiglyze XR (saxagliptin and metformin HCl extended-release), approved by the FDA
on November 5, 2010, is now available by prescription in pharmacies across the United States. Kombiglyze XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across hemoglobin A1c levels, fasting plasma glucose and post-prandial glucose.Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both saxagliptin and metformin is appropriate. Kombiglyze XR should not be used for patients with type 1 diabetes or diabetic ketoacidosis and has not been studied in combination with insulin.
Consistent with the Prescribing Information (PI) for metformin alone, the PI for Kombiglyze XR contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with Kombiglyze XR.
Once-a-day Kombiglyze XR combines saxagliptin (also known as ONGLYZA™), a DPP-4 inhibitor, and metformin XR, a biguanide, in one tablet for the treatment of type 2 diabetes. Kombiglyze XR should generally be administered once a day with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The maximum daily recommended dose is 5 mg for saxagliptin and 2,000 mg for metformin extended-release.