Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved JANUMET® XR (sitagliptin and metformin hydrochloride (HCl) extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA® (sitagliptin), with extended-release metformin. JANUMET XR provides a convenient once-daily treatment option for healthcare providers and patients who need help to control their blood sugar.
“This is important because many patients with type 2 diabetes require treatment with multiple drugs to maintain blood sugar control, and JANUMET XR is a new option to help more patients get to their glucose goals.”
JANUMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and extended-release metformin is appropriate. JANUMET XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR.
The FDA approved JANUMET XR based upon a clinical bioequivalence study that demonstrated that administration of JANUMET XR was equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and metformin HCl extended- release. Extended-release metformin was as effective as immediate-release metformin.
"JANUMET XR is a new treatment that adds once-daily convenience to the powerful efficacy of JANUMET for patients with type 2 diabetes," said Barry J. Goldstein, M.D., Ph.D., vice president, Diabetes and Endocrinology, Merck. "This is important because many patients with type 2 diabetes require treatment with multiple drugs to maintain blood sugar control, and JANUMET XR is a new option to help more patients get to their glucose goals."
The labeling for JANUMET XR contains a boxed warning for lactic acidosis, a rare, but serious complication that can occur due to metformin accumulation.
JANUMET XR is contraindicated in patients with renal impairment (e.g., serum creatinine levels ≥1.5 mg/dL for men, ≥1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia; hypersensitivity to metformin HCl; acute or chronic metabolic acidosis, including diabetic ketoacidosis (diabetic ketoacidosis should be treated with insulin); history of a serious hypersensitivity reaction to JANUMET XR or sitagliptin, such as anaphylaxis or angioedema.
When sitagliptin was used in combination with a sulfonylurea or with insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo used in combination with a sulfonylurea or with insulin. Therefore, patients also receiving an insulin secretagogue (e.g., sulfonylurea) or insulin may require a lower dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
There have been postmarketing reports of worsening renal function in patients taking sitagliptin with or without metformin, including acute renal failure, sometimes requiring dialysis. Before initiation of therapy with JANUMET XR and at least annually thereafter, renal function should be assessed and verified as normal. There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking sitagliptin with or without metformin. After initiation of JANUMET XR, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, JANUMET XR should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR.