Type 2 Diabetes Treatment Invokamet XR Approved

The FDA has just approved Janssen’s Invokamet XR, a once-daily, fixed-dose combination of canagliflozin (Invokana) and extended-release metformin hydrochloride, for first-line treatment for type 2 diabetes in adults as an adjunct to diet and exercise.

Invokamet XR is available in 4 dosages in tablets containing canagliflozin 50 mg or 150 mg, and metformin XR 500 mg or 1000 mg. The recommended dosing is 2 tablets taken once a day during the morning meal.

“Invokamet XR offers the convenience of once-daily dosing and provides physicians needed flexibility for tailoring treatment to the needs of type 2 diabetes patients, especially those with higher A1C levels,” said John Anderson, MD, in a press release. “As with Invokamet, physicians can prescribe the XR formulation to adults when they are first diagnosed with type 2 diabetes or as additional therapy for people whose A1C levels are not well controlled with either agent alone.”

Invokamet is the first fixed-dose tablet to combine the sodium glucose co-transporter 2 inhibitor, canagliflozin, and immediate-release metformin hydrochloride. It initially received approval from the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled with metformin or canagliflozin, or who are already being treated with both medications separately. In May 2016, the drug’s indication was expanded to include adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.

Studies have shown a significantly greater reduction in HbA1C levels with Invokamet XR treatment than with metformin alone. Canagliflozin aids the patients’ kidneys in depleting sugar levels through urination, and metformin decreases glucose production in the liver and improves the body’s response to insulin.

Type 2 diabetes treatment guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology, as well as from the American Diabetes Association, all recommend dual therapy for patients with high HbA1C levels, and Invokamet XR aligns with their recommendation.

Invokamet XR carries a Boxed Warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation. Other serious adverse effects associated with the drug are dehydration, ketoacidosis, kidney problems, hyperkalemia, serious urinary tract infections, and hypoglycemia. Patients who have kidney problems or are on dialysis should not take Invokamet XR.