FDA approved Invokamet (canagliflozin/metformin) for Type 2 DiabetesFDA approved Invokamet for type 2 diabetes in adults and children 10 and older.

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that reduces renal glucose reabsorption, leading to increased urinary glucose excretion. Metformin HCl is a biguanide that improves glycemic control by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity.

Invokamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin, when used as a component of Invokamet, is also indicated in adults with type 2 diabetes mellitus to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in those with established cardiovascular disease, and to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in those with diabetic nephropathy with albuminuria greater than 300 mg/day. It is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

Assess renal function before initiating and as clinically indicated. Correct volume depletion before initiating. Individualize the starting dose based on the patient's current regimen and renal function. The maximum recommended total daily dosage is 300 mg of canagliflozin and 2,000 mg of metformin HCl. Initiation is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2 due to the metformin component. Invokamet is taken as one tablet orally twice daily with meals. Gradually escalate the metformin HCl dosage to reduce gastrointestinal adverse reactions. May need to be discontinued at the time of, or prior to, iodinated contrast imaging procedures. Withhold at least 3 days prior to surgery or procedures associated with prolonged fasting.

Trial data not available in label.

Not reported in label.

Invokamet combines the glycemic efficacy of metformin with the cardiovascular and renal benefits of canagliflozin. It may be considered for patients with type 2 diabetes who require additional glycemic control and who have or are at risk for cardiovascular or renal disease, as supported by the canagliflozin indications. However, it is not recommended for type 1 diabetes.