FDA approved Invokamet XR (canagliflozin/metformin) for Type 2 DiabetesFDA approved new once-daily pill for type 2 diabetes

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 XR 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. Additionally, canagliflozin, as a component of Invokamet XR, is 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 and albuminuria greater than 300 mg/day. It is not recommended for glycemic control in patients with type 1 diabetes mellitus.

Assess renal function before initiating and as clinically indicated. Correct volume depletion before initiation. Individualize the starting dose based on the patient's current regimen and renal function. The maximum recommended total daily dosage is canagliflozin 300 mg and metformin HCl 2,000 mg. Initiation is not recommended in patients with eGFR less than 45 mL/min/1.73 m². Take two tablets orally once daily with the morning meal; swallow whole, never crush, cut, or chew. 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.

Contraindications include severe renal impairment (eGFR less than 30 mL/min/1.73 m²), end-stage renal disease, or dialysis, and metabolic acidosis including diabetic ketoacidosis. Warnings include risk of volume depletion, hypotension, ketoacidosis, acute kidney injury, urosepsis and pyelonephritis, hypoglycemia with concomitant insulin or sulfonylurea use, necrotizing fasciitis of the perineum (Fournier's gangrene), genital mycotic infections, increased LDL cholesterol, and metformin-associated lactic acidosis. Assess renal function before initiation and as clinically indicated. Correct volume depletion before starting therapy.

Invokamet XR combines an SGLT2 inhibitor with metformin, offering a once-daily option for patients with type 2 diabetes who need both agents. The canagliflozin component provides additional cardiovascular and renal risk reduction in appropriate high-risk patients. It is not recommended for type 1 diabetes. Clinicians should consider this combination for patients who require metformin and canagliflozin and prefer once-daily dosing, while monitoring renal function and volume status.