FDA Approves Invokana (canagliflozin) for Type 2 Diabetes and Related Conditions

Invokana is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. It works by blocking glucose reabsorption in the kidney, leading to increased urinary glucose excretion and lowering blood glucose levels.

Invokana is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes and established cardiovascular disease. Additionally, it is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic nephropathy with albuminuria >300 mg/day. Limitations of use: not recommended for glycemic control in type 1 diabetes or in adults with type 2 diabetes and eGFR <30 mL/min/1.73 m2.

The recommended starting dose is 100 mg orally once daily, taken before the first meal of the day. For additional glycemic control, the dose may be increased to 300 mg once daily in patients tolerating 100 mg with eGFR ≥60 mL/min/1.73 m2. In patients with eGFR 30 to <60 mL/min/1.73 m2, the maximum recommended dose is 100 mg once daily. Initiation is not recommended if eGFR <30 mL/min/1.73 m2, but patients already on Invokana with albuminuria >300 mg/day may continue 100 mg once daily for cardiorenal risk reduction. Assess renal function before initiating and as clinically indicated. Correct volume depletion before starting. Withhold Invokana at least 3 days prior to major surgery or procedures associated with prolonged fasting.

Trial data not available in label.

Not reported in label.

Invokana is a second-line or later agent for glycemic control in type 2 diabetes, with additional benefits for cardiovascular and renal outcomes in appropriate patients. It is not recommended for type 1 diabetes or for glycemic control in advanced renal impairment (eGFR <30 mL/min/1.73 m2).