Medication Monitor

Generic Name (Trade Name—Company)
October 2, 2019


Canagliflozin approved to slow progression of diabetic kidney disease

Janssen announced that FDA has approved a new indication for canagliflozin to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease.

The recommended starting dose is 100 mg once daily, taken before the first meal of the day. The dose can be increased to 300 mg once daily in patients tolerating 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control

The drug includes a boxed warning for patients with type 2 diabetes who have established cardiovascular disease (CVD) or who are at risk for CVD. Canagliflozin has been associated with lower limb amputations in these patients, most frequently of the toe and midfoot; some also involved the leg.

The most common adverse effects of canagliflozin include vaginal yeast infections and yeast infections of the penis; as well as changes in urination, including urgent need to urinate more often, in larger amounts, or at night.