FDA Approves Dapagliflozin Tablets (dapagliflozin) for Heart Failure Risk Reduction and Glycemic Control in Type 2 Diabetes

Dapagliflozin tablets is a sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Dapagliflozin tablets is indicated: 1) To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. 2) As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Dapagliflozin tablets is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It is also not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m², as it is likely to be ineffective in this setting based upon its mechanism of action.

Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating.

For glycemic control: The recommended starting dosage is 5 mg orally once daily. Dosage can be increased to 10 mg orally once daily for additional glycemic control. For patients with an eGFR greater than or equal to 45 mL/min/1.73 m², the dosage is the same as for normal renal function. Not recommended for glycemic control if eGFR is less than 45 mL/min/1.73 m².

For all other indications (e.g., heart failure risk reduction): The recommended dosage is 10 mg orally once daily. For patients with an eGFR greater than or equal to 25 mL/min/1.73 m², the dosage is the same as for normal renal function. Initiation is not recommended in patients with an eGFR less than 25 mL/min/1.73 m².

Withhold dapagliflozin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting.

Trial data not available in label.

Not reported in label.

Not reported in label.