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

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

Dapagliflozin tablets are 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 are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Dapagliflozin tablets are 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 they are likely to be ineffective in this setting based on 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 type 2 diabetes and renal impairment, the recommended dosage for glycemic control in patients with eGFR ≥45 mL/min/1.73 m² is the same as for normal renal function. Not recommended for glycemic control if eGFR <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 adults with renal impairment receiving dapagliflozin for indications other than glycemic control, the recommended dosage in patients with eGFR ≥25 mL/min/1.73 m² is the same as for normal renal function. Initiation is not recommended in patients with eGFR <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.

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