FDA Approves Dapagliflozin Tablets (dapagliflozin) for Type 2 Diabetes and Heart Failure Risk Reduction
The FDA has approved dapagliflozin tablets, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for use in adults with type 2 diabetes mellitus. The approval covers two distinct indications: as an adjunct to diet and exercise to improve glycemic control, and to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes who also have either established cardiovascular disease or multiple cardiovascular risk factors.
This approval provides clinicians with an SGLT2 inhibitor option for managing both hyperglycemia and cardiovascular risk in this patient population. The label includes specific dosing guidance and limitations of use, particularly regarding renal function. For glycemic control, the drug is not recommended for patients with an eGFR less than 45 mL/min/1.73 m², as it is likely to be ineffective in this setting.
Clinicians should assess renal function and volume status prior to initiation. The recommended dosage for glycemic control starts at 5 mg once daily, while the 10 mg once daily dose is indicated for heart failure risk reduction and can be used for additional glycemic control.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Dapagliflozin tablets are a sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Dapagliflozin tablets are indicated for two uses in adults: 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. They are 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 they are likely to be ineffective in this setting based on the 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 patients with an 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 for patients with an eGFR ≥25 mL/min/1.73 m² is the same as for normal renal function. Initiation is not recommended in patients with an 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.
Not reported in label.
Not reported in label.
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