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

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

Dapagliflozin tablets are indicated for two uses in adults with type 2 diabetes mellitus: 1) As an adjunct to diet and exercise to improve glycemic control. 2) 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.

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.

For glycemic control, the recommended starting dosage is 5 mg orally once daily. The dosage can be increased to 10 mg orally once daily for additional glycemic control. For reducing the risk of hospitalization for heart failure, the recommended dosage is 10 mg orally once daily.

Prior to initiation, assess renal function and assess/correct volume status if depleted. For glycemic control, the drug is not recommended if eGFR is less than 45 mL/min/1.73 m². For the heart failure risk reduction indication, the recommended dosage is the same for patients with eGFR ≥25 mL/min/1.73 m²; initiation is not recommended if eGFR is 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. Resume when the patient is clinically stable and has resumed oral intake.

The label states that dapagliflozin has been studied in adult patients as monotherapy, in combination with metformin, pioglitazone, sulfonylurea (glimepiride), sitagliptin (with or without metformin), metformin plus a sulfonylurea, or insulin (with or without other oral antidiabetic therapy), compared to a sulfonylurea (glipizide), and in combination with a GLP-1 receptor agonist (exenatide extended-release) added-on to metformin. It has also been studied in adult patients with type 2 diabetes mellitus and moderate renal impairment. Specific trial data and outcomes for efficacy are not detailed in the provided label text.

Not reported in label.

Dapagliflozin tablets are an SGLT2 inhibitor indicated for glycemic control in type 2 diabetes and for reducing heart failure hospitalization risk in a specific high-risk subset of patients with type 2 diabetes. Its use for glycemic control is limited by renal function (eGFR ≥45 mL/min/1.73 m²). The label provides specific dosing for each indication.