INDICATIONS AND USAGE（适应症）

Type 2 Diabetes Mellitus

FARXIGA (dapagliflozin) is indicated:

·as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

·to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

Heart Failure

FARXIGA is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.

DOSAGE（服用剂量）

Type 2 Diabetes Mellitus

To improve glycemic control, the recommended starting dose of FARXIGA is 5 mg orally once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.

To reduce the risk of hospitalization for heart failure in patients with type 2 diabetes mellitus and established CVD or multiple CV risk factors, the recommended dose of FARXIGA is 10 mg orally once daily.

Heart Failure

The recommended dose of FARXIGA is 10 mg orally once daily.

ADVERSE REACTIONS（不良反应）

Volume Depletion

Ketoacidosis in Patients with Diabetes Mellitus

Urosepsis and Pyelonephritis

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)

Genital Mycotic Infections

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc/spl-doc?hl=Dapagliflozin

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