Dapagliflozin

What it is and how it works

Mechanism of Action Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.

Indications

(dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use • FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus . • FARXIGA is 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 m 2 . FARXIGA is likely to be ineffective in this setting based upon its mechanism of action.

Dosage and administration (summary)

• Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating. • To improve 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 all other indications, the recommended dosage is 10 mg orally once daily. • See full prescribing information for dosage recommendations in patients with renal impairment. ( 2.2 , 2.3 ) • Withhold FARXIGA for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting.

Contraindications

is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with FARXIGA . • History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA.

Warnings and precautions

• Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue FARXIGA if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.

Pregnancy

Pregnancy Risk Summary Based on animal data showing adverse renal effects, FARXIGA is not recommended during the second and third trimesters of pregnancy. Limited data with FARXIGA in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage.

Storage and supply

Product: 50090-3481 NDC: 50090-3481-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC Product: 50090-3482 NDC: 50090-3482-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC

Source: Dapagliflozin (Farxiga) — US FDA prescribing information, 2026-07-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.