Active Ingredient and Strength	DAPAGLIFLOZIN PROPANEDIOL 6.15 MG EQV DAPAGLIFLOZIN - 5 MG
Dosage Form	TABLET, FILM COATED
Manufacturer and Country	ASTRAZENECA PHARMACEUTICALS LP - UNITED STATES ASTRAZENECA PHARMACEUTICAL CO. LTD (PRIMARY AND SECONDARY PACKAGER) - CHINA
Registration Number	SIN14541P
Licence Holder	ASTRAZENECA SINGAPORE PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	A10BK01

4.1 Therapeutic indications

Type 2 diabetes mellitus

FORXIGA is indicated in adults with type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise. FORXIGA can be given as monotherapy or in combination with other medicinal products indicated for the treatment of type 2 diabetes mellitus.

For study results with respect to combination of therapies, effects on glycemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Heart failure

FORXIGA is indicated in adults with heart failure (NYHA class II–IV) to reduce the risk of cardiovascular death and hospitalization for heart failure (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Chronic kidney disease

FORXIGA is indicated as an adjunct to standard therapy to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular (CV) death in adults with chronic kidney disease at risk of progression.

FORXIGA is not indicated for use in patients with type 1 diabetes.

FORXIGA should not be used for the treatment of diabetic ketoacidosis.

4.2 Posology and method of administration

Type 2 diabetes mellitus

The recommended dose of FORXIGA is 10 mg taken orally once daily at any time of the day regardless of meals.

Heart failure

The recommended dose of FORXIGA is 10 mg taken orally once daily at any time of the day regardless of meals.

Chronic kidney disease

The recommended dose of FORXIGA is 10 mg taken orally once daily at any time of the day regardless of meals.

Special populations

Patients with renal impairment

No dosage adjustment is required based on renal function.
Due to limited experience, it is not recommended to initiate treatment with FORXIGA in patients with GFR < 25 mL/min, however patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, end-stage kidney disease and CV death.

The glucose lowering efficacy of FORXIGA is reduced in patients with eGFR <45 mL/min/1.73 m² (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, if eGFR falls below 45 mL/min/1.73 m², additional glucose lowering treatment should be considered in patients with diabetes mellitus.

Patients with hepatic impairment

No dosage adjustment for FORXIGA is necessary for patients with mild and moderate hepatic impairment. FORXIGA should not be used in patients with severe hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric and adolescent patients

Safety and effectiveness of FORXIGA in pediatric and adolescent patients have not been established.

Geriatric patients

No dosage adjustment for FORXIGA is required based on age (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Older patients are more likely to have impaired renal function. The renal function recommendations provided for all patients also apply to elderly patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

FORXIGA is contraindicated in patients with a history of any serious hypersensitivity reaction to the active substance or to any of the excipients.