Posology: Monotherapy and add-on combination therapy: The recommended dose is 10 mg dapagliflozin once daily.
When dapagliflozin is used in combination with insulin or an insulin secretagogue, such as a sulphonylurea, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see Interactions and Adverse Reactions).
Initial Combination Therapy: The recommended starting doses of Forxiga and metformin when used as initial combination therapy are 10 mg Forxiga plus 500 mg metformin once daily. Patients with inadequate glycemic control on this dose should further have their metformin dose increased according to approved local label guidelines.
Special populations: Renal impairment: Forxiga is not recommended for the treatment of diabetes in patients where eGFR is persistently below 45 ml/min/1.73 m2 as the glycaemic efficacy is dependent on renal function (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions). No dosage adjustment is required based on renal function.
Hepatic impairment: No dosage adjustment is necessary for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Elderly (≥ 65 years): In general, no dosage adjustment is recommended based on age. Renal function and risk of volume depletion should be taken into account (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established. No data are available.
Method of administration: Forxiga can be taken orally once daily at any time of day with or without food. Tablets are to be swallowed whole.