Posology: Type 2 diabetes mellitus: 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.
Heart failure: The recommended dose is 10mg dapagliflozin once daily.
In the DAPA-HF study, dapagliflozin was administered in conjuction with other heart failure therapies (see Pharmacology: Pharmacodynamics under Actions).
Chronic kidney disease: The recommended dose is 10mg dapagliflozin once daily.
In the DAPA-CKD study, dapagliflozin was administered in conjunction with other chronic kidney disease therapies (see Pharmacology: Pharmacodynamics under Actions).
Special populations: Renal impairment: No dosage adjustment is required based on renal function.
Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min.
In patients with diabetes mellitus, the glucose lowering efficacy of dapagliflozin is reduced when the glomerular filtration rate is < 45 ml/min, and is likely absent in patients with severe renal impairment.
Therefore, if GFR falls below 45 mL/min, additional glucose lowering treatment should be considered in patients with diabetes mellitus if further glycaemic control is needed (see Precautions, Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
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): No dosage adjustment is recommended based on age.
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.