Type 2 diabetes mellitus: Forxiga is indicated in adults aged 18 years and older with type 2 diabetes mellitus as: Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Add-on combination therapy: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see Precautions, Interactions and Pharmacology: Pharmacodynamics under Actions for available data on different combinations).
Initial Combination: Forxiga is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when diet and exercise have failed to provide adequate glycemic control and there are poor prospects for response to metformin monotherapy (for example, high initial HbA1c levels).
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.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see Precautions, Interactions and Pharmacology: Pharmacodynamics under Actions.
Heart failure: Forxiga 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.
Chronic kidney disease: Forxiga is indicated in adults for the treatment of chronic kidney disease.