DAPAGLIFLOZIN VIATRIS (Seed Pharma Pty Ltd)

Type 2 diabetes mellitus

Glycaemic control

[TRADE NAME] is indicated in adults with type 2 diabetes mellitus:

• as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.
• as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy (for example, high initial haemoglobin A1c [HbA1c] levels).
• in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 Pharmacodynamic properties – Clinical trials and section 4.4 Special warnings and precautions for use for available data on different add-on combination therapies).

Prevention of hospitalisation for heart failure

[TRADE NAME] is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 Pharmacodynamic properties –Clinical trials).

Heart failure

[TRADE NAME] is indicated in adults for the treatment of symptomatic heart failure independent of left ventricular ejection fraction, as an adjunct to standard of care therapy (see section 5.1 Pharmacodynamic properties).

Chronic kidney disease

[TRADE NAME] is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2, 3 or 4) (see section 5.1 Pharmacodynamic properties, Clinical trial – Chronic kidney disease).