MAFDapagliflozin Tablet 5 mg, 10 mg
1) Treatment of type 2 diabetes mellitus, as a dual therapy
• In combination with metformin for patients with HbA1c > 7% despite treatment with metformin monotherapy;
• In combination with a sulfonylurea for patients with HbA1c > 7% despite treatment with sulfonylurea monotherapy and when metformin is contraindicated or not tolerated;
2) Treatment of type 2 diabetes mellitus as a triple therapy
• In combination with metformin and a sulfonylurea for patients with HbA1c > 7% despite treatment with optimal doses of dual therapy
3) Treatment of type 2 diabetes mellitus in combination with insulin, with or without metformin
4) Treatment of adults with chronic heart failure (NYHA class II to IV) with reduced ejection fraction (left ventricular ejection fraction of 40% or less) as part of a quadruple therapy including a beta blocker, either an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI), and a mineralocorticoid receptor antagonist (MRA) unless contraindicated or not tolerated.
5) Treatment of adults with chronic kidney disease:
• who are receiving optimal standard treatment which includes an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) at maximum tolerated doses, unless contraindicated; and
• have an estimated glomerular filtration rate (eGFR) of 25 to 75 mL/min/1.73m2 at the start of treatment; and
• have type 2 diabetes mellitus or have a urinary albumin to creatinine ratio (uACR) of ≥ 200 mg/g (22.6 mg/mmol).