Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1 Dapagliflozin 10mg Tablet A10BX09-999-T32-01-XXX A/KK Indication 1:
Dapagliflozin is indicated for use as an add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, to improve glycemic control in adult patients with type 2 diabetes mellitus when these, together with diet and exercise, do not provide adequate glycaemic control.

Indication 2:
Dapagliflozin is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).

Indication 3:
To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class ll-lV) with reduced ejection fraction.

Indication 4:
For cardiorenal protection in adult patients with chronic kidney disease, with or without Type 2 Diabetes Mellitus, with eGFR≥25mL/min/1.73m2 and urine albumin creatinine ratio (UACR) ≥200-5,000mg/m2 (or the equivalent in uPRC/u-dipstick) receiving stable treatment with ACEi or ARB (unless they are contraindicated or not tolerated).
Indication 1:
Patients with HbA1c between 6.5%-10.0% while on single / combination anti-diabetic therapy.

Indication 2:
Patients with HbA1c not more than 10.0% while on adequate trial of metformin.

Indication 3:
Treatment to be initiated in hospital setting before continuation of treatment for stable patients by Family Medicine Specialist (FMS) in the primary care setting;
All patients must be counselled regarding risk of euglycemic ketoacidosis before initiation of treatment.

Indication 4:
In adult patients with underlying Type 2 Diabetes Mellitus, to be used only if HbA1c level <10%.
All patients must be counselled regarding risk of euglycemic ketoacidosis before initiation of treatment.



10 mg once daily