What is the recommended usage and dosage of Farxiga (dapagliflozin) for patients with type 2 diabetes or heart failure?

Recommended Usage and Dosage of Farxiga (Dapagliflozin) for Type 2 Diabetes and Heart Failure

For patients with type 2 diabetes and heart failure, Farxiga (dapagliflozin) should be administered at 10 mg orally once daily, with no dose titration needed for cardiovascular or renal benefits, regardless of diabetes status. 1

Dosing for Type 2 Diabetes (Glycemic Control)

• The recommended starting dose for glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes is 5 mg orally once daily 1
• The dose can be increased to 10 mg orally once daily for additional glycemic control if needed 1
• For patients with eGFR ≥45 mL/min/1.73 m², no dose adjustment is required 2, 1
• Dapagliflozin is not recommended for glycemic control in patients with eGFR <45 mL/min/1.73 m² as it is likely to be ineffective due to its mechanism of action 2, 3, 1

Dosing for Heart Failure

• For patients with heart failure (with reduced or preserved ejection fraction), the recommended dose is 10 mg orally once daily 2, 3, 1
• Dapagliflozin has demonstrated significant benefits in reducing:
  • Risk of cardiovascular death or hospitalization for heart failure 2
  • Risk of first worsening heart failure event 2
  • Risk of cardiovascular death 2
• These benefits are consistent regardless of diabetes status 2, 4
• For heart failure patients with renal impairment:
  • The recommended dose is 10 mg daily for patients with eGFR ≥25 mL/min/1.73 m² 3, 1
  • Initiation is not recommended in patients with eGFR <25 mL/min/1.73 m² 3, 1
  • If eGFR falls below 25 mL/min/1.73 m² during treatment, patients may continue dapagliflozin 10 mg daily 3, 1

Dosing for Chronic Kidney Disease

• For patients with chronic kidney disease at risk of progression, the recommended dose is 10 mg orally once daily 1
• Dapagliflozin reduces the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease 3, 1
• For CKD patients with renal impairment:
  • The same 10 mg daily dose is recommended for patients with eGFR ≥25 mL/min/1.73 m² 3, 1
  • Initiation is not recommended with eGFR <25 mL/min/1.73 m² 3, 1

Important Clinical Considerations

• Assess renal function prior to initiation and periodically thereafter 3, 1
• Assess volume status before starting; correct volume depletion if present 3, 1
• Withhold dapagliflozin for at least 3 days prior to major surgery or procedures requiring prolonged fasting 3, 1
• Resume when the patient is clinically stable and has resumed oral intake 1
• Consider reducing or stopping sulfonylureas/glinides or reducing insulin dose by approximately 20% when initiating dapagliflozin to prevent hypoglycemia 3

Monitoring for Adverse Effects

• Monitor for genital mycotic infections and urinary tract infections, which occur more frequently with dapagliflozin 3, 5
• Watch for signs of volume depletion, especially in elderly patients or those on diuretics 3, 1
• Be alert for rare but serious euglycemic diabetic ketoacidosis, particularly in situations of acute illness or reduced food intake 3, 1
• Dapagliflozin has a low propensity to cause hypoglycemia when used alone or with metformin, but risk increases when combined with insulin or insulin secretagogues 6

Evidence of Clinical Benefits

• In the DAPA-HF trial, dapagliflozin reduced the risk of worsening heart failure or cardiovascular death by 26% (HR 0.74) in patients with HFrEF 2, 7
• In the DELIVER trial, dapagliflozin reduced the risk of worsening heart failure or cardiovascular death by 18% (HR 0.82) in patients with HFpEF 2
• Benefits in heart failure patients are consistent regardless of background glucose-lowering therapies in patients with diabetes 8