What is the usage and dosage of Forxiga (dapagliflozin)?

Forxiga (Dapagliflozin): Usage and Dosage Guidelines

Forxiga (dapagliflozin) is recommended at a dose of 10 mg orally once daily for heart failure, chronic kidney disease, and cardiovascular risk reduction, while for glycemic control in type 2 diabetes, the starting dose is 5 mg daily (can be increased to 10 mg daily if needed). 1

Indications

Dapagliflozin is FDA-approved for multiple indications:

• Type 2 diabetes mellitus: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older 1
• Heart failure: To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure (with both reduced and preserved ejection fraction) 2, 3
• Chronic kidney disease: To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression 2, 1
• Cardiovascular risk reduction: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors 3, 1

Dosing Recommendations

For Type 2 Diabetes (Glycemic Control)

• Starting dose: 5 mg orally once daily 1
• Dose adjustment: Can be increased to 10 mg once daily for additional glycemic control 1
• Renal considerations:
  • For eGFR ≥45 mL/min/1.73 m²: No dose adjustment required 2, 1
  • For eGFR <45 mL/min/1.73 m²: Not recommended for glycemic control (likely ineffective due to mechanism of action) 2, 1

For Heart Failure, Chronic Kidney Disease, and Cardiovascular Risk Reduction

• Fixed dose: 10 mg orally once daily 3, 1
• Renal considerations:
  • For eGFR ≥25 mL/min/1.73 m²: No dose adjustment required 2, 1
  • For eGFR <25 mL/min/1.73 m²: Not recommended for initiation 2, 1
  • If eGFR falls below 25 mL/min/1.73 m² during treatment: May continue 10 mg daily 2, 1

Clinical Benefits

Cardiovascular Benefits

• Reduces risk of hospitalization for heart failure by 27-35% in patients with type 2 diabetes 4
• Reduces risk of cardiovascular death or hospitalization for heart failure by 26% in patients with heart failure with reduced ejection fraction (HFrEF) 3, 5
• Reduces risk of worsening heart failure or cardiovascular death by 18% in patients with heart failure with preserved ejection fraction (HFpEF) 3
• Benefits are consistent regardless of diabetes status 4, 3

Renal Benefits

• Reduces risk of sustained eGFR decline, end-stage kidney disease, and renal death by 44% 2
• Slows the rate of eGFR decline in patients with chronic kidney disease 2
• Most effective in patients with albuminuria (UACR 200-5000 mg/g) 2

Safety Considerations

Temporary Interruption for Surgery

• Withhold dapagliflozin for at least 3 days before major surgery or procedures requiring prolonged fasting 3, 1
• Resume when the patient is clinically stable and has resumed oral intake 1

Monitoring Requirements

• Assess renal function prior to initiation and periodically thereafter 2, 1
• Assess volume status before starting; correct volume depletion if present 2, 3, 1
• Consider reducing diuretic dose if patient is at risk for volume depletion 3

Common Adverse Effects

• Genital mycotic infections (more common in women) 2, 3, 6
• Urinary tract infections 2, 3
• Volume depletion 2, 3, 1
• Euglycemic diabetic ketoacidosis (rare) 2, 3, 1

Contraindications

• History of serious hypersensitivity reaction to dapagliflozin 1
• Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus 1

Special Populations

Pediatric Patients

• Approved for glycemic control in type 2 diabetes for patients aged 10 years and older 1
• Starting dose: 5 mg once daily, can be increased to 10 mg once daily 1

Patients with Renal Impairment

• For glycemic control: Not recommended if eGFR <45 mL/min/1.73 m² 2, 1
• For heart failure and kidney disease: Not recommended for initiation if eGFR <25 mL/min/1.73 m² 2, 1
• If already on treatment and eGFR falls below 25 mL/min/1.73 m²: May continue 10 mg daily 2, 1

By following these guidelines, clinicians can appropriately prescribe Forxiga (dapagliflozin) to maximize benefits while minimizing risks across its various indications.