What is the recommended use and dosage of Forxiga (dapagliflozin) in patients with type 2 diabetes?

Recommended Use and Dosage of Forxiga (Dapagliflozin) in Type 2 Diabetes

Forxiga (dapagliflozin) is recommended at a starting dose of 5 mg once daily, which can be increased to 10 mg once daily for additional glycemic control in patients with type 2 diabetes with eGFR ≥45 mL/min/1.73 m². 1

Indications for Forxiga in Type 2 Diabetes

• Forxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus 1
• Particularly recommended for patients with type 2 diabetes who have cardiovascular disease (CVD) or are at high/very high cardiovascular risk to reduce cardiovascular events 2
• Recommended to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors 1
• Recommended to lower the risk of heart failure hospitalization in patients with type 2 diabetes 2

Dosing Guidelines

• Initial dose: 5 mg orally once daily 1
• Dose titration: Can be increased to 10 mg once daily for additional glycemic control if needed 1
• Administration: Can be taken at any time of day, with or without food 1

Renal Function Considerations

• eGFR ≥45 mL/min/1.73 m²: Standard dosing (5-10 mg once daily) for glycemic control 1
• eGFR <45 mL/min/1.73 m²: Not recommended for glycemic control as it is likely to be ineffective 1
• eGFR 25-<45 mL/min/1.73 m²: 10 mg daily for cardiovascular and kidney benefits (not for glycemic control) 2
• eGFR <25 mL/min/1.73 m²: Initiation not recommended; however, patients may continue 10 mg daily if already on treatment and tolerating it well for cardiovascular and kidney benefits until dialysis 2

Clinical Benefits Beyond Glycemic Control

• Reduces risk of major adverse cardiovascular events (MACE) in patients with established CVD or multiple risk factors 2
• Reduces risk of hospitalization for heart failure by 27% compared to placebo 2
• Associated with reductions in body weight (average 2.6 kg over 102 weeks compared to placebo plus low-dose metformin) 3
• Provides blood pressure-lowering effects 4
• May slow progression of diabetic kidney disease 2

Special Considerations

• Heart Failure: Dapagliflozin 10 mg daily is recommended for patients with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF), regardless of diabetes status, to reduce risk of worsening heart failure and cardiovascular death 2
• Chronic Kidney Disease: 10 mg daily is recommended to reduce risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with CKD at risk of progression 2, 1
• Surgery: Withhold Forxiga for at least 3 days prior to major surgery or procedures associated with prolonged fasting 1

Common Adverse Effects and Monitoring

• Genital mycotic infections: More common with dapagliflozin than placebo, particularly in women 4, 5, 6
• Urinary tract infections: Higher incidence compared to placebo 5, 6
• Hypoglycemia: Low risk when used as monotherapy or with metformin, but risk increases when combined with insulin or insulin secretagogues 5, 6
• Volume depletion: Assess volume status before initiation, particularly in elderly patients or those on diuretics 1
• Diabetic ketoacidosis (DKA): Rare but serious risk; monitor for signs/symptoms 1

Contraindications

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

Practical Algorithm for Prescribing Forxiga in Type 2 Diabetes

1. Assess patient eligibility:

   • Confirm diagnosis of type 2 diabetes
   • Check renal function (eGFR)
   • Evaluate cardiovascular risk status

2. Determine appropriate indication:

   • Glycemic control (eGFR ≥45 mL/min/1.73 m²)
   • Cardiovascular risk reduction (especially with established CVD)
   • Heart failure risk reduction
   • Renal protection

3. Select starting dose:

   • Start with 5 mg once daily for glycemic control
   • Consider 10 mg once daily for cardiovascular/renal indications

4. Monitor and follow-up:

   • Assess glycemic response after 3 months
   • Monitor renal function periodically
   • Watch for signs of genital infections, UTIs, and volume depletion
   • Consider dose increase to 10 mg if needed for glycemic control

5. Adjust based on comorbidities:

   • Heart failure: Maintain 10 mg dose
   • Declining renal function: Follow renal dosing guidelines