Dosing recommendations of oral factor Xa inhibitors for VTE from different regulatory agencies
| Drug . | Renal clearance, % . | Standard dose for VTE . | FDA . | Health Canada . | EMA . |
|---|---|---|---|---|---|
| Rivaroxaban | 33 | 15 mg twice daily for 21 days, then 20 mg daily | • Avoid use if CrCl <15 mL/min | • Avoid use if CrCl <15 mL/min | • Avoid use if CrCl <15 mL/min • Use with caution for CrCl 15-29 mL/min • For CrCl <50 mL/min, a reduction from 20 mg to 15 mg daily can be considered if risk of bleeding outweighs recurrent VTE |
| Apixaban | 27 | 10 mg twice daily for 7 days, then 5 mg twice daily | • No dose adjustment for any CrCl | • Avoid use if CrCl <15 mL/min • Use with caution for CrCl 15-29 mL/min | • Avoid use if CrCl <15 mL/min • Use with caution for CrCl 15-29 mL/min |
| Edoxaban | 50 | LWMH for ≥5 days, then 60 mg daily | • Not recommended if CrCl <15 mL/min • CrCl 15-50 mL/min: 30 mg daily | • Avoid use if CrCl <30 mL/min • Weight ≤60 kg, CrCl 30-50 mL/min, or coadministration with P-gp inhibitors: 30 mg daily | • Avoid use if CrCl <15 mL/min • Weight ≤60 kg, CrCl 15-50 mL/min, or coadministration with P-gp inhibitors: 30 mg daily |
| Drug . | Renal clearance, % . | Standard dose for VTE . | FDA . | Health Canada . | EMA . |
|---|---|---|---|---|---|
| Rivaroxaban | 33 | 15 mg twice daily for 21 days, then 20 mg daily | • Avoid use if CrCl <15 mL/min | • Avoid use if CrCl <15 mL/min | • Avoid use if CrCl <15 mL/min • Use with caution for CrCl 15-29 mL/min • For CrCl <50 mL/min, a reduction from 20 mg to 15 mg daily can be considered if risk of bleeding outweighs recurrent VTE |
| Apixaban | 27 | 10 mg twice daily for 7 days, then 5 mg twice daily | • No dose adjustment for any CrCl | • Avoid use if CrCl <15 mL/min • Use with caution for CrCl 15-29 mL/min | • Avoid use if CrCl <15 mL/min • Use with caution for CrCl 15-29 mL/min |
| Edoxaban | 50 | LWMH for ≥5 days, then 60 mg daily | • Not recommended if CrCl <15 mL/min • CrCl 15-50 mL/min: 30 mg daily | • Avoid use if CrCl <30 mL/min • Weight ≤60 kg, CrCl 30-50 mL/min, or coadministration with P-gp inhibitors: 30 mg daily | • Avoid use if CrCl <15 mL/min • Weight ≤60 kg, CrCl 15-50 mL/min, or coadministration with P-gp inhibitors: 30 mg daily |
EMA, European Medicines Agency; FDA, Food and Drug Administration.