What is the recommended dose of Xarelto (rivaroxaban) for patients with atrial fibrillation?

Xarelto Dosing for Atrial Fibrillation

The standard dose of rivaroxaban (Xarelto) for atrial fibrillation is 20 mg once daily with the evening meal, reduced to 15 mg once daily in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). 1, 2

Standard Dosing

• Administer 20 mg once daily with the evening meal for patients with nonvalvular atrial fibrillation and normal to mildly impaired renal function 1, 2
• Taking rivaroxaban with food (specifically the evening meal) is essential for adequate absorption and consistent anticoagulant effect 1, 2
• This dosing regimen was validated in the ROCKET AF trial, demonstrating noninferiority to warfarin for preventing stroke and systemic embolism 3

Dose Reduction Criteria

Reduce to 15 mg once daily with the evening meal in the following situations:

• Moderate renal impairment (CrCl 30-49 mL/min) - this is the primary FDA-approved indication for dose reduction 1, 2
• The ROCKET AF trial demonstrated that patients with moderate renal impairment receiving 15 mg once daily achieved similar serum concentrations and clinical outcomes as those with better renal function receiving 20 mg 1, 4

Important Caveats About Dose Reduction

• Do NOT reduce the dose based solely on advanced age (≥80 years) or low body weight - these are not validated dose reduction criteria according to European Society of Cardiology guidelines 1
• The only validated reasons to use 15 mg rivaroxaban are moderate renal impairment or high bleeding risk (HAS-BLED score ≥3) per European guidelines 1
• Real-world data shows that rivaroxaban is frequently underdosed inappropriately, with up to 52% of patients receiving reduced doses without meeting labeling criteria 5

Renal Function Monitoring

• Assess creatinine clearance before initiating therapy 1, 2
• Recheck renal function annually in stable patients, or 2-3 times per year in patients with moderate renal impairment (CrCl 30-49 mL/min) 1
• Rivaroxaban is not recommended in patients with severe renal impairment (CrCl <30 mL/min) according to European guidelines 1
• The FDA has approved a 15 mg dose for patients with CrCl 15-50 mL/min 6

Administration Instructions

• For patients who cannot swallow tablets whole, crush rivaroxaban and combine with a small amount of applesauce followed by food 2
• For patients with NG tubes or gastric feeding tubes, crush the tablet and mix with a small amount of water before administering via the tube 2
• If a dose is missed, patients should follow specific instructions based on their dosing schedule as outlined in the prescribing information 2

Clinical Evidence

The ROCKET AF trial enrolled 14,264 patients with nonvalvular atrial fibrillation and demonstrated that rivaroxaban 20 mg once daily (15 mg in those with moderate renal impairment) was noninferior to warfarin for preventing stroke or systemic embolism (1.7% vs 2.2% per year, hazard ratio 0.79) 3. Importantly, rivaroxaban showed significant reductions in intracranial hemorrhage (0.5% vs 0.7%) and fatal bleeding (0.2% vs 0.5%) compared to warfarin 3.