From the Guidelines
The dose of Xarelto (rivaroxaban) for atrial fibrillation is 20 mg once daily for patients with a creatinine clearance (CrCl) of > 95 mL/min or 51-95 mL/min, and 15 mg once daily for patients with a CrCl of 31-50 mL/min or 15-30 mL/min.
Important Considerations
- The dose of rivaroxaban should be taken with the evening meal to ensure adequate absorption 1.
- For patients with a CrCl of < 15 mL/min, the dose is still 15 mg once daily, although pharmacokinetic data are limited 2, 3.
- Other non-renal considerations, such as drug interactions, may also apply when determining the dose of rivaroxaban.
Renal Function and Dosing
The recommended doses of rivaroxaban according to renal function are as follows:
- CrCl > 95 mL/min: 20 mg once daily
- CrCl 51-95 mL/min: 20 mg once daily
- CrCl 31-50 mL/min: 15 mg once daily
- CrCl 15-30 mL/min: 15 mg once daily
- CrCl < 15 mL/min: 15 mg once daily (limited pharmacokinetic data) 2, 3 It is essential to note that these recommendations are based on the 2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of atrial fibrillation 2, 3.
From the FDA Drug Label
The evidence for the efficacy and safety of XARELTO was derived from Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) [NCT00403767], a multi-national, double-blind study comparing XARELTO (at a dose of 20 mg once daily with the evening meal in patients with CrCl >50 mL/min and 15 mg once daily with the evening meal in patients with CrCl 30 to 50 mL/min) to warfarin (titrated to INR 2.0 to 3. 0) to reduce the risk of stroke and non-central nervous system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation (AF)
The dose of Xarelto (rivaroxaban) for atrial fibrillation is:
- 20 mg once daily with the evening meal in patients with CrCl >50 mL/min
- 15 mg once daily with the evening meal in patients with CrCl 30 to 50 mL/min 4
From the Research
Dose of Xarelto (Rivaroxaban) for Atrial Fibrillation
The dose of Xarelto (rivaroxaban) for atrial fibrillation is as follows:
- 20 mg once daily for patients with normal renal function 5, 6
- 15 mg once daily for patients with moderate renal impairment 5, 7
- 10 mg once daily for patients with severe renal impairment (CrCl 15-29 ml/min) 8
- 10 mg twice daily for patients with CrCl 70-159 ml/min 8
- 15 mg twice daily for patients with CrCl 160-250 ml/min 8
Renal Impairment Considerations
Renal impairment is a significant factor in determining the dose of rivaroxaban for atrial fibrillation. Patients with moderate renal impairment should receive a reduced dose of 15 mg once daily 5, 7. The dose should be adjusted based on the patient's creatinine clearance (CrCl) 8.
Clinical Trials and Studies
Several clinical trials and studies have evaluated the efficacy and safety of rivaroxaban for atrial fibrillation, including the ROCKET AF trial 5, 6 and the Japanese ROCKET AF trial 5. These studies have demonstrated that rivaroxaban is noninferior to warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation 5, 6. However, the choice of anticoagulant should be individualized based on patient characteristics and medical history 9.