From the Guidelines
The recommended dose of Xarelto (rivaroxaban) for patients with non-valvular atrial fibrillation is 20 mg once daily taken with food, as indicated in the 2018 study published in Circulation 1. For patients with impaired kidney function (creatinine clearance 15-50 mL/min), the dose should be reduced to 15 mg once daily with food. This medication should be taken at the same time each day to maintain consistent blood levels. Patients should not stop taking Xarelto without consulting their healthcare provider as this could increase the risk of stroke. If a dose is missed, it should be taken as soon as possible on the same day, but patients should not double up to make up for a missed dose. Xarelto works by inhibiting Factor Xa, a key component in the blood clotting process, thereby reducing the risk of blood clot formation that could lead to stroke in patients with atrial fibrillation. Regular monitoring of kidney function is important while on this medication, as dosage adjustments may be needed if kidney function changes over time. Key points to consider when prescribing Xarelto include:
- The medication should be taken with food to ensure adequate absorption, as noted in the 2014 guideline for the management of patients with atrial fibrillation 1.
- Patients with a creatinine clearance of <15 mL/min should not be given Xarelto, as stated in the 2014 guideline 1.
- The safety and efficacy of combining Xarelto with an antiplatelet agent have not been established, as mentioned in the 2012 science advisory for healthcare professionals from the American Heart Association/American Stroke Association 1. It is essential to follow the recommended dosage and administration guidelines to minimize the risk of adverse effects and ensure the effectiveness of the medication in preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation.
From the FDA Drug Label
In the ROCKET AF trial, patients with CrCl 30 to 50 mL/min were administered XARELTO 15 mg once daily resulting in serum concentrations of rivaroxaban and clinical outcomes similar to those in patients with better renal function administered XARELTO 20 mg once daily 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)
The recommended dose of Xarelto (rivaroxaban) for patients with non-valvular atrial fibrillation is:
- 20 mg once daily with the evening meal for patients with CrCl >50 mL/min
- 15 mg once daily with the evening meal for patients with CrCl 30 to 50 mL/min 2
From the Research
Recommended Dose of Xarelto for Non-Valvular Atrial Fibrillation
The recommended dose of Xarelto (rivaroxaban) for patients with non-valvular atrial fibrillation is:
- 20 mg once daily for patients with normal renal function 3
- 15 mg once daily for patients with moderate renal impairment (creatinine clearance 30-49 mL/min) 3
- For patients with severe renal impairment (creatinine clearance 15-29 mL/min), the dose should be adjusted based on the patient's renal function 4
- For patients with end-stage kidney disease, low-dose rivaroxaban (10 mg once daily) may be beneficial 5
Considerations for Dosing
When determining the dose of Xarelto, the following factors should be considered:
- Renal function: patients with renal impairment may require a reduced dose 3, 4
- Age: older patients may require a reduced dose 6
- Weight: patients with a low body weight (<50 kg) may require a reduced dose 6
- Concomitant medications: patients taking antiplatelet drugs or other non-vitamin K oral anticoagulants may require a reduced dose 7
Clinical Evidence
Studies have shown that Xarelto is effective in preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation, with a similar safety profile to warfarin 3, 6. However, the optimal dose of Xarelto in certain patient populations, such as those with severe renal impairment or end-stage kidney disease, is still being studied 4, 5. Additionally, clinical practice has shown that Xarelto dosing is often not in line with labeling recommendations, with potential underdosing being a concern 7.