What is the normal dose of Xarelto (Rivaroxaban)?

From the Guidelines

The normal dose of Xarelto (rivaroxaban) for atrial fibrillation is 20 mg once daily with food, and for patients with reduced kidney function (creatinine clearance 15-49 mL/min), the dose should be reduced to 15 mg once daily with food. This recommendation is based on the most recent and highest quality study available, which is the 2023 ACC/AHA/ACCp/HRS guideline for the diagnosis and management of atrial fibrillation 1.

Key Considerations

• The dose of Xarelto may vary depending on the condition being treated, such as deep vein thrombosis (DVT) or pulmonary embolism (PE), and the patient's kidney function.
• For DVT or PE treatment, patients typically start with 15 mg twice daily with food for the first 21 days, then continue with 20 mg once daily.
• For DVT/PE prevention after hip or knee replacement surgery, 10 mg once daily is recommended.
• It is essential to take Xarelto exactly as prescribed and not miss doses, as this could increase the risk of blood clots.

Mechanism of Action and Side Effects

• Xarelto works by blocking Factor Xa, a key component in blood clot formation.
• Side effects may include bleeding, and patients should report any unusual bleeding or bruising to their healthcare provider immediately.
• Xarelto should be taken at the same time each day to maintain consistent blood levels.

Renal Dosing Adjustment

• For patients with reduced kidney function, the dose of Xarelto should be adjusted according to the creatinine clearance (CrCl) level.
• The 2023 ACC/AHA/ACCp/HRS guideline recommends a dose reduction to 15 mg once daily for patients with CrCl 15-50 mL/min 1.

Comparison with Other Studies

• The 2018 study on antithrombotic therapy in patients with atrial fibrillation treated with oral anticoagulation undergoing percutaneous coronary intervention also recommends a dose of 20 mg once daily for Xarelto 2.
• The 2016 ESC guidelines for the management of atrial fibrillation also recommend a dose of 20 mg once daily for Xarelto 3.

However, the 2023 ACC/AHA/ACCp/HRS guideline is the most recent and highest quality study, and its recommendations should be followed.

From the FDA Drug Label

Patients with CrCl <30 mL/min were not studied, but administration of XARELTO 15 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment In the EINSTEIN trials, patients with CrCl values <30 mL/min at screening were excluded from the studies, but administration of XARELTO is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) The combined analysis of the RECORD 1–3 clinical efficacy studies did not show an increase in bleeding risk for patients with CrCl 30 to 50 mL/min and reported a possible increase in total venous thromboemboli in this population In patients with CrCl <30 mL/min a dose of XARELTO 10 mg once daily is expected to result in serum concentrations of rivaroxaban similar to those in patients with moderate renal impairment (CrCl 30 to <50 mL/min) Patients with a CrCl <15 mL/min at screening were excluded from COMPASS and VOYAGER, and limited data are available for patients with a CrCl of 15 to 30 mL/min. In patients with CrCl <30 mL/min, a dose of 2.5 mg XARELTO twice daily is expected to give an exposure similar to that in patients with moderate renal impairment (CrCl 30 to <50 mL/min)

The normal dose of Xarelto (Rivaroxaban) varies based on the indication and renal function:

• For treatment of DVT and/or PE: 15 mg once daily 4
• For prophylaxis of DVT following hip or knee replacement surgery: 10 mg once daily 4
• For prophylaxis of venous thromboembolism in acutely ill medical patients: 10 mg once daily 4
• For reduction of risk of major cardiovascular events in patients with CAD and reduction of risk of major thrombotic vascular events in patients with PAD: 2.5 mg twice daily 4

From the Research

Normal Dose of Xarelto (Rivaroxaban)

The normal dose of Xarelto (Rivaroxaban) varies depending on the patient's condition and renal function.

• For patients with nonvalvular atrial fibrillation, the recommended dose is 20 mg once daily, or 15 mg once daily for patients with moderate renal impairment 5.
• For patients with venous thromboembolism, the recommended dose is 15 mg twice daily for 3 weeks, followed by 20 mg once daily 6.
• A study suggests that rivaroxaban dosing could be more effective and/or safer for more patients if increased dosing precision is available, with proposed dosing recommendations of 10 mg once daily (CrCl 15-29 ml/min), 15 mg once daily (CrCl 30-69 ml/min), 10 mg twice daily (CrCl 70-159 ml/min), and 15 mg twice daily (CrCl 160-250 ml/min) 7.
• Another study found that elderly patients with venous thromboembolism receiving rivaroxaban at a dose of 10 mg once daily had a lower risk of bleeding and a similar rate of recurrent VTE compared to those receiving higher doses 8.

Factors Affecting Dose

Several factors can affect the dose of Xarelto (Rivaroxaban), including:

• Renal function: patients with moderate renal impairment may require a reduced dose of 15 mg once daily 5, 7.
• Age: elderly patients may be at higher risk of bleeding and may require a lower dose 9, 8.
• Concomitant medications: certain medications, such as aspirin, may increase the risk of bleeding when taken with rivaroxaban 8.
• Hepatic function: patients with severe liver insufficiency should not receive rivaroxaban, while those with mild hepatic impairment may not require a dose adjustment 6, 9.