What is the recommended dosage of Rivaroxaban (Xarelto) for patients with various conditions?

From the Guidelines

Rivaroxaban dosing varies based on the specific condition being treated, with a standard dose of 20 mg once daily with food for atrial fibrillation, and dose adjustments for patients with reduced kidney function or other conditions. For atrial fibrillation, the standard dose is 20 mg once daily with food, though patients with reduced kidney function (creatinine clearance 15-50 mL/min) should receive 15 mg once daily with food, as indicated in the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation 1.

• For treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), patients typically start with 15 mg twice daily with food for 21 days, followed by 20 mg once daily with food for the remainder of treatment.
• For DVT/PE prevention after hip or knee replacement surgery, 10 mg once daily is recommended, starting 6-10 hours after surgery once hemostasis is established, as stated in the 2012 ACCP guidelines for anticoagulant therapy 1.
• For prevention of recurrent DVT/PE, 10 mg once daily is used after completing at least 6 months of standard treatment. Rivaroxaban should be taken with food to enhance absorption, particularly for doses above 10 mg, and patients should never abruptly stop taking rivaroxaban without medical guidance due to increased stroke risk, as noted in the 2020 ACC expert consensus decision pathway for anticoagulant and antiplatelet therapy in patients with atrial fibrillation or venous thromboembolism undergoing percutaneous coronary intervention or with atherosclerotic cardiovascular disease 1. The most recent guidelines from the 2022 ACC expert consensus decision pathway for integrating atherosclerotic cardiovascular disease and multimorbidity treatment recommend prioritizing the highest dose indicated for rivaroxaban, such as the AF dose, over lower doses for other conditions, and considering dose reductions for patients with reduced renal function 1. Rivaroxaban works by directly inhibiting Factor Xa in the coagulation cascade, preventing thrombin formation and subsequent clot development, making consistent dosing essential for maintaining therapeutic anticoagulation levels.

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 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 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 the RECORD 1–3 trials, patients with CrCl values <30 mL/min at screening were excluded from the studies, but administration 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) 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)

The recommended dosage of Rivaroxaban (Xarelto) varies depending on the condition being treated and the patient's renal function.

• For patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE), the recommended dose is 15 mg twice daily for the first 21 days, followed by 20 mg once daily for the remaining treatment period.
• For patients with non-valvular atrial fibrillation, the recommended dose is 20 mg once daily.
• For patients with chronic kidney disease (CKD) not on dialysis, the recommended dose is 2.5 mg twice daily.
• For patients undergoing hip or knee replacement surgery, the recommended dose is 10 mg once daily.
• For patients with end-stage renal disease (ESRD) on dialysis, there is limited data available, and the use of XARELTO is not recommended. It is essential to note that the dosage may need to be adjusted based on the patient's renal function, and the patient should be closely monitored for signs and symptoms of bleeding 2.

From the Research

Rivaroxaban Dosage

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

• For patients with atrial fibrillation, the approved dosage is 15 mg or 20 mg once daily, depending on renal function 3.
• For patients with deep vein thrombosis or pulmonary embolism, the recommended dosage is 15 mg twice daily for 3 weeks, followed by 20 mg once daily 4.
• For patients with nonvalvular atrial fibrillation, the recommended dosage is 15 mg or 20 mg once daily, depending on renal function 5.
• For patients with renal insufficiency, the dosage may need to be adjusted, with proposed dosing recommendations including 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) 3.
• For patients undergoing elective knee or hip replacement surgery, the recommended dosage is 10 mg once daily for 12-14 days 6.

Special Considerations

• Rivaroxaban has a high bioavailability and moderate pharmacokinetic variability, and its dosage regimen was derived from pharmacologic data to balance efficacy and bleeding risk 4, 6.
• The drug is relatively easy to use, but adjustments of dose are needed in individuals with impaired renal functions 6, 7.
• Rivaroxaban has a lower potential for drug interactions compared with warfarin, but potential strategies for reversing its anticoagulant effect are still being reviewed 7.
• Health systems will need to perform a systematic safety evaluation and ensure that numerous hospital policies related to anticoagulation are updated to include rivaroxaban 7.