How long should a patient with pulmonary embolism be on Xarelto (rivaroxaban)?

Duration of Xarelto (Rivaroxaban) for Pulmonary Embolism

For pulmonary embolism, patients should take Xarelto 15 mg twice daily for 3 weeks (21 days), followed by 20 mg once daily for a minimum of 3 months, with total duration determined by recurrence risk factors. 1

Initial Treatment Phase (First 3 Weeks)

• Start with 15 mg twice daily for exactly 21 days - this intensive dosing phase is critical for acute PE treatment and requires no initial heparin bridging 2, 1
• The 21-day intensive period should not be shortened, as Japanese real-world data showed patients receiving shorter durations (1-8 days) had increased VTE recurrence rates (6.10% vs 2.60% per patient-year) compared to the standard 17-24 day duration 3
• No parenteral anticoagulation is needed before starting rivaroxaban, making it a true single-drug regimen unlike dabigatran or edoxaban which require heparin lead-in 2, 1

Maintenance Phase (After 3 Weeks)

• Switch to 20 mg once daily after completing the 21-day intensive phase 2, 1
• This maintenance dose continues for the remainder of treatment duration 1

Total Treatment Duration

Minimum Duration

• All patients require at least 3 months of total anticoagulation (including the initial 3-week intensive phase) 2, 1
• This 3-month minimum applies regardless of whether PE was provoked or unprovoked 2

Extended Duration Considerations

• For patients at higher risk of recurrence, treatment should continue beyond 3 months 1
• The EINSTEIN EXT trial demonstrated that continuing rivaroxaban 20 mg once daily was superior to placebo for extended VTE prevention 4
• For extended secondary prevention, physicians can choose between 20 mg once daily or 10 mg once daily based on individual bleeding risk and recurrence risk 4

Clinical Evidence Supporting This Regimen

• The EINSTEIN-PE trial (n=4,832) established non-inferiority to standard enoxaparin/warfarin therapy with a recurrence rate of 2.1% vs 1.8% (HR 1.12; 95% CI 0.75-1.68) 5
• Major bleeding was significantly lower with rivaroxaban (1.1% vs 2.2%, HR 0.49; 95% CI 0.31-0.79) compared to standard therapy 2, 5
• Rivaroxaban reduced hospital length of stay by a mean of 1.7 days in North American PE patients 2

Common Pitfalls to Avoid

• Do not confuse the 15 mg dose with 150 mg - dispensing errors have occurred when rivaroxaban 15 mg twice daily was misread as 150 mg (the dabigatran dose for atrial fibrillation) 6
• Do not skip the twice-daily intensive phase - jumping directly to 20 mg once daily increases recurrence risk 3
• Do not stop at 21 days - the minimum total duration is 3 months, not 3 weeks 2, 1

Special Populations

• Cancer patients with PE can be treated with the same rivaroxaban regimen, with evidence supporting similar or better efficacy compared to dalteparin 1
• Dose adjustments are not routinely needed, and no coagulation monitoring is required 1