What is the recommended dose of Rivaroxaban (Xarelto) for Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)?

Rivaroxaban Dosing for DVT and PE

For treatment of acute DVT or PE, rivaroxaban should be initiated at 15 mg orally twice daily with food for the first 21 days, followed by 20 mg once daily with food for maintenance therapy. 1, 2, 3

Initial Treatment Phase (Days 1-21)

• Start with 15 mg orally twice daily with food for exactly 21 days 1, 2, 4, 3
• No parenteral anticoagulation (heparin or enoxaparin) is required before starting rivaroxaban, making it a true single-drug regimen 1, 2, 4
• Food administration is critical during this phase as it significantly improves drug absorption and provides stronger anticoagulation when thrombus burden is highest 4
• This higher-intensity dosing during the acute phase was specifically designed to achieve rapid therapeutic anticoagulation comparable to initial parenteral therapy 5, 6

Maintenance Phase (After Day 21)

• Transition to 20 mg once daily with food after completing the 21-day initial treatment 1, 2, 4, 3
• Continue this dose for a minimum of 3 months total treatment duration 2, 4
• The once-daily maintenance dosing improves convenience and adherence compared to twice-daily regimens 2
• Total treatment duration should be determined by underlying VTE risk factors (provoked vs. unprovoked, cancer, thrombophilia) 1, 2

Extended Secondary Prevention (After ≥6 Months)

For patients requiring anticoagulation beyond 6 months:

• Option 1: Continue 20 mg once daily with food for full-intensity anticoagulation 1
• Option 2: Reduce to 10 mg once daily (with or without food) for lower-intensity extended prophylaxis 1, 2
• The reduced 10 mg dose is appropriate only after completing at least 6 months of full-dose therapy, specifically for unprovoked VTE requiring indefinite anticoagulation 2
• Choose between these options based on balancing recurrence risk versus bleeding risk 4

Critical Dosing Distinctions

The VTE treatment dose differs from atrial fibrillation dosing: The maintenance dose for VTE must be 20 mg daily, not the 15 mg daily dose used in some AF studies 1

Special Populations

Cancer-Associated VTE

• Use the same standard dosing regimen: 15 mg twice daily for 21 days, then 20 mg once daily 1, 4
• Rivaroxaban demonstrates similar efficacy to low-molecular-weight heparin with potentially lower major bleeding rates (2% vs 5%) 4

Renal Impairment

• Moderate impairment (CrCl 30-49 mL/min): No dose adjustment required for DVT/PE treatment 4
• Severe impairment (CrCl 15-30 mL/min): Reduce to 15 mg once daily after the initial 21-day period 2
• CrCl <15 mL/min: Avoid rivaroxaban entirely 4

Hepatic Impairment

• Avoid in moderate-to-severe liver disease or hepatic coagulopathy 4

Practical Administration Details

• If dose is missed during twice-daily phase: Take immediately when remembered, can take two 15 mg doses together if needed to maintain schedule 3
• If dose is missed during once-daily phase: Take as soon as remembered on the same day, then resume regular schedule 3
• For patients unable to swallow tablets: Crush and mix with applesauce followed by food, or mix with water for NG/gastric tube administration 3
• No routine coagulation monitoring required, unlike warfarin 1, 4

Common Pitfalls to Avoid

• Do not start with 20 mg once daily from day 1 - this provides inadequate initial anticoagulation intensity 5, 6
• Do not omit food with dosing - bioavailability is significantly reduced without food 4, 3
• Do not use the 10 mg reduced dose before completing 6 months of full-intensity therapy 1, 2
• Do not confuse AF dosing with VTE dosing - they are different regimens 1

Clinical Evidence Supporting This Regimen

The EINSTEIN-DVT and EINSTEIN-PE trials (n=8,281 patients combined) demonstrated that this rivaroxaban dosing regimen was noninferior to enoxaparin/warfarin for preventing recurrent VTE (2.1% vs 1.8-3.0%) with significantly lower major bleeding rates (1.1% vs 2.2%, HR 0.49) 1, 7, 8