What is the recommended dose of Xarelto (Rivaroxaban) for a patient with acute proximal Deep Vein Thrombosis (DVT) and normal renal function?

Rivaroxaban Dosing for Acute Proximal DVT with Normal Renal Function

For patients with acute proximal DVT and normal renal function, rivaroxaban should be administered at 15 mg twice daily with food for the first 21 days, followed by 20 mg once daily with food for the remainder of the treatment period. 1, 2, 3

Initial Treatment Phase

• The initial intensive treatment phase consists of 15 mg twice daily with food for 21 days
• This higher initial dosing regimen is designed to provide intensive anticoagulation during the acute phase when the thrombus burden and risk of extension are highest
• Taking rivaroxaban with food is essential as it increases bioavailability by approximately 39% for the 15 mg and 20 mg tablets 2
• Doses should be taken approximately 12 hours apart during the initial phase

Maintenance Phase

• After 21 days, transition to 20 mg once daily with food
• This maintenance dose provides continued protection against recurrent VTE while balancing efficacy and bleeding risk
• The once-daily dosing in the maintenance phase improves convenience and adherence

Important Clinical Considerations

Administration Requirements

• Must be taken with food to ensure optimal absorption 1, 2, 3
• For patients who cannot swallow tablets whole, the tablet can be crushed and mixed with applesauce followed by food 3
• If a dose is missed during the twice-daily phase, the patient should take it immediately to ensure the intake of 30 mg total daily dose 3

Monitoring

• No routine coagulation monitoring is required 2
• Baseline testing should include CBC, renal and hepatic function tests, aPTT, and PT/INR before initiating therapy 2
• Follow-up testing should include hemoglobin, hematocrit, and platelet count at regular intervals 2

Treatment Duration

• For provoked DVT: minimum 3 months of treatment 2
• For unprovoked DVT or persistent risk factors: extended treatment may be necessary 1, 2
• After completing 6 months of initial therapy, patients continuing on extended therapy can either remain on 20 mg once daily or transition to 10 mg once daily for long-term prevention 1, 2

Contraindications and Precautions

• Avoid in patients with severe renal impairment (CrCl <15 mL/min) 2
• Avoid in hepatic disease associated with coagulopathy 2
• Use caution with drugs that are strong inhibitors of both CYP3A4 and P-glycoprotein 2

Clinical Evidence Supporting This Regimen

This dosing regimen is supported by high-quality evidence from clinical trials, including the EINSTEIN DVT and PE studies, which demonstrated that rivaroxaban was as effective as standard therapy (enoxaparin followed by vitamin K antagonist) for the treatment of DVT, with a similar or better safety profile 4.

The pharmacokinetic profile of rivaroxaban shows that:

• Maximum plasma concentrations are reached 2-4 hours after tablet intake 5
• Oral bioavailability is high (80-100%) for the 15 mg and 20 mg tablets when taken with food 5
• Terminal half-life is 5-9 hours in healthy young subjects 5

This two-phase dosing regimen (intensive initial treatment followed by maintenance dosing) has been specifically designed to address the higher risk of thrombus extension and embolization in the acute phase while providing convenient long-term protection.