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Rivaroxaban (Xarelto®)

National Drug Monograph

June 2012

VA Pharmacy Benefits Management Services,

Medical Advisory Panel, and VISN Pharmacist Executives

The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. These documents will be updated when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current.

Executive Summary:

▪ Rivaroxaban is an oral, direct factor Xa inhibitor that is FDA approved for the 1) prophylaxis of venous thromboembolism (VTE) in patients undergoing total hip replacement (THR) or total knee replacement (TKR) surgery and 2) prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

▪ VTE prophylaxis dosing: The recommended dose of rivaroxaban is 10 mg orally once daily without regard to food. Treatment should be initiated at least 6-10 hours after surgery and once hemostasis has been established. The recommended duration of treatment is 35 days for THR and 12 days for TKR. Rivaroxaban should be avoided in patients with a CrCl 50 ml/min. A reduced dose of 15 mg orally once daily with the evening meal is recommended for patients with a CrCl of 30-50 ml/min. Patients with a CrCl ................
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