Medication Monitor



Generic Name (Trade Name—Company)
Notes
July 1, 2011

Rivaroxaban

(Xarelto—Bayer, Janssen Pharmaceuticals)
First oral factor Xa inhibitor approved for DVT prophylaxis

Uses:

Prophylaxis of deep vein thrombosis (DVT) that may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery

This novel oral anticoagulant is a factor Xa inhibitor that is dosed as 10 mg once daily for 35 days following hip replacement surgery and for 12 days following knee replacement surgery. According to a company press release, approval was based on results from the RECORD 1, 2, and 3 studies, which compared rivaroxaban 10 mg/d with enoxaparin 40 mg/d for DVT prophylaxis following knee or hip replacement surgery. In all studies, use of rivaroxaban was associated with significantly fewer venous thromboembolic events compared with enoxaparin (P < 0.001 all 3 studies). The incidences of major bleeding and any bleeding events were low in both groups and occurred at a similar rate.