Medication Monitor

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


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


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.