Janssen Pharmaceuticals announced FDA approval of Xarelto (rivaroxaban) tablets for the prevention of deep vein thrombosis (DVT) that may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. Pivotal data from the Xarelto Phase 3 clinical development program reflected in the approved label showed significantly greater efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin and when comparing extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin, followed by placebo. In these trials, rivaroxaban and enoxaparin demonstrated similar safety profiles including low rates of major bleeding. Xarelto is approved for use at a 10mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery.
Xarelto is an anticoagulant and works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.
For more information call (800) JANSSEN or visit www.xareltohcp.com.