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FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
Date:7/1/2011

s from these highly preventable surgical complications."

About XARELTO® (rivaroxaban tablets)

XARELTO® is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. XARELTO® belongs to a group of medicines called anticoagulants. It works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots. XARELTO® is the third New Drug Application the U.S. FDA has approved from the Janssen Pharmaceutical Companies this year.

Additionally, XARELTO® is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. The extensive program of clinical trials evaluating rivaroxaban makes the compound the most studied oral, Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare.

Important Safety Information

WHAT IS XARELTO®?

XARELTO® (rivaroxaban tablets) is a prescription medicine used to help prevent blood clots from forming in patients after hip or knee replacement surgery.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

  • You should take XARELTO® exactly as directed by your doctor
  • Do not skip a dose or stop taking XARELTO® unless you are advised to do so by your doctor. Stopping may increase your risk of a blood clot
  • If a dose is missed, take XARELTO® as soon as possible and continue on the following day, taking XARELTO® as directed by your doctor. Do not take two doses at the same time
  • XARELTO® can cause b
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SOURCE Janssen Pharmaceuticals, Inc.
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