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Published on 6 July 2011

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Xarelto to prevent DVT approved by FDA

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XARELTO® (rivaroxaban tablets), marketed by Janssen Pharmaceuticals Inc. in the U.S., is the only once-daily, oral anticoagulant with FDA approval for the prevention of deep vein thrombosis (DVT) in patients undergoing surgery for knee or hip replacements.

Annually, over 800,000 Americans have knee or hip replacements, and the surgery holds an increased risk of DVT and pulmonary embolism (PE), which can be life-threatening conditions. As PE can result if a DVT breaks off and travels to the lungs, the American College of Chest Physicians recommend anticoagulants are used post surgery and post discharge for up to 35 days.  However, DVT and PE remain the leading causes of rehospitalisation after these types of surgery.

“The approval of once-daily XARELTO® tablets will provide a new option to help protect patients from developing venous blood clots following knee or hip replacement surgery,” said Louis M. Kwong, M.D., Professor of Orthopedic Surgery at Harbor-UCLA Medical Center and researchers in the clinical trials. “XARELTO® has a proven clinical benefit over one of today’s most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice.”

XARELTO® is approved for use at a 10 mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery.

“Shorter hospital stays following hip and knee replacement surgeries have made the prevention of venous blood clots an outpatient issue, and XARELTO® provides a safe and effective oral treatment option that can be easily transitioned from use in hospital to home,” said Paul Chang, M.D., Vice President, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, Inc. “We’re pleased to make XARELTO® tablets available to physicians to help them better protect their patients from these highly preventable surgical complications.”

Janssen Pharmaceuticals Inc

 



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