Approved December 2001
Deep vein thrombosis prophylaxis
Arixtra, an injectable solution for subcutaneous use, has been approved as a preventative treatment for deep vein thrombosis (DVT) in adults undergoing hip fracture, hip replacement, or knee replacement surgery. It is adminstered through a single dose, prefilled syringe, affixed with an automatic needle protection system. Arixtra is the only antithrombotic agent approved in the United States for hip fracture surgery.
DVT is caused by a blood clot forming in a deep vein in the leg. It may cause pain and swelling, and enlargement and discoloration of the veins. The clot can grow in size and block other veins. Most seriously, portions of the clot may break away and travel through the veins to the lungs, leading to a life threatening pulmonary embolism.
International randomized, double-blind phase III trials evaluated the use of Arixtra in more than 7,000 subjects undergoing hip fracture, hip replacement or knee replacement surgeries. Results demonstrated Arixtra to provide a superior benefit in comparison to the reference treatment.
Adverse events associated with the use of Arixtra may include (but are not limited to) the following:
Arixtra (fondaparinux sodium) exhibits antithrombotic activity, which is the result of antithrombin III (ATIII)-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, fondaparinux sodium activates the innate neutralization of Factor Xa by ATIII. This neutralization interupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development.
For additional information on Arixtra, please visit Sanofi-Synthelabo.
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