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FDA Approves Xarelto (Rivaroxoban)

28-Nov-2011

 

General Information:

Xarelto (rivaroxaban) is a factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation.

Xarelto is specifically indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery.

Xarelto is supplied as a tablet for oral administration. The recommended initial dose is 10 mg taken orally once daily with or without food. The initial dose should be taken at least 6 to 10 hours after surgery once hemostasis has been established. For hip replacement surgery a treatment duration of 35 days is recommended. For knee replacement surgery a treatment duration of 12 days is recommended.

 

Side Effects:

Adverse events associated with the use of Xarelto may include, but are not limited to, the following:

major bleeding events; wound secretion; pruritus

 

Mechanism of Action:

Xarelto (rivaroxaban) is a factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation.

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