Janssen announced that the Food and Drug Administration (FDA) has approved the 10mg dosage strength of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing ≥6 months of initial anticoagulant therapy.
The approval was based on data from EINSTEIN CHOICE, a Phase 3 randomized, double-blind, superiority study (n=3,365) which included patients with VTE already treated with 6–12 months of initial anticoagulation therapy; these patients then received Xarelto 10mg or 20mg once daily or aspirin 100mg once daily for another 12 months. The data showed Xarelto-treated patients had significantly fewer recurrent VTE vs. aspirin-treated patients.[HMICMS
The 10mg dose specifically lowered the risk of recurrent VTE by 74% and the 20mg dose by 66%. Regarding safety, all 3 treatment arms exhibited low rates of major bleeding (Xarelto 10mg: 0.4%, Xarelto 20mg: 0.5%, aspirin: 0.3%).
The Xarelto prescribing information recommends initiating treatment with 15mg twice daily for the first 21 days after a VTE occurrence. For Days 22 through at least 180, the dose should be decreased to 20mg once daily. Then after at least 180 days, patients at continued risk for deep vein thrombosis (DVT) and/or pulmonary embolism (PE) can be prescribed 10mg once daily.
Xarelto, a factor Xa inhibitor, is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to treat DVT and PE; to reduce the risk of recurrence of DVT, PE following 6 months treatment for DVT, PE; and as prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
For more information call (800) 526-7736 or visit Xarelto.com.