FDA Approves Rivaroxaban 10 mg for Recurrent VTE

The 10 mg dose of rivaroxaban substantially lowered the risk for recurrent venous thromboembolism.

The US Food and Drug Administration (FDA) has approved the 10 mg dosage strength of rivaroxaban (Xarleto; Janssen Pharmaceuticals) to reduce the continued risk for recurrent venous thromboembolism (VTE) after completing at least 6 months of initial anticoagulant therapy. 

The approval was based on data from EINSTEIN CHOICE, a phase 3 randomized, double-blind, superiority study (n=3365) which included patients with VTE already treated with 6 to 12 months of initial anticoagulation therapy; these patients then received rivaroxaban 10 mg or 20 mg once daily or aspirin 100 mg once daily for another 12 months. The data showed patients treated with rivaroxaban had significantly fewer recurrent VTE vs patients treated with aspirin.

The 10 mg dose specifically lowered the risk for recurrent VTE by 74% and the 20 mg dose by 66%. Regarding safety, all 3 treatment arms exhibited low rates of major bleeding (rivaroxaban 10 mg: 0.4%, rivaroxaban 20 mg: 0.5%, aspirin: 0.3%).

The rivaroxaban prescribing information recommends initiating treatment with 15 mg twice daily for the first 21 days after a VTE occurrence. For days 22 through at least 180, the dose should be decreased to 20 mg 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 10 mg once daily.

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Rivaroxaban, a factor Xa inhibitor, is approved to reduce the risk for 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.


FDA approves new 10 mg dosing for Xarelto (rivaroxaban) to reduce the continued risk of venous thromboembolism (VTE) [news release]. Titusville, NJ: Janssen Pharmaceuticals, Inc; October 30, 2017. Accessed November 20, 2017.

This article originally appeared on The Cardiology Advisor