The 10 mg once-daily dose of rivaroxaban (Xarelto) has been approved by the FDA for reducing continued risk for recurrent venous thromboembolism (VTE) after patients complete at least 6 months of initial anticoagulation therapy.
The approval was based on the findings from the EINSTEIN CHOICE study, which assessed patients with VTE who were already treated with 6 to 12 months of initial anticoagulation therapy. Patients then received rivaroxaban 10 mg once daily, rivaroxaban 20 mg once daily, or aspirin 100 mg once daily for up to an additional year of treatment.
Results indicated that rivaroxaban was more efficacious compared with aspirin for reducing the risk of a recurrent event, with 10 mg of rivaroxaban reducing the risk of recurrent VTE by 74% and 20 mg by 66%. Major bleeding rates were also similar to aspirin.
The prescribing information for the drug provides instructions for physicians to begin treatment with twice-daily doses of rivaroxaban 15 mg for the first 21 days following a VTE. The daily dose transitions to rivaroxaban 20 mg on day 22 through at least day 180. The 10 mg once-daily dose can be prescribed after at least 180 days (6 months) for patients at continued risk for deep vein thrombosis and/or pulmonary embolism.
The drug was approved following an FDA Priority Review.
FDA Approves New 10 mg Dosing for XARELTO® (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE) [press release]. Titusville, NJ: Janssen Pharmaceuticals Inc.