FDA Approves Lower Dose of Rivaroxaban for Recurrent VTE

The U.S. Food and Drug Administration approved 10 mg once-daily dosing for rivaroxaban to prevent recurrent venous thromboembolism (VTE) after at least six months of initial anticoagulation therapy. Physicians should continue to start patients on rivaroxaban 15 mg twice-daily for the first 21 days after a VTE event, then change the dose to 20 mg once-daily on days 22 through 180, and then decrease the daily dose to 10 mg at six months.

The decision was based on data from the EINSTEIN CHOICE trial, which found that treatment with rivaroxaban led to a lower risk of recurrent VTE, compared to aspirin, with similar rates of major bleeding. The study evaluated patients with VTE who were already treated with six to 12 months of initial anticoagulation therapy and then received rivaroxaban 10 mg once-daily, rivaroxaban 20 mg once-daily, or aspirin 100 mg once-daily for as long as 12 months. Patients taking either rivaroxaban dose had significantly fewer recurrent VTE episodes, compared with those taking aspirin: Rivaroxaban 10 mg reduced the risk of recurrent VTE by 74 percent, and rivaroxaban 20 mg reduced it by 66 percent. All three treatment groups had low rates of major bleeding (0.4% with rivaroxaban 10 mg, 0.5% with rivaroxaban 20 mg, and 0.3% with aspirin).

Source: Janssen Pharmaceuticals press release, October 30, 2017.