FDA approves new drug for prophylaxis of venous thromboembolism- Drug Information Update

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On June, 23, 2017, the U.S. Food and Drug Administration approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

The most common adverse reactions (≥5%) with betrixaban were related to bleeding. Overall, 54% of patients receiving betrixaban experienced at least one adverse reaction compared with 52% taking enoxaparin. The frequency of patients reporting serious adverse reactions was similar between betrixaban (18%) and enoxaparin (17%). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4% and 1.2% for betrixaban and enoxaparin, respectively. The incidence rate for major bleeding episodes was 0.67% and 0.57% for betrixaban and enoxaparin, respectively. 

The recommended dose of betrixaban is an initial single dose of 160 mg starting on day 1, followed by 80 mg once daily taken for 35 to 42 days at the same time each day with food.

For more information, please visit: Bevyxxa.