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FDA Approves Bevyxxa for Prophylaxis of VTE

FDA news release; 2017 Jun 23

The FDA has approved Bevyxxa (betrixaban) for the prophylaxis of venous thromboembolism (VTE) in adult patients. The drug is manufactured by Portola Pharmaceuticals, Inc. (San Francisco, CA).

Indications: Bevyxxa (betrixaban) is approved 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 morbidity and other risk factors for VTE.

Dosage/administration: Recommended dose is an initial dose of 160 mg, followed by 80 mg once daily, taken at the same time each day with food. The recommended duration of treatment is 35 to 42 days.

Adverse reactions: The most common adverse reaction (>5%) is bleeding.

Citation:

US Food and Drug Administration. FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients. FDA Web site. Updated June 23, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564422.htm. Accessed June 29, 2017.

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