Betrixaban Approved as Oral VTE Preventive

FDA and Portola Pharmaceuticals today announced the approval of betrixaban oral capsules to reduce the risk of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who have restricted mobility or other risk factors for thromboembolic complications.

Betrixaban will be available between August and November 2017 under the brand name Bevyxxa, according to the company.

The labeling for betrixaban describes the drug as a factor Xa inhibitor that blocks its target site without the need for a cofactor. Treatment with betrixaban decreases thrombin generation and does not directly affect platelet aggregation.

The labeling includes an FDA-required Medication Guide to inform patients that the drug may cause serious bleeding, especially in people who have severe kidney problems or use medications in addition to betrixaban that increase the risk of bleeding.

The Medication Guide and a boxed warning in the labeling also state that patients who take betrixaban and undergo spinal puncture or neuraxial anesthesia procedures are at increased risk for epidural and spinal hematomas, which can cause long-term or permanent paralysis.

Betrixaban is contraindicated in patients with active pathological bleeding.

The labeling recommends an initial 160-mg dose of betrixaban taken with food. On subsequent days, patients should receive 80 mg of the drug once daily with food and at the same time of day. Treatment should continue for a total of 35-42 days.

In patients who have severe kidney impairment or take a P-glycoprotein inhibitor, the recommended initial dose of betrixaban, a substrate of P-glycoprotein, is 80 mg followed by 40-mg daily doses afterward to reduce the risk of serious bleeding.

Concomitant use of betrixaban and anticoagulants, antiplatelet drugs, and thrombolytics may increase the risk of bleeding.

Betrixaban’s anticoagulant effect lasts for at least 72 hours after the most recent dose is administered, and there is no established way to reverse the drug’s activity, according to the labeling.

Bleeding-related problems were the most frequently reported adverse events in the clinical study that supported FDA’s approval of betrixaban.

Betrixaban will be supplied as 40- and 80-mg capsules in bottles of 100 each that should be stored at room temperature.