Company: Portola Pharmaceuticals
Approval Status: Approved June 2017
Specific Treatments: the prophylaxis of venous thromboembolism
Therapeutic Areas Cardiology/Vascular Diseases
Bevyxxa (betrixaban) is a factor Xa (FXa) inhibitor.
Bevyxxa is specifically indicated 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.
Bevyxxa is supplied as a capsule for oral administration. The recommended dose is an initial single 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. Reduce dose for patients with severe renal impairment. Reduce dose for patients on P-glycoprotein (P-gp) inhibitors.
The FDA approval of Bevyxxa was based on APEX, a randomized, double-blind, multinational study comparing extended duration Bevyxxa to short duration of enoxaparin in the prevention of venous thromboembolic events (VTE) in an acutely medically ill hospitalized population with risk factors for VTE. Oral betrixaban for 35 to 42 days was compared with injectable enoxaparin for 6 to 14 days followed by placebo. Bevyxxa efficacy was measured in the modified Intent-to-Treat (mITT) analysis, which includes 7,441 patients assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal DVT or symptomatic DVT, non-fatal PE or VTE-related death. Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4 percent vs. 6.0 percent) with no significant increase in major bleeding (0.67 percent vs. 0.57 percent). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4 percent and 1.2 percent for betrixaban and enoxaparin, respectively.
Adverse effects associated with the use of Bevyxxa may include, but are not limited to, the following:
The Bevyxxa label comes with the following Black Box Warning:
Epidural or spinal hematomas may occur in patients treated with betrixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. The risk of these events may be increased by the use of in-dwelling epidural catheters or the concomitant use of medical products affecting hemostasis. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
Mechanism of Action
Bevyxxa (betrixaban) is a factor Xa (FXa) inhibitor. It selectively blocks the active site of FXa and does not require a cofactor (such as Anti-thrombin III) for activity. Betrixaban inhibits free FXa and prothrombinase activity. By directly inhibiting FXa, betrixaban decreases thrombin generation (TG). Betrixaban has no direct effect on platelet aggregation.
For additional information regarding Bevyxxa or 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, please visit http://www.bevyxxa.com/