Betrixaban (Bevyxxa)

An oral direct factor Xa inhibitor approved for:

1) Extended VTE prophylaxis (35-42 days) in adults hospitalized for acute medical illness, using the following dosing strategies:

• 160mg x1 dose,  then 80mg daily for 35-42 days in patients with CrCl > 30 ml/min
• 80mg x1 dose, then 40mg daily for 35-42 days patients with CrCl 15-30 ml/min or taking concomitant P-gp inhibitors

Relevant Clinical Trials

Cohen AT, Harrington RA, Goldhaber SZ, et al for APEX Investigators. Extended thromboprophylaxis with betrixaban in acutely ill medical patients. N Engl J Med 2016; 375:534-44.

Therapeutic monitoring

Betrixaban is not intended to be monitored using routine coagulation testing. Its fixed dosing is not intended to be adjusted on the basis of any coagulation laboratory parameter. As a result of FXa inhibition, betrixaban prolongs clotting tests such as prothrombin time (PT)/ INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of betrixaban

Suggestions for Reversal and Management of Bleeding

There is NO REVERSAL AGENT OR ANTIDOTE for betrixaban. Very limited data are available to guide management of bleeding. 

Mild Bleeding

  • Delay next dose or discontinue therapy

Moderate to Severe Bleeding

  • Symptomatic treatment
  • Mechanical compression 
  • Surgical intervention
  • Fluid replacement and hemodynamic support
  • Blood product transfusion
  • Oral charcoal may block the continued absorption from the gut 
  • NOTE: Not dialyzable

Life Threatening Bleeding

  • Measures above
  • Last resort: PCC - Kcentra