Stephan Moll, MD writes… On June 23, 2017, the FDA approved a 5th new oral anticoagulant for clinical use, Bevyxxa® (= Betrixaban). It is approved to prevent DVT and PE in patients who are significantly immobile during and after hospitalization for an acute medical illness. Full prescribing information: here. FDA details: here.
In the APEX study that led to FDA approval (reference 1), Bevyxxa® was given for 5-6 weeks during and after hospitalization to patients with acute medical illnesses (heart failure, respiratory failure, infectious disease, rheumatic disease, or stroke) who had reduced mobility and were at high risk for VTE. It was compared to 10 +/- 4 days of Enoxaparin at prophylactic dose. Fewer VTE (composite of asymptomatic proximal DVT and symptomatic VTE) occurred in the patients treated with Bevyxxa®, without a higher rate of major bleeding.
Consequences for my Practice
Bevyxxa® has not been studied in patients who have a DVT or PE and should not be used in such patients. However, it can be considered for 5-6 weeks for significantly immobile patients who are at high risk for a blood clot during and after a hospital admission for a severe acute medical illness. As a hematologist, I am not much involved in the medical care of these patients. The health care professionals who need to judge whether their elderly, sick patients who are discharged from the hospital should be on this drug are probably mostly hospitalists, congestive heart failure services, and those MDs who take care of these medically sick patients in the specific health care system the MD practices in. Similarly, it is those MDs (with input from pharmacists and discharge planners) who should be involved in institutional algorithm/guideline development as to which patients are to be prescribed this treatment.
- Cohen AT et al. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. APEX Investigators. N Engl J Med. 2016 Aug 11;375(6):534-44.
Disclosure: Dr. Moll has consulted for Portola, Janssen, and Boehringer-Ingelheim.
Last updated: July 6th, 2017