Generic Name and Formulations:
Betrixaban 40mg, 80mg; caps.
Indications for BEVYXXA:
Prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who are at risk for thromboembolic complications.
Limitations Of use:
Safety and efficacy not established in patients with prosthetic heart valves.
Take with food. Initially 160mg as a single dose, followed by 80mg once daily for 35–42 days. Severe renal impairment (CrCl ≥15–<30mL/min) or concomitant P-gp inhibitors: initially 80mg as a single dose, followed by 40mg once daily for 35–42 days.
Active pathological bleeding.
Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture (see full labeling); monitor for signs/symptoms of neurological impairment. Increased risk of bleeding; monitor for signs/symptoms of blood loss; discontinue if active pathological hemorrhage occurs. Severe renal impairment: reduce Bevyxxa dose (see Adult); monitor closely and evaluate any signs/symptoms of blood loss. Hepatic impairment: not recommended. Labor & delivery. Pregnancy: risk of pregnancy-related hemorrhage. Nursing mothers.
Increased risk of bleeding with concomitant aspirin, antiplatelets, anticoagulants, heparin, thrombolytics, SSRIs, SNRIs, and NSAIDs. Potentiated by P-gp inhibitors (eg, amiodarone, azithromycin, verapamil, ketoconazole, clarithromycin): reduce Bevyxxa dose (see Adult); monitor closely and evaluate any signs/symptoms of blood loss. Severe renal impairment (CrCl ≥15–<30mL/min): do not use Bevyxxa if receiving concomitant P-gp inhibitor.
Factor Xa inhibitor.
Bleeding events (may be serious or fatal), urinary tract infection, constipation, hypokalemia, hypertension, headache, nausea, diarrhea, hypersensitivity reactions.