Thromboembolic disorders:
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.
Adult Dosage:
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.
Children Dosage:
Not established.
BEVYXXA Contraindications:
Active pathological bleeding.
Boxed Warning:
Spinal/epidural hematoma.
BEVYXXA Warnings/Precautions:
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. Moderate and severe hepatic impairment or hepatic disease associated with coagulopathy: not recommended. Labor & delivery. Pregnancy: risk of pregnancy-related hemorrhage. Nursing mothers.
BEVYXXA Classification:
Factor Xa inhibitor.
BEVYXXA Interactions:
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. Antagonized by P-gp inducers (eg, carbamazepine, phenytoin, rifampin, St. John's wort); avoid Bevyxxa use. Severe renal impairment (CrCl ≥15–<30mL/min): avoid Bevyxxa if receiving concomitant P-gp inhibitors.
Adverse Reactions:
Bleeding events (may be serious or fatal), urinary tract infection, constipation, hypokalemia, hypertension, headache, nausea, diarrhea, hypersensitivity reactions.
Generic Drug Availability:
NO
How Supplied:
Caps—100
