For: Prevention of Venous Thromboembolism
Bevyxxa (betrixaban) is an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized for an acute medical illness. Clinical Information
Gen. Code and Des.
77648 betrixaban maleate ORAL CAPSULE 80 MG
Strength
80 mg
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
20120414 DIRECT FACTOR XA INHIBITORS
Active Ingredients
17304 betrixaban maleate 936539809
Inactive Ingredients
10138 blue dye
2549 gelatin 9000708
915 dextrose 5996101
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 [see Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
BEVYXXA is 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 [see Clinical Studies (14)].
Limitations of Use:
The safety and effectiveness of BEVYXXA have not been established in patients with prosthetic heart valves because this population has not been studied.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
The recommended dose of BEVYXXA is an initial single dose of 160 mg, followed by 80 mg once daily. Daily oral doses should be given at the same time of day with food.
The recommended duration of treatment is 35 to 42 days.
2.2 Severe Renal Impairment
For patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault using actual body weight) the recommended dose of BEVYXXA is an initial single dose of 80 mg followed by 40 mg once daily [see Warnings and Precautions (5.3), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. The recommended duration of treatment is 35 to 42 days.
2.3 Use with P-gp Inhibitors
For patients receiving or starting concomitant P-gp inhibitors the recommended dose of BEVYXXA is an initial single dose of 80 mg followed by 40 mg once daily [see Warnings and Precautions (5.4), Drug Interactions (7.1), Clinical Pharmacology (12.3)]. The recommended duration of treatment is 35 to 42 days.
2.4 Missed Dose
If a dose of BEVYXXA is not taken at the scheduled time, the dose should be taken as soon as possible on the same day. The BEVYXXA dose should not be doubled to make up for a missed dose.
3 DOSAGE FORMS AND STRENGTHS
40 mg and 80 mg capsules
80 mg, size 2 hard gelatin capsules are light grey with 80 printed in black, and have a blue cap with PTLA printed in white.
40 mg, size 4 hard gelatin capsules are light grey with 40 printed in black, and have a light blue cap with PTLA printed in white.
