HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BEVYXXA safely and effectively. See full prescribing information for BEVYXXA.
BEVYXXA ® (betrixaban) capsules, for oral use
Initial U.S. Approval: 2017
WARNING: SPINAL/EPIDURAL HEMATOMA SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED 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. (5.2)
INDICATIONS AND USAGE
BEVYXXA is a factor Xa (FXa) inhibitor 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. (1)
Limitations of Use:
Safety and efficacy of BEVYXXA have not been established in patients with prosthetic heart valves because this population has not been studied. (1)
DOSAGE AND ADMINISTRATION
The recommended dose of BEVYXXA is an initial single dose of 160 mg, followed by 80 mg once daily, taken at the same time each day with food. The recommended duration of treatment is 35 to 42 days. (2.1)
Reduce dose for patients with severe renal impairment. (2.2)
Reduce dose for patients on P-glycoprotein (P-gp) inhibitors. (2.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 40 mg and 80 mg (3)
CONTRAINDICATIONS
Active pathological bleeding. (4)
Severe hypersensitivity reaction to betrixaban. (4)
WARNINGS AND PRECAUTIONS
Risk of Bleeding: Can cause serious, potentially fatal bleeding. Promptly eva luate signs and symptoms of blood loss. (5.1)
Severe Renal Impairment: Increased risk of bleeding events; reduce BEVYXXA dose (2.2, 5.3)
Concomitant P-gp Inhibitors: Increased risk of bleeding events; reduce BEVYXXA dose (2.3, 5.4)
ADVERSE REACTIONS
Most common adverse reaction (incidence > 5%) is bleeding. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Portola Pharmaceuticals at 1-866-777-5947 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
P-gp inhibitors increase the blood levels of betrixaban. Reduce BEVYXXA dose. (7.1)
Anticoagulants: Avoid concomitant use. (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: Use only if potential benefit outweighs the potential risk to the mother or fetus (8.1)
Renal Impairment: Reduce dose. (8.6)
Hepatic Impairment: Avoid use (8.7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 6/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SPINAL/EPIDURAL HEMATOMA
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Severe Renal Impairment
2.3 Use with P-gp Inhibitors
2.4 Missed Dose
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Bleeding
5.2 Spinal/Epidural Anesthesia or Puncture
5.3 Use in Patients with Severe Renal Impairment
5.4 Use in Patients on Concomitant P-gp Inhibitors
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Inhibitors of P-gp
7.2 Anticoagulants, Antiplatelets, and Throm |
