bolytics
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
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.
4 CONTRAINDICATIONS
BEVYXXA is contraindicated in patients with:
Active pathological bleeding [see WARNINGS AND PRECAUTIONS (5.1) and ADVERSE REACTIONS (6.1)]
Severe hypersensitivity reaction to betrixaban [see ADVERSE REACTIONS (6.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Bleeding
BEVYXXA increases the risk of bleeding and can cause serious and potentially fatal bleeding. Promptly eva luate any signs or symptoms of blood loss [see ADVERSE REACTIONS (6.1)].
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs) [see DRUG INTERACTIONS (7.2)].
Advise patients of signs and symptoms of blood loss and to report them immed |
