Betrixaban

Betrixaban is used to prevent venous thromboembolism in patients hospitalized for acute medical illness at risk for thromboembolic complications.

Betrixaban is available under the following different brand names: Bevyxxa.

Dosages of Betrixaban:

Adult and Pediatric Dosage Forms and Strengths

Capsule

• 40mg
• 80mg

Dosage Considerations – Should be Given as Follows:

Venous Thromboembolism Prevention

• Patients hospitalized for acute medical illness at risk for thromboembolic complications
• Moderate or severe restricted mobility and other risk factors for VTE: 160 mg orally once initially, then 80 mg once daily
• Recommended duration of treatment: 35-42 days

Dosage Modifications

Coadministration with P-gp inhibitors

• An initial single dose of 80 mg, then 40 mg orally once daily for 35-42 days
• Patients taking P-gp inhibitor who also have severe renal impairment: Not recommended

Renal impairment

• Mild-to-moderate (CrCl greater than 30 mL/minute): No dose adjustment is needed
• Severe (CrCl 15 or greater to less than 30 mL/minute): Initial single dose of 80 mg, then 40 mg orally once daily for 35-42 days

Hepatic impairment

• Mild: No dose adjustment required
• Moderate-to-severe: Avoid use; these patients may have intrinsic coagulation abnormalities

Dosing Considerations

Limitations of use

• Safety and efficacy not established for patients with prosthetic heart valves (not studied)
• Safety and efficacy not established in pediatric patients

Common side effects of betrixaban include:

• Clinically relevant nonmajor bleeding
• Nosebleed
• Blood in urine
• Major bleeding
• Gastrointestinal bleeding
• Intracranial hemorrhage (rare)
• Fatal bleeding (rare)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of betrixaban include:
  • apixaban
  • rivaroxaban
• Serious interactions of betrixaban include:
  • edoxaban
  • erdafitinib
  • fondaparinux
  • lasmiditan
• Betrixaban has moderate interactions with at least 136 different drugs.
• Betrixaban has no listed mild interactions with other drugs.

Warnings

This medication contains betrixaban. Do not take Bevyxxa if you are allergic to betrixaban or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Black Box Warnings

Spinal/epidural hematoma

• Epidural or spinal hematomas may occur in patients who are receiving neuraxial anesthesia or undergoing spinal puncture
• These hematomas may result in long-term or permanent paralysis
• Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of legs, bowel, or bladder); if neurological compromise is noted, urgent treatment is necessary
• Consider the benefits and risks before neuraxial intervention in patients who are anticoagulated or to be anticoagulated
• Management
  • Do not remove an epidural catheter earlier than 72 hours after the last administration of betrixaban
  • Do not administer the next betrixaban dose earlier than 5 hours after catheter removal
  • If traumatic puncture occurs, delay administering betrixaban for 72 hours

• Factors that can increase the risk include
  • Use of indwelling epidural catheters
  • Concomitant use of other drugs that affect hemostasis (e.g., NSAIDs, platelet inhibitors, other anticoagulants)
  • History of traumatic or repeated epidural or spinal punctures
  • History of spinal deformity or spinal surgery
  • Optimal timing between the administration of drug and neuraxial procedures is not known

Contraindications

• Active pathological bleeding
• Severe hypersensitivity

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Betrixaban?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Betrixaban?"

Cautions

• Increases bleeding risk and can cause serious and potentially fatal bleeding; promptly evaluate any signs or symptoms of blood loss; there is no established way to reverse betrixaban’s anticoagulant effect, which can persist for at least 72 hours after the last dose; protamine, vitamin K, and tranexamic acid are not expected to reverse betrixaban anticoagulant activity
• Risk of paralysis with neuraxial anesthesia
• Increased bleeding risk with severe renal impairment)

Drug interaction overview

• P-gp substrate
• Reduce betrixaban dose if coadministration with P-gp inhibitors, owing to increased bleeding risk; avoid coadministration in patients with severe renal impairment receiving concomitant P-gp inhibitors
• Avoid coadministration with P-gp inducers owing to potential for decreased systemic exposure and pharmacodynamic effects of betrixaban
• Coadministration with drugs affecting hemostasis increases bleeding risk; examples include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, Selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs), and nonsteroidal anti-inflammatory drugs (NSAIDs)

Pregnancy and Lactation

No data exist with betrixaban use in pregnant women, but treatment is likely to increase risk of hemorrhage during pregnancy and delivery. Use betrixaban during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

It is unknown if betrixaban is distributed in human breast milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for betrixaban, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.