Betrixaban Maleate

Name: Betrixaban Maleate

Introduction

Betrixaban maleate is a direct factor Xa inhibitor.1

Uses for Betrixaban Maleate

Betrixaban maleate has the following uses:

Betrixaban maleate 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 betrixaban maleate have not been established in patients with prosthetic heart valves because this population has not been studied.1

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

  • P-gp inhibitors increase the blood levels of betrixaban. Reduce betrixaban maleate dose.1

  • Anticoagulants: Avoid concomitant use.1

Advice to Patients

Advise the patient to read the FDA-approved patient labeling (Medication Guide).1

Risk of Bleeding

Advise patients that it might take longer than usual for bleeding to stop, and that they may bruise or bleed more easily when treated with betrixaban maleate. Instruct patients to report any unusual bleeding to their physician. 1

Instruct patients to tell their physicians and dentists that they are taking betrixaban maleate, and/or any other products known to affect bleeding (including nonprescription products, such as aspirin or NSAIDs), before any surgery or medical or dental procedure is scheduled and before any new drug is taken.1

Use in Patients with Severe Renal Impairment

Advise patients that the risk of bleeding is higher in people who have severe kidney problems (severe renal impairment).1

Spinal/Epidural Hematoma

Advise patients having neuraxial anesthesia or spinal puncture to watch for signs and symptoms of spinal or epidural hematomas, such as numbness or weakness of the legs, or bowel or bladder dysfunction. Instruct patients to contact their physician immediately if any of these symptoms occur.1

Pregnancy and Lactation

Advise female patients to inform their physicians if they are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed during treatment with betrixaban maleate.1

How to Take Betrixaban Maleate

Instruct patients to take betrixaban maleate with food, and instruct patients on what to do if a dose is missed.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Betrixaban Maleate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsule, Gelatin Coated

40 mg

Bevyxxa

Portola Pharmaceuticals Inc.

80 mg

Bevyxxa

Portola Pharmaceuticals Inc.

For the Consumer

Applies to betrixaban: oral capsule

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Call your doctor at once if you have:

  • easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);

  • unexpected pain or swelling;

  • any bleeding that will not stop;

  • headache, dizziness, weakness, feeling like you might pass out;

  • urine that looks red, pink, or brown; or

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Bleeding is the most common side effect of betrixaban.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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