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-NOW APPROVED-

Introducing the first and only oral anticoagulant indicated for 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

Please see Important Safety Information, including boxed WARNING, and Full Prescribing Information.

For US Health Care Professionals Only

VIEW THE CLINICAL TRIAL ABSTRACT

Results from the phase 3 pivotal trial were published in the American Heart Journal

American Heart Journal Logo

"The safety and efficacy of full- versus reduced-dose betrixaban in the Acute Medically Ill VTE (Venous Thromboembolism) Prevention With Extended-Duration Betrixaban (APEX) trial"

For US Health Care Professionals Only

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Indication and Important Safety Information for Bevyxxa (betrixaban)

INDICATION

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.

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.

SELECT IMPORTANT SAFETY INFORMATION

WARNING: SPINAL/EPIDURAL HEMATOMA
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.

CONTRAINDICATIONS

  • Active pathological bleeding
  • Severe hypersensitivity reaction to BEVYXXA

WARNINGS AND PRECAUTIONS

Risk of Bleeding

  • BEVYXXA increases the risk of bleeding and can cause serious and potentially fatal bleeding.
  • 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).
  • Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room.
  • Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.
  • Discontinue BEVYXXA in patients with active pathological bleeding.
  • There is no established way to reverse the anticoagulant effect of BEVYXXA, which can be expected to persist for at least 72 hours after the last dose.

Spinal/Epidural Anesthesia or Puncture

  • When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis.
  • An epidural catheter should not be removed earlier than 72 hours after the last administration of BEVYXXA. The next BEVYXXA dose is not to be administered earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of BEVYXXA for 72 hours.
  • Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel, or bladder dysfunction). If neurological compromise is noted, urgent diagnosis and treatment is necessary.

Use in Patients with Severe Renal Impairment

  • Patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault) taking BEVYXXA may have an increased risk of bleeding events.
  • Reduce dose of BEVYXXA, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients.

Use in Patients on Concomitant P-glycoprotein (P-gp) Inhibitors

  • Patients on concomitant P-gp inhibitors with BEVYXXA may have an increased risk of bleeding.
  • Reduce dose of BEVYXXA, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients.
  • Avoid use of BEVYXXA in patients with severe renal impairment receiving concomitant P-gp inhibitors.

ADVERSE REACTIONS

  • The most common adverse reactions with BEVYXXA were related to bleeding (> 5%).

USE IN SPECIFIC POPULATIONS

Hepatic Impairment

  • BEVYXXA has not been evaluated in patients with hepatic impairment, because these patients may have intrinsic coagulation abnormalities.
  • BEVYXXA is not recommended in patients with hepatic impairment.

Please see full Prescribing Information and Important Safety Information, including boxed WARNING.

Reference:

1. Bevyxxa [package insert]. South San Francisco, CA: Portola, Inc; 2017.

Click here for complete Important Safety Information for Bevyxxa (betrixaban)

SELECT IMPORTANT SAFETY INFORMATION

WARNING: SPINAL/EPIDURAL HEMATOMA
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.