Andexanet alfa

Administration

  • Type: factor Xa inhibitor reversal, antidote
  • Dosage Forms: solution reconstituted, 100 mg per vial
  • Routes of Administration: IV
  • Common Trade Names: Andexxa

Adult Dosing

Determined by last dose, type of factor Xa inhibitor, and dose of inhibitor

  • Last dose >8 hours ago
    • Low dose
  • Last dose <8 hours or unknown
    • Apixaban
      • <5 mg: Low dose
      • >5 mg/unknown: High dose
    • Rivaroxaban
      • <10 mg: Low dose
      • >10 mg/unknown: High dose

Low Dose

400 mg IV bolus at rate of ~30 mg/minute, followed 2 minutes later by 4 mg/minute for up to 120 minutes

High Dose

800 mg IV bolus at rate of ~30 mg/minute, followed 2 minutes later by 8 mg/minute for up to 120 minutes

Special Populations

Pregnancy Rating

  • not known

Lactation risk

  • not known

Renal Dosing

  • None

Hepatic Dosing

  • None

Contraindications

  • Allergy to class/drug

Adverse Reactions

Serious

  • Arterial and venous thromboembolism
    • DVT (6%)
    • Ischemic stroke (5%)
    • Myocardial infarction (3%)
    • Pulmonary embolism (3%)
  • Acute Respiratory failure (1%)
  • Cardiac arrest
  • Sudden death

Common

  • Infusion site reaction
  • UTI (5%)
  • Pneumonia (5%)

Pharmacology

  • Half-life: 5 to 7 hours

Mechanism of Action

  • Binds and sequesters factor Xa inhibitors
  • Inhibits the activity of the Tissue Factor Pathway Inhibitor (TFPI), increasing tissue factor-initiated thrombin generation

Comments

  • FDA approved in May 2018, limited availability June 2018 with broader commercial launch in early 2019
  • Cost, $3,300 per 100 mg vial

See Also

References

  • Lu, G., DeGuzman, F. R., Hollenbach, S. J., Karbarz, M. J., Abe, K., Lee, G., … Sinha, U. (2013). A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nature Medicine, 19(4), 446–451.
  • Andexxa (andexanet alfa) [prescribing information]. South San Francisco, CA: Portola Pharmaceuticals, Inc; May 2018

Authors:

Matthew Rosen