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
  • Note: Discontinue production in the US - Dec 2025

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

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
  • After accelerated approval, was found by the FDA to have risks outweighing benefits due to increased risk of thrombosis, and the US has since ceased production since Decemeber 2025

See Also

References

FDA

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