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Factor Xa inhibitor reversal agent Pregnancy: Limited data. Use if life-threatening haemorrhage.

Andexanet Alfa (Ondexxya)

Brand names: Ondexxya

Adult dose

Dose: Low dose: 400 mg IV bolus at 30 mg/min, then 480 mg IV infusion at 4 mg/min over 2 hours; High dose: 800 mg bolus, then 960 mg infusion
Route: IV (bolus then infusion)
Frequency: Single course
Max: High dose (800 mg bolus + 960 mg infusion) for rivaroxaban >10 mg or apixaban >10 mg taken ≤8 hours ago or unknown timing
Reversal of apixaban or rivaroxaban in acute major/life-threatening bleeding. Low dose: apixaban ≤5 mg BD or rivaroxaban ≤10 mg OD taken >8 hours ago. High dose: apixaban >5 mg BD or rivaroxaban >10 mg OD or unknown timing. Not available in all centres — use 4-factor PCC (Beriplex 50 units/kg) as alternative.

Paediatric dose

Route: IV
Frequency: Not established in children
Max: Not established
Not established in children. Contact haematology specialist.

Dose adjustments

Renal

No dose adjustment required.

Hepatic

No dose adjustment required.

Clinical pearls

  • Only licensed for Factor Xa inhibitor reversal (apixaban, rivaroxaban)
  • ANNEXA-4 trial: haemostatic efficacy 82%
  • Expensive and not universally available — 4-factor PCC (50 units/kg) used in most UK centres
  • Thrombosis risk after reversal: restart anticoagulation as soon as clinically safe
  • Does not reverse dabigatran — use idarucizumab for dabigatran reversal

Contraindications

  • Hypersensitivity to andexanet alfa

Side effects

  • Thromboembolic events (high risk — underlying condition unprotected after reversal)
  • Infusion-related reactions
  • Pneumonia

Interactions

  • No significant drug interactions

Monitoring

  • Anti-Xa levels
  • Clinical haemostasis
  • Thromboembolism

Reference: BNFc; BNF; NICE NG196; ANNEXA-4 trial; Ondexxya SPC. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.