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Andexanet alfa for reversing anticoagulation

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2 Information about andexanet alfa

Marketing authorisation indication

2.1 Andexanet alfa (Ondexxya, Portola Pharmaceuticals) has a conditional marketing authorisation for 'adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding'.

Dosage in the marketing authorisation

2.2 There are 2 possible doses for andexanet alfa, depending on the timing of the last dose of apixaban or rivaroxaban:

  • Low dose: 400 mg initial intravenous bolus at a target rate of 30 mg per minute, then 4 mg per minute by intravenous infusion for 120 minutes (480 mg)

  • High dose: 800 mg initial intravenous bolus at a target rate of 30 mg per minute, then 8 mg per minute by intravenous infusion for 120 minutes (960 mg).

2.3 For full details of the dosage schedules, see the summary of product characteristics.

Price

2.4 £11,100 per 4-vial pack of 200 mg of powder for solution for infusion (excluding VAT, BNF online accessed March 2020). The average cost of a course of treatment at list price is £15,000 per patient.