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37360711000001100

Refrigerated Storage

OndexxyaAlexion Pharma UK Ltd

Alexion Pharma UK Ltd
Ondexxya
200 mg powder for solution for infusion

Contact Alexion Pharma UK Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

7 October 2021

New Medicines

OndexxyaAnticoagulation reversal - antidote to edoxaban

Information

Ondexxya
Licence extension / variation
Portola Pharmaceuticals
Portola Pharmaceuticals

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Factor Xa inhibitor antidote. First-in-class recombinant, modified Factor Xa molecule that directly reverses the effects of Factor Xa inhibitors.
It has been estimated that around 1-4% of pts treated with Factor Xa inhibitors may experience major bleeding and 1% may require emergency surgery. Development of a specific antidote designed to reverse the anticoagulant activity of Factor Xa inhibitors may provide an important treatment option for pts who experience a major bleeding event or require emergency surgery [10].
Anticoagulation reversal - antidote to edoxaban
Intravenous