andexanet alfa
Ondexxya · ATC code V03AB
Also known as: Andeksanet alfa
- Key facts
- Active substance
- andexanet alfa
- Drug class
- Antidote
- ATC code
- V03AB
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Ondexxya 200 mg powder for solution for infusion
- Marketing authorisation holder
- AstraZeneca AB
- Information as of
- 2026-10-28
Key facts
Andexanet alfa is a recombinant antidote to direct factor Xa inhibitors. It is used to reverse apixaban or rivaroxaban in life-threatening or uncontrolled bleeding.
What it is used for
- Adults treated with a direct factor Xa inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding (Ondexxya).
Dosing
- Hospital use only. Intravenous bolus at about 30 mg/min, followed by a continuous infusion for 120 minutes.
- Low dose: 400 mg bolus over 15 minutes, then 4 mg/min for 120 minutes (480 mg). High dose: 800 mg bolus over 30 minutes, then 8 mg/min for 120 minutes (960 mg).
- Apixaban: last dose ≤ 5 mg - low dose; > 5 mg taken < 8 hours before - high dose; ≥ 8 hours - low dose.
- Rivaroxaban: last dose ≤ 10 mg - low dose; > 10 mg taken < 8 hours before - high dose; ≥ 8 hours - low dose.
- If the strength or timing of the last dose is unknown, no dose recommendation is available. After the bleed stops, re-anticoagulation should be considered.
Contraindications
- Hypersensitivity to the active substance or any other ingredient.
- Known allergic reaction to hamster proteins.
Important warnings
- Clinical benefit in morbidity or mortality has not been demonstrated; not suitable for pre-treatment of urgent surgery; use for edoxaban or enoxaparin reversal is not recommended due to lack of data.
- Monitor by clinical parameters (haemostasis, re-bleeding, thromboembolic events), not anti-FXa activity, as commercial assays give erroneously elevated values.
- Thromboembolic events: higher thrombosis risk with the high dose and in patients on rivaroxaban.
- Unresponsiveness to heparin has been reported when used before or during procedures requiring heparinisation.
Side effects
- Healthy volunteers: mostly mild or moderate infusion-related reactions (flushing, feeling hot, cough, dysgeusia, dyspnoea).
- Patients with major bleeding: most frequently pyrexia (8.8%), ischaemic stroke (6.7%) and myocardial infarction (4.6%).
- Uncommon: transient ischaemic attack, cardiac arrest. See the full text for more.
Interactions
- Andexanet alfa may neutralise the anticoagulant effect of heparin; its use as an antidote for heparin or low-molecular-weight heparin has not been evaluated and is not recommended.
Pregnancy and breastfeeding
- No data in pregnant women; not recommended during pregnancy or in women of childbearing potential not using contraception.
- Breast-feeding should be discontinued during treatment.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- OndexxyaAstraZeneca AB · EMEA/H/C/004108
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Ondexxya
- Liechtenstein
- Ondexxya
- Norway
- Ondexxya
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Ondexxya – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/ondexxya-epar-product-information_en.pdf
- Wikidata (CC0): ATC V03AB.
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.