Ondexxya (andexanet alfa)

Description

What is Ondexxya (andexanet alfa) for?

Ondexxya (andexanet alfa), is a Factor Xa inhibitor reversal agent indicated for patients treated with rivaroxaban and apixaban, when rapid reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.^[1]

It is available in lyophilized powder form in single-use vials of 200 mg or 100 mg of andexanet alfa.^[1]

How does Ondexxya (andexanet alfa) work?

Factor Xa (FXa) inhibitors such as apixaban and rivaroxaban are widely used in the clinic to prevent and to treat thromboembolism. Thromboembolism is obstruction in vessels due to formation of blood clots. FXa is a protein that helps blood clot, and its inhibitors are used to have an anticoagulant (blood-thinning) effect. However, a complication of treatment with these anticoagulants is major bleeding.^[2]

Ondexxya (andexanet alfa) is a recombinant protein that has been designed to bind to FXa inhibitors. It works by binding and sequestering FXa inhibitors, making them unable to promote anticoagulation. Hereby it is able to rapidly reverse their blood-thinning effect, and to stop bleeding.^[2]

Where has Ondexxya (andexanet alfa) been approved?

Ondexxya (andexanet alfa) was approved for the reversal of the anticoagulating effects of rivaroxaban and apixaban in patients with life-threatening or uncontrolled bleeding by:

• The European Medicines Agency (EMA), Europe, on April 26, 2019.^[3]
• The Food and Drug Administration (FDA), USA, with accelerated approval under the brand name Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) on May 3, 2018.^[4]

This is the first and only approved antidote for apixaban- or rivaroxaban-treated patients with uncontrolled bleeding.^[3]

The EMA granted approval under conditional marketing authorisation, to support the development of and early access to medicines that address unmet medical needs of patients in the European Union.^[3]

The FDA granted Andexxa with Orphan Drug and Breakthrough Therapy designations, to support the development of medicines which treat a serious or life-threatening condition and fill an unmet medical need.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Ondexxya (andexanet alfa) taken?

The standard dosage is:^[1]

• • Low dose:
    • 400 mg, administered as an intravenous bolus at a target rate of 30 mg/min.
    • Followed by administration of a continuous infusion of 4 mg/min for up to 120 minutes (480 mg).
  • High dose:
    • 800 mg, administered as an intravenous bolus at a target rate of 30 mg/min.
    • Followed by administration of a continuous infusion of 8 mg/min for 120 minutes (960 mg).

The recommended dosing of Ondexxya is based on the specific FXa inhibitor (apaxiban or rivaroxaban), dose and time since the patient last took the FXa inhibitor.^[1]

Patients being treated with (oral) anticoagulation drugs have underlying disease states which puts them at increased risk of developing thromboembolism. Treating patients with a reversal agent such as Ondexxya increases their thrombotic risk. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.^[1]

Complete information about Ondexxya (andexanet alfa) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Ondexxya?

Common adverse reactions

The most common adverse reactions (≥5% of patients) listed in the prescribing information include:^[1]

• • • Urinary tract infections
    • Pneumonia

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• • • Arterial and venous thromboembolic events
    • Ischemic events, including myocardial infarction and ischemic stroke
    • Cardiac arrest
    • Sudden deaths

Use in a specific population

It is not yet known if Ondexxya affects an unborn baby. The manufacturer makes no recommendation regarding use during pregnancy.^[1]