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  • Ondexxya (andexanet alfa)

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    Description

    Ondexxya, also known as andexanet alfa, is a recombinant coagulation factor Xa (FXa) inhibitor reversal agent. It is used in emergency situations to reverse the effects of direct or indirect FXa inhibitors, such as apixaban (Eliquis) or rivaroxaban (Xarelto), in patients experiencing uncontrolled or life-threatening bleeding. Ondexxya works by neutralizing the action of FXa inhibitors, restoring normal blood clotting processes in the body.

    How Ondexxya Works

    Ondexxya is a modified recombinant version of human factor Xa, which acts as a decoy receptor. FXa inhibitors such as rivaroxaban and apixaban bind to Ondexxya instead of their target endogenous factor Xa, thus allowing natural coagulation to occur again. Ondexxya competes with the FXa inhibitors, reducing their anticoagulant effect and enabling the body to form clots where needed. This is particularly crucial in emergency situations like severe bleeding or when rapid reversal is required for urgent surgeries.

    Indications

    Ondexxya is indicated for the following:
    • Reversal of anticoagulation effects in patients treated with direct or indirect FXa inhibitors (such as apixaban or rivaroxaban) during life-threatening or uncontrolled bleeding.
    • Emergency reversal of anticoagulation before urgent surgical or invasive procedures.

    Side Effects

    Common side effects of Ondexxya include:
    • Infusion-related reactions (e.g., feeling hot, flushing, or sweating)
    • Urinary tract infections
    • Pneumonia
    Serious side effects may include:
    • Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism)
    • Myocardial infarction (heart attack)
    • Ischemic stroke
    • Death due to thrombotic events

    Contraindications

    Ondexxya should be avoided or used with caution in the following conditions:
    • Hypersensitivity: Contraindicated in patients with known hypersensitivity to andexanet alfa or any of its components.
    • Thromboembolic disorders: Patients with a history of thromboembolic events should be carefully monitored, as Ondexxya may increase the risk of clot formation.
    • Recent stroke or heart attack: Caution is advised in patients who have recently had a stroke or heart attack, as the risk of thrombotic complications may be higher.
    • Pregnancy and breastfeeding: The safety of Ondexxya in pregnant or breastfeeding women has not been established, and it should be used only if clearly needed.

    Price of Ondexxya in Different Countries

    The cost of Ondexxya can vary by country and healthcare system. Below is a table showing the price of Ondexxya in different countries, along with links to references:
    Country Price (per treatment) Source
    United States $58,000 – $60,000 for two vials GoodRx
    United Kingdom £45,000 for two vials NHS UK
    Canada CAD 75,000 for two vials DrugBank
    Australia AUD 90,000 for two vials PBS Australia
    Germany €50,000 for two vials Medikamentenpreis

    Top 5 Global Brands Related to FXa Inhibitors and Reversal Agents

    • Ondexxya (Andexanet Alfa) – The primary FXa inhibitor reversal agent used to reverse the effects of direct and indirect FXa inhibitors.
    • Xarelto (Rivaroxaban) – A widely used oral anticoagulant (FXa inhibitor) prescribed for the prevention of blood clots.
    • Eliquis (Apixaban) – Another popular FXa inhibitor for treating and preventing blood clots.
    • Bevyxxa (Betrixaban) – A discontinued FXa inhibitor that was used for extended thromboprophylaxis.
    • Pradaxa (Dabigatran) – While a direct thrombin inhibitor, it is part of the broader category of anticoagulants used to prevent thromboembolic events.
     
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