![]() The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ANNEXA-4 Phase III clinical trial showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding. Ondexxya (andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Partnerships, alliances and recognition.You may report side effects to FDA at 1-80. Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur. Pain, swelling, burning, or irritation around the IV needle. Heart attack symptoms-chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.Ĭommon side effects of coagulation factor Xa may include: Signs of a blood clot-sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg or Get emergency medical help if you have any of these symptoms after being treated with Andexxa, especially if you have not started taking anticoagulant medication again: Reversing the effects of anticoagulant medication may increase your risk of a blood clot, heart attack, stroke, or death. Call your doctor at once if you have:Ĭough with mucus, chest pain, and shortness of breath Get emergency medical help if you have signs of an allergic reaction: hives difficult breathing swelling of your face, lips, tongue, or throat.Īndexxa may cause serious side effects. ![]()
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