An improvement in hemostasis has not been established. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. Indications and Usage for AndexxaĪndexxa is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Ischemic events, including myocardial infarction and ischemic stroke.Arterial and venous thromboembolic events.
Treatment with Andexxa has been associated with serious and life-threatening adverse events, including: ( 5.1)
WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS
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