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Safety has not been evaluated in patients with thromboembolic events or disseminated intravascular coagulation within 2 weeks prior to the bleeding event or in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within 7 days prior to the bleeding event. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with andexanet alfa. Monitor patients for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. Thromboembolic and ischemic risks: Arterial and venous thromboembolic events, ischemic events, and cardiac events (including sudden death) were observed within 3 to 30 days postadministration (median time to first event: 7 days).Anti-factor Xa activity returns to placebo levels ~2 hours after completion of bolus or continuous infusion thereafter, anti-factor Xa activity decreases at a rate similar to the clearance of factor Xa inhibitors. Anti-factor Xa activity re-elevation: There is a rapid and substantial decrease in anti-factor Xa activity corresponding to the bolus dose, which is sustained during the continuous infusion.Timing of Factor Xa Inhibitor Last Dose Before Andexanet alfa Initiation High dose: 800 mg IV bolus administered at a rate of ~30 mg/minute, followed within 2 minutes by an IV infusion of 8 mg/minute for up to 120 minutes.Īndexanet alfa Dose Based on Apixaban or Rivaroxaban Dose

Low dose: 400 mg IV bolus administered at a rate of ~30 mg/minute, followed within 2 minutes by an IV infusion of 4 mg/minute for up to 120 minutes. Resume anticoagulant therapy as soon as medically appropriate following treatment. Life-threatening bleeding associated with apixaban or rivaroxaban: Note: Safety and efficacy of >1 dose of andexanet alfa has not been established. Life-threatening bleeding associated with edoxaban or betrixaban (off-label use): IV: 800 mg IV bolus administered at a rate of ~30 mg/minute, followed within 2 minutes by an IV infusion of 8 mg/minute for up to 120 minutes (ACC Baugh 2019 Cuker 2019).

Life-threatening bleeding associated with factor Xa inhibitors: Note: Generally used for life-threatening bleeding or bleeding into a critical organ that is not controlled with maximal supportive measures (eg, activated charcoal, antifibrinolytic agent) (ACC Baugh 2019 Cuker 2019).