Both studies evaluated the percent change in anti-FXa activity, from baseline to nadir, for the low-dose and high-dose regimens of bolus followed by continuous infusion.

The approval of Andexxa was based on two phase 3 studies (Study 1 ANNEXA-A Study 2 ANNEXA-R), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of rivaroxaban and apixaban in healthy participants. Use an alternative anticoagulant to heparin if anticoagulation is needed. Prior to heparinization, avoid use of Andexxa for the reversal of direct FXa inhibitors (apixaban and rivaroxaban). Using Andexxa as an antidote for heparin has not been established. May interfere with the anticoagulant effect of heparin. Use of Heparin Following Administration of Andexxa

Approximately 2 hours after completion of bolus or continuous infusion, anti-FXa activity returned to the placebo levels. There was a rapid and substantial decrease in anti-FXa activity corresponding to the Andexxa bolus from baseline, and this was sustained through the end of the continuous infusion. The time course of anti-FXa activity following Andexxa administration was consistent among healthy volunteer studies and the ANNEXA-4 study in bleeding patients. Re-elevation or Incomplete Reversal of Anti-FXa Activity The safety of Andexxa has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event. The safety of Andexxa has not been evaluated in patients who experienced thromboembolic events or disseminated intravascular coagulation within 2 weeks prior to the life-threatening bleeding event requiring treatment with Andexxa. Monitor for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest.įollowing treatment with Andexxa, resume anticoagulant therapy as soon as possible to reduce thromboembolic risk. Part of the Search for a drug monograph: GO

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