The FDA approval of Andexxa was based on data from two Phase III ANNEXA studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy subjects. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients. Andexxa was approved under the FDA's Accelerated Approval pathway.

High Dose: Initial IV Bolus: 800 mg at a target rate of 30 mg/min. Follow-On IV Infusion: 8mg/min for up to 120 minutes. Administer as an intravenous (IV) bolus, with a target rate of 30 mg/min, followed by continuous infusion for up to 120 minutes.There are two dosing regimens: Low Dose: Initial IV Bolus: 400 mg at a target rate of 30 mg/min 4 mg/min for up to 120 minutes. Follow-On IV Infusion: 4mg/min for up to 120 minutes. Dose Andexxa based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient’s last dose of FXa inhibitor. As a result, the native Factor Xa is available to participate in the coagulation process and restore hemostasis (normal clotting).Īndexxa is specifically indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.Īndexxa is supplied as a lyophilized powder for solution for intravenous injection.

Adexxa (andexanet alfa) works by acting as a decoy for Factor Xa inhibitors in the blood, thereby preventing them from inhibiting the activity of native Factor Xa.

Andexxa availability