Andexanet Alfa: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Andexanet Alfa. Educational only — not medical advice.

Labeled uses

ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14) ] . An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.

Source: FDA labeling via NIH DailyMed (set 2d9d90a6…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.

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