Nineteen subjects who were anticoagulated with rivaroxaban had elevated baseline anti-FXa activity levels >300 ng/mL. Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors. The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion. This decrease was sustained through the end of the ANDEXXA continuous infusion. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the ANDEXXA bolus. The time course of anti-FXa activity following ANDEXXA administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients. Re-elevation or Incomplete Reversal of Anti-FXa Activity Safety of ANDEXXA also 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 two weeks prior to the life-threatening bleeding event requiring treatment with ANDEXXA. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA. Monitor patients treated with ANDEXXA for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. Of these 223, 18 subjects (8%) had a thrombotic event and/or ischemic event after resumption.

Of the 352 subjects who received ANDEXXA, 223 received at least one anticoagulation dose within 30 days after treatment. A total of 63 (18%) experienced 88 thromboembolic or ischemic events. Of the 63 subjects who experienced a thrombotic event, the median time to first event was 7 days, and 21 subjects experienced the event within the first three days. The thromboembolic and ischemic risks were assessed in 352 bleeding subjects who received ANDEXXA. SELECT IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS

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