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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