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 Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial. warfarin: results from the ROCKET AF trial. Management of major bleeding events in patients treated with rivaroxaban vs. Truven Health Analytics, DOAC Market Data Report. Truven Bleeding Events Report: Commercial, Medicare, & Medicaid Populations. Reversing factor Xa inhibitors–clinical utility of andexanet alfa. Management of factor Xa inhibitor-associated life-threatening major hemorrhage: a retrospective multi-center analysis. Milling TJ Jr, Clark CL, Feronti C, et al. Management of patients on non-vitamin K antagonist oral anticoagulants in the acute care and periprocedural setting: a scientific statement from the American Heart Association. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Steffel J, Verhamme P, Potpara TS, et al. 2020 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Solution Set Oversight Committee. Tomaselli GF, Mahaffey KW, Cuker A, et al. Boston, MA: Alexion Pharmaceuticals, Inc. ANDEXXA ® (coagulation factor Xa (recombinant), inactivated-zhzo).

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