A Tertiary Care Center’s Experience with Andexanet Alfa for Reversal of Factor Xa Inhibitor Associated Intracranial Hemorrhage (P3.9-008)

Objective: Describe a case series of patients reversed with andexanet alfa for factor Xa (FXa) inhibitor associated intracranial hemorrhage. Background: Andexanet alfa (ANDEXXA®, Portola pharmaceuticals) was recently FDA approved as a temporary reversal agent for rivaroxaban or apixaban due to life-threatening or uncontrolled bleeding. Andexanet alfa received US Orphan Drug and FDA Breakthrough Therapy designation through an accelerated approval pathway. This approval was based on interim data from an ongoing multicenter, prospective, single-group, open label study, ANNEXA-4. Our institution obtained a limited early supply of andexanet alfa in June 2018. We report our clinical experience using andexanet alfa in eight patients with Fxa inhibitor associated intracranial hemorrhage. Design/Methods: A case series of patients who received andexanet alfa for FXa inhibitor associated intracranial hemorrhage at the University of Cincinnati Medical Center from June through October 2018. Results: Eight patients received andexanet alfa for FXa inhibitor associated intracranial hemorrhage (6 male, median age 70, median GCS 14). Four patients presented with subdural hemorrhage, three with intracerebral hemorrhage, and one with subarachnoid hemorrhage. Two patients received prothrombin complex concentrate prior to andexanet alfa. Six patients had “good” or “excellent” hemostasis as defined by ANNEXA-4 criteria. Six thrombotic events in four patients were recorded including, multifocal ischemic stroke, cortical vein thrombosis, pulmonary embolism, superficial venous thrombosis and two myocardial infarctions occurring a median of 3 days post bleed. Four patients were dead at 30 days, two patients were discharged to inpatient rehab, one to nursing facility and one to a long term acute care facility. Conclusions: We present a clinical case series of patients receiving andexanet alfa for intracranial hemorrhage. We encourage other early supply centers to track and publish patient cases. Disclosure: Dr. Smith has nothing to disclose. Dr. Beatty has nothing to disclose. Dr. Keegan has nothing to disclose. Dr. Robinson has nothing to disclose. Dr. walsh has nothing to disclose. Dr. garber has nothing to disclose.