Andexanet Alfa for Factor Xa Inhibitor-Associated Intracerebral Hemorrhage: Does a Specific Reversal Agent Justify Its Cost?

Direct oral anticoagulants have been rapidly adopted for the prevention of acute ischemic stroke and the treatment of venous thromboembolism.1 Despite direct oral anticoagulants being associated with less incidence of intracranial hemorrhage (ICH) than vitamin K antagonists, the risk is still present, up to 2% in some observational studies.2 In 2015, the Food and Drug Administration granted accelerated approval to idarucizumab, a monoclonal antibody that binds to dabigatran, a direct thrombin inhibitor, and neutralizes its activity. At that time, factor Xa (fXa) inhibitors (rivaroxaban and apixaban) still did not have a specific reversal agent, and guidelines recommend the off-label use of 4-factor prothrombin complex concentrates (4F-PCCs) to treat patients taking these medications and presenting with major bleeding.3

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