Other studies have shown high rates of mortality in patients with factor Xa inhibitor-related ICH, ranging from 27% in-hospital mortality among patients with intracerebral hemorrhage (also known as an intraparenchymal hemorrhage, a subset of ICH) Citation 10 to 37% 30-day mortality among patients with ICH Citation 3.Īndexanet alfa (coagulation factor Xa inactivated-zhzo) is a specific reversal agent that binds to and sequesters factor Xa inhibitor molecules, thereby rapidly reducing anti-factor Xa activity and restoring endogenous factor Xa activity Citation 11, Citation 12. In a US MarketScan analysis, ICH was associated with substantially higher mortality than any other type of major bleeding and was associated with a high healthcare resource burden, including hospitalization costs of >$45,000 Citation 4.

In the 3-year, prospective ORANGE (ORal ANticoagulant aGEnt-associated bleeding adverse events reporting system) study conducted in the United Kingdom, ICH was a strong predictor of death Citation 9. Real-world studies have shown that in patients with ICH, morbidity, resource utilization, and mortality rates are particularly high. Intracranial hemorrhage (ICH) contributes to considerable healthcare resource use and economic burden. More than 84,000 patients who were treated with factor Xa inhibitors in 2015 were hospitalized in the United States for major bleeding Citation 4, with annualized rates of major bleeding ranging from 1% to 4% Citation 6, Citation 8. Like vitamin K antagonists, these agents, as a class, carry a small risk for major bleeding events, which are associated with considerable morbidity and mortality and result in substantial economic burden Citation 3–7.

Direct oral factor Xa inhibitors, such as apixaban and rivaroxaban, are used for the prevention of ischemic stroke, as well as for the prevention and treatment of venous thromboembolism Citation 1, Citation 2.

Andexxa alfa