They also had safety concerns given the in vitro effects and clinical thrombosis rates of up to 18% in early studies. The FDA clinical reviewers had concerns about the short half-life of Andexxa and the lack of correlation of in vitro activity with clinical efficacy. Understand US Food and Drug Administration Concerns This off target effect can cause acceleration of the generation of FXa and thrombin which could promote thrombosis.

Andexxa also binds and inhibits tissue factor pathway inhibitor (TFPI). Because of the short duration of action, anti-FXa activity starts to resume to baseline after the 2-hour infusion and goes back to the baseline by 4 hours after drug initiation. The half-life of Andexxa is far shorter than the FXa inhibitors.

It has been shown in vitro to rapidly reduce anti-FXa activity. In this article, we discuss key aspects to consider when evaluating Andexxa for formulary addition.Īndexxa is a modified form of human Factor Xa which works by acting as a decoy that binds to factor Xa (FXa) inhibitors. Furthermore, the off-label use and FDA concerns, conflicting society recommendations, and financial impact add another challenging layer to this evaluation. The ANNEXA-4 study and clinical trials with prothrombin complex concentrate (PCC) also have their limitations. Currently, there are no studies comparing the safety and efficacy of Andexxa to the current standard of care. The recent publication of ANEXXA-4 and the wider availability for Andexxa in 2019 has led many hospital Pharmacy and Therapeutics (P&T) committees to discuss whether Andexxa should be added to formulary. In May 2018, Andexxa (coagulation factor Xa, inactivated-zhzo or formerly andexanet alfa) received accelerated approval from the Food and Drug Administration (FDA) as a specific reversal for rivaroxaban- and apixaban-treated patients with life-threatening or uncontrolled bleeding despite not establishing improvement in hemostasis.

Ethics Curriculum for Neurocritical Care Fellowship.

Neurocritical Care Research Network (NCRN).

Neurocritical Care Research Central (NCRC).

Andexxa drug