In this article, we discuss key aspects to consider when evaluating Andexxa for formulary addition.
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.
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