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Andexxa (Andexanet Alfa)

Andexxa (andexanet alfa) binds to anti-Xa inhibitors like apixaban and rivoraxaban to temporarily reverse their anticoagulant effects.

 

Andexxa (andexanet alfa) binds to anti-Xa inhibitors like apixaban and rivoraxaban to temporarily reverse their anticoagulant effects. Andexxa was granted accelerated approval to meet an unmet healthcare need, raising questions because of the single-arm trial, high-medication cost, and unknown benefit compared to standard of care at the time, KCentra (4F-PCC)


I’ve listed the dosing recommendations per the package insert above, which is based on timing and strength of last dose. Per AHA/ACC guidelines, Andexxa has a weak recommendation over KCentra for ICH, if available.


ANEXXA-4 was the landmark trial that included 249 evaluated patients. Excellent or good hemostasis was seen in 82% of patients with 14% dying and 10% having a thrombotic event within 30 days. Anti-Xa activity was reduced, but was not associated with hemostatis efficacy.


Retrospective and meta-analysis lean towards KCentra appearing to have similiar hemostatic efficacy and lower reported rates of thrombotic events. Additionally, lower median GCS were reported in KCentra groups compared to ANEXXA-4, meaning they were more likely to have worse outcomes. Laboratory markers, such as anti-xa activity and thrombin generation, show in-vivo benefit without clinical application. ANEXXA-S is another single-arm ANDEXXA trial specifically in surgical patients, but was terminated early due to severe adverse events. I’d appreciate if you hit the like button, share teh #PHARMFAX with a friend, and I hope you learned something new.


Recommended Read/Watch


KCentra (4F-PCC) - https://www.instagram.com/p/Cq83EnQAIHc/


Protamine and UFH - https://www.instagram.com/p/CqvN_EKAkuL/


Mannitol vs HTS - https://www.instagram.com/p/Cp73wwoAFzp/


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