Vol 81, Supp. I (2023): Zeszyty Edukacyjne 1/2023
Opinie i stanowiska ekspertów
Published online: 2023-09-27
Stanowisko ekspertów Polskiego Towarzystwa Kardiologicznego dotyczące stosowania andeksanetu alfa w warunkach polskich — interdyscyplinarny protokół
DOI: 10.33963/v.kp.96509
Abstract
Andeksanet alfa (AA) jest rekombinowanym, nieaktywnym analogiem ludzkiego czynnika Xa (FXa), skutecznie odwracającym działanie jego inhibitorów — dostępnych w Polsce rywaroksabanu i apiksabanu. Lek otrzymał rejestrację po opublikowaniu wyników badania ANNEXA-4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXA Inhibitors 4), w którym udowodniono jego skuteczność w przywracaniu hemostazy w zagrażających życiu krwawieniach w grupie pacjentów stosujących te leki przeciwkrzepliwe. Dlatego AA jest obecnie zalecany u pacjentów stosujących terapię apiksabanem lub rywaroksabanem z masywnymi i niemożliwymi do opanowania krwotokami, w tym udarami krwotocznymi i krwawieniami z przewodu pokarmowego. Najodpowiedniejsze do oszacowania stężenia rywaroksabanu i apiksabanu w osoczu, poza jego bezpośrednią oceną, są chromogenne testy anty-Xa specyficzne dla leku. Brak aktywności anty-Xa stwierdzony przy użyciu tych oznaczeń wyklucza istotne klinicznie stężenie inhibitora FXa w osoczu. Dawka AA nie powinna być natomiast modyfikowana na podstawie wyników badań hemostazy. Zależy ona wyłącznie od czasu, jaki upłynął od przyjęcia ostatniej dawki inhibitora FXa, oraz od dawki i rodzaju stosowanego przewlekle leku. Andeksanet alfa podawany jest w postaci bolusa dożylnego a następnie włączony zostaje wlew dożylny leku. Maksymalne odwrócenie aktywności anty-Xa następuje w ciągu 2 minut od zakończenia podawania bolusa, a kontynuowanie ciągłej infuzji dożylnej umożliwia utrzymanie efektu aż do 2 godzin po jego zakończeniu. Ponieważ aktywność leku przeciwkrzepliwego może się pojawić ponownie po zakończeniu wlewu, obecnie nie jest jasne, w jakim momencie po podaniu AA można (ponownie) podać inhibitory FXa lub heparynę.
Keywords: andeksanet alfaantidotumapiksabandoustne antykoagulanty niebędące antagonistami witaminy Kkrwawienierywaroksaban
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