{"id":1838,"date":"2023-02-06T16:21:00","date_gmt":"2023-02-06T15:21:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1838"},"modified":"2024-03-30T16:30:29","modified_gmt":"2024-03-30T15:30:29","slug":"25-liecivo-andexanet-alfa-ondexxya-na-liecbu-zivot-ohrozujuceho-krvacaveho-stavu-alebo-pri-potrebe-okamziteho-neodkladneho-chirurgickeho-vykonu-u-pacientov-uzivajucich-xabany","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/25-liecivo-andexanet-alfa-ondexxya-na-liecbu-zivot-ohrozujuceho-krvacaveho-stavu-alebo-pri-potrebe-okamziteho-neodkladneho-chirurgickeho-vykonu-u-pacientov-uzivajucich-xabany\/","title":{"rendered":"25: Lie\u010divo andexanet alfa (Ondexxya) na lie\u010dbu \u017eivot ohrozuj\u00faceho krv\u00e1cav\u00e9ho stavu alebo pri potrebe okam\u017eit\u00e9ho neodkladn\u00e9ho chirurgick\u00e9ho v\u00fdkonu u pacientov u\u017e\u00edvaj\u00facich xab\u00e1ny"},"content":{"rendered":"<ol class=\"wp-block-list\">\n<li><strong>Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n<p>U pacientov so sklonom k tromb\u00f3ze sa do procesu zr\u00e1\u017eania krvi zasahuje liekmi, ktor\u00e9 obmedzuj\u00fa zhlukovanie trombocytov &#8211; antitrombotikami a liekmi, ktor\u00e9 br\u00e1nia vzniku tromb\u00ednu &#8211; antikoagulanciami. D\u00f4vod, pre\u010do je nutn\u00e9 zasahova\u0165 do procesu zr\u00e1\u017eania krvi je, \u017ee u rizikov\u00fdch pacientov \u010dastej\u0161ie vedie ku krvn\u00fdm zrazenin\u00e1m. D\u00f4sledkom m\u00f4\u017ee by\u0165 nedokrvenie postihnut\u00e9ho tkaniva alebo org\u00e1nu. Ak sa zrazenina vytvor\u00ed v tepne z\u00e1sobuj\u00facej srdce, doch\u00e1dza k srdcov\u00e9mu infarktu, v pr\u00edpade upchatia mozgovej tepny m\u00f4\u017ee by\u0165 v\u00fdsledkom cievna mozgov\u00e1 pr\u00edhoda a rovnako sa zrazenina m\u00f4\u017ee dosta\u0165 a\u017e do p\u013e\u00fac, kde m\u00f4\u017ee sp\u00f4sobi\u0165 p\u013e\u00facnu emb\u00f3liu.<\/p>\n\n\n\n<p>Pou\u017eitie antikoagulant\u00edk (liekov p\u00f4sobiacich proti zr\u00e1\u017eanlivosti krvi, napr. apixab\u00e1n a rivaroxab\u00e1n) je av\u0161ak spojen\u00e9 so zv\u00fd\u0161en\u00fdm rizikom krv\u00e1cania, ke\u010f\u017ee anti-koagula\u010dn\u00e9 lieky obmedzuj\u00fa zhlukovanie trombocytov, \u010do je k\u013e\u00fa\u010dov\u00e9 pri zastaven\u00ed krv\u00e1cania najm\u00e4 v pr\u00edpade \u00farazov, \u010di chirurgick\u00fdch z\u00e1krokov. Krv\u00e1canie u&nbsp;pacientov na anti-koagula\u010dnej lie\u010dbe m\u00f4\u017ee by\u0165 preto \u017eivot ohrozuj\u00face.&nbsp;<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"2\">\n<li><strong>O ak\u00fd liek sa jedn\u00e1?<\/strong><\/li>\n<\/ol>\n\n\n\n<p>Andexanet alfa, \u00fa\u010dinn\u00e1 l\u00e1tka lieku Ondexxya, je prote\u00edn, ktor\u00fd p\u00f4sob\u00ed ako protil\u00e1tka pre \u00fastne pod\u00e1van\u00e9 lieky proti zr\u00e1\u017eanlivosti krvi &#8211; apixab\u00e1n a rivaroxab\u00e1n. V\u00fdsledkom je, \u017ee andexanet alfa neutralizuje \u00fa\u010dinok t\u00fdchto liekov, \u010d\u00edm sa zv\u00fd\u0161i zr\u00e1\u017eanlivos\u0165 krvi.<\/p>\n\n\n\n<p>N\u00e1vrh \u00fahrady za balenie Ondexxya 200 mg pr\u00e1\u0161ok na inf\u00fazny roztok (v balen\u00ed s\u00fa dokopy 4 liekovky) je 14 923,52 \u20ac. Liek je zo svojej podstaty ur\u010den\u00fd na pod\u00e1vanie v\u00fdlu\u010dne v \u00fastavnej zdravotnej starostlivosti.<\/p>\n\n\n\n<p>Ondexxya (andexanet alfa) bola podmiene\u010dne autorizovan\u00e1 Eur\u00f3pskou liekovou agent\u00farou v apr\u00edli 2019.<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"3\">\n<li><strong>Ako sa na andexanet alfa pozeraj\u00fa odborn\u00edci?&nbsp;<\/strong><\/li>\n<\/ol>\n\n\n\n<p>V r\u00e1mci zapojenia odborn\u00edkov bol (21.11.2022) osloven\u00fd hlavn\u00fd odborn\u00edk na anest\u00e9ziol\u00f3giu a intenz\u00edvnu medic\u00ednu na Slovensku. Do hodnotenia sa hlavn\u00fd odborn\u00edk ku d\u0148u publikovania tohto dokumentu nezapojil.<\/p>\n\n\n\n<ol class=\"wp-block-list\" start=\"4\">\n<li><strong>\u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n<p>Dr\u017eite\u013e registr\u00e1cie (AstraZeneca) navrhuje, aby bola lie\u010dba liekom Ondexxya hraden\u00e1 pre dospel\u00fdch pacientov na lie\u010dbu \u017eivot ohrozuj\u00faceho krv\u00e1cav\u00e9ho stavu alebo pri potrebe okam\u017eit\u00e9ho neodkladn\u00e9ho chirurgick\u00e9ho v\u00fdkonu u pacientov u\u017e\u00edvaj\u00facich xab\u00e1ny (apixab\u00e1n a rivaroxab\u00e1n).<\/p>\n\n\n\n<p class=\"has-custom-highlight-background-color has-background\">NIHO odpor\u00fa\u010da <strong>nevyhovie\u0165 <\/strong>\u017eiadosti o kategorizovanie lieku Ondexxya, nako\u013eko je ur\u010den\u00fd na pod\u00e1vanie v \u00fastavnej zdravotnej starostlivosti a\u00a0nejde ani o liek na inovat\u00edvnu lie\u010dbu pod\u013ea \u010dl\u00e1nku 2 kapitoly 1 nariadenia eur\u00f3pskeho parlamentu a rady \u010d. 1394\/2007 z 13. novembra 2007 o liekoch na inovat\u00edvnu lie\u010dbu, \u010d\u00edm nesp\u013a\u0148a z\u00e1konn\u00e9 krit\u00e9ri\u00e1 pre zaradenie do zoznamu kategorizovan\u00fdch liekov.<\/p>","protected":false},"excerpt":{"rendered":"<p>NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Ondexxya, nako\u013eko je ur\u010den\u00fd na pod\u00e1vanie v \u00fastavnej zdravotnej starostlivosti a\u00a0nejde ani o liek na inovat\u00edvnu lie\u010dbu&#8230;<\/p>","protected":false},"author":3,"featured_media":1839,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[87,86],"class_list":["post-1838","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-andexanet-alfa","tag-ondexxya"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1838","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1838"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1838\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1839"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1838"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1838"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1838"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}