{"id":16548,"date":"2026-05-21T11:49:18","date_gmt":"2026-05-21T09:49:18","guid":{"rendered":"https:\/\/www.czech-neuro.cz\/?p=16548"},"modified":"2026-05-21T11:50:31","modified_gmt":"2026-05-21T09:50:31","slug":"dulezite-bezpecnostni-informace-tykajici-se-cenobamatu","status":"publish","type":"post","link":"https:\/\/www.czech-neuro.cz\/aktualita\/dulezite-bezpecnostni-informace-tykajici-se-cenobamatu\/","title":{"rendered":"Ontozry (cenobam\u00e1t): Nov\u00e9 po\u017eadavky na monitorov\u00e1n\u00ed funkce jater v&nbsp;souvislosti s&nbsp;hl\u00e1\u0161en\u00edmi z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater"},"content":{"rendered":"<p><span style=\"color: #cc0000; font-size: 18pt;\"><strong>CAVE!<\/strong><\/span><\/p>\n<p><span style=\"color: #126da3; font-size: 14pt;\"><strong>Informa\u010dn\u00ed dopis pro zdravotnick\u00e9 pracovn\u00edky<\/strong><\/span><br \/>\n12.&nbsp;kv\u011btna 2026<\/p>\n<p><strong>Ontozry (cenobam\u00e1t): Nov\u00e9 po\u017eadavky na monitorov\u00e1n\u00ed funkce jater v&nbsp;souvislosti s&nbsp;hl\u00e1\u0161en\u00edmi z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater<\/strong><\/p>\n<p>V\u00e1\u017een\u00e1 pan\u00ed doktorko, v\u00e1\u017een\u00fd pane doktore,<\/p>\n<p>spole\u010dnost <strong>Angelini Pharma \u010cesk\u00e1 republika s.r.o<\/strong>. ve spolupr\u00e1ci se St\u00e1tn\u00edm \u00fastavem pro kontrolu l\u00e9\u010div a&nbsp;Evropskou agenturou pro l\u00e9\u010div\u00e9 p\u0159\u00edpravky by V\u00e1s r\u00e1da informovala o&nbsp;n\u00e1sleduj\u00edc\u00edm:<\/p>\n<p><strong>Shrnut\u00ed problematiky<\/strong><\/p>\n<ul>\n<li><strong>U pacient\u016f l\u00e9\u010den\u00fdch p\u0159\u00edpravkem Ontozry byly hl\u00e1\u0161eny p\u0159\u00edpady z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater v\u010detn\u011b jatern\u00edho selh\u00e1n\u00ed, z&nbsp;nich\u017e mnoh\u00e9 se vyskytly v&nbsp;souvislosti s&nbsp;polyterapi\u00ed s&nbsp;jin\u00fdmi antiepileptiky.<\/strong><\/li>\n<li><strong>P\u0159ed zah\u00e1jen\u00edm l\u00e9\u010dby p\u0159\u00edpravkem Ontozry je nutn\u00e9 vyhodnotit jatern\u00ed testy a&nbsp;b\u011bhem l\u00e9\u010dby funkci jater pravideln\u011b monitorovat.<\/strong><\/li>\n<li><strong>U pacient\u016f se zn\u00e1mkami nebo p\u0159\u00edznaky nazna\u010duj\u00edc\u00edmi po\u0161kozen\u00ed jater m\u00e1 b\u00fdt neprodlen\u011b provedeno klinick\u00e9 vy\u0161et\u0159en\u00ed a&nbsp;vy\u0161et\u0159en\u00ed jatern\u00edch funkc\u00ed.<\/strong><\/li>\n<li><strong>Pacienti maj\u00ed b\u00fdt pou\u010deni, aby okam\u017eit\u011b vyhledali l\u00e9ka\u0159skou pomoc, pokud se u&nbsp;nich vyskytnou zn\u00e1mky nebo p\u0159\u00edznaky nazna\u010duj\u00edc\u00ed po\u0161kozen\u00ed jater.<\/strong><\/li>\n<li><strong>Pokud existuje podez\u0159en\u00ed na po\u0161kozen\u00ed jater nebo je po\u0161kozen\u00ed jater prok\u00e1z\u00e1no, je t\u0159eba zv\u00e1\u017eit sn\u00ed\u017een\u00ed d\u00e1vky p\u0159\u00edpravku Ontozry nebo jeho vysazen<\/strong><\/li>\n<\/ul>\n<p><strong>Dal\u0161\u00ed informace o&nbsp;bezpe\u010dnostn\u00edm riziku a&nbsp;n\u00e1sledn\u00e1 doporu\u010den\u00ed<\/strong><\/p>\n<p>Ontozry je antiepileptikum indikovan\u00e9 k&nbsp;p\u0159\u00eddatn\u00e9 l\u00e9\u010db\u011b fok\u00e1ln\u00edch z\u00e1chvat\u016f se sekund\u00e1rn\u00ed generalizac\u00ed nebo bez n\u00ed u&nbsp;dosp\u011bl\u00fdch pacient\u016f s&nbsp;epilepsi\u00ed bez adekv\u00e1tn\u00ed kontroly navzdory p\u0159edchoz\u00ed l\u00e9\u010db\u011b nejm\u00e9n\u011b 2 antiepileptiky.<\/p>\n<p>P\u0159i l\u00e9\u010db\u011b p\u0159\u00edpravkem Ontozry se zv\u00fd\u0161en\u00e9 hodnoty jatern\u00edch enzym\u016f vyskytuj\u00ed s&nbsp;frekvenc\u00ed \u010dast\u00e9; v&nbsp;souhrnn\u00fdch placebem kontrolovan\u00fdch, dvojit\u011b zaslepen\u00fdch klinick\u00fdch studi\u00edch byly zv\u00fd\u0161en\u00e9 hodnoty ALT a&nbsp;AST hl\u00e1\u0161eny u&nbsp;1,6 %, resp. 1,4&nbsp;% pacient\u016f l\u00e9\u010den\u00fdch p\u0159\u00edpravkem Ontozry, ve srovn\u00e1n\u00ed s&nbsp;0 %, resp. 0,4&nbsp;% v&nbsp;placebo skupin\u011b. Byl patrn\u00fd trend z\u00e1vislosti na d\u00e1vce, p\u0159i\u010dem\u017e u&nbsp;pacient\u016f, kte\u0159\u00ed dost\u00e1vali maxim\u00e1ln\u00ed denn\u00ed d\u00e1vku p\u0159\u00edpravku Ontozry (tj.&nbsp;400 mg), dos\u00e1hlo zv\u00fd\u0161en\u00ed hodnot a\u017e 3,6&nbsp;% pro ALT a&nbsp;2,7&nbsp;% pro AST. P\u0159i&nbsp;hodnocen\u00ed tohoto specifick\u00e9ho bezpe\u010dnostn\u00edho rizika byly zji\u0161t\u011bny 4 p\u0159\u00edpady z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater, kter\u00e9 pravd\u011bpodobn\u011b souvisely s&nbsp;p\u0159\u00edpravkem Ontozry, v\u010detn\u011b jednoho p\u0159\u00edpadu spl\u0148uj\u00edc\u00edho krit\u00e9ria Hyova z\u00e1kona (metoda slou\u017e\u00edc\u00ed k&nbsp;predikci pravd\u011bpodobnosti, \u017ee l\u00e9\u010div\u00fd p\u0159\u00edpravek m\u016f\u017ee vyvolat z\u00e1va\u017en\u00e9 po\u0161kozen\u00ed jater). D\u00e1le bylo zdokumentov\u00e1no 24 p\u0159\u00edpad\u016f, kter\u00e9 byly hodnoceny jako mo\u017en\u00e1 souvisej\u00edc\u00ed s&nbsp;p\u0159\u00edpravkem Ontozry.<\/p>\n<p>V\u011bt\u0161ina hl\u00e1\u0161en\u00ed z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater, kter\u00e1 mohou souviset s&nbsp;p\u0159\u00edpravkem Ontozry, vznikla p\u0159i&nbsp;jeho sou\u010dasn\u00e9m pod\u00e1v\u00e1n\u00ed s&nbsp;jin\u00fdmi antiepileptiky. P\u0159\u00ed\u010diny a&nbsp;mechanismy hepatotoxicity souvisej\u00edc\u00ed s&nbsp;p\u0159\u00edpravkem Ontozry z\u016fst\u00e1vaj\u00ed z&nbsp;velk\u00e9 \u010d\u00e1sti neobjasn\u011bny.<\/p>\n<p>Vzhledem k&nbsp;nov\u011b zji\u0161t\u011bn\u00e9mu riziku z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater je nutn\u00e9 p\u0159ed zah\u00e1jen\u00edm l\u00e9\u010dby p\u0159\u00edpravkem Ontozry zkontrolovat hladiny s\u00e9rov\u00fdch transamin\u00e1z (ALT a&nbsp;AST), gama-glutamyltransfer\u00e1zy (GGT), alkalick\u00e9 fosfat\u00e1zy a&nbsp;celkov\u00e9ho bilirubinu a&nbsp;b\u011bhem l\u00e9\u010dby je monitorovat. U&nbsp;pacient\u016f, kte\u0159\u00ed vykazuj\u00ed zn\u00e1mky nebo p\u0159\u00edznaky sv\u011bd\u010d\u00edc\u00ed pro po\u0161kozen\u00ed jater, jako jsou \u00fanava, anorexie, bolest b\u0159icha v&nbsp;prav\u00e9m horn\u00edm kvadrantu, tmav\u00e1 mo\u010d nebo \u017eloutenka, m\u00e1 b\u00fdt neprodlen\u011b provedeno klinick\u00e9 vy\u0161et\u0159en\u00ed a&nbsp;vy\u0161et\u0159en\u00ed jatern\u00edch funkc\u00ed. Pacienti maj\u00ed b\u00fdt rovn\u011b\u017e pou\u010deni, aby rozpoznali zn\u00e1mky nebo p\u0159\u00edznaky nazna\u010duj\u00edc\u00ed po\u0161kozen\u00ed jater a&nbsp;aby v&nbsp;p\u0159\u00edpad\u011b jejich v\u00fdskytu neprodlen\u011b vyhledali l\u00e9ka\u0159skou pomoc.<\/p>\n<p>Pokud existuje podez\u0159en\u00ed na po\u0161kozen\u00ed jater nebo je po\u0161kozen\u00ed jater prok\u00e1z\u00e1no, je t\u0159eba zv\u00e1\u017eit sn\u00ed\u017een\u00ed d\u00e1vky nebo vysazen\u00ed cenobam\u00e1tu v&nbsp;souladu s&nbsp;doporu\u010den\u00edmi uveden\u00fdmi v&nbsp;souhrnu \u00fadaj\u016f o&nbsp;p\u0159\u00edpravku (tj.&nbsp;vyhnout se n\u00e1hl\u00e9mu vysazen\u00ed, pokud to nen\u00ed nezbytn\u00e9, aby se minimalizovalo riziko opakovan\u00e9ho v\u00fdskytu z\u00e1chvat\u016f, tzv.&nbsp;rebound fenom\u00e9nu).<\/p>\n<p>Informace o&nbsp;p\u0159\u00edpravku Ontozry budou aktualizov\u00e1ny v&nbsp;souladu s&nbsp;t\u011bmito nov\u00fdmi bezpe\u010dnostn\u00edmi informacemi. To zahrnuje upraven\u00e9 upozorn\u011bn\u00ed odr\u00e1\u017eej\u00edc\u00ed v\u00fd\u0161e uveden\u00e1 doporu\u010den\u00ed a&nbsp;d\u00e1le je dopln\u011bno po\u0161kozen\u00ed jater jako ne\u017e\u00e1douc\u00ed \u00fa\u010dinek s&nbsp;frekvenc\u00ed vz\u00e1cn\u00e9 (m\u016f\u017ee se vyskytnout a\u017e u&nbsp;1 z&nbsp;1&nbsp;000 pacient\u016f).<\/p>\n<p><strong>Hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f<\/strong><\/p>\n<p><em>Tento l\u00e9\u010div\u00fd p\u0159\u00edpravek podl\u00e9h\u00e1 dal\u0161\u00edmu sledov\u00e1n\u00ed. To umo\u017en\u00ed rychl\u00e9 z\u00edsk\u00e1n\u00ed nov\u00fdch informac\u00ed o&nbsp;bezpe\u010dnosti. \u017d\u00e1d\u00e1me zdravotnick\u00e9 pracovn\u00edky, aby hl\u00e1sili jak\u00e1koli podez\u0159en\u00ed na ne\u017e\u00e1douc\u00ed \u00fa\u010dinky.<\/em><\/p>\n<p>Jak\u00e9koli podez\u0159en\u00ed na z\u00e1va\u017en\u00fd nebo neo\u010dek\u00e1van\u00fd ne\u017e\u00e1douc\u00ed \u00fa\u010dinek a&nbsp;jin\u00e9 skute\u010dnosti z\u00e1va\u017en\u00e9 pro zdrav\u00ed l\u00e9\u010den\u00fdch osob mus\u00ed b\u00fdt hl\u00e1\u0161eno St\u00e1tn\u00edmu \u00fastavu pro kontrolu l\u00e9\u010div.<\/p>\n<p>Hl\u00e1\u0161en\u00ed je mo\u017en\u00e9 zas\u00edlat pomoc\u00ed ti\u0161t\u011bn\u00e9ho nebo elektronick\u00e9ho formul\u00e1\u0159e dostupn\u00e9ho na webov\u00fdch str\u00e1nk\u00e1ch S\u00daKL.<\/p>\n<p>Podrobnosti o&nbsp;hl\u00e1\u0161en\u00ed najdete na: <a href=\"http:\/\/sukl.gov.cz\/nezadouciucinky\" target=\"_blank\" rel=\"noopener\">sukl.gov.cz\/nezadouciucinky<\/a><\/p>\n<p>Adresa pro zas\u00edl\u00e1n\u00ed je St\u00e1tn\u00ed \u00fastav pro kontrolu l\u00e9\u010div, odbor farmakovigilance, \u0160rob\u00e1rova 49\/48, Praha 10, 100&nbsp;00, email: <a href=\"mailto:farmakovigilance@sukl.gov.cz\" target=\"_blank\" rel=\"noopener\">farmakovigilance@sukl.gov.cz<\/a><\/p>\n<p><strong>Kontaktn\u00ed \u00fadaje na dr\u017eitele rozhodnut\u00ed o&nbsp;registraci<\/strong><\/p>\n<p>S p\u0159\u00edpadn\u00fdmi dal\u0161\u00edmi dotazy se pros\u00edm obracejte na z\u00e1stupce dr\u017eitele rozhodnut\u00ed o&nbsp;registraci.<\/p>\n<p><em><strong>Angelini Pharma \u010cesk\u00e1 republika s.r.o.<\/strong><\/em><br \/>\n<em>Palachovo n\u00e1m\u011bst\u00ed 799\/5, Star\u00fd L\u00edskovec, 625&nbsp;00 Brno \u010cesk\u00e1 republika<\/em><br \/>\n<em>Telefonn\u00ed linka 24\/7: (+420) 737&nbsp;227&nbsp;993<\/em><br \/>\n<em>E-mail: <a href=\"mailto:farmakovig@angelini.cz\" target=\"_blank\" rel=\"noopener\">farmakovig@angelini.cz<\/a>\u00a0<\/em><br \/>\n<em><a href=\"http:\/\/www.angelinipharma.cz\" target=\"_blank\" rel=\"noopener\">www.angelinipharma.cz\u00a0<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CAVE! Informa\u010dn\u00ed dopis pro zdravotnick\u00e9 pracovn\u00edky 12.&nbsp;kv\u011btna 2026 Ontozry (cenobam\u00e1t): Nov\u00e9 po\u017eadavky na monitorov\u00e1n\u00ed funkce jater v&nbsp;souvislosti s&nbsp;hl\u00e1\u0161en\u00edmi z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed&#8230;<\/p>\n","protected":false},"author":23,"featured_media":16549,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_searchwp_excluded":"","kia_subtitle":""},"categories":[1],"tags":[],"class_list":["post-16548","post","type-post","status-publish","has-post-thumbnail","hentry","category-nezarazene"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.2 (Yoast SEO v26.2) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Ontozry (cenobam\u00e1t): Nov\u00e9 po\u017eadavky na monitorov\u00e1n\u00ed funkce jater v souvislosti s hl\u00e1\u0161en\u00edmi z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater - \u010cesk\u00e1 neurologick\u00e1 spole\u010dnost<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.czech-neuro.cz\/aktualita\/dulezite-bezpecnostni-informace-tykajici-se-cenobamatu\/\" \/>\n<meta property=\"og:locale\" content=\"cs_CZ\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ontozry (cenobam\u00e1t): Nov\u00e9 po\u017eadavky na monitorov\u00e1n\u00ed funkce jater v souvislosti s hl\u00e1\u0161en\u00edmi z\u00e1va\u017en\u00e9ho po\u0161kozen\u00ed jater\" \/>\n<meta property=\"og:description\" content=\"CAVE! 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