Le document pr\u00e9sente le contenu principal du rapport public d\u2019\u00e9valuation europ\u00e9en (EPAR) consacr\u00e9 \u00e0 Febuxostat Viatris (anciennement Febuxostat Mylan), \u00e9labor\u00e9 par l\u2019Agence europ\u00e9enne des m\u00e9dicaments dans le cadre de la proc\u00e9dure d\u2019autorisation de mise sur le march\u00e9 dans l\u2019Union europ\u00e9enne et de d\u00e9finition des conditions d\u2019utilisation. Il s\u2019agit d\u2019un m\u00e9dicament g\u00e9n\u00e9rique ayant pour sp\u00e9cialit\u00e9 de r\u00e9f\u00e9rence Adenuric, contenant la m\u00eame substance active, le f\u00e9buxostat, et agissant selon le m\u00eame m\u00e9canisme.<\/p>\n
Febuxostat Viatris est destin\u00e9 au traitement chez l\u2019adulte de l\u2019hyperuric\u00e9mie chronique (taux \u00e9lev\u00e9s d\u2019acide urique dans le sang) lorsque celle\u2011ci s\u2019accompagne de d\u00e9p\u00f4ts de cristaux d\u2019urate, se traduisant notamment par la goutte (arthrite goutteuse, tophi). Il est \u00e9galement indiqu\u00e9 pour traiter et pr\u00e9venir l\u2019hyperuric\u00e9mie chez des adultes atteints de cancers h\u00e9matologiques recevant une chimioth\u00e9rapie et expos\u00e9s au risque de syndrome de lyse tumorale, complication associ\u00e9e \u00e0 une \u00e9l\u00e9vation brutale de l\u2019uric\u00e9mie pouvant entra\u00eener des atteintes r\u00e9nales.<\/p>\n
Le m\u00e9dicament est disponible sous forme de comprim\u00e9s dos\u00e9s \u00e0 80 mg et 120 mg, d\u00e9livr\u00e9s uniquement sur prescription m\u00e9dicale. Pour l\u2019hyperuric\u00e9mie chronique, la posologie recommand\u00e9e est de 80 mg une fois par jour, avec possibilit\u00e9 d\u2019augmentation \u00e0 120 mg une fois par jour si l\u2019uric\u00e9mie reste sup\u00e9rieure \u00e0 6 mg\/dl apr\u00e8s deux \u00e0 quatre semaines. Des crises de goutte peuvent survenir durant les premiers mois de traitement ; il est alors recommand\u00e9 d\u2019associer, pendant au moins six mois, un autre traitement de pr\u00e9vention des crises sans interrompre Febuxostat Viatris en cas de pouss\u00e9e. Pour la pr\u00e9vention et le traitement de l\u2019hyperuric\u00e9mie li\u00e9e \u00e0 la chimioth\u00e9rapie dans les cancers h\u00e9matologiques, la dose recommand\u00e9e est de 120 mg une fois par jour, en d\u00e9butant le traitement deux jours avant la chimioth\u00e9rapie et en le poursuivant pendant au moins sept jours.<\/p>\n
Sur le plan pharmacologique, le f\u00e9buxostat agit par inhibition de la xanthine oxydase, enzyme n\u00e9cessaire \u00e0 la production d\u2019acide urique dans l\u2019organisme, ce qui permet de diminuer et de maintenir \u00e0 un niveau bas l\u2019uric\u00e9mie afin de limiter la formation et l\u2019accumulation de cristaux d\u2019urate et de r\u00e9duire les manifestations cliniques de la goutte. Le document renvoie les patients aux informations pratiques contenues dans la notice et \u00e0 la consultation du m\u00e9decin ou du pharmacien pour les modalit\u00e9s concr\u00e8tes d\u2019utilisation. L\u2019ensemble des \u00e9l\u00e9ments pr\u00e9sent\u00e9s s\u2019inscrit dans le cadre de la r\u00e9gulation europ\u00e9enne des m\u00e9dicaments et illustre la disponibilit\u00e9 d\u2019un g\u00e9n\u00e9rique pour une indication de longue dur\u00e9e \u00e0 fort enjeu de morbidit\u00e9 (goutte, complications r\u00e9nales, syndromes de lyse tumorale) dans plusieurs \u00c9tats membres de l\u2019UE. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente le contenu principal du rapport public d\u2019\u00e9valuation europ\u00e9en (EPAR) consacr\u00e9 \u00e0 Febuxostat Viatris (anciennement Febuxostat Mylan), \u00e9labor\u00e9 par l\u2019Agence europ\u00e9enne des m\u00e9dicaments dans le cadre de la […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-21457","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21457","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21457"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21457\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21457"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21457"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21457"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}