{"id":21534,"date":"2026-10-20T09:22:45","date_gmt":"2026-10-20T09:22:45","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21534"},"modified":"2026-10-20T09:22:45","modified_gmt":"2026-10-20T09:22:45","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-arikayce-liposomal-amikacine-date-dautorisation-27-10-2020-revision-6-statut-autorise","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21534","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Arikayce liposomal, amikacine, Date d\u2019autorisation : 27\/10\/2020, R\u00e9vision : 6, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Arikayce liposomal est un antibiotique destin\u00e9 au traitement chez l\u2019adulte des infections pulmonaires dues au complexe Mycobacterium avium (MAC), bact\u00e9ries environnementales pr\u00e9sentes notamment dans le sol et l\u2019eau. Il est indiqu\u00e9 pour des patients sans mucoviscidose ayant des options th\u00e9rapeutiques limit\u00e9es. Le m\u00e9dicament a obtenu le statut de \u00ab m\u00e9dicament orphelin \u00bb le 8 avril 2014, en raison de la raret\u00e9 de cette infection.<\/p>\n<p>Arikayce liposomal contient de l\u2019amikacine, un antibiotique de la classe des aminosides. L\u2019amikacine agit en perturbant la production de prot\u00e9ines n\u00e9cessaires aux bact\u00e9ries, ce qui endommage puis d\u00e9truit celles-ci. Dans cette sp\u00e9cialit\u00e9, l\u2019amikacine est incorpor\u00e9e dans des liposomes (nanoparticules lipidiques), ce qui permet au m\u00e9dicament de rester plus longtemps dans le poumon.<\/p>\n<p>Une \u00e9tude principale men\u00e9e aupr\u00e8s de 336 patients a montr\u00e9 une efficacit\u00e9 mod\u00e9r\u00e9e d\u2019Arikayce liposomal pour obtenir une n\u00e9gativation des cultures de MAC. Apr\u00e8s 6 mois de traitement, 29 % des patients recevant le traitement standard associ\u00e9 \u00e0 Arikayce liposomal avaient des pr\u00e9l\u00e8vements respiratoires n\u00e9gatifs, contre 9 % des patients recevant uniquement le traitement standard. Parmi les patients ayant obtenu une clairance de l\u2019infection avec Arikayce liposomal, 55 % restaient n\u00e9gatifs trois mois apr\u00e8s l\u2019arr\u00eat du traitement, alors qu\u2019aucun patient sous traitement standard seul n\u2019\u00e9tait n\u00e9gatif trois mois apr\u00e8s l\u2019arr\u00eat.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents concernent les voies respiratoires : dysphonie, toux, dyspn\u00e9e et h\u00e9moptysie touchent plus d\u2019une personne sur dix. D\u2019autres effets ind\u00e9sirables fr\u00e9quents sont des douleurs buccales ou pharyng\u00e9es, une fatigue, des diarrh\u00e9es, une aggravation des bronchectasies infect\u00e9es, des naus\u00e9es et des bronchospasmes. Des effets ind\u00e9sirables importants, en particulier au cours des premiers mois de traitement, ont conduit l\u2019Agence \u00e0 recommander de limiter l\u2019utilisation d\u2019Arikayce liposomal aux patients ayant peu d\u2019alternatives th\u00e9rapeutiques.<\/p>\n<p>Le m\u00e9dicament ne doit pas \u00eatre utilis\u00e9 chez les patients pr\u00e9sentant une hypersensibilit\u00e9 au soja, \u00e0 un aminoside ou \u00e0 l\u2019un des composants du produit. Il est contre-indiqu\u00e9 en association avec un autre aminoside et chez les patients ayant une insuffisance r\u00e9nale s\u00e9v\u00e8re. L\u2019ensemble des effets ind\u00e9sirables figure dans la notice du m\u00e9dicament. Ces \u00e9l\u00e9ments pr\u00e9sentent un int\u00e9r\u00eat pour le suivi des politiques de prise en charge des maladies rares infectieuses et pour l\u2019\u00e9valuation du rapport b\u00e9n\u00e9fice\/risque des traitements innovants par voies respiratoires. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/arikayce-liposomal\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Arikayce liposomal est un antibiotique destin\u00e9 au traitement chez l\u2019adulte des infections pulmonaires dues au complexe Mycobacterium avium (MAC), bact\u00e9ries environnementales pr\u00e9sentes notamment dans le sol et l\u2019eau. Il est [&hellip;]<\/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-21534","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\/21534","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=21534"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21534\/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=21534"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21534"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21534"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}