Deferasirox Accord est un m\u00e9dicament g\u00e9n\u00e9rique autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement de la surcharge martiale chronique (exc\u00e8s de fer dans l\u2019organisme). Il contient la m\u00eame substance active (d\u00e9f\u00e9rasirox) et agit de la m\u00eame mani\u00e8re que le m\u00e9dicament de r\u00e9f\u00e9rence Exjade d\u00e9j\u00e0 autoris\u00e9 dans l\u2019UE. Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale et le traitement doit \u00eatre initi\u00e9 et suivi par un m\u00e9decin exp\u00e9riment\u00e9 dans la prise en charge de la surcharge en fer.<\/p>\n
Deferasirox Accord est indiqu\u00e9 chez diff\u00e9rents groupes de patients pr\u00e9sentant une surcharge en fer li\u00e9e \u00e0 des transfusions sanguines ou, dans certains cas, \u00e0 une absorption excessive de fer par l\u2019intestin. Il concerne : les patients \u00e0 partir de 6 ans atteints de b\u00eata-thalass\u00e9mie majeure recevant fr\u00e9quemment des transfusions sanguines ; les enfants de 2 \u00e0 5 ans atteints de b\u00eata-thalass\u00e9mie majeure avec transfusions fr\u00e9quentes lorsque la d\u00e9f\u00e9rioxamine (autre ch\u00e9lateur du fer) ne peut pas \u00eatre utilis\u00e9e ou est insuffisante ; les patients \u00e0 partir de 2 ans atteints de b\u00eata-thalass\u00e9mie majeure avec transfusions peu fr\u00e9quentes lorsque la d\u00e9f\u00e9rioxamine ne peut pas \u00eatre utilis\u00e9e ou est insuffisante ; les patients \u00e0 partir de 2 ans souffrant d\u2019autres formes d\u2019an\u00e9mie n\u00e9cessitant des transfusions, lorsque la d\u00e9f\u00e9rioxamine ne peut pas \u00eatre utilis\u00e9e ou est insuffisante. Il est \u00e9galement indiqu\u00e9 chez les patients \u00e0 partir de 10 ans atteints de syndromes thalass\u00e9miques non transfusionnels, lorsque la d\u00e9f\u00e9rioxamine ne peut pas \u00eatre utilis\u00e9e ou est insuffisante ; dans ce dernier cas, la surcharge en fer r\u00e9sulte d\u2019une absorption intestinale excessive et non de transfusions.<\/p>\n
Le m\u00e9dicament est disponible sous forme de comprim\u00e9s pellicul\u00e9s \u00e0 90 mg, 180 mg et 360 mg, \u00e0 prendre une fois par jour, \u00e0 heure fixe. La dose initiale d\u00e9pend du poids du patient, de l\u2019indication pr\u00e9cise et du niveau de surcharge en fer. Elle est ensuite ajust\u00e9e si n\u00e9cessaire tous les 3 \u00e0 6 mois, en fonction des param\u00e8tres de fer dans le sang. La surveillance et l\u2019ajustement de la posologie rel\u00e8vent du m\u00e9decin prescripteur.<\/p>\n
Sur le plan m\u00e9canistique, le d\u00e9f\u00e9rasirox est un ch\u00e9lateur du fer : il se fixe au fer en exc\u00e8s pour former un complexe (ch\u00e9late) \u00e9limin\u00e9 principalement dans les selles, ce qui permet de r\u00e9duire la surcharge martiale et de pr\u00e9venir les l\u00e9sions d\u2019organes (notamment cardiaques et h\u00e9patiques) li\u00e9es \u00e0 l\u2019accumulation de fer.<\/p>\n
Les \u00e9tudes d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 clinique dans les indications autoris\u00e9es ont \u00e9t\u00e9 r\u00e9alis\u00e9es avec le m\u00e9dicament de r\u00e9f\u00e9rence Exjade et n\u2019ont pas \u00e9t\u00e9 r\u00e9p\u00e9t\u00e9es pour Deferasirox Accord, conform\u00e9ment au cadre applicable aux g\u00e9n\u00e9riques. L\u2019entreprise a fourni des donn\u00e9es sur la qualit\u00e9 pharmaceutique du produit et a men\u00e9 une \u00e9tude d\u00e9montrant la bio\u00e9quivalence entre Deferasirox Accord et le m\u00e9dicament de r\u00e9f\u00e9rence, ce qui soutient l\u2019extension de l\u2019offre th\u00e9rapeutique pour la prise en charge de la surcharge en fer dans l\u2019UE. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Deferasirox Accord est un m\u00e9dicament g\u00e9n\u00e9rique autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement de la surcharge martiale chronique (exc\u00e8s de fer dans l\u2019organisme). Il contient la m\u00eame substance active (d\u00e9f\u00e9rasirox) […]<\/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-21590","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\/21590","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=21590"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21590\/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=21590"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21590"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21590"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}