Le document pr\u00e9sente l\u2019\u00e9valuation r\u00e9alis\u00e9e au niveau europ\u00e9en pour le m\u00e9dicament Iasibon, conduite par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments, en vue de l\u2019octroi d\u2019une autorisation de mise sur le march\u00e9 dans l\u2019Union europ\u00e9enne. Iasibon est un m\u00e9dicament g\u00e9n\u00e9rique dont la substance active est l\u2019acide ibandronique, similaire au m\u00e9dicament de r\u00e9f\u00e9rence Bondronat d\u00e9j\u00e0 autoris\u00e9 dans l\u2019UE.<\/p>\n
Iasibon est disponible sous forme de concentr\u00e9 pour solution pour perfusion intraveineuse et de comprim\u00e9s dos\u00e9s \u00e0 50 mg. Il est indiqu\u00e9 pour deux usages principaux : d\u2019une part, en perfusion ou par voie orale, pour pr\u00e9venir les \u00e9v\u00e9nements osseux (fractures et complications osseuses n\u00e9cessitant un traitement) chez les patients atteints d\u2019un cancer du sein avec m\u00e9tastases osseuses ; d\u2019autre part, en perfusion, pour traiter l\u2019hypercalc\u00e9mie d\u2019origine tumorale (taux \u00e9lev\u00e9s de calcium sanguin li\u00e9s \u00e0 un cancer). Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale et le traitement doit \u00eatre initi\u00e9 par un m\u00e9decin exp\u00e9riment\u00e9 dans la prise en charge du cancer.<\/p>\n
Pour la pr\u00e9vention des \u00e9v\u00e9nements osseux, Iasibon peut \u00eatre administr\u00e9 soit par perfusion de 6 mg d\u2019une dur\u00e9e minimale de 15 minutes, renouvel\u00e9e toutes les trois \u00e0 quatre semaines, soit par un comprim\u00e9 pris une fois par jour. La prise orale est soumise \u00e0 des conditions strictes : \u00e0 jeun depuis au moins six heures (nuit) et au moins 30 minutes avant toute prise alimentaire ou boisson, avec un grand verre d\u2019eau plate. Il est pr\u00e9cis\u00e9 qu\u2019en cas d\u2019eau du robinet tr\u00e8s calcaire, une eau faiblement min\u00e9ralis\u00e9e en bouteille doit \u00eatre utilis\u00e9e. Le comprim\u00e9 doit \u00eatre aval\u00e9 en position assise ou debout, sans \u00eatre croqu\u00e9, suc\u00e9 ni \u00e9cras\u00e9, et le patient ne doit pas s\u2019allonger durant l\u2019heure suivant la prise. Pour les patients pr\u00e9sentant une insuffisance r\u00e9nale mod\u00e9r\u00e9e ou s\u00e9v\u00e8re, des adaptations de posologie sont pr\u00e9vues : perfusion \u00e0 dose r\u00e9duite sur une dur\u00e9e d\u2019une heure, ou prise orale espac\u00e9e (tous les deux jours ou une fois par semaine).<\/p>\n
Pour le traitement de l\u2019hypercalc\u00e9mie tumorale, Iasibon est administr\u00e9 par perfusion de 2 ou 4 mg sur deux heures, en fonction de la s\u00e9v\u00e9rit\u00e9 de l\u2019hypercalc\u00e9mie. La normalisation de la calc\u00e9mie est habituellement obtenue en une semaine.<\/p>\n
Sur le plan pharmacologique, l\u2019acide ibandronique appartient \u00e0 la classe des bisphosphonates. Il inhibe l\u2019activit\u00e9 des ost\u00e9oclastes, cellules responsables de la r\u00e9sorption osseuse, ce qui r\u00e9duit la perte de masse osseuse et diminue le risque de fractures chez les patients ayant des m\u00e9tastases osseuses. La limitation de la d\u00e9gradation osseuse contribue \u00e9galement \u00e0 r\u00e9duire la lib\u00e9ration de calcium dans le sang chez les patients atteints de tumeurs, ce qui est pertinent pour le traitement de l\u2019hypercalc\u00e9mie. En tant que g\u00e9n\u00e9rique, le d\u00e9veloppement clinique d\u2019Iasibon a \u00e9t\u00e9 limit\u00e9 \u00e0 la d\u00e9monstration de sa bio\u00e9quivalence par rapport au m\u00e9dicament de r\u00e9f\u00e9rence. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente l\u2019\u00e9valuation r\u00e9alis\u00e9e au niveau europ\u00e9en pour le m\u00e9dicament Iasibon, conduite par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments, en vue de […]<\/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-20893","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\/20893","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=20893"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20893\/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=20893"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20893"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20893"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}