Le document pr\u00e9sente le contenu principal du rapport europ\u00e9en d\u2019\u00e9valuation publique (EPAR) relatif au m\u00e9dicament Filgrastim Hexal et les recommandations du Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments. Il pr\u00e9cise que l\u2019EPAR comprend, outre ce r\u00e9sum\u00e9, une notice destin\u00e9e aux patients et une discussion scientifique d\u00e9taillant les fondements des avis du CHMP.<\/p>\n
Filgrastim Hexal est une solution injectable ou pour perfusion, en seringue pr\u00e9remplie, contenant du filgrastim (30 ou 48 millions d\u2019unit\u00e9s). Il s\u2019agit d\u2019un m\u00e9dicament biosimilaire, c\u2019est\u2011\u00e0\u2011dire qu\u2019il est similaire \u00e0 un m\u00e9dicament biologique de r\u00e9f\u00e9rence d\u00e9j\u00e0 autoris\u00e9 dans l\u2019Union europ\u00e9enne et contenant la m\u00eame substance active. Le m\u00e9dicament de r\u00e9f\u00e9rence est Neupogen. Filgrastim Hexal est soumis \u00e0 prescription m\u00e9dicale obligatoire.<\/p>\n
Le m\u00e9dicament est indiqu\u00e9 pour stimuler la production de globules blancs (neutrophiles) dans plusieurs situations cliniques : r\u00e9duction de la dur\u00e9e de neutrop\u00e9nie et de la survenue de neutrop\u00e9nie f\u00e9brile chez des patients recevant une chimioth\u00e9rapie cytotoxique ; r\u00e9duction de la dur\u00e9e de neutrop\u00e9nie chez des patients soumis \u00e0 un traitement de destruction m\u00e9dullaire pr\u00e9alable \u00e0 une greffe de moelle osseuse, lorsqu\u2019ils sont expos\u00e9s \u00e0 un risque de neutrop\u00e9nie s\u00e9v\u00e8re et prolong\u00e9e ; augmentation du taux de neutrophiles et r\u00e9duction du risque infectieux chez des patients neutrop\u00e9niques ayant des ant\u00e9c\u00e9dents d\u2019infections graves et r\u00e9p\u00e9t\u00e9es ; traitement de neutrop\u00e9nies persistantes chez des patients pr\u00e9sentant une infection par le VIH \u00e0 un stade avanc\u00e9, afin de r\u00e9duire le risque d\u2019infections bact\u00e9riennes lorsque d\u2019autres traitements ne sont pas appropri\u00e9s. Filgrastim Hexal peut \u00e9galement \u00eatre utilis\u00e9 chez les personnes qui vont donner des cellules souches sanguines en vue d\u2019une greffe, pour favoriser la mobilisation de ces cellules \u00e0 partir de la moelle osseuse.<\/p>\n
L\u2019administration se fait par injection sous\u2011cutan\u00e9e ou par perfusion intraveineuse. Le mode d\u2019administration, la posologie et la dur\u00e9e de traitement d\u00e9pendent de l\u2019indication, du poids corporel du patient et de la r\u00e9ponse au traitement. Le m\u00e9dicament est en g\u00e9n\u00e9ral administr\u00e9 dans un centre sp\u00e9cialis\u00e9, mais une auto\u2011injection sous\u2011cutan\u00e9e est possible apr\u00e8s formation appropri\u00e9e du patient. La notice fournit des informations pratiques compl\u00e9mentaires.<\/p>\n
La substance active, le filgrastim, est tr\u00e8s proche de la prot\u00e9ine humaine \u00ab facteur de stimulation des colonies de granulocytes \u00bb (G\u2011CSF). Elle est produite par technologie ADN recombinant \u00e0 partir d\u2019une bact\u00e9rie g\u00e9n\u00e9tiquement modifi\u00e9e, et agit de la m\u00eame mani\u00e8re que le G\u2011CSF naturel en stimulant la production de neutrophiles. L\u2019ensemble de ces \u00e9l\u00e9ments est pr\u00e9sent\u00e9 dans le cadre de la proc\u00e9dure europ\u00e9enne d\u2019\u00e9valuation, sous la responsabilit\u00e9 du CHMP, afin d\u2019encadrer l\u2019usage de ce biosimilaire dans l\u2019Union europ\u00e9enne. (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 europ\u00e9en d\u2019\u00e9valuation publique (EPAR) relatif au m\u00e9dicament Filgrastim Hexal et les recommandations du Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence […]<\/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-21887","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\/21887","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=21887"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21887\/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=21887"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21887"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21887"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}