Le document pr\u00e9sente l\u2019\u00e9valuation r\u00e9alis\u00e9e par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments dans le cadre du rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) concernant Ratiograstim. Ce m\u00e9dicament, disponible uniquement sur ordonnance, est une solution pour injection ou perfusion contenant du filgrastim. Il s\u2019agit d\u2019un m\u00e9dicament biosimilaire, c\u2019est-\u00e0-dire comparable \u00e0 un m\u00e9dicament biologique d\u00e9j\u00e0 autoris\u00e9 dans l\u2019Union europ\u00e9enne et contenant la m\u00eame substance active ; son m\u00e9dicament de r\u00e9f\u00e9rence est Neupogen.<\/p>\n
Ratiograstim est indiqu\u00e9 pour stimuler la production de globules blancs (neutrophiles) dans plusieurs situations cliniques : r\u00e9duction de la dur\u00e9e de la neutrop\u00e9nie et de la fr\u00e9quence des neutrop\u00e9nies f\u00e9briles chez les patients recevant une chimioth\u00e9rapie cytotoxique ; r\u00e9duction de la dur\u00e9e de la neutrop\u00e9nie chez les patients trait\u00e9s par th\u00e9rapies d\u00e9truisant les cellules de la moelle osseuse avant une greffe de moelle, lorsqu\u2019ils sont \u00e0 risque de neutrop\u00e9nie s\u00e9v\u00e8re prolong\u00e9e ; augmentation du taux de neutrophiles et r\u00e9duction du risque infectieux chez des patients neutrop\u00e9niques pr\u00e9sentant des ant\u00e9c\u00e9dents d\u2019infections graves et r\u00e9p\u00e9t\u00e9es ; prise en charge de la neutrop\u00e9nie persistante chez des patients atteints d\u2019infection \u00e0 VIH avanc\u00e9e, afin de diminuer le risque d\u2019infections bact\u00e9riennes lorsque d\u2019autres options ne sont pas adapt\u00e9es. Ratiograstim est \u00e9galement utilis\u00e9 chez les personnes devant donner des cellules souches sanguines pour une greffe, afin de favoriser la mobilisation de ces cellules depuis la moelle osseuse vers le sang.<\/p>\n
Le m\u00e9dicament est administr\u00e9 par injection sous-cutan\u00e9e ou par perfusion intraveineuse. Le mode d\u2019administration, la posologie et la dur\u00e9e du traitement varient selon l\u2019indication, le poids du patient et la r\u00e9ponse au traitement. Il est en g\u00e9n\u00e9ral administr\u00e9 dans un centre sp\u00e9cialis\u00e9, mais une auto-injection sous-cutan\u00e9e est possible apr\u00e8s une formation appropri\u00e9e du patient. Les informations d\u00e9taill\u00e9es pour les patients figurent dans la notice, qui fait partie de l\u2019EPAR.<\/p>\n
La substance active, le filgrastim, est tr\u00e8s similaire au facteur de croissance des colonies de granulocytes (G-CSF) humain. Elle est produite par technologie ADN recombinante, \u00e0 partir d\u2019une bact\u00e9rie modifi\u00e9e g\u00e9n\u00e9tiquement pour fabriquer ce facteur. Le filgrastim agit comme le G-CSF naturel en stimulant la moelle osseuse pour augmenter la production de globules blancs. L\u2019\u00e9valuation scientifique d\u00e9taill\u00e9e ayant conduit aux recommandations du CHMP figure dans la discussion scientifique de l\u2019EPAR. Les \u00e9l\u00e9ments fournis rel\u00e8vent principalement du cadre europ\u00e9en d\u2019autorisation des m\u00e9dicaments biosimilaires et de leurs indications en oncologie, h\u00e9matologie et prise en charge de l\u2019infection \u00e0 VIH avanc\u00e9e. (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 par le Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments dans le cadre du rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) concernant Ratiograstim. […]<\/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-21159","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\/21159","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=21159"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21159\/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=21159"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21159"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21159"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}