Le document pr\u00e9sente les principales caract\u00e9ristiques de Tevagrastim, un m\u00e9dicament \u00e9valu\u00e9 au niveau europ\u00e9en par le Committee for Medicinal Products for Human Use (CHMP) dans le cadre du rapport public europ\u00e9en d\u2019\u00e9valuation (EPAR). Tevagrastim est une solution pour injection ou perfusion contenant du filgrastim. Il s\u2019agit d\u2019un m\u00e9dicament biosimilaire, c\u2019est-\u00e0-dire similaire \u00e0 un m\u00e9dicament biologique de r\u00e9f\u00e9rence d\u00e9j\u00e0 autoris\u00e9 dans l\u2019Union europ\u00e9enne, en l\u2019occurrence Neupogen, et contenant la m\u00eame substance active.<\/p>\n
Tevagrastim est utilis\u00e9 pour stimuler la production de globules blancs, en particulier les neutrophiles. Il est indiqu\u00e9 pour r\u00e9duire la dur\u00e9e de la neutrop\u00e9nie et la survenue de neutrop\u00e9nie f\u00e9brile chez les patients recevant une chimioth\u00e9rapie cytotoxique, pour r\u00e9duire la dur\u00e9e de la neutrop\u00e9nie chez les patients soumis \u00e0 un traitement de destruction des cellules de la moelle osseuse avant une greffe de moelle lorsque le risque de neutrop\u00e9nie s\u00e9v\u00e8re prolong\u00e9e est \u00e9lev\u00e9, pour augmenter le nombre de neutrophiles et r\u00e9duire le risque d\u2019infections chez les patients neutrop\u00e9niques pr\u00e9sentant des ant\u00e9c\u00e9dents d\u2019infections s\u00e9v\u00e8res et r\u00e9p\u00e9t\u00e9es, ainsi que pour traiter la neutrop\u00e9nie persistante chez les patients atteints d\u2019une infection par le VIH \u00e0 un stade avanc\u00e9 lorsque les autres options th\u00e9rapeutiques ne sont pas appropri\u00e9es, afin de diminuer le risque d\u2019infections bact\u00e9riennes. Tevagrastim peut \u00e9galement \u00eatre utilis\u00e9 chez les personnes s\u2019appr\u00eatant \u00e0 faire un don de cellules souches sanguines en vue d\u2019une greffe, afin de favoriser la mobilisation de ces cellules depuis la moelle osseuse vers le sang.<\/p>\n
Le m\u00e9dicament est soumis \u00e0 prescription m\u00e9dicale. Il est administr\u00e9 par injection sous-cutan\u00e9e ou par perfusion intraveineuse, dans des conditions g\u00e9n\u00e9ralement encadr\u00e9es par un centre de traitement sp\u00e9cialis\u00e9. La posologie et la dur\u00e9e du traitement varient selon l\u2019indication, le poids corporel du patient et la r\u00e9ponse au traitement. Une auto-injection sous-cutan\u00e9e est possible apr\u00e8s formation appropri\u00e9e du patient. Le document renvoie \u00e0 la notice pour les informations d\u00e9taill\u00e9es destin\u00e9es aux patients et au rapport de discussion scientifique de l\u2019EPAR pour les \u00e9l\u00e9ments techniques justifiant les recommandations du CHMP.<\/p>\n
Sur le plan pharmacologique, la substance active filgrastim est tr\u00e8s proche d\u2019une prot\u00e9ine humaine naturelle, le facteur de stimulation des colonies de granulocytes (G-CSF). Elle est produite par une technologie d\u2019ADN recombinant, \u00e0 partir d\u2019une bact\u00e9rie g\u00e9n\u00e9tiquement modifi\u00e9e pour fabriquer ce facteur. Le filgrastim agit comme le G-CSF naturel en stimulant la moelle osseuse afin d\u2019augmenter la production de globules blancs. L\u2019\u00e9valuation europ\u00e9enne a port\u00e9 sur la d\u00e9monstration que Tevagrastim est comparable au m\u00e9dicament de r\u00e9f\u00e9rence en termes de composition en substance active et de mode d\u2019action. Les implications pour les politiques publiques concernent principalement la disponibilit\u00e9 d\u2019une alternative biosimilaire encadr\u00e9e au niveau de l\u2019Union europ\u00e9enne, dans des indications li\u00e9es \u00e0 la prise en charge des effets h\u00e9matologiques de certains traitements lourds (chimioth\u00e9rapie, greffe de moelle) et de situations de neutrop\u00e9nie \u00e0 risque infectieux \u00e9lev\u00e9. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente les principales caract\u00e9ristiques de Tevagrastim, un m\u00e9dicament \u00e9valu\u00e9 au niveau europ\u00e9en par le Committee for Medicinal Products for Human Use (CHMP) dans le cadre du rapport public […]<\/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-21160","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\/21160","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=21160"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21160\/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=21160"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21160"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21160"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}