Le document pr\u00e9sente la synth\u00e8se de l\u2019\u00e9valuation europ\u00e9enne (EPAR) du m\u00e9dicament Spectrila r\u00e9alis\u00e9e par l\u2019Agence europ\u00e9enne des m\u00e9dicaments, aboutissant \u00e0 sa recommandation d\u2019autorisation dans l\u2019Union europ\u00e9enne et \u00e0 la d\u00e9finition de ses conditions d\u2019utilisation. Spectrila est indiqu\u00e9 chez l\u2019adulte et l\u2019enfant dans le traitement de la leuc\u00e9mie aigu\u00eb lymphoblastique (LAL), en association avec d\u2019autres m\u00e9dicaments anticanc\u00e9reux. Il contient comme substance active l\u2019asparaginase.<\/p>\n
Spectrila est administr\u00e9 par perfusion intraveineuse toutes les 72 heures, avec une posologie ajust\u00e9e \u00e0 l\u2019\u00e2ge et \u00e0 la surface corporelle du patient. Sa prescription et son administration sont r\u00e9serv\u00e9es aux professionnels de sant\u00e9 exp\u00e9riment\u00e9s en canc\u00e9rologie, en milieu hospitalier disposant de mat\u00e9riel de r\u00e9animation. Le m\u00e9dicament est disponible uniquement sur prescription, sous forme de poudre en flacon \u00e0 reconstituer en solution pour perfusion. Les informations pratiques d\u2019utilisation rel\u00e8vent de la notice destin\u00e9e aux patients et de la consultation m\u00e9dicale ou pharmaceutique.<\/p>\n
Sur le plan pharmacologique, l\u2019asparaginase est une enzyme qui diminue les concentrations sanguines de l\u2019acide amin\u00e9 asparagine. Les cellules leuc\u00e9miques d\u00e9pendent de cet acide amin\u00e9 pour leur croissance et leur multiplication, de sorte que sa d\u00e9pl\u00e9tion sanguine entra\u00eene leur mort. Les cellules normales sont moins affect\u00e9es car elles peuvent synth\u00e9tiser leur propre asparagine. Dans une \u00e9tude portant sur 199 enfants atteints de LAL, Spectrila, utilis\u00e9 en association avec d\u2019autres traitements, s\u2019est montr\u00e9 aussi efficace qu\u2019un autre m\u00e9dicament \u00e0 base d\u2019asparaginase pour r\u00e9duire l\u2019asparagine sanguine : 95 % des patients trait\u00e9s par Spectrila et 94 % de ceux recevant l\u2019autre sp\u00e9cialit\u00e9 ont pr\u00e9sent\u00e9 une d\u00e9pl\u00e9tion compl\u00e8te de l\u2019asparagine.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quents (plus d\u20191 patient sur 10) incluent des r\u00e9actions allergiques (bouff\u00e9es vasomotrices, \u00e9ruption cutan\u00e9e, hypotension, urticaire, dyspn\u00e9e), des troubles digestifs (diarrh\u00e9e, naus\u00e9es, vomissements, douleurs abdominales), une fatigue, des \u0153d\u00e8mes li\u00e9s \u00e0 une r\u00e9tention hydrique, une hyperglyc\u00e9mie, une hypoalbumin\u00e9mie et d\u2019autres anomalies biologiques. Les effets ind\u00e9sirables graves mentionn\u00e9s comprennent des r\u00e9actions allergiques s\u00e9v\u00e8res, des \u00e9v\u00e9nements thromboemboliques, des pancr\u00e9atites et des atteintes h\u00e9patiques.<\/p>\n
Spectrila est contre-indiqu\u00e9 chez les patients pr\u00e9sentant une allergie connue \u00e0 toute pr\u00e9paration d\u2019asparaginase, ceux ayant une pancr\u00e9atite aigu\u00eb, une h\u00e9patopathie s\u00e9v\u00e8re ou des troubles de la coagulation. Il ne doit pas \u00eatre utilis\u00e9 chez les patients ayant des ant\u00e9c\u00e9dents de pancr\u00e9atite, d\u2019h\u00e9morragies s\u00e9v\u00e8res ou de thromboses survenues apr\u00e8s un traitement par asparaginase. Les restrictions compl\u00e8tes figurent dans la notice. Les \u00e9l\u00e9ments fournis insistent sur l\u2019efficacit\u00e9 de Spectrila pour r\u00e9duire l\u2019asparagine sanguine, param\u00e8tre cl\u00e9 pour le contr\u00f4le des cellules leuc\u00e9miques, tout en rappelant les risques de toxicit\u00e9 n\u00e9cessitant un encadrement hospitalier sp\u00e9cialis\u00e9. Ces informations s\u2019inscrivent dans le cadre de l\u2019autorisation et du suivi d\u2019un m\u00e9dicament anticanc\u00e9reux au niveau de l\u2019UE, avec des enjeux de s\u00e9curit\u00e9 d\u2019utilisation et d\u2019acc\u00e8s au traitement pour les patients atteints de LAL. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le document pr\u00e9sente la synth\u00e8se de l\u2019\u00e9valuation europ\u00e9enne (EPAR) du m\u00e9dicament Spectrila r\u00e9alis\u00e9e par l\u2019Agence europ\u00e9enne des m\u00e9dicaments, aboutissant \u00e0 sa recommandation d\u2019autorisation dans l\u2019Union europ\u00e9enne et \u00e0 la d\u00e9finition […]<\/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-21474","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\/21474","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=21474"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21474\/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=21474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}