{"id":21147,"date":"2026-10-15T12:48:44","date_gmt":"2026-10-15T12:48:44","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=21147"},"modified":"2026-10-15T12:48:44","modified_gmt":"2026-10-15T12:48:44","slug":"rapport-europeen-public-devaluation-des-medicaments-a-usage-humain-epar-cabometyx-cabozantinib-date-dautorisation-09-09-2016-revision-21-statut-autorise-titre-tra","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=21147","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation des m\u00e9dicaments \u00e0 usage humain (EPAR) : Cabometyx, cabozantinib, Date d\u2019autorisation : 09\/09\/2016, R\u00e9vision : 21, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Le document pr\u00e9sente les effets ind\u00e9sirables les plus fr\u00e9quents et les effets ind\u00e9sirables graves associ\u00e9s au m\u00e9dicament Cabometyx, utilis\u00e9 dans plusieurs indications canc\u00e9rologiques (carcinome r\u00e9nal, carcinome h\u00e9patocellulaire, carcinome thyro\u00efdien diff\u00e9renci\u00e9 et tumeurs neuroendocrines). Il renvoie, pour l\u2019exhaustivit\u00e9 des effets ind\u00e9sirables et des contre-indications, \u00e0 la notice du m\u00e9dicament.<\/p>\n<p>Chez les patients atteints de carcinome r\u00e9nal, de carcinome h\u00e9patocellulaire, de carcinome thyro\u00efdien diff\u00e9renci\u00e9 ou de tumeurs neuroendocrines, les effets ind\u00e9sirables les plus fr\u00e9quents (pouvant toucher jusqu\u2019\u00e0 25 % des patients) sont la diarrh\u00e9e, la fatigue, les naus\u00e9es, la diminution de l\u2019app\u00e9tit, le syndrome main-pied (\u00e9rythrodysesth\u00e9sie palmo-plantaire, associant \u00e9ruption cutan\u00e9e et engourdissements des paumes et des plantes) et l\u2019hypertension art\u00e9rielle.<\/p>\n<p>Les effets ind\u00e9sirables graves les plus fr\u00e9quents (pouvant toucher plus de 1 % des patients) varient selon l\u2019indication. Pour le carcinome r\u00e9nal, ils incluent notamment pneumonie, douleur abdominale, hypertension art\u00e9rielle, diarrh\u00e9e, naus\u00e9es, vomissements, perte d\u2019app\u00e9tit, vertiges, fatigue, d\u00e9shydratation, thrombose veineuse profonde, hyponatr\u00e9mie et hypomagn\u00e9s\u00e9mie (taux bas de sodium et de magn\u00e9sium sanguins), syndrome main-pied, faiblesse, embolie et embolie pulmonaire. Pour le carcinome h\u00e9patocellulaire, les effets graves les plus fr\u00e9quents comprennent enc\u00e9phalopathie h\u00e9patique, fatigue, vomissements, douleur abdominale, hyponatr\u00e9mie, syndrome main-pied, faiblesse, diarrh\u00e9e et thrombop\u00e9nie (baisse du nombre de plaquettes). Pour le carcinome thyro\u00efdien diff\u00e9renci\u00e9, ils incluent diarrh\u00e9e, \u00e9panchement pleural, pneumonie, an\u00e9mie, ost\u00e9on\u00e9crose de la m\u00e2choire, embolie pulmonaire, thrombose veineuse profonde, syndrome main-pied, douleurs, hypertension art\u00e9rielle et hypocalc\u00e9mie (taux bas de calcium sanguin). Pour les tumeurs neuroendocrines, les effets graves les plus fr\u00e9quents sont l\u2019hypertension art\u00e9rielle, la fatigue, les vomissements, la diarrh\u00e9e, les naus\u00e9es et les embolies, y compris embolie pulmonaire.<\/p>\n<p>L\u2019information disponible \u00e9mane de la documentation officielle du m\u00e9dicament (notice), qui pr\u00e9cise les fr\u00e9quences et la nature des risques. Ces donn\u00e9es sont pertinentes pour le suivi de la pharmacovigilance, l\u2019\u00e9valuation du rapport b\u00e9n\u00e9fice\/risque et la surveillance des impacts potentiels sur les syst\u00e8mes de sant\u00e9 (prise en charge des effets ind\u00e9sirables graves et des complications thromboemboliques, m\u00e9taboliques ou h\u00e9patiques). Aucun \u00e9l\u00e9ment du texte ne pr\u00e9cise de contexte national particulier ni de d\u00e9cision r\u00e9glementaire sp\u00e9cifique. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/cabometyx\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Le document pr\u00e9sente les effets ind\u00e9sirables les plus fr\u00e9quents et les effets ind\u00e9sirables graves associ\u00e9s au m\u00e9dicament Cabometyx, utilis\u00e9 dans plusieurs indications canc\u00e9rologiques (carcinome r\u00e9nal, carcinome h\u00e9patocellulaire, carcinome thyro\u00efdien diff\u00e9renci\u00e9 [&hellip;]<\/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 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