{"id":123652,"date":"2024-09-25T09:00:02","date_gmt":"2024-09-25T13:00:02","guid":{"rendered":"https:\/\/wfh.org\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/"},"modified":"2024-11-15T14:28:41","modified_gmt":"2024-11-15T19:28:41","slug":"mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/","title":{"rendered":"Mise \u00e0 jour sur le d\u00e9faut de fabrication chez Novo Nordisk concernant NovoSeven\u00a9, qui provoque des p\u00e9nuries pour NovoEight\u00a9 et Esperoct\u00a9"},"content":{"rendered":"\t\t
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Les probl\u00e8mes potentiels d\u2019approvisionnement en NovoEight (un concentr\u00e9 de facteur VIII \u00e0 demi-vie standard) et en Esperoct (un concentr\u00e9 de facteur VIII \u00e0 demi-vie prolong\u00e9e), qui pourraient \u00eatre importants, peuvent cependant \u00eatre att\u00e9nu\u00e9s par l\u2019usage de certains concentr\u00e9s de facteur de coagulation \u00e0 demi-vie standard et\/ou prolong\u00e9e. L\u2019EHC, la FMH et la NBDF demandent \u00e0 Novo Nordisk de fournir en temps utile des informations sur d\u2019\u00e9ventuelles ruptures de stock et d\u2019indiquer la chronologie pr\u00e9vue pour le retour \u00e0 la normale.<\/p>\n

Les ruptures de stock de NovoSeven auront potentiellement des cons\u00e9quences plus importantes, car il n\u2019existe que peu d\u2019alternatives et que ce produit est utilis\u00e9 dans un grand nombre d\u2019indications. NovoSeven est indiqu\u00e9 dans le traitement des \u00e9pisodes de saignement et dans la pr\u00e9vention des saignements en cas de chirurgie ou de proc\u00e9dure invasive pour les groupes de patient\u00b7es suivants\u00a0:<\/p>\n

    \n
  • les patientes atteint\u00b7es d\u2019h\u00e9mophilie h\u00e9r\u00e9ditaire avec inhibiteurs du facteur VIII ou IX > 5\u00a0unit\u00e9s de Bethesda (BU)\u00a0;<\/li>\n
  • les patientes atteint\u00b7es d\u2019h\u00e9mophilie h\u00e9r\u00e9ditaire pr\u00e9sentant une possible r\u00e9ponse anamnestique forte en cas d\u2019administration de facteur VIII ou de facteur IX\u00a0;<\/li>\n
  • les patientes atteint\u00b7es d\u2019h\u00e9mophilie acquise\u00a0;<\/li>\n
  • les patientes atteint\u00b7es d\u2019h\u00e9mophilie h\u00e9r\u00e9ditaire avec d\u00e9ficit en facteur VII\u00a0;<\/li>\n
  • les patientes atteint\u00b7es d\u2019une thrombasth\u00e9nie de Glanzmann avec r\u00e9action actuelle ou pass\u00e9e \u00e0 des transfusions de plaquettes, ou pour qui les plaquettes ne sont pas disponibles\u00a0;<\/li>\n
  • les patientes pr\u00e9sentant une h\u00e9morragie post-partum s\u00e9v\u00e8re, lorsque les produits ut\u00e9rotoniques ne suffisent pas \u00e0 atteindre l\u2019h\u00e9mostase.<\/li>\n<\/ul>\n

    Les indications pour le NovoSeven sont pour la prise en charge de situation qui peuvent mettre en jeu le pronostic vital, et il n\u2019existe de plus pas d\u2019alternative claire \u00e0 ce produit, \u00e0 l\u2019exception du Sevenfact dans certains pays et du complexe prothrombique activ\u00e9, c\u2019est-\u00e0-dire le FEIBA. Le FEIBA est indiqu\u00e9 selon un r\u00e9gime strict dans le cas des patient\u00b7es atteint\u00b7es d\u2019h\u00e9mophilie A avec inhibiteurs qui sont sous emicizumab.<\/p>\n

    Le d\u00e9faut de fabrication n\u2019a provoqu\u00e9 aucun probl\u00e8me s\u00e9rieux d\u2019approvisionnement pour l\u2019instant, mais son impact r\u00e9el pourrait se manifester plus tard, probablement d\u2019ici la fin 2024.<\/p>\n

    L\u2019EHC, la FMH et la NBDF ont pris contact avec leurs organisations nationales membres (ONM) et les tiendront inform\u00e9es de toute information pertinente communiqu\u00e9e par Novo Nordisk. Les centres de traitement de l\u2019h\u00e9mophilie (CTH) et les organismes de r\u00e9glementation du monde entier sont au courant de la situation.<\/p>\n

    L\u2019EHC, la FMH et la NBDF restent en contact avec Novo Nordisk et devraient avoir plus de d\u00e9tails sur les stocks plac\u00e9s en quarantaine, le nombre de flacons qui pourront \u00eatre exp\u00e9di\u00e9s et utilis\u00e9s, et la chronologie pr\u00e9vue pour un retour \u00e0 la normale concernant ces trois m\u00e9dicaments.<\/p>\n

    En attendant, l\u2019EHC, la FMH et la NBDF recommandent aux patient\u00b7es qui utilisent NovoSeven, NovoEight et Esperoct de contacter leurs prestataires de sant\u00e9 pour leur demander conseil.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    \u00c0 la mi-juin 2024, l\u2019European Haemophilia Consortium (EHC), la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) et la National Bleeding Disorder Foundation (NBDF) ont pris connaissance d\u2019un d\u00e9faut de fabrication dans la ligne de production Novo Nordisk (au Danemark) de certains produits de traitement de l\u2019h\u00e9mophilie et d\u2019autres troubles de la coagulation. Ce d\u00e9faut de fabrication a provoqu\u00e9 un potentiel remplissage incomplet de certains flacons de NovoSeven (1 et 2 mg) dans certains pays, qui en ont \u00e9t\u00e9 inform\u00e9s, ce qui a provoqu\u00e9 des p\u00e9nuries de NovoSeven, de NovoEight et d\u2019Esperoct.<\/p>\n","protected":false},"author":13,"featured_media":123162,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[177,197,338],"tags":[],"search-category":[85],"class_list":["post-123652","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite-medicale","category-declarations-publiques-et-recommandations-de-la-fmh","category-featured-3-fr","search-category-article"],"yoast_head":"\nMise \u00e0 jour sur le d\u00e9faut de fabrication chez Novo Nordisk concernant NovoSeven\u00a9, qui provoque des p\u00e9nuries pour NovoEight\u00a9 et Esperoct\u00a9 | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mise \u00e0 jour sur le d\u00e9faut de fabrication chez Novo Nordisk concernant NovoSeven\u00a9, qui provoque des p\u00e9nuries pour NovoEight\u00a9 et Esperoct\u00a9\" \/>\n<meta property=\"og:description\" content=\"\u00c0 la mi-juin 2024, l\u2019European Haemophilia Consortium (EHC), la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH) et la National Bleeding Disorder Foundation (NBDF) ont pris connaissance d\u2019un d\u00e9faut de fabrication dans la ligne de production Novo Nordisk (au Danemark) de certains produits de traitement de l\u2019h\u00e9mophilie et d\u2019autres troubles de la coagulation. Ce d\u00e9faut de fabrication a provoqu\u00e9 un potentiel remplissage incomplet de certains flacons de NovoSeven (1 et 2 mg) dans certains pays, qui en ont \u00e9t\u00e9 inform\u00e9s, ce qui a provoqu\u00e9 des p\u00e9nuries de NovoSeven, de NovoEight et d\u2019Esperoct.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/\" \/>\n<meta property=\"og:site_name\" content=\"FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/wfhemophilia\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-09-25T13:00:02+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-15T19:28:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/wfh.org\/wp-content\/uploads\/2024\/09\/EHC-NBDF-WFH-dual-declaration-header-FR.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"627\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mitch Semienchuk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mitch Semienchuk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/\"},\"author\":{\"name\":\"Mitch Semienchuk\",\"@id\":\"https:\/\/wfh.org\/fr\/#\/schema\/person\/4aea5b13c1966452a640eef39423925b\"},\"headline\":\"Mise \u00e0 jour sur le d\u00e9faut de fabrication chez Novo Nordisk concernant NovoSeven\u00a9, qui provoque des p\u00e9nuries pour NovoEight\u00a9 et Esperoct\u00a9\",\"datePublished\":\"2024-09-25T13:00:02+00:00\",\"dateModified\":\"2024-11-15T19:28:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/\"},\"wordCount\":553,\"publisher\":{\"@id\":\"https:\/\/wfh.org\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-defaut-de-fabrication-chez-novo-nordisk-concernant-novoseven-novoeight-et-esperoct\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/wfh.org\/wp-content\/uploads\/2024\/09\/EHC-NBDF-WFH-dual-declaration-header-FR.jpg\",\"articleSection\":[\"Actualit\u00e9 m\u00e9dicale\",\"D\u00e9clarations publiques et recommandations de la FMH\",\"Featured 3 - 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