Tecfidera® (diméthyl fumarate): nouvelles mesures pour minimiser le risque de leucoencéphalopathie multifocale progressive (LEMP) – Lettre aux professionnels de santé

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06 Décembre 2015- Cette information vient d’ANSM et est destinée aux neurologues et infirmières spécialisées dans la sclérose en plaques

En octobre 2014, un cas de LEMP d’évolution fatale a été rapporté chez un patient traité par Tecfidera depuis 4,5 ans, dans un contexte de lymphopénie sévère et prolongée. D’autres cas ont été confirmés depuis.

Aussi, de nouvelles recommandations ont été mises en place pour minimiser le risque de LEMP chez les patients traités par Tecfidera :

  • Avant de commencer un traitement par Tecfidera
    Faire pratiquer un hémogramme incluant une numération des lymphocytes, un IRM de référence de moins de 3 mois et informer les patients sur le risque de LEMP
  • En cours du traitement par Tecfidera
    Surveiller l’hémogramme incluant la numération des lymphocytes tous les 3 mois, envisager l’arrêt du traitement par Tecfidera chez les patients ayant un nombre de lymphocytes inférieur à 0,5 x 109/L persistant pendant plus de 6 mois et, si le traitement est interrompu en raison d’une lymphopénie, surveiller les patients jusqu’à ce que le taux de lymphocytes revienne à la normale.

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Joseph Gut - thasso Professeur de pharmacologie et de toxicologie. Expert en médecine théragenomique et personnalisé el le sécurité individualisé des médicaments. Expert dans pharmaco- et toxico-génétique. Expert en matière de sécurité humaine de médicaments, les produits chimiques, les polluants environnementaux, et des ingrédients alimentaires.

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