Direct Healthcare Professional Communication (DHPC) on Gilenya® (fingolimod): updated recommendations to minimise the risk of drug-induced liver injury (DILI)
2020.11.10
Active substance: fingolimod
Novartis would like to inform you in agreement with European Medicines Agency (EMA) and Federal Institute for Drugs and Medical Devices, of cases of acute liver failure requiring liver transplant and clinically significant liver injury have been reported in patients treated with fingolimod. The guidance for monitoring liver function and the criteria for discontinuation have been updated with additional details to minimise the risk of DILI.
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