Updated recommendations regarding Gilenya-induced liver injury
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Updated recommendations regarding Gilenya-induced liver injury Updated guidance are now available for liver function monitoring and criteria for treatment discontinuation of fingolimod (Gilenya) following cases of liver injury, says a Novartis Ireland representative. In agreement with the EMA and Ireland’s Health Product Regulatory Authority, Novartis Ireland’s Chief Scientific Officer Dr Bishember Kathuria recently released a Dear Healthcare Professional Communication, following the most recent periodic review of safety data that revealed three cases of liver failure requiring liver transplantation in fingolimod-treated patients. Dr Kathuria added that one of these cases implied "a strong causal relationship" with fingolimod and that "cases of clinically significant liver injury have also been reported". During clinical development of this multiple sclerosis therapy, elevated ALT levels (≥3-times ULN)* occurred in 8% of adult patients treated with fingolimod 0.5mg, and elevations of 5-times the ULN occurred in 1.8% of fingolimodtreated patients. Accordingly, the guidance for fingolimod use and criteria for discontinuation have been updated to include the below-mentioned information to help minimise the risk of drug-induced liver injury (DILI), including: • liver function testing (including serum bilirubin) should be performed before starting fingolimod and at months 1, 3, 6, 9 and 12 on therapy and periodically thereafter until 2 months after discontinuing fingolimod. • more frequent monitored should be undertaken in the absence of clinical symptoms, if liver transaminases are >3-times the ULN but
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