Risk of serious liver injury with pirfenidone: updated advice
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Risk of serious liver injury with pirfenidone: updated advice Serious cases of drug-induced liver injury (DILI), including some fatalities, are linked with pirfenidone (Esbriet) therapy within the first year of initiation, according to the UK Government.1 Updated advice on liver function testing was published in a recent Drug Safety Update following the release of a "Dear Healthcare Professional" letter from Dr James Mawby of Roche Products Ireland, in agreement with the EMA and Ireland’s Health Products Regulatory Authority (HPRA).2 Esbriet is an anti-fibrotic and anti-inflammatory medicine approved for the treatment of idiopathic pulmonary fibrosis (IPF). Dr Mawby explained that "recently, serious hepatic adverse events including isolated cases with fatal outcome have been reported in IPF patients treated with pirfenidone. Although the aetiology is unclear, idiosyncratic reactions may underlie DILI following treatment with pirfenidone". He added that during clinical development of pirfenidone, "an increased cumulative incidence of hepatic treatment-emergent adverse events was observed in patients treated with pirfenidone (9.5%) vs. placebo (4.3%), the majority of which were laboratory abnormalities". Roche Products Ireland, the EMA and the HPRA have collectively advised that liver function testing (of ALT, AST and bilirubin levels) should be performed before initiating Esbriet therapy, subsequently every month for the first 6 months, and then every 3 months for the duration of treatment. In the event that patients treated with pirfenidone experience symptoms indicative of DILI,* prompt clinical evaluation and liver function testing should be performed. Furthermore, the Esbriet dose should be adjusted or permanently discontinued if patients experience significant elevation of liver aminotransferase levels or clinical signs and symptoms of liver injury, as per guidance in the Summary of Product Characteristics for Esbriet. * including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. 1. UK Government. Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing. Internet Document : 11 Nov 2020. Available from: URL: https:/ /www.gov.uk/drug-safety-update/pirfenidone-esbriet-risk-of-serious-liver-injury-updated-advice-on-liver-function-testing. 2. Mawby J. Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI) with Esbriet (pirfenidone). Internet Document : 29 Oct 2020. Available from: URL: https://www.hpra.ie/docs/default-source/default-document-library/important-safety-information---esbriet-(pirfenidone).pdf. 803517505
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Reactions 21 Nov 2020 No. 1831
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