Important safety update on ESBRIET® (pirfenidone) and Drug-Induced Liver Injury (DILI)

F. Hoffmann-La Roche Ltd. would like to inform healthcare professionals of new safety information regarding DILI with Esbriet^® (pirfenidone). Clinical manifestations of DILI including cases with fatal outcome - possibly caused by idiosyncratic reactions to Esbriet^® - have recently been reported in individual patients. Based on these findings, the prescribing information for Esbriet^® will be updated to adequately describe the risk of clinically relevant DILI and recommend additional monitoring of liver function in the presence of clinical signs or symptoms suggestive of liver injury. Healthcare professionals are advised on the monitoring of hepatic transaminase and bilirubin levels during drug treatment and prompt measurement of liver function tests in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.