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.
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

19 Dec 2019

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

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.