Risk of drug-induced liver injury (DILI) reported with Zelboraf® (vemurafenib)

Roche would like to inform healthcare professionals of the risk of drug-induced liver injury (DILI) reported with Zelboraf^® (vemurafenib). Based on an analysis of liver-related adverse events reported with Zelboraf^® use, 63 cases out of an estimated 20,000 patients treated with Zelboraf^®were identified as having experienced DILI. There were two severe cases reported as hepatic failure. Healthcare professionals are reminded to monitor transaminases, alkaline phosphatase, and bilirubin before initiation of treatment and monthly during treatment, or as clinically indicated. Liver injury should be managed using dose reduction, temporary interruption, or treatment discontinuation of Zelboraf^®, as indicated in the Package Insert for Zelboraf^®.

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 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.