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®.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 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.