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.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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