Risk of premature epiphyseal fusion with Erivedge® (vismodegib)

Roche would like to inform healthcare professionals of the risk of premature epiphyseal fusion associated with the use of Erivedge®(vismodegib). Three cases of premature epiphyseal fusion in paediatric medulloblastoma patients have been reported with Erivedge®treatment, two of which were within the setting of a clinical trial and one case was from off-label use. In 2 of 3 cases, the fusion of the growth plate appeared to progress even after treatment discontinuation. These findings confirm the risk that was identified based on observation of irreversible closure of the femoral epiphyseal growth plate in vismodegib treated rats. Healthcare professionals are advised to take into consideration the above safety information when prescribing Erivedge®, and to use Erivedge® in accordance to its approved indication.

 
 
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.