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.