Zelboraf® (Vemurafenib) and the risks of Dupuytren’s Contracture and Plantar Fascial Fibromatosis

Roche would like to inform healthcare professionals that cases of Dupuytren’s contracture and plantar fascial fibromatosis have been reported with Zelboraf^® (vemurafenib) use. The reported cases of Dupuytren’s contracture seen with Zelboraf^® were characterized by thickening or appearance of visible cords in the palm of one or both hands. In the majority of patients, the event persisted when Zelboraf^® treatment was maintained, while symptoms improved or resolved when Zelboraf^® was interrupted or discontinued. In addition to Dupuytren’s contracture, rare cases of mild and moderate plantar fascial fibromatosis were also reported. Healthcare professionals are advised to inform patients of these risks and exercise caution in patients with pre-existing Dupuytren’s contracture and plantar fascial fibromatosis and to follow the dose modification guidance for adverse events. Roche is working with HSA to strengthen the product label for Zelboraf^®. Please refer to the letter for more details.