As a form of Risk Management Plan (RMP) implemented by Pharmaceutical Industries, Roche Indonesia Ltd. as the party appointed by Boehringer Ingelheim Ltd. to implement pharmacovigilance on ZELBORAF (Vemurafenib) product, published Dear Healthcare Professional Communication (DHPC) on the risk of Dupuytren Involvement and Fascial Plantar Fibromatosis on Zelboraf® use. Although the incidence of Dupuytrent Contracture and Fascial Plantar is uncommon, as well as improving and restoring conditions after Zelboraf® therapy is suspended or terminated completely, healthcare professional need to provide information about these risks to patients and should be vigilant when handling patients with Dupuytren contracture and Fibial Fibromatosis Plantar that had already existed before. More detailed security information can be found on DHPC Zelboraf® approved by NADFC.
Jakarta, June 2017
NATIONAL PHARMACOVIGILANCE CENTER
Download : Safety Communication DHPC Zelboraf (Vemurafenib).PDF