Zelboraf® (vemurafenib): Important Drug Warning – Risk of Dupuytren’s Contracture and Plantar Fascial Fibromatosis

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Date: 26 April 2017

 

Description:

Zelboraf® is indicated for the treatment of unresectable or metastatic melanoma specifically with V600 mutation in the BRAF gene. Cases of Dupuytren’s contracture (thickening or appearance of visible cords on the palms) and plantar fascial fibromatosis (thickening of deep connective tissues in the feet) have been reported with the use of Zelboraf®. Patients should be informed of this risk, and Zelboraf® should be used with caution in those with pre-existing Dupuytren’s contracture or plantar fascial fibromatosis. These conditions should be managed with temporary interruption or discontinuation of Zelboraf® treatment, as detailed in the product information leaflet. For further information, please refer to the Direct Healthcare Professional Communication (DHPC) issued by Roche (Malaysia) Sdn. Bhd. in agreement with NPRA.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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