ADR that result in revision of patient information
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| Singapore: Zelboraf® (Vemurafenib) and the risks of Dupuytren's contracture and plantar fascial fibromatosis |
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Singapore Health Science Authority (HSA) announced that 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 following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../zelboraf-vemurafenibandtherisksofdupuytrenscontractureandplantar.html
In Hong Kong, Zelboraf Film-coated Tab 240mg (HK-61970) is a pharmaceutical product registered by Roche Hong Kong Limited (Roche HK), and is a prescription only medicine. As confirmed with Roche HK, the company will issue a "Dear Healthcare Professional Letter" to inform local healthcare professionals on the above risks. So far, the Department of Health has not received any adverse drug reaction report related to the product. In view of the above HSA announcement on strengthening of product label of Zelboraf, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, February 15, 2017
Issued at HKT 15:00
Roche HK informed the DH that the company has issued a “Dear Healthcare Professional Letter” on the above risks to oncologists, dermatologists and pharmacies under Hospital Authority on 14 March 2017.
Content last updated: Thursday, April 13, 2017
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