ADR that result in revision of patient information
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| Canada: ZELBORAF (vemurafenib) - Association with Liver Problems |
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Hoffmann-La Roche Limited (Roche Canada), in consultation with Health Canada, would like to inform you of important new safety information regarding the risk of Drug Induced Liver Injury (DILI) reported with ZELBORAF.
ZELBORAF is indicated as a monotherapy for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. Drug Induced Liver Injury (DILI), including cases of severe liver injury, has been reported with ZELBORAF. The ZELBORAF Product Monograph will be updated to include appropriate information regarding the risk of DILI and physicians should discuss the currently available information regarding benefits and risks of ZELBORAF with their patients. Prescribers are reminded to monitor transaminases, alkaline phosphatase, and bilirubin before initiation of ZELBORAF treatment and monthly during treatment, or as clinically indicated. Liver injury should be managed using dose reduction, temporary interruption, or treatment discontinuation of ZELBORAF.
There were no reported deaths among the 63 cases of liver injury. There were two severe cases (based on the DILI severity index by the same Expert Working Group), both reported as hepatic failure; the outcome of one case of severe liver injury was reported as completely resolved with ZELBORAF discontinuation while the outcome of the second severe liver injury case is not available at this time.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../38867a-eng.php
In Hong Kong, there is one registered pharmaceutical product Zelboraf Film-coated Tab 240mg (HK-61970) containing vemurafenib, and it is a prescription only medicine. The product insert of Zelboraf Tab in HK has already included special warning on liver injury associated with the use of vemurafenib, and the relevant precautionary measures. So far, the Department of Health has not received any adverse reaction report in connection with the drug, and will keep vigilant against any new safety updates related to the drug.
Ends/ Tuesday, April 08, 2014
Issued at HKT 14:00
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