ADR that result in revision of patient information
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| Singapore: Xgeva (denosumab 120mg) – Updated recommendations for calcium monitoring related to the risk of severe symptomatic hypocalcaemia (SSH) |
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GlaxoSmithKline would like to provide updated recommendations for risk mitigation of severe symptomatic hypocalcaemia (SSH) associated with Xgeva. Clinical manifestations of SSH associated with Xgeva have been reported in the post-marketing setting, including QTc interval prolongation, tetany, seizures, coma and altered mental status. Fatal cases of SSH have also been reported. Monitoring of calcium levels is now recommended in all patients at baseline and during treatment, especially in the first weeks of initiating therapy.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../denosumab_severe_symptomatic_hypocalcemia.html
In Hong Kong, Xgeva Solution for Injection 120mg (HK-61163) is registered by GlaxoSmithKline Limited (GSK) and is a prescription-only medicine. On 16 September 2014, GSK had informed the Department of Health (DH) of the updated recommendations for risk mitigation of severe symptomatic hypocalcaemia associated with Xgeva, and the information was posted on the Drug Office website on the same day. In addition, GSK had also issued letters to inform local healthcare professionals on the updated recommendations, and submitted application to DH to include the new safety information in the package insert of Xgeva. So far, DH has not received any local adverse drug reaction report related to Xgeva. DH will continue to keep vigilant on further safety update of the drug.
Ends/ Wednesday, October 08, 2014
Issued at HKT 14:00
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