Prolia® (denosumab 60mg) and Xgeva® (denosumab 120mg) – Clinically significant cases of hypercalcaemia after cessation of treatment with denosumab in paediatric patients

GlaxoSmithKline (GSK) Pte Ltd would like to inform healthcare professionals of important new safety information in paediatric patients with growing skeletons who were being administered denosumab. Weeks to months following denosumab discontinuation in patients with growing skeletons, cases of clinically significant hypercalcaemia in patients presenting with nausea and vomiting with or without acute renal failure, requiring hospitalisation, have been observed as part of routine safety review by Amgen, the manufacturer of denosumab and GSK’s partner in Singapore. Healthcare professionals are advised to monitor for the development of hypercalcaemia following discontinuation of denosumab treatment in those patients with growing skeletons at the time of initiating treatment with denosumab. Please refer to the letters for more information.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.