Product Information for the fully human monoclonal antibody denosumab have been updated regarding the potential risk of QT interval prolongation associated with hypocalcaemia.
Hypocalcaemia is a known effect of denosumab and was already captured in the PI, the TGA said in its latest Medicines Safety Update.
The potential risk of QT interval prolongation was identified during a TGA assessment of adverse event reports relating to this medicine. Denosumab is currently available in Australia under the brands Prolia and Xgeva.
For more information on the changes click here.