Denosumab PI updated to reflect potential cardiac risk

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. 

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