FDA adds Boxed Warning for increased risk of severe hypocalcaemia in patients with advanced chronic kidney disease taking denosumab
This follows a review of available information, with a particularly high risk of severe hypocalcaemia noted in patients on dialysis. The warning and new labelling contains information to help reduce this risk, including appropriate patient selection and increased monitoring.
Source:
US Food and Drug Administration
SPS commentary:
In patients with advanced CKD taking denosumab, severe hypocalcaemia has resulted in serious harm, including hospitalisation, life-threatening events, and death. As a result, the FDA is revising the US prescribing information to include a new Boxed Warning.
The UK SPC for Prolia (denosumab) lists hypocalcaemia as a contra-indication and includes information in the precautions section on identifying those at risk for hypocalcaemia, including those with severe renal impairment.