Xgeva is indicated for the prevention of skeletal events (including pathological fracture, radiation or surgery to bone, and spinal cord compression) in patients with bone metastases caused by solid tumours. Hypocalcaemia was identified as a common adverse event in clinical trials; however, severe fatal cases have been reported in the postmarketing period.
Higher risk when initiating therapy
Hypocalcaemia can occur at any time during therapy with denosumab but most commonly occurs within the first six months of dosing. In severe cases, the patient may present with altered mental status, tetany, seizures and QT interval prolongation.
Prescribers are reminded of the following recommendations to minimise risk:
- Correct hypocalcaemia before starting therapy
- Administer calcium and vitamin D supplements unless hypercalcaemia is present
- Consider additional calcium supplementation if hypocalcaemia occurs
- Monitor calcium levels in patients with severe renal impairment (CrCl <30ml/min) or receiving dialysis.
Further information: Amgen