Xgeva: risk of hypocalcaemia in cancer setting

1 November 2012

Amgen has sent a letter to healthcare professionals reminding them of the risk of severe symptomatic hypocalcaemia associated with use of Xgeva (denosumab) and highlighting the potential for late-onset hypocalcaemia.

Xgeva is given by subcutaneous injection every four weeks

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.

View Xgeva drug record

View letter to healthcare professionals

Further information: Amgen

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