Other safety alerts
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| Updated recommendations for Xgeva (denosumab) regarding calcium monitoring related to the risk of severe symptomatic hypocalcemia |
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GlaxoSmithKline Limited (GSK), a licensed drug wholesaler, informed the Department of Health (DH) about updated recommendations for Xgeva (denosumab) regarding calcium monitoring related to the risk of severe symptomatic hypocalcemia (SSH). Xgeva is indicated for the prevention of skeletal related events in adults with bone metastases from solid tumors and it is not indicated for the prevention of skeletal-related events in patients with multiple myeloma. The Xgeva prescribing information communicates the risk of severe symptomatic hypocalcemia including reports of fatal cases in the post-marketing setting. The ongoing pharmacovigilance program further characterizes the onset of hypocalcemia and the clinical manifestations, allowing GSK to provide updated recommendations for risk mitigation.
In the post-marketing experience, clinical manifestations of SSH associated with Xgeva have included QTc interval prolongation, tetany, seizures, and altered mental status (including coma). The majority of the SSH cases occurred within the first 30 days after first dose of Xgeva. Fatal cases of SSH have been reported. In clinical trials in patients with bone metastasis, severe hypocalcemia (laboratory values for corrected serum calcium <7mg/dL or <1.75 mmol/L) occurred in 3.1% of patients receiving treatment with Xgeva, 1.4% of patients receiving Xgeva had hypocalcemia reported as a serious adverse event.
GSK advised Healthcare providers to monitor calcium levels in all patients at baseline and throughout the duration of treatment especially in the first few weeks. Other recommendations related to management of hypocalcemia related to Xgeva treatment include:
1. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Xgeva.
2. Supplementation of calcium and vitamin D is required in all patients, unless hypercalcemia is present.
3. If hypocalcemia occurs, additional short-term calcium supplementation may be necessary.
4. Patients with severe renal impairment or receiving dialysis are at a higher risk of hypocalcemia.
In Hong Kong, Xgeva Solution for Injection 120mg (HK-61163) is registered by GSK and is a prescription only medicine. Regarding this issue, GSK informed DH that they will issue a “Dear Healthcare Professional Letter” to inform healthcare professionals. Besides, GSK is going to submit the application to change the package insert by including the relevant safety information. DH has not received any relevant adverse drug reaction in connection with Xgeva so far and will keep vigilant on any safety updates of the drug.
Ends/ Tuesday, September 16, 2014
Issued at HKT 15:00
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