Other safety alerts
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| Xgeva® (denosumab 120mg) and Prolia® (denosumab 60mg/ml) - Clinically significant cases of hypercalcemia after cessation of treatment with denosumab in paediatric patients |
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GlaxoSmithKline Limited (GSK), a licensed drug wholesaler, informed the Department of Health (DH) about clinically significant cases of hypercalcemia after cessation of treatment with denosumab in paediatric patients. Denosumab is marketed under the brand names of Xgeva® and Prolia® with different strengths and indications. GSK is going to issue letters to healthcare practitioners who may be affected by this new signal, notably, oncologists, paediatric oncologists, metabolic specialists, endocrinologists, rheumatologists, orthopedic surgeons, paediatricians and pharmacists.
The information delivered by GSK is as follows:
Xgeva®
Xgeva® is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors, and is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.
Prolia®
Prolia® is indicated for the following uses:
1) Treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.
2) Treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
3) Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.
4) Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
GSK would like to inform healthcare practitioners of important new safety information in patients with growing skeletons being administered denosumab. Weeks to months following denosumab discontinuation in patients with growing skeletons, cases of clinically significant hypercalcemia in patients presenting with nausea and vomiting with or without acute renal failure, requiring hospitalization, have been observed as part of routine safety review by Amgen, the manufacturer of denosumab and GSK’s partner in Hong Kong. The index case was seen in a skeletally mature paediatric patient who had a growing skeleton, and was being treated for giant cell tumor of the bone. Denosumab is not indicated for patients with giant cell tumor of the bone in Hong Kong. Patients with growing skeletons have received denosumab for indications that have not been approved such as osteogenesis imperfecta, fibrous dysplasia, and juvenile Paget’s disease of bone.
Health care practitioners are advised to monitor patients with growing skeletons at the time of denosumab introduction/treatment for the development of hypercalcemia following denosumab discontinuation.
The overall benefit risk profile of denosumab remains favourable for the approved indications.
Healthcare practitioners are advised of the following:
‧ Denosumab should not be administered for non-approved indications.
‧ Monitor for hypercalcemia post discontinuation of denosumab in individuals with skeletons that are still growing,
‧ Treat hypercalcemia as appropriate for symptoms of patient.
‧ Monitor renal function, as appropriate in cases of hypercalcemia.
In Hong Kong, there are three registered pharmaceutical products containing denosumab, namely Xgeva® Solution for Injection 120mg (HK-61163), Prolia® Solution for Injection in Pre-filled Syringe 60mg/ml (USA) (HK-60588) and Prolia® Solution for Injection in Pre-filled Syringe 60mg/ml (the Netherlands) (HK-60589). All products are registered by GSK, and are prescription-only medicines. So far, the DH has received one case of adverse drug reaction (ADR) on Xgeva® and two cases of ADR on Prolia®, and none of them are related to hypercalcemia. GSK is going to issue a "Dear Healthcare Professional Letter" to inform the healthcare professionals about the issue today. The DH will maintain close contact with GSK to monitor any action deemed necessary and keep vigilant on any safety updates of the drug.
Ends/ Monday, July 6, 2015
Issued at HKT 09:00 |
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