Denosumab
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Various toxicities following off-label treatment: 2 case reports In a case series of 3 patients, two girls aged 12 years were described, who developed hypocalcaemia, hypophosphatemia, rebound-hypercalcaemia or increased serum alkaline phosphatase following off-label treatment with denosumab. Patient number 1: The 12-year-old girl, who had recurrent aneurysmal bone cyst (ABC) of the pelvis, started receiving offlabel treatment with denosumab. She received one-year course of SC denosumab 120mg monthly, with additional loading dose on day 8 (she missed her scheduled day 15 loading dose). Concomitantly, she received calcium carbonate and colecalciferol [vitamin-D supplementation]. In the first month of therapy, she exhibited denosumab-related asymptomatic grade 2 hypocalcaemia along with hypophosphataemia. Denosumab was withdrawn. Within 2 months, her serum calcium level normalised without any treatment. Five months after her last dose of denosumab, she was admitted with serum calcium of 15.5 mg/dL indicating grade 3–4 rebound hypercalcaemia (symptoms comprised severe diffuse abdominal pain, vomiting and nausea), requiring hospitalisation. The girl received furosemide, calcitonin and bisphosphonates for the reduction of serum calcium levels. Following discharge, her serum calcium levels normalised. However, the in the subsequent month, she experienced 2 episodes of asymptomatic hypercalcaemia, which normalised with furosemide therapy. At the time of report, her serum calcium levels had been normal. Patient number 3: The 12-year-old girl, who had cherubism, started receiving off-label treatment with SC denosumab 120mg monthly, scheduled for 1 year, with additional loading doses on day 8 and 15. Over the course of a year she had received a total of 13 doses of denosumab. Concomitantly, she received calcium carbonate and colecalciferol. Within 1 month after starting denosumab therapy, her pain and oral bleeding (symptoms of cherubism) resolved completely. Subsequently, she developed denosumab-related grade 3 hypocalcaemia (symptoms comprised numbness in hands, generalised weakness and tingling) requiring hospitalisation. Additionally, she developed denosumab-related hypophosphatemia; however, her serum parathyroid hormone levels were normal. Her serum alkaline phosphatase initially increased in response to denosumab therapy before subsequently decreasing. Therefore, the dose of denosumab was decreased to 60mg monthly. After 10 months of therapy, she was started on a weaning schedule to gradually discontinue denosumab. She received her 11th dose 2 months after dose 10, and her 12th dose 2 months after dose 11. Dose 13 was planned to be administered 3 months after her dose 12. At the time of report, her final dose would be 4 months after the previous dose [not all outcomes stated]. Author comment: "[W]e present our experience treating 3 pediatric patients off‐label with denosumab". "Toxicities associated with treatment included. . .(CTCAE v4.0) grade 2 hypocalcemia and rebound grade 3 to 4 hypercalcemia". "[T]he
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