Daily supplementation of at least 500 mg Ca & 400 IU vit D is required, unless hypercalcaemia is present. Risk of hypocalcaemia; osteonecrosis of the jaw & external auditory canal; atypical femoral fractures. Multiple vertebral fractures may occur following discontinuation of treatment. Risk of clinically significant hypercalcaemia wk to mth following treatment discontinuation in patients w/ giant cell tumour of bone & in patients w/ growing skeletons. Monitor for radiologic signs of malignancy, new radiolucency or osteolysis. Concomitant use w/ other denosumab-containing products; biphosphonates. Rare hereditary problems of fructose intolerance. Patients w/ severe renal impairment (CrCl <30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia. Hepatic impairment. Pregnancy & lactation. Not recommended in paed patients <18 yr other than skeletally mature adolescents w/ giant cell tumour of bone.