Xgeva

Denosumab

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults w/ advanced malignancies involving bone. Treatment of adults & skeletally mature adolescents w/ giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

SC Prevention of skeletal related events in adults w/ advanced malignancies involving bone 120 mg single dose once every 4 wk into thigh, abdomen or upper arm. Giant cell tumour of bone 120 mg single dose once every 4 wk into thigh, abdomen or upper arm, w/ additional 120 mg doses on days 8 & 15 of 1st mth of therapy.

Hypersensitivity. Severe, untreated hypocalcaemia. Unhealed lesions from dental or oral surgery.

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, particularly in patients w/ risk factors eg, osteoporosis or prior fractures. 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 patients w/ giant cell tumour of bone for radiologic signs of malignancy, new radiolucency or osteolysis. Should not be concomitantly used w/ other denosumab-containing products (for osteoporosis indications); bisphosphonates. 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. Patients w/ hepatic impairment. Not recommended in pregnant women & women of child-bearing potential not using contraception. Lactation. Not recommended in paed patients <18 yr other than skeletally mature adolescents (12-17 yr) w/ giant cell tumour of bone.

Hypocalcaemia; dyspnoea; diarrhoea; musculoskeletal pain. New primary malignancy; hypophosphataemia; tooth extraction; hyperhidrosis, alopecia, osteonecrosis of the jaw.

Agents Affecting Bone Metabolism

M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.

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