Xgeva適治華

Xgeva

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Denosumab
Indications/Uses
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.
Dosage/Direction for Use
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.
Contraindications
Hypersensitivity. Severe, untreated hypocalcaemia. Unhealed lesions from dental or oral surgery.
Special Precautions
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.
Adverse Reactions
Hypocalcaemia; dyspnoea; diarrhoea; musculoskeletal pain. New primary malignancy; hypophosphataemia; tooth extraction; hyperhidrosis, osteonecrosis of the jaw.
ATC Classification
M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Presentation/Packing
Form
Xgeva soln for inj 120 mg/1.7 mL (70 mg/mL)
Packing/Price
1's
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