Zuellig Pharma
Concise Prescribing Info
Prevention of skeletal related events (pathological fracture, bone radiation, spinal cord compression or bone surgery) in patients w/ multiple myeloma & bone metastases from solid tumours. Adults & skeletally mature adolescents w/ giant cell bone tumour that is unresectable or where surgical resection likely results in severe morbidity.
Dosage/Direction for Use
Prevention of skeletal related events in adult w/ multiple myeloma & bone metastasis from solid tumours 120 mg single SC inj once every 4 wk. Giant cell bone tumour 120 mg single SC inj once every 4 wk w/ additional 120 mg doses on days 8 & 15 for 1st mth of therapy.
Hypersensitivity. Severe untreated hypocalcaemia; unhealed lesions from dental or oral surgery.
Special Precautions
Not recommended in patients w/ growing skeletons. Ensure adequate intake of Ca & Vit D to correct hypocalcemia prior to therapy. Osteonecrosis of the jaw (ONJ) & external auditory canal. Atypical femoral & multiple vertebral fractures. Multiple vertebral fractures following discontinuation of treatment. Perform oral & dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Monitor Ca level in patients w/ risk factors for hypocalcaemia. Not to be used concomitantly w/ other denosumab-containing products & bisphosphonates. Fructose intolerance. Severe renal impairment (CrCl <30 mL/min) or dialysis patients. Hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 5 mth after last dose. Not recommended during pregnancy. Lactation. Not recommended in paed <18 yr.
Adverse Reactions
Hypocalcaemia; dyspnoea; diarrhoea; musculoskeletal pain. New primary malignancy; hypophosphataemia; tooth extraction; hyperhidrosis; ONJ.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Xgeva soln for inj 120 mg/1.7 mL
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