Dnoclast

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

SC Inj into the thigh, abdomen or upper arm. Supplementation of Ca & vit D daily unless hypercalcaemia is present. Adult Giant cell tumour of bone 120 mg as single inj once every 4 wk w/ additional 120 mg doses on days 8 & 15 of 1st mth of therapy. Prevention of skeletal related events w/ advanced malignancies involving bone 120 mg as single inj once every 4 wk.

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

Not recommended in patients w/ growing skeletons. Consider therapy discontinuation if atypical femur fracture is suspected; temporary treatment interruption in patients who develop osteonecrosis of the jaw (ONJ) until condition resolves & contributing risk factors are mitigated. Delay start of treatment/new treatment course in patients w/ unhealed open soft tissue lesions in the mouth. Severe symptomatic hypocalcaemia (most cases occurring in 1st wk of initiating therapy). Osteonecrosis of external auditory canal; possible risk factors include steroid use, chemotherapy &/or infection or trauma. Atypical femoral fractures w/ little or no trauma in subtrochanteric & diaphyseal regions of femur & w/ certain co-morbid conditions (eg, vit D deficiency, RA, hypophosphatasia) & w/ use of certain pharmaceutical agents (eg, bisphosphonates, glucocorticoids, PPIs). Correct pre-existing hypocalcemia prior to initiating therapy. Monitor Ca levels prior to initial dose, w/in 2 wk after initial dose & if suspected symptoms of hypocalcaemia occur. Consider additional Ca level monitoring during therapy in patients w/ risk factors for hypocalcaemia, or if otherwise indicated based on clinical condition of patient. Regularly monitor Ca levels especially in patients w/ accompanying parathyroid hormone elevations w/ increasing renal impairment. Perform dental exam w/ preventive dentistry & individual benefit-risk assessment prior to treatment; invasive dental procedures while on treatment & avoid in close proximity to treatment administration. Evaluate patient's risk of developing ONJ eg, potency of medicinal product, route of administration & cumulative dose of bone resorption therapy, cancer, co-morbid conditions, smoking, concomitant therapies w/ corticosteroids, chemotherapy, angiogenesis inhibitors, RT to head & neck, poor oral hygiene, periodontal disease, poorly fitting dentures, pre-existing dental disease, invasive dental procedures. Maintain good oral hygiene, receive routine dental check-ups, & immediately report any oral symptoms eg, dental mobility, pain or swelling, or non-healing of sores or discharge during treatment. Report new or unusual thigh, hip, or groin pain. Monitor for signs & symptoms of hypercalcaemia & consider periodic assessment of serum Ca & re-evaluate Ca & vit D supplementation requirements; radiological signs of malignancy, new radiolucency or osteolysis. Contains sorbitol (or fructose). Not to be treated concomitantly w/ other denosumab containing medicinal products indicated for osteoporosis; bisphosphonates. Severe renal impairment (CrCl <30 mL/min) or receiving dialysis. Hepatic impairment. Not recommended in pregnant women & women of child-bearing potential not using contraception. Advise women not to become pregnant during & for at least 5 mth after treatment. Lactation. Not recommended in paed patients <18 yr other than skeletally mature adolescents (12-17 yr) w/ giant cell tumour of bone.

Hypocalcaemia; dyspnoea; musculoskeletal pain. New primary malignancy; hypophosphataemia; tooth extraction; hyperhidrosis; ONJ.

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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