XGEVA Solution for Injection 120 mg/vial

INJECTION, SOLUTION

**4.2 Posology and method of administration** XGEVA should be administered under the responsibility of a healthcare professional. Posology Supplementation of at least 500 mg calcium and 400 international units vitamin D is required in all patients, unless hypercalcaemia is present (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours_ The recommended dose of XGEVA is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm. _Giant cell tumour of the bone_ The recommended dose of XGEVA is 120 mg administered as a subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm, with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy. _Renal impairment_ No dose adjustment is required in patients with renal impairment (see section 4.4 for recommendations relating to monitoring of calcium, 4.8 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In clinical studies of patients without advanced cancer with varying degrees of renal function (including severe renal impairment \[creatinine clearance < 30 ml/min\] or receiving dialysis) there was a greater risk of developing hypocalcaemia with increasing degree of renal impairment and in the absence of calcium supplementation. Monitoring calcium levels and adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_ The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Elderly patients (age ≥ 65)_ No dose adjustment is required in elderly patients (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of XGEVA have not been established in paediatric patients (age < 18) other than skeletally mature adolescents (aged 13 – 17 years) with giant cell tumour of bone. XGEVA is not recommended for use in paediatric patients other than skeletally mature adolescents (aged 13 – 17 years) with giant cell tumour of bone (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). XGEVA was studied in a phase II open-label trial that enrolled a subset of 28 paediatric patients (aged 13 – 17 years) with giant cell tumour of bone who had reached skeletal maturity defined by at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus) and body weight ≥ 45 kg. In animal studies, inhibition of RANK/RANK ligand (RANKL) with a construct of osteoprotegerin bound to Fc (OPG-Fc) has been coupled to inhibition of bone growth and lack of tooth eruption (see section 5.3 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Therefore, treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition. Method of administration For subcutaneous use. For instructions for use, handling and disposal see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.