XGEVA SOLUTION FOR INJECTION 120 MG/VIAL [SIN14116P]

Product Info

XGEVA SOLUTION FOR INJECTION 120 MG/VIAL

[SIN14116P]

4.1 Therapeutic indications

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with multiple myeloma and in patients with bone metastases from solid tumours.

Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Severe, untreated hypocalcaemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).