Xgeva Dosage/Direction for Use

XGEVA should be administered under the responsibility of a healthcare professional.
Posology: Supplementation of at least 500 mg calcium and 400 IU vitamin D daily is required in all patients, unless hypercalcaemia is present (see Precautions).
Prevention of skeletal-related events in adults with multiple myeloma and bone metastasis from solid tumours: The recommended dose is 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm.
Giant cell tumour of bone: 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 with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy.
Patients in the phase II study who underwent complete resection of giant cell tumour of bone did receive an additional 6 months of treatment following the surgery as per study protocol.
Patients with giant cell tumour of bone should be evaluated at regular intervals to determine whether they continue to benefit from treatment. In patients whose disease is controlled by XGEVA, the effect of interruption or cessation of treatment has not been evaluated, however limited data in these patients does not indicate a rebound effect upon cessation of treatment.
Renal impairment: No dose adjustment is required in patients with renal impairment (see Precautions for recommendations relating to monitoring of calcium, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly patients (age ≥ 65): No dose adjustment is required in elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of XGEVA have not been evaluated in paediatric patients (age < 18) other than skeletally mature adolescents (aged 12-17 years) with giant cell tumour of bone.
XGEVA is not recommended in paediatric patients (age < 18) other than skeletally mature adolescents (aged 12-17 years) with giant cell tumour of bone (see Precautions).
Treatment of skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity: the posology is the same as in adults.
Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption, and these changes were partially reversible upon cessation of RANKL inhibition (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Method of administration: For subcutaneous use.
For instructions for use, handling and disposal see Special precautions for disposal and other handling under Cautions for Usage.