Prolia Solution for Injection 60 mg/ml (Prefilled Syringe)

INJECTION, SOLUTION

**Dosage and Administration** Administration Administration should be performed by an individual who has been adequately trained in injection techniques. Dosage The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. All patients should receive calcium 1,000 mg daily and at least 400 international units vitamin D daily whilst undergoing treatment. If a dose of Prolia is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection. Populations _Children_ Prolia is not indicated for use in paediatric patients. In clinical trials, hypercalcemia has been reported very commonly in paediatric patients with osteogenesis imperfecta treated with denosumab. Some cases required hospitalisation and were complicated by acute renal injury (see Warnings and Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 Pre-Clinical Safety Data – _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. _Elderly_ Based on the available safety and efficacy data in the elderly, no dosage adjustment is required (see Pharmacokinetics: Special Patient Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal Impairment_ Based on the available safety and efficacy data in the elderly, no dosage adjustment is required in patients with renal impairment (see Pharmacokinetics: Special Patient Populations – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 mL/min). Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia. Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis. _Hepatic Impairment_ The safety and efficacy of Prolia have not been studied in patients with hepatic impairment.