Prolia Dosage/Direction for Use

Administration: Administration should be performed by an individual who has been adequately trained in injection techniques.
Dosage: The recommended dose of PROLIA is a single subcutaneous injection of 60 mg administered once every 6 months.
Patients should receive adequate calcium and vitamin D supplements whilst undergoing treatment.
Populations: Children: PROLIA is not recommended in paediatric patients as the safety and efficacy of PROLIA have not been established in the paediatric age group. 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 PHARMACOLOGY: Toxicology: Preclinical safety data under Actions). 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 PHARMACOLOGY: Pharmacokinetics: Special patient populations under Actions).
Renal impairment: Based on the available safety and efficacy data in the elderly, no dosage adjustment is required in patients with renal impairment (see PHARMACOLOGY: Pharmacokinetics: Special patient populations under Actions).
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.