The recommended dose of Denosumab (Prolia) is a single subcutaneous injection 60 mg administered once every 6 months.
Patients should receive calcium and vitamin D supplements whilst undergoing treatment.
Populations: Children: Denosumab (Prolia) is not recommended in paediatric patients as the safety and effectiveness of Denosumab (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: Pre-Clinical 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 hypocalcemia. 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 Denosumab (Prolia) have not been studied in patients with hepatic impairment.
Administration: Administration should be performed by an individual who has been adequately trained in injection techniques.