Prolia

Prolia Dosage/Direction for Use

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Administration: For subcutaneous use.
Administration should be performed by an individual who has been adequately trained in injection techniques.
The instructions for use, handling and disposal are given in Instructions for Use/Handling under Cautions for Usage.
Dosage: The recommended dose of Prolia is a single subcutaneous injection of 60 mg administered once every 6 months.
Patients should receive calcium and vitamin D supplements whilst undergoing treatment.
Populations: Elderly (age ≥65): No dose adjustment is required in elderly patients.
Renal impairment: No dose adjustment is required in patients with renal impairment (see Precautions for recommendations relating to monitoring of calcium).
No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (GFR < 30 mL/min).
Hepatic impairment: The safety and efficacy of Prolia have not been studied in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Prolia should not be used in children aged < 18 years because of safety concerns of serious hypercalcaemia, and potential inhibition of bone growth and lack of tooth eruption (see Precautions and Pharmacology: Toxicology: Preclinical safety data under Actions).
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