Jubbonti Dosage/Direction for Use

Posology: The recommended dose is 60 mg denosumab administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm.
Patients must be adequately supplemented with calcium and vitamin D (see Precautions).
Patients treated with Jubbonti should be given the package leaflet and the patient reminder card.
The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of denosumab on an individual patient basis, particularly after 5 or more years of use (see Precautions).
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 (glomerular filtration rate [GFR] <30 mL/min).
Patient 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 denosumab have not been studied in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Jubbonti 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). Currently available data for children aged 2 to 17 years are described in Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions.
Method of 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 Special precautions for disposal and other handling under Cautions for Usage.