Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.
Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).
The recommended dose of Prolia is 60 mg 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 section 4.4).
Patients treated with Prolia 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 section 4.4).
No dose adjustment is required in patients with renal impairment (see section 4.4 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).
The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
No dose adjustment is required in elderly patients.
Prolia is not recommended in paediatric patients (age <18) as the safety and efficacy of Prolia in these patients have not been established. Inhibition of RANK/RANK ligand (RANKL) in animal studies has been coupled to inhibition of bone growth and lack of tooth eruption (see section 5.3).
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 section 6.6.
There is no experience with overdose in clinical studies. Denosumab has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.
Shelf life: 3 years.
Once removed from the refrigerator, Prolia may be stored at room temperature (up to 25°C) for up to 30 days in the original container. It must be used within this 30 days period.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep the container in the outer carton in order to protect from light.
One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle, with or without needle guard.
The needle cover of the pre-filled syringe contains dry natural rubber, which is a derivative of latex (see section 4.4).
Pack size of one pre-filled syringe, presented in blistered (pre-filled syringe with or without a needle guard) or unblistered packaging (pre-filled syringe without a needle guard only).
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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