Osvyrti is a medicine used to treat: * osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones). In women who have been through the menopause, Osvyrti reduces the risk of fractures in the spine and elsewhere in the body, including in the hip; * bone loss in men receiving treatment for prostate cancer that increases their risk of fractures. Osvyrti reduces the risk of fractures in the spine; * bone loss in adults at increased risk of fractures due to long term treatment with corticosteroid medicines given by mouth or injection. Osvyrti contains the active substance denosumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Osvyrti is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Osvyrti is Prolia.
Therapeutic Indication
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab 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. In men with prostate cancer receiving hormone ablation, denosumab 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.
Therapeutic Area (MeSH)
ATC Code
M05BX04
ATC Item
N/A
Pharmacotherapeutic Group
Drugs for treatment of bone diseases
Active Substance (Summary)
N/AINN / Common Names
EMA Name
Osvyrti
Medicine Name
Osvyrti
Aliases
N/ANo risk management plan link.
