Zadenvi is a medicine used to treat the following conditions: * 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 Zadenvi reduces the risk of fractures in the spine and elsewhere in the body, including the hip; * bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Zadenvi reduces the risk of fractures in the spine; * bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection. Zadenvi contains the active substance denosumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Zadenvi is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Zadenvi 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 (see section 5\.1\). In men with prostate cancer receiving hormone ablation, ZADENVI 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\).
Therapeutic Area (MeSH)
ATC Code
M05BX04
ATC Item
N/A
Pharmacotherapeutic Group
Drugs for treatment of bone diseases
Active Substance (Summary)
INN / Common Names
EMA Name
Zadenvi
Medicine Name
Zadenvi
Aliases
N/ANo risk management plan link.
