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denosumab

Prolia, Xgeva · ATC code M05BX04

Key facts
Active substance
denosumab
ATC code
M05BX04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Prolia 60 mg solution for injection in pre-filled syringe · XGEVA 120 mg solution for injection / XGEVA 120 mg solution for injection in pre-filled syringe
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-27

Key facts

Denosumab is a monoclonal antibody against RANKL that inhibits bone resorption. As Prolia it is used for osteoporosis and bone loss; as XGEVA for bone metastases and giant cell tumour of bone.

What it is used for

  • Prolia: osteoporosis in postmenopausal women and in men at increased risk of fractures
  • Prolia: bone loss from hormone ablation in prostate cancer and from long-term systemic glucocorticoid therapy
  • XGEVA: prevention of skeletal related events in adults with advanced malignancies involving bone
  • XGEVA: unresectable giant cell tumour of bone in adults and skeletally mature adolescents

Dosing

  • Prolia: 60 mg subcutaneously once every 6 months (thigh, abdomen or upper arm); adequate calcium and vitamin D supplementation
  • Prolia: need for continued treatment re-evaluated periodically, particularly after 5 or more years
  • XGEVA, bone metastases: 120 mg subcutaneously once every 4 weeks
  • XGEVA, giant cell tumour: 120 mg every 4 weeks, plus 120 mg on days 8 and 15 of the first month
  • XGEVA: at least 500 mg calcium and 400 IU vitamin D daily unless hypercalcaemia is present
  • No dose adjustment in renal impairment or the elderly; Prolia not used in children under 18 years

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Prolia: hypocalcaemia
  • XGEVA: severe, untreated hypocalcaemia; unhealed lesions from dental or oral surgery

Important warnings

  • Correct hypocalcaemia before starting; severe symptomatic cases including fatal ones reported, mostly in the first weeks
  • Calcium monitoring before the first dose and within two weeks after it (in predisposed patients or with XGEVA)
  • Osteonecrosis of the jaw and atypical femoral fractures
  • Concomitant glucocorticoids are an additional risk factor for hypocalcaemia

Side effects

  • Prolia: very common musculoskeletal pain and pain in the extremity; common urinary and upper respiratory tract infections
  • Prolia: uncommon cellulitis; rare hypocalcaemia, hypersensitivity, osteonecrosis of the jaw, atypical femoral fractures
  • XGEVA: very common hypocalcaemia (mostly within the first 2 weeks) and musculoskeletal pain; osteonecrosis of the jaw commonly observed

Interactions

  • Prolia: no effect on the pharmacokinetics of midazolam (CYP3A4)
  • XGEVA: no interaction studies; no clinically relevant changes with chemotherapy or hormone therapy

Pregnancy and breastfeeding

  • Not recommended in pregnancy or in women not using contraception; avoid pregnancy for at least 5 months after treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • Acvybra · biosimilarReddy Holding GmbH · EMEA/H/C/006734
  • Bildyos · biosimilarSciencepharma Sp. z o.o · EMEA/H/C/006434
  • Bilprevda · biosimilarSciencepharma Sp. z o.o · EMEA/H/C/006435
  • Bomyntra · biosimilarFresenius Kabi Deutschland GmbH · EMEA/H/C/006269
  • Conexxence · biosimilarFresenius Kabi Deutschland GmbH · EMEA/H/C/006268
  • Degevma · biosimilarTeva GmbH · EMEA/H/C/006239
  • Denbrayce · biosimilarMabxience Research SL · EMEA/H/C/006199
  • Denosumab Ascend · biosimilarAscend GmbH · EMEA/H/C/006626
  • Enwylma · biosimilarZentiva k.s. · EMEA/H/C/006376
  • Evfraxy · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/006526
  • Izamby · biosimilarMabxience Research SL · EMEA/H/C/006152
  • Jubbonti · biosimilarSandoz GmbH · EMEA/H/C/005964
Show all 31 brand names

Source: European Medicines Agency (EMA), product information

Turkey

  • DnoclastABBOTT LABORATUARLARI İTHALAT İHRACAT VE TİC. LTD. ŞTİ. · 1 register entry
  • ProliaAMGEN İLAÇ TİC. LTD. ŞTİ. · 1 register entry
  • ResynivABBOTT LABORATUARLARI İTHALAT İHRACAT VE TİC. LTD. ŞTİ. · 1 register entry
  • XgevaAMGEN İLAÇ TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Bildyos, Bilprevda, Bomyntra, Conexxence, Degevma, Denbrayce, Denosumab Intas, Enwylma, Evfraxy, Izamby, Jubbonti, Jubereq, Junod, Kefdensis, Osenvelt, Osqay, Osvyrti, Ponlimsi, Prolia, Rolcya, Stoboclo, Vevzuo, Wyost, Xgeva, Yaxwer, Zadenvi, Zvogra
Liechtenstein
Bildyos, Bilprevda, Bomyntra, Conexxence, Degevma, Denbrayce, Denosumab Intas, Enwylma, Evfraxy, Izamby, Jubbonti, Jubereq, Junod, Kefdensis, Osenvelt, Osqay, Osvyrti, Ponlimsi, Rolcya, Stoboclo, Vevzuo, Wyost, Yaxwer, Zadenvi, Zvogra
Norway
Bildyos, Bilprevda, Bomyntra, Conexxence, Degevma, Denbrayce, Denosumab Intas, Enwylma, Evfraxy, Izamby, Jubbonti, Jubereq, Junod, Kefdensis, Osenvelt, Osqay, Osvyrti, Ponlimsi, Prolia, Rolcya, Stoboclo, Vevzuo, Wyost, Xgeva, Yaxwer, Zadenvi, Zvogra

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Prolia – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/prolia-epar-product-information_en.pdf
  2. European Medicines Agency. Xgeva – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xgeva-epar-product-information_en.pdf
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.