Romosozumab 105mg/1.17ml solution for injection pre-filled disposable devices
Requires a prescription from a doctor or prescriber
Romosozumab is a humanized monoclonal antibody indicated for the treatment of osteoperosis in postmenopausal women at high risk of fracture and patients who have failed in other treatments or are intolerant to other osteoperosis therapies[L9554].
Safety information for pregnancy and breastfeeding
Pregnancy
Breastfeeding
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
Report a side effect
Submit a Yellow Card report to the MHRA
Official medicine documents
Yellow Card
Report side effects (MHRA)
Drug safety updates
MHRA alerts for Romosozumab
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Romosozumab
Browse all iDAP reports
Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Romosozumab
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Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Romosozumab on the MHRA register
Evenity 105mg/1.17ml solution for injection pre-filled pens
WHO defined daily dose (DDD)
7 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(3)
Romosozumab for treating severe osteoporosis (TA791)
Abaloparatide for treating osteoporosis after menopause (TA991)
Osteoporosis (QS149)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 29 · Randomised trials: 14 · 2014–2026
Showing the 50 most relevant studies, sorted by most relevant.
Sarah Davis, Emma Simpson, Jean Hamilton, et al.
Health Technology Assessment, 2020
Bente L Langdahl, Cesar Libanati, Daria B Crittenden, et al.
The Lancet, 2017
E Michael Lewiecki, Tomasz Blicharski, Stefan Goemaere, et al.
The Journal of Clinical Endocrinology & Metabolism, 2018
Fang Lv, Xiaoling Cai, Wenjia Yang, et al.
Bone, 2020
Shih-Hao Cheng, William C. Chu, Wen-Hsiang Chou, et al.
Drug Safety, 2024
E.L. Simpson, Marrissa Martyn-St James, Jean Hamilton, et al.
Bone, 2020
Sara Kaveh, Hossein Hosseinifard, Nashmil Ghadimi, et al.
Clinical Rheumatology, 2020
Ge Gao, J. Cui, Yuanyuan Xie, et al.
Frontiers in Medicine, 2024
B. Ferrer, M. García, Sara Rojas Herrera, et al.
Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases, 2025
Mingwei Hu, Yifan Zhang, Jianjun Guo, et al.
Frontiers in Endocrinology, 2023
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
12.8 days
Mechanism
Osteocytes secrete sclerostin which inhibits bone formation by binding to low-de…
Food interactions
2 warnings
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
2 to 7 days
[L9554]
…
Half-life
12.8 days
[L9554]
Protein binding
10%
[A31470][A177074]
…
Volume of distribution
3.92L
[L9554]
Metabolism
[L9554]
…
Elimination
[A31470][A177074]
…
Clearance
0.38mL
[L9554]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
[L9554]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 378 interactions
[L9554]
However, patients with severe renal impairment or who are on dialysis are at an increased risk of hypocalcemia.
[L9554]
A patient's weight will affect their level of romosozumab exposure.
[L9554]
Romosozumab has not been shown to be associated with carcinogenicity or impairment of fertility, and is not expected to be mutagenic.
[L9554]
Romosozumab is not indicated in pregnancy, lactation, or pedatric patients.
[L9554]
Romosozumab is associated with skeletal defects in the offspring of rats given romosozumab and is detected in the excreted milk.
[L9554]
Romosozumab is currently undergoing post marketing surveillance to ensure the risk of major adverse cardiac events is not being underestimated.
[L5924]
There is currently an expected hazard ratio of 1.30 compared to current treatments for osteoporosis, though hip and vertebral fractures may have an equal impact on overall quality of life.
[L5924]
Romosozumab targets and inhibits the protein sclerostin, thereby preventing inhibition of bone formation by allowing Wnt to bind to LDL receptor-related proteins 5 and 6[A177056][A177062]. Activation of the Wnt pathways leads to downstream signalling, translocation of beta catenin to the osteoblast nucleus where it promotes survival and proliferation of osteoblasts[A177062].
Sclerostin also promotes bone resorption through increasing production of receptor activator of nuclear factor kappa-beta-ligand (RANKL)[A177062].
Romosozumab's inhibition of sclerostin also inhibits the increase in RANKL dependant increases in osteoclast activity and bone resorption[A177056][A177062]. Both effects from the same therapy have not been seen in other osteoporosis treatments to date[A177056].
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L9554]
Subcutaneous bioavailability is 50 to 70%.
[A177056][A177062]
[L9554]
[A31470][A177074]
In about 10%[A177062] to 18.1%[L9554] of cases patients develop antibodies against romosozumab. 4.7% of the patients developed neutralizing antibodies.
[L9554]
The presence of antibodies against romosozumab can reduce the availability of romosozumab by 22%, and 63% in the case of neutralizing antibodies.
[L9554]
[L9554]
[L9554]
[A31470][A177074]
[L9554]
Proteins and enzymes this drug interacts with in the body
ATC M05BX06
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Romosozumab
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72