Romosozumab
Romosozumab is a monoclonal antibody medication that inhibits sclerostin, a protein that normally suppresses bone formation. It is used to treat osteoporosis in postmenopausal women at high risk for fractures, working by increasing bone formation while modestly decreasing bone resorption.
A sclerostin inhibitor antibody that builds bone density in osteoporosis patients at high fracture risk.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- M05BX06
- RxNorm
- 2123126
- Generic
- Romosozumab
- Class
- atc-m05
- Brands
- Evenity
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Overdose information
Special Populations
14 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
discontinue therapy if pregnancy occurs
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid
avoid use near term due to potential effects on fetal bone development
fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot applicable
discontinue breastfeeding or discontinue drug, considering importance of drug to mother
monitor infant for adverse effects
geriatric
elderly 65no dose adjustment required
can be used in elderly patients at recommended dose
monitor for cardiovascular events as per boxed warning
geriatric
elderly 75individualize therapy
use with caution, assess cardiovascular risk before initiating
monitor cardiovascular status and bone mineral density
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsnot applicable
not indicated for use in pediatric patients under 18 years
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
infantsnot applicable
not indicated for use in infants
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild renal impairmentno dose adjustment required
can be used at standard dose
standard monitoring
renal_impairment
moderate renal impairmentuse with caution
use with caution, consider risks versus benefits
monitor renal function periodically
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentuse with caution
limited clinical data, use only if benefits outweigh risks
close monitoring of renal function and adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentunknown
use with caution, limited data available
monitor for adverse effects
hepatic_impairment
moderate hepatic impairmentnot studied
use not recommended due to lack of data
monitor closely if used
hepatic_impairment
severe hepatic impairmentnot studied
not recommended
not applicable
Statistics and clinical data
Drug class
Classification under FDA drug database
Primary indication
Therapeutic indication approved by FDA
FDA approval year
FDA regulatory approval timeline
Mechanism of action
Pharmacological mechanism of action
Treatment of osteoporosis in postmenopausal women at high risk for fractures, including those with a history of osteoporotic fractures or who have failed other osteoporosis therapies.
Romosozumab is a humanized monoclonal antibody that binds to and inhibits sclerostin, a negative regulator of bone formation. By blocking sclerostin, it promotes bone formation by osteoblasts and, to a lesser extent, reduces bone resorption by osteoclasts, resulting in increased bone mass and strength.
Administered as monthly subcutaneous injections by a healthcare professional. Carries a boxed warning for potential increased risk of cardiovascular events. Typically used as a second-line agent after other osteoporosis treatments and for a limited duration of 12 months due to cardiovascular safety concerns.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy