Denosumab
Denosumab is a monoclonal antibody medication used to treat conditions involving excessive bone loss, such as osteoporosis and bone metastases. It works by targeting and blocking RANKL, a protein essential for osteoclast formation and activity, thereby reducing bone breakdown. This medication is administered as a subcutaneous injection and is prescribed for patients at high risk of fractures or skeletal complications.
Denosumab is a RANKL inhibitor monoclonal antibody that reduces bone resorption by preventing osteoclast activation, used primarily for osteoporosis and bone metastases.
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
- M05BX04
- RxNorm
- 993449
- Generic
- Denosumab
- Class
- atc-m05
- Brands
- Xgeva, Wyost, Jubbonti, Conexxence, Bomyntra, Stoboclo, Osenvelt, Bilprevda, Bildyos, Ospomyv, Enoby, Xtrenbo, Bosaya, Aukelso, Xbryk
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe, injection, solution
- 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.
Dosage and administration
- Usual dose
- 60mg
- Maximum
- consult physician
- Frequency
- every 6 months
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 120mg
- Maximum
- consult physician
- Frequency
- every 4 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 60mg
- Maximum
- consult physician
- Frequency
- every 6 months
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks. Women of childbearing potential should use effective contraception during treatment and for at least 5 months after last dose.
regular fetal monitoring
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 and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near term due to risk of neonatal hypocalcemia
monitor neonatal calcium levels at birth
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot recommended
discontinue breastfeeding or discontinue drug, considering importance of drug to mother
monitor infant calcium levels if exposure occurs
geriatric
elderlyno dosage adjustment required
use standard dosing. Monitor renal function and calcium levels regularly.
regular monitoring of serum calcium and renal function
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsnot recommended
not approved for use in pediatric patients. Studies showed increased risk of skeletal abnormalities in juvenile animals.
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
severe renal impairmentno dosage adjustment needed but requires monitoring
supplement with calcium and vitamin D. Monitor serum calcium more frequently.
frequent serum calcium monitoring before and during treatment
Use with caution and monitor for adverse effects.
renal_impairment
mild moderate renal impairmentno dosage adjustment required
ensure adequate calcium and vitamin D intake. Monitor calcium levels.
periodic serum calcium monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentno specific guidance
use with caution. No clinical studies in patients with hepatic impairment.
monitor clinical response and adverse effects
hepatic_impairment
severe hepatic impairmentnot recommended
not studied - avoid use unless benefits outweigh risks
monitor for efficacy and safety
Statistics and clinical data
Drug class
Drug class information
Mechanism of action
Pharmacological mechanism
Common uses
Therapeutic indications
FDA approval year
Regulatory approval information
Treatment of osteoporosis in postmenopausal women at high risk for fractures, giant cell tumor of bone, hypercalcemia of malignancy, and prevention of skeletal-related events in patients with solid tumors metastatic to bone.
Denosumab is a fully human monoclonal antibody that binds with high affinity to RANKL, preventing it from interacting with its receptor RANK on osteoclasts and their precursors. This inhibits osteoclast formation, function, and survival, resulting in decreased bone resorption and increased bone density.
Administered as a subcutaneous injection every 6 months for osteoporosis indications. Requires adequate calcium and vitamin D supplementation. Can cause hypocalcemia, particularly in patients with renal impairment. Associated with risks of osteonecrosis of the jaw and atypical femoral fractures. Must not be discontinued without medical advice as bone density may rapidly decline. Not recommended during pregnancy.
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