Burosumab
Burosumab is a monoclonal antibody medication designed to treat X-linked hypophosphatemia (XLH), a rare genetic disorder characterized by abnormally low phosphate levels in the blood. It works by binding to and neutralizing fibroblast growth factor 23 (FGF23), a hormone that when present in excess, causes the kidneys to excrete too much phosphate and produce insufficient active vitamin D.
Burosumab treats X-linked hypophosphatemia by blocking FGF23, allowing the kidneys to reabsorb phosphate and normalize vitamin D production.
Key facts at a glance
- ATC
- M05BX05
- RxNorm
- 2043855
- Generic
- Burosumab
- Class
- atc-m05
- Brands
- Crysvita
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- 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
- 0.5 mg/kg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.8 mg/kg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.5 mg/kg every 2 weeks
- Maximum
- consult physician
- Frequency
- every 2 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
use only if clearly needed, benefits outweigh potential risks
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
continue only if benefits outweigh risks
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
consider discontinuation near term due to potential fetal exposure
regular fetal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment
decide whether to discontinue nursing or discontinue drug
monitor infant for adverse effects
geriatric
elderlyno adjustment
no specific dose adjustment required based on age
standard monitoring
pediatric_age
children 1 to 12 yearsweight-based dosing
approved for pediatric patients 1 year and older with XLH
regular serum phosphorus monitoring, periodic renal ultrasound
renal_impairment
mild to moderateno adjustment
no dose adjustment needed for mild to moderate renal impairment
standard monitoring
hepatic_impairment
mild to moderateuse with caution
use with caution, no formal studies conducted
monitor for efficacy and adverse effects
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Biological classification of Burosumab
FDA approval year
Regulatory approval timeline for Crysvita
Primary indication
Approved therapeutic indication
Mechanism of action
Pharmacological mechanism of action
Burosumab is indicated for the treatment of X-linked hypophosphatemia (XLH) in adults and children aged 1 year and older. It may also be used for tumor-induced osteomalacia, a similar condition caused by phosphate-wasting tumors.
Burosumab is a human monoclonal antibody that binds specifically to FGF23, preventing it from interacting with its receptor. By inhibiting FGF23, burosumab restores normal renal phosphate reabsorption and increases the production of 1,25-dihydroxy vitamin D, thereby improving phosphate levels and bone mineralization.
Burosumab is administered as a subcutaneous injection, typically under the supervision of a healthcare provider. Regular monitoring of serum phosphate and calcium levels is required to ensure therapeutic effectiveness and avoid hyperphosphatemia. Common side effects may include injection site reactions, headache, and tooth abscesses. Patients should be advised about the risk of hypersensitivity reactions and the importance of adherence to monitoring schedules.
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