Naxitamab
Naxitamab is a monoclonal antibody medication designed to treat neuroblastoma by targeting the GD2 glycolipid antigen found on cancer cells. It is indicated for relapsed or refractory high-risk neuroblastoma, typically administered in combination with GM-CSF. The drug works by binding to GD2 on tumor cells, enabling the immune system to recognize and destroy neuroblastoma cells.
Naxitamab is a targeted antibody therapy for relapsed or refractory neuroblastoma that binds to GD2 on cancer cells to facilitate their destruction by the immune system.
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
- L01FX21
- RxNorm
- 2474039
- Generic
- Naxitamab
- Class
- atc-l01
- Brands
- Danyelza
- 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
- 9 mg/kg per dose
- Maximum
- consult physician
- Frequency
- days 1, 3, and 5 of each 28-day cycle
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 9 mg/kg per dose
- Maximum
- consult physician
- Frequency
- days 1, 3, and 5 of each 28-day cycle
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 9 mg/kg per dose
- Maximum
- consult physician
- Frequency
- days 1, 3, and 5 of each 28-day cycle
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring via ultrasound
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near term as IgG antibodies can cross placenta
fetal monitoring and assessment of newborn
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingno adjustment needed
discontinue breastfeeding during treatment and for at least 6 months after last dose
monitor infant for signs of immune suppression
Use with caution and monitor for adverse effects.
pediatric_age
children 1 year and olderweight-based dosing
approved for pediatric patients 1 year and older with high-risk neuroblastoma
monitor for infusion-related reactions and neurotoxicity
geriatric
elderlyno specific adjustment
use with caution due to limited clinical data in elderly populations
monitor renal and hepatic function, watch for infusion reactions
Use with caution and monitor for adverse effects.
renal_impairment
moderate to severeno adjustment needed
no formal dose adjustment required; monoclonal antibodies are not renally excreted as intact molecules
standard monitoring
hepatic_impairment
mild to moderateno specific adjustment
use with caution; monoclonal antibodies are metabolized via proteolysis not hepatic CYP enzymes
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Original FDA approval date for Naxitamab (Danyelza)
Therapeutic class
Classification as anti-GD2 monoclonal antibody for neuroblastoma treatment
Indication
FDA-approved indication in combination with GM-CSF
Target
Mechanism of action targeting GD2 antigen on neuroblastoma cells
Naxitamab is indicated for the treatment of relapsed or refractory high-risk neuroblastoma in patients aged 1 year and older who have demonstrated partial response, minor response, or stable disease to prior therapy. It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF).
Naxitamab is a monoclonal antibody that specifically binds to GD2, a disialoganglioside that is overexpressed on neuroblastoma cells and certain normal cells of neuroectodermal origin. By binding to GD2 on cancer cells, naxitamab enables immune recognition and destruction of tumor cells.
Naxitamab carries a risk of serious adverse reactions including severe pain (neuropathic pain), infusion-related reactions, and neurotoxicity. Patients require pre-medication for pain management and careful monitoring during and after infusion. Treatment should be administered by healthcare professionals experienced in managing neuroblastoma and its complications.
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