Prescription medicine
Naxitamab Brand names: Danyelza
Naxitamab (Danyelza) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the naxitamab FDA label on DailyMed (effective August 7, 2026); every naxitamab label on DailyMed.
Highlights of the record
FDA label of August 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS INFUSION-RELATED.
REACTIONS and NEUROTOXICITY WARNING: SERIOUS INFUSION-RELATED REACTIONS and NEUROTOXICITY See full prescribing information for complete boxed warning Serious Infusion-Related Reactions: DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each DANYELZA infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity ( 2.2 , 2.3 , 4 , 5.1 ). Neurotoxicity: DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity ( 2.2 , 2.3 , 5.2 ). Serious Infusion-Related Reactions DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Infusion reactions of any Grade occurred in 94-100% of patients. Severe infusion reactions occurred in 32-68% and serious infusion reactions occurred in 4 - 18% of patients in DANYELZA clinical studies [see Warnings and Precautions (5.1) ]. Premedicate prior to each DANYELZA infusion as recommended and monitor patients for at least 2 hours following completion of each infusion. […]
Used for
From the label: indications and usageDANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
Forms and strengths
- 40 mg/10ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 241 through July 30, 2026
What is naxitamab used for?
From the label: indications and usageDANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). […]
FDA pharmacologic class: Glycolipid Disialoganglioside-directed Antibody.
Source: FDA drug label (DANYELZA), BTG International Inc., effective August 7, 2026 (SPL set b0f5ee96-369f-4cb9-a783-3bfa70fe8f90), via openFDA; the full label on DailyMed
What does the patient leaflet for naxitamab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DANYELZA?DANYELZA may cause serious side effects, including: Serious infusion-related reactions. DANYELZA can cause serious infusion-related reactions that require immediate medical attention. Infusion-related reactions are common with DANYELZA. Tell your healthcare provider right away if you get any signs or symptoms during or after your DANYELZA infusion, including: swelling of your face, eyes, lips, mouth, or tongue itching redness on your face (flushing) skin rash or hives trouble breathing cough or wheezing noisy high-pitched breathing feeling faint or dizziness (low blood pressure) Nervous system problems. Talk to your healthcare provider right away if you have new symptoms or worsening of nervous system problems, including: Severe pain from nerves (neuropathic pain), including pain in the belly (abdomen), bone, neck, legs or arms. Pain is common with DANYELZA and can be severe. Inflammation of the spinal cord. Signs or symptoms may include: weakness in your legs or arms bladder and bowel problems pain in back, legs, or stomach (abdomen) numbness tingling burning sensation Reversible Posterior Leukoencephalopathy Syndrome (RPLS – also known as Posterior Reversible Encephalopathy Syndrome - PRES). PRES is a condition that affects the brain. Your healthcare provider will monitor your blood pressure and check for any neurologic symptoms after your DANYELZA infusion. Signs or symptoms of PRES may include: severe headache vision changes changes in mental status, such as confusion, disorientation, or decreased alertness difficulty speaking weakness in your arms or legs seizures Numbness, tingling, or burning sensation in the arms or legs. Nervous system problems of the eye. […]
Source: FDA drug label (DANYELZA), BTG International Inc., effective August 7, 2026 (SPL set b0f5ee96-369f-4cb9-a783-3bfa70fe8f90), via openFDA; the full label on DailyMed
Is there a generic for naxitamab (Danyelza)?
No generic naxitamab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the naxitamab label say about other medicines?
The naxitamab label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Premedicate with an antihistamine, acetaminophen, an H2 antagonist and corticosteroid as recommended [see Dosage and Administration (2.2) ]. |
| Gabapentin | warnings and precautions | Premedicate with drugs that treat neuropathic pain (e.g., gabapentin) and oral opioids. |
Source: FDA drug label (DANYELZA), BTG International Inc., effective August 7, 2026 (SPL set b0f5ee96-369f-4cb9-a783-3bfa70fe8f90), via openFDA; the full label on DailyMed
What do FAERS reports show for naxitamab?
The FDA Adverse Event Reporting System holds 241 reports that list naxitamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 84 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other glycolipid disialoganglioside-directed antibodys
- the pharmacologic class, with prices and generics
- Naxitamab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other