Prescription medicine
Dinutuximab Brand names: Unituxin
Dinutuximab (Unituxin) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the dinutuximab FDA label on DailyMed (effective July 6, 2026, United Therapeutics Corporation); the BLA 125516 record on Drugs@FDA; every dinutuximab label on DailyMed.
Highlights of the record
FDA label of July 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY.
See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.1) ]. Neurotoxicity: Unituxin causes severe neuropathic pain. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. Severe peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma. Severe peripheral motor neuropathy has also been reported. Discontinue for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ]. Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with Unituxin. Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion. […]
Used for
From the label: indications and usageUnituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ].
Forms and strengths
- 3.5 mg/ml
Injection.
On the market
- Earliest approval on file
- March 10, 2015 Unituxin, United Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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
- 832 through July 30, 2026
What is dinutuximab used for?
From the label: indications and usageUnituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ]. […]
FDA pharmacologic class: Glycolipid Disialoganglioside-directed Antibody.
Source: FDA drug label (Unituxin), United Therapeutics Corporation, effective July 6, 2026 (SPL set d66bdf0d-9d65-45de-ae5b-a58617c27492), via openFDA; the full label on DailyMed
Is there a generic for dinutuximab (Unituxin)?
No generic dinutuximab is approved (Drugs@FDA, October 8, 2026).
- 2015 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dinutuximab label say about other medicines?
The dinutuximab label names 1 other medicine 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 |
|---|---|---|
| Morphine | warnings and precautions | Neurotoxicity Pain In Study 1, 114 (85%) patients treated in the Unituxin/RA group experienced pain despite pre-treatment with analgesics, including morphine sulfate infusion. |
Source: FDA drug label (Unituxin), United Therapeutics Corporation, effective July 6, 2026 (SPL set d66bdf0d-9d65-45de-ae5b-a58617c27492), via openFDA; the full label on DailyMed
What do FAERS reports show for dinutuximab?
The FDA Adverse Event Reporting System holds 832 reports that list dinutuximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 168 are coded as a death and 283 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.
Reports received each year
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
- Dinutuximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other