Quick answers
- What is Dinutuximab used for?
- The FDA-approved label (Unituxin, United Therapeutics Corporation, July 6, 2026) says: “Unituxin (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 […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dinutuximab have a boxed warning?
- Yes. The FDA label for Unituxin has a boxed warning (“WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dinutuximab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dinutuximab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dinutuximab?
- 1 company lists prescription products of Dinutuximab in the FDA NDC Directory, including United Therapeutics Corporation.
What Dinutuximab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Unituxin (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 […]. …
— FDA label: Unituxin, United Therapeutics Corporation, effective July 6, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Unituxin |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- United Therapeutics Corporation1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125516 UNITUXIN | United Therap | March 10, 2015 | 3, latest October 10, 2025 2025: Labeling · 2020: Labeling · 2017: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1606278, 1606283 |
|---|---|
| SPL set ID of the quoted label | d66bdf0d-9d65-45de-ae5b-a58617c27492 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125516 |
| Active ingredients (FDA) | DINUTUXIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Unituxin, United Therapeutics Corporation, effective July 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →