Dinutuximab: uses, dosing, side effects & brands
Dinutuximab is a glycolipid disialoganglioside-directed antibody sold in the U.S. under one brand, for neuroblastoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Glycolipid Disialoganglioside-Directed Antibody
- Treats
- Neuroblastoma
- Available as
- Injectable
- Sold as
- Unituxin
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How dinutuximab is dosed
From the FDA label for Unituxin (application BLA125516). Other dinutuximab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Verify that patients have adequate hematologic, respiratory, hepatic, and renal function prior to initiating each course of Unituxin [see Clinical Studies (14) ] . Administer required premedication and hydration prior to initiation of each Unituxin infusion [see Dosage and Administration (2.2) ] . 17.5 mg/m 2 /day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles. ( 2.1 , 2.4 ) 2.1 Recommended Dose The recommended dose of Unituxin is 17.5 mg/m 2 /day administered as an intravenous infusion over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles (Table 1 and Table 2) [see Dosage and Administration (2.4) and Clinical Studies (14) ] . Initiate at an infusion rate of 0.875 mg/m 2 /hour for 30 minutes. The infusion rate can be gradually increased as tolerated to a maximum rate of 1.75 mg/m 2 /hour. Follow dose modification instructions for adverse reactions [see Dosage and Administration (2.3) ] . Table 1: Schedule of Unituxin Administration for Cycles 1, 3, and 5 Cycle Day 1 through 3 4 5 6 7 8 through 24 Cycles 1, 3, and 5 are 24 days in duration. Unituxin X X X X Table 2: Schedule of Unituxin Administration for Cycles 2 and 4 Cycle Day 1 through 7 8 9 10 11 12 through 32 Cycles 2 and 4 are 32 days in duration. Unituxin X X X X 2.2 Required Pre-treatment Guidelines Intravenous Hydration Administer 0.9% Sodium Chloride…
Dinutuximab side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infusion Reactions [see Boxed Warning and Warnings and Precautions (5.1) ] Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome [see Boxed Warning and Warnings and Precautions (5.2) ] Capillary Leak Syndrome [see Warnings and Precautions (5.3) ] Hypotension [see Warnings and Precautions (5.4) ] Infection [see Warnings and Precautions (5.5) ] Bone Marrow Suppression [see Warnings and Precautions (5.6) ] Electrolyte Abnormalities [see Warnings and Precautions (5.7) ] Atypical Hemolytic Uremic Syndrome [see Warnings and Precautions (5.8) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.9) ] The most common adverse drug reactions (≥25%) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. ( 5 , 6.1 ) The most common serious adverse reactions (≥5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome. ( 5 , 6.1 ) To report SUSPECTED ADVERSE…
Who shouldn’t take dinutuximab
Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. History of anaphylaxis to dinutuximab. ( 4 )
Dinutuximab drug interactions
No drug-drug interaction studies have been conducted with dinutuximab.
Every dinutuximab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Unituxin.
Dinutuximab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for dinutuximab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of dinutuximab during breastfeeding. Because dinutuximab is a large protein molecule with a molecular weight of about 150,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, dinutuximab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during dinutuximab therapy.
National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about dinutuximab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 546 reports naming dinutuximab, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pyrexia70 reports
- neoplasm progression39 reports
- thrombocytopenia32 reports
- diarrhoea30 reports
- anaemia29 reports
- pancytopenia29 reports
- therapy partial responder29 reports
- device related infection25 reports
Read these as a signal, not a rate. A report does not mean dinutuximab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is dinutuximab?
Unituxin (Dinutuximab) is a glycolipid disialoganglioside-directed antibody used to treat Neuroblastoma.
What kind of drug is dinutuximab?
The FDA classifies dinutuximab as a glycolipid disialoganglioside-directed antibody. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take dinutuximab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run dinutuximab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does dinutuximab come in?
Across the brands we track, dinutuximab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic dinutuximab?
We do not currently list a generic-labelled dinutuximab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Dinutuximab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/dinutuximab
- MLA
- “Dinutuximab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/dinutuximab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for dinutuximab on DailyMed (NIH) ↗ — including its boxed warning in full.