Dinutuximab Injection
Dinutuximab is a monoclonal antibody used in combination with other medicines to treat high-risk neuroblastoma (a type of cancer) in pediatric patients.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Unituxin carries a boxed warning — the most serious FDA safety alert — for two major risks: life-threatening infusion reactions and severe nerve pain.
Infusion reactions: Serious, potentially life-threatening reactions — including anaphylaxis (a sudden, severe allergic reaction) — occurred in 26% of patients treated with Unituxin. Patients must receive IV fluids and pre-medications (including antihistamines) before every infusion. The infusion must be stopped immediately if a severe reaction occurs, and Unituxin must be permanently discontinued if anaphylaxis develops.
Neurotoxicity (nerve damage and pain): Unituxin causes severe nerve pain in the majority of patients. IV opioid pain medicine must be given before, during, and for 2 hours after every infusion. Severe sensory nerve damage occurred in 2% to 9% of patients with neuroblastoma, and severe motor nerve damage (affecting movement) has also been reported. Unituxin must be permanently stopped if pain cannot be controlled, if sensory nerve damage is severe, or if moderate-to-severe motor nerve damage develops.
📖 Dinutuximab Injection: Patient Information Guide
A plain-language walkthrough of Dinutuximab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Dinutuximab injection (brand name Unituxin) is a targeted cancer medicine approved for use in pediatric patients.
- Unituxin is indicated for the treatment of pediatric patients with high-risk neuroblastoma who have achieved at least a partial response to prior first-line multiagent, multimodality therapy
- Unituxin must be used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA) — it is not approved for use alone
- Prior therapy must have included induction chemotherapy, surgery, high-dose consolidation chemotherapy with autologous stem cell transplant, and radiation therapy
⚙️How it works▾
Dinutuximab is a monoclonal antibody — a lab-engineered protein designed to recognize a very specific target. It binds to a molecule called GD2, which sits on the surface of neuroblastoma cancer cells (as well as some normal nerve-related cells). Once dinutuximab attaches to GD2, it triggers two immune system processes: antibody-dependent cell-mediated cytotoxicity (ADCC), where immune cells are recruited to kill the tagged cancer cell, and complement-dependent cytotoxicity (CDC), where blood proteins are activated to break down the cell. Together, these actions help the immune system identify and destroy neuroblastoma cells.
💊How it's taken▾
Unituxin is given only by intravenous (IV) infusion in a hospital or clinical setting — never at home or by IV push. Each infusion runs slowly over 10 to 20 hours, and is given on 4 consecutive days per cycle. Treatment is organized into up to 5 cycles, with cycles alternating between approximately 24 and 32 days in length depending on whether GM-CSF or IL-2 is being used alongside Unituxin.
- Required pre-treatment before every infusion includes IV hydration, opioid pain medicine, antihistamines, and fever-reducing medicine
- Patients are monitored closely during and for at least 4 hours after each infusion
- Dose adjustments or stopping treatment may be needed depending on how a patient tolerates the medicine — the care team manages this
🤒Side effects — in detail▾
Unituxin causes side effects in nearly all patients. The most commonly reported ones include:
- Pain — abdominal, back, extremity, or generalized (occurred in the majority of patients)
- Fever (pyrexia)
- Infusion reactions — such as hives, rash, fever, or chills during or shortly after the infusion
- Low blood pressure (hypotension)
- Low blood cell counts — including low platelets (thrombocytopenia), low red blood cells (anemia), and low white blood cells (neutropenia, lymphopenia)
- Electrolyte imbalances — especially low sodium, potassium, and calcium levels
- Vomiting, diarrhea, and nausea
- Elevated liver enzymes (alanine aminotransferase, aspartate aminotransferase)
- Fluid leakage from blood vessels (capillary leak syndrome)
- Hives (urticaria)
Serious reactions — including life-threatening infusion reactions, severe nerve pain and damage, dangerous drops in blood pressure, serious infections, and rare neurological events — require immediate medical attention and may require the infusion to be slowed, paused, or permanently stopped.
⚠️Warnings & precautions▾
- Life-threatening infusion reactions occurred in 26% of patients, including anaphylaxis. Required pre-medications and IV fluids must be given before every infusion, and patients must be monitored for at least 4 hours afterward.
- Severe nerve pain (neurotoxicity) occurred in the majority of patients. IV opioid pain medicine is required before, during, and for 2 hours after each infusion. Permanent nerve damage affecting movement has also been reported and did not always resolve.
- Capillary leak syndrome — where fluid leaks out of blood vessels, causing swelling, low blood pressure, and breathing problems — occurred in 23% of patients at severe grades.
- Hypotension (low blood pressure) requiring medical intervention occurred in 16% of patients at severe grades.
- Serious infections and sepsis occurred more often in patients receiving Unituxin than in those who did not.
- Bone marrow suppression: significant drops in platelets, red blood cells, and white blood cells are common and require close monitoring.
- Electrolyte abnormalities — particularly low sodium and potassium — are common and must be monitored daily during treatment.
- Rare but serious neurological events include eye disorders, prolonged urinary retention, transverse myelitis (inflammation of the spinal cord), and RPLS (reversible posterior leukoencephalopathy syndrome — a brain condition causing headaches, vision changes, and seizures).
- Embryo-fetal toxicity: Unituxin may harm an unborn baby. Effective contraception is required during treatment and for 2 months after the last dose.
🔀What it interacts with▾
No formal drug-drug interaction studies have been conducted with dinutuximab. However, given the medicines used alongside Unituxin and the seriousness of its side effects, the care team will review all medications carefully.
- Opioid pain medicines (such as morphine, fentanyl, or hydromorphone) are required during treatment — the care team manages these as part of the protocol
- Antihistamines (such as diphenhydramine), acetaminophen, and ibuprofen are used as pre-medications and require careful dosing coordination
- Gabapentin or IV lidocaine may be added if pain is not controlled by opioids alone
- Hydrocortisone (a corticosteroid) may be used in certain infusion reaction situations as directed by the care team
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- History of anaphylaxis to dinutuximab: Unituxin is contraindicated — it must not be given to patients who have had a severe allergic reaction to it before
- Pregnancy: Unituxin may harm a developing baby. Pregnant patients should be told of the risk, and females of reproductive potential must use effective contraception during treatment and for 2 months after the final dose
- Breastfeeding: Breastfeeding should be stopped during Unituxin treatment due to the potential for serious harm to a nursing infant
- Kidney impairment: Unituxin has not been formally studied in patients with kidney disease; no dose guidance is available
- Liver impairment: Unituxin has not been formally studied in patients with liver disease; no dose guidance is available
- Geriatric patients: Safety and effectiveness in elderly patients have not been established
- Pediatric patients: Safety and effectiveness are established in pediatric patients aged approximately 11 months to 15 years with high-risk neuroblastoma based on clinical trial data
- Blood counts, kidney function, liver function, and respiratory status must be checked before starting each cycle of treatment
🔬Pharmacokinetics — how your body processes it▾
Dinutuximab is given directly into the bloodstream by IV infusion, so it does not need to be absorbed like an oral medicine. In children with high-risk neuroblastoma, the drug reaches peak blood levels during the infusion and distributes into a relatively small volume of body fluid, suggesting it stays mostly in the bloodstream rather than spreading widely into tissues. The body clears dinutuximab slowly, with a terminal half-life (the time it takes for half the drug to leave the body) of about 10 days, and clearance increases as body size increases. Some patients develop antibodies against dinutuximab, which can speed up how quickly the body clears the drug, though this did not appear to significantly affect safety outcomes in clinical studies.
📦How to store it▾
Store Unituxin vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light until time of use. Do not freeze or shake the vial.
📄 Written from Dinutuximab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Dinutuximab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Unituxin and why is my child getting it? ▾
Will my child be in a lot of pain during the infusion? ▾
What side effects should I watch for at home between treatments? ▾
Could Unituxin cause lasting nerve damage? ▾
Is Unituxin safe if someone in the family is pregnant or breastfeeding? ▾
How will the team know if Unituxin is causing serious problems? ▾
Is Dinutuximab Injection available over the counter? ▾
When was Dinutuximab Injection first available? ▾
💬 Answers drafted from Dinutuximab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Dinutuximab Injection comes
Dinutuximab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Unituxin is used intravenously to treat pediatric patients with high-risk neuroblastoma in combination with GM-CSF, IL-2, and 13-cis-retinoic acid
- Unituxin is given to patients who have achieved at least a partial response to prior first-line multiagent, multimodality therapy
- Unituxin is administered as a slow intravenous infusion only — never as an IV push or bolus injection
- Unituxin is given over 10 to 20 hours for 4 consecutive days per cycle, for up to 5 cycles
- Unituxin must be diluted before administration and infused within 4 hours of preparation; discard any unused portion
- Required IV fluids, opioid pain medicine, antihistamines, and fever reducers must be given before and during each Unituxin infusion
📊 Dinutuximab Injection across the U.S. market
How Dinutuximab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Dinutuximab Injection products
A representative set of FDA-listed product records for Dinutuximab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 3.5 mg/mL | Intravenous | United Therapeutics Corporation × 4 listings | BLA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Dinutuximab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dinutuximab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dinutuximab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Dinutuximab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1606274 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1657967In current FDA listingsClinical drug / strength (SCD) 5 ML dinutuximab 3.5 MG/MLRxCUI 1606278
Look up RxCUI 1606274 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Dinutuximab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Dinutuximab Injection belongs to the Glycolipid Disialoganglioside-directed Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. United Therapeutics Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.