UNITUXIN (Dinutuximab)

UNITUXIN (dinutuximab) is an antibody treatment for children with high-risk neuroblastoma, a cancer of immature nerve cells that most often starts in the adrenal glands. It is used in the maintenance phase, after the child has had at least a partial response to first-line treatment: intensive chemotherapy, surgery, stem cell transplant and radiotherapy. The US label approves it only as part of a combination with GM-CSF, interleukin-2 (IL-2) and 13-cis-retinoic acid (isotretinoin).

Dinutuximab is a chimeric mouse-human IgG1 antibody that attaches to GD2, a glycolipid on the surface of neuroblastoma cells. Once bound, it marks those cells for destruction by the immune system, through antibody-dependent cell-mediated cytotoxicity and complement activation. GD2 is also present on normal nerve tissue, which is why nerve pain is the most typical side effect.

Its approval was based on a randomised study of 226 children aged 11 months to 15 years, enrolled after their stem cell transplant. Adding dinutuximab with GM-CSF and IL-2 to isotretinoin lowered the risk of relapse or death (event-free survival hazard ratio 0.57). After three more years of follow-up, 27% of the dinutuximab group had died against 42% of those given isotretinoin alone.

Unituxin should not be confused with Qarziba (dinutuximab beta), a related anti-GD2 antibody produced by a different process and licensed in Europe; the two are not interchangeable without the oncologist’s decision. Other neuroblastoma medicines we help families obtain include Danyelza (naxitamab) and Iwilfin (eflornithine).

• Boxed warning, infusion reactions: serious, potentially life-threatening reactions happened in 26% of patients. Every infusion needs IV fluids, an antihistamine and paracetamol beforehand, and staff ready to treat anaphylaxis. Unituxin is stopped for good after anaphylaxis.
• Boxed warning, nerve toxicity: 85% of children in the main study had pain despite strong painkillers, and half had grade 3 pain. Intravenous morphine is started before each infusion and continued until 2 hours after it ends. Severe sensory or motor neuropathy, urinary retention, transverse myelitis and a reversible brain-swelling syndrome (RPLS) have also been reported.
• Capillary leak and low blood pressure: fluid can leak from blood vessels into tissues; this was severe in 23% of patients, and grade 3–4 hypotension occurred in 16%. Close monitoring in a hospital ward is needed during each 4-day course.
• Infection and blood counts: serious bloodstream infection (13%) and sepsis (18%) were more common than in the control group. Grade 3–4 falls in platelets (39%), haemoglobin (34%) and neutrophils (34%) were seen.
• Salts and kidneys: low potassium (37% grade 3–4) and low sodium (23%) are frequent, so electrolytes are checked at least daily during treatment. Atypical haemolytic uraemic syndrome occurred in two patients in another study and requires permanent discontinuation.
• Eye problems such as blurred vision and dilated pupils were reported in about 15% of patients in one study.
• It may harm an unborn baby. Female patients able to become pregnant should use effective contraception during treatment and for 2 months after the last dose.
• Most common side effects overall: pain (85%), fever (72%), low platelets (66%), low lymphocytes (62%), infusion reactions (60%), low blood pressure (60%) and low sodium (58%).

How many vials does a child need?

The dose is 17.5 mg per square metre of body surface a day, infused over 10 to 20 hours on four days in a row, for up to five cycles. Each vial contains exactly 17.5 mg and cannot be stored once opened, so a child with a body surface area of 1.0 m² or less uses one vial per treatment day: 4 vials per cycle and up to 20 for the full course. Larger children need two vials a day. The treating centre confirms the count.

What documents does the hospital need to send?

• Prescription from the paediatric oncologist with body surface area, dose and planned cycles
• Histopathology and staging report showing high-risk neuroblastoma
• A summary of the first-line treatment and the response achieved (Unituxin is for children with at least a partial response)
• Name of the hospital and treating unit, and the parent or guardian’s ID

Because each course runs as an inpatient admission, we can coordinate with the hospital pharmacy so that delivery lines up with the admission date.

How is Unituxin stored and given?

The vials must stay refrigerated at 2–8 °C, protected from light and never frozen or shaken, so they are shipped in cold-chain packing. The dose is diluted in 100 mL of normal saline, the infusion is started within 4 hours of mixing, and it is run slowly: 0.875 mg/m² an hour for the first 30 minutes, then increased if tolerated. It is never given as a push or bolus.

Is Unituxin available in India or Europe?

We found no CDSCO approval or Indian brand of dinutuximab (checked November 2026). Europe is not a source either: the EU licence was withdrawn in March 2017 because the company could not supply enough to meet demand. Supply for Indian patients therefore comes from the US market through named patient import.

United Therapeutics is the only maker of Unituxin, and its supply has been tight before; it is the reason the product left the EU market. We confirm availability with the US distributor before the first cycle, and it helps to plan the orders for later cycles early so that a child’s schedule does not depend on a last-minute purchase. Vials travel sealed in their original cartons, packed to stay at 2–8 °C.

Hospitals and families can ask about the Unituxin price in India and delivery timelines on +91 96548 60915 or +91 93100 90915, on WhatsApp at +91 98104 69557, on the toll-free number 1800 1200 365, or by email at info@indianpharmanetwork.in.

Global Approval Status:

• United States: approved by the FDA on 10 March 2015 (BLA 125516, United Therapeutics); label most recently updated in 2025.
• European Union: authorised in August 2015 but withdrawn on 20 March 2017 at the company’s request because of supply limits.
• Canada: listed in the Health Canada drug database (DIN 02483076).
• India: no CDSCO approval found.

Sources:

• UNITUXIN US Prescribing Information, DailyMed
• Drugs@FDA: BLA 125516
• EMA: Unituxin (withdrawn) EPAR

Information last checked: November 2026.

What is Unituxin used for?

Maintenance treatment of high-risk neuroblastoma in children who responded at least partly to first-line therapy, given together with GM-CSF, IL-2 and isotretinoin.

How does dinutuximab work?

It binds GD2 on neuroblastoma cells and directs immune cells and complement to destroy them.

Why is morphine given with each infusion?

Because GD2 is also found on nerves, the antibody causes significant nerve pain; the label requires an IV opioid before, during and for 2 hours after every infusion.

Is Unituxin the same as Qarziba?

No. Both target GD2, but Qarziba is dinutuximab beta, made by a different process and with its own dosing schedule.

Who manufactures Unituxin?

United Therapeutics Corporation in the USA.

Is Unituxin FDA approved?

Yes, since March 2015, for children with high-risk neuroblastoma.