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Unituxin
Dinutuximab Beta
$18720.00
1
BrandBranded medicine· By EUSA Pharma (Recordati)
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FDA boxed warningSerious infusion reactions and neurotoxicity
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
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
About Unituxin
Overview
Unituxin contains dinutuximab, a monoclonal antibody. It is used with GM-CSF, interleukin-2 and 13-cis-retinoic acid to treat children with high-risk neuroblastoma whose cancer has responded at least partly to initial treatment using multiple medicines and treatment methods. It binds to a substance called GD2 on neuroblastoma cells, helping the immune system destroy those cells.
What it treats
- High-risk neuroblastoma in children who have had at least a partial response to initial treatment using multiple medicines and treatment methods. Unituxin is used with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA).
Safety information
Side effects
Common side effects include pain, fever, infusion reactions, low blood pressure, vomiting, diarrhoea and hives. Blood tests may show low levels of platelets, red blood cells or certain white blood cells; low sodium, potassium, calcium or albumin; and raised liver enzymes. Capillary leak syndrome, where fluid leaks from small blood vessels, is also common and can be serious. Contact a doctor immediately for serious infusion reactions, severe pain, infections, low blood pressure or capillary leak syndrome. Other serious effects include nerve damage, changes in vision or loss of vision, prolonged inability to pass urine, inflammation of the spinal cord, and reversible posterior leukoencephalopathy syndrome, a serious neurological condition. Reduced blood cell production, disturbances in blood electrolyte levels, and atypical haemolytic uraemic syndrome, a serious blood and kidney disorder, also require medical attention. Unituxin may harm an unborn baby. People who could become pregnant should use effective contraception.
FDA boxed warning
Serious infusion reactions and neurotoxicity
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
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
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Unituxin must not be used in anyone who has previously had anaphylaxis (a severe allergic reaction) to dinutuximab. Conditions requiring close monitoring include fluid leaking from small blood vessels (capillary leak syndrome), low blood pressure, reduced blood cell counts and abnormal blood electrolyte levels. Blood counts and electrolytes should be monitored during treatment. Treatment must be paused during a systemic infection until it has resolved. Visual disturbances, including a dilated pupil that reacts slowly to light, require treatment to be paused. Recurrent eye problems or loss of vision require permanent discontinuation. Treatment must also be permanently stopped if prolonged inability to pass urine, inflammation of the spinal cord (transverse myelitis), reversible posterior leukoencephalopathy syndrome (RPLS), or atypical hemolytic uremic syndrome develops. Unituxin may harm an unborn baby. Women who could become pregnant should use effective contraception.
Using Unituxin
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label UNITUXIN (DINUTUXIMAB) INJECTION [UNITED THERAPEUTICS CORPORATION] (DailyMed, retrieved 19 September 2026).
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