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Unituxin

dinutuximab
Used for Neuroblastoma
Used for Neuroblastoma

Unituxin (dinutuximab) is an anti-GD2 monoclonal antibody. It’s used to treat advanced, high-risk neuroblastoma, which is a type of cancer that mostly affects children. Unituxin (dinutuximab) is infused through the veins daily for 4 days in a row during each treatment cycle. It's usually given along with other anticancer medications. Some of the most common side effects of Unituxin (dinutuximab) include pain and infusion-related reactions, such as rash and fever.

Last reviewed on February 1, 2024
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What is Unituxin (dinutuximab)?

What is Unituxin (dinutuximab) used for?

How Unituxin (dinutuximab) works

Unituxin (dinutuximab) is a monoclonal antibody that finds and attaches to the GD2 target. These are markers found on the surface of cells, including healthy cells. But neuroblastoma cells have a lot more of these markers

When Unituxin (dinutuximab) attaches to the cancer cells, it signals the immune system to destroy them.

Drug Facts

Common BrandsUnituxin
Drug ClassAnti-GD2 monoclonal antibody
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the side effects of Unituxin (dinutuximab)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Pain (85%)
  • Fever (72%)
  • Lower blood cell counts (up to 66%)
  • Infusion reactions (60%)
  • Low blood pressure (60%)
  • Changes in liver labs (56%)
  • Vomiting (46%)
  • Diarrhea (43%)
  • Lower electrolyte levels in the blood (up to 43%)
  • Capillary leak syndrome (40%)
  • Hives (37%)
  • Low oxygen levels (24%)

Other Side Effects

  • Swelling
  • Bleeding
  • High blood pressure
  • Nausea
  • Fast heartbeat
  • Infections
  • Peripheral neuropathy
  • Weight gain
  • Less appetite

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious infusion-related reactions: Hives, low blood pressure, lip and face swelling, breathing problems, wheezing, weakness, dizziness, chest pain, rash, flushing
  • Posterior reversible encephalopathy syndrome (PRES): Severe headaches, seizures, confusion, changes in vision, difficulty staying awake, trouble speaking
  • Transverse myelitis: Weakness in the legs or arms, back pain, tingling or numbing feelings, more frequent need to urinate, and constipation
  • Dangerously low blood pressure: Dizziness, fainting, blurry vision, nausea, weakness, lightheaded
  • Capillary leak syndrome: Unusual weakness or fatigue, feeling faint or lightheaded, less urine, swelling of the ankles, hands, or feet, or trouble breathing, low blood pressure
  • Severe infections: Fevers, chills or sweats, shortness of breath, or fast heartbeat

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
  • Dilated pupils
  • Eye pain, change in vision, vision loss
  • Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
  • Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
  • Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
  • Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
  • Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
  • Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
  • Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
  • Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
  • Stomach pain, bloody diarrhea, pale skin, unusual weakness or fatigue, decrease in the amount of urine, which may be signs of hemolytic uremic syndrome
  • Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
  • Trouble passing urine
  • Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Unituxin (dinutuximab)

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Pros

Only need to receive infusion for 4 days of each cycle, up to 5 cycles total

Can improve overall survival in children with neuroblastoma

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Cons

Must stay in the hospital to be monitored for infusion-related side effects, like swelling and breathing problems

Not safe in pregnancy or breastfeeding

pharmacist-tips

Pharmacist tips for Unituxin (dinutuximab)

pharmacist
  • You’ll likely be admitted to the hospital for Unituxin (dinutuximab) infusions. The length of the hospital stay depends on how long the infusion takes and how your body responds to the therapy, but usually lasts at least 4 days. Consider bringing a book, games, or something to help pass the time while you’re in the hospital

    • Make sure you know when you’ll need to be admitted to the hospital and mark the dates on your calendar so you can keep track of hospital admissions. This will help you anticipate when you might need to take time off work or schedule childcare for siblings, if needed.

      • Let your care team know right away if you have any breathing problems, swelling, or dizziness during the Unituxin (dinutuximab) infusion. These reactions can be serious and your provider will need to slow down your infusion and treat your symptoms right away.

        • Let your provider know right away if you have trouble urinating after receiving Unituxin (dinutuximab). This might be a side effect of some of the pain medications you're receiving. Your provider will ask you to stop taking them to see if this helps. But the problem still doesn't go away, they might ask you to stop Unituxin (dinutuximab) treatment because this might be a sign of nerve damage from this medication.

          • Unituxin (dinutuximab) can cause vision changes, including blurry vision and sensitivity to light. Usually, these side effects should get better after a couple of weeks. If not, your provider might ask you to stop Unituxin (dinutuximab) treatment to prevent further damage.

            • Receiving Unituxin (dinutuximab) raises your risk of developing an infection because it lowers your blood cell counts. Even after you leave the hospital, it’s important to wash your hands often and limit coming in contact with large crowds or people who might be sick. Consider wearing a face mask, especially if you will be in a crowded space. Contact your provider if you develop a fever, which can be a sign of an infection. It’s important that your care team treat an infection quickly.

              • You might bleed or bruise more easily because receiving Unituxin (dinutuximab) can lower platelet levels. Make sure you’re careful to avoid injuries. If you play any sports, discuss with your provider whether you should continue playing. If you fall or get seriously injured, get medical help right away so your care team can check for signs of bleeding inside the body.

                • To limit bleeding while receiving Unituxin (dinutuximab), use a soft bristle toothbrush while brushing teeth and an electric razor if shaving. Check with your provider if you should continue to floss because some people might be at higher risk of gums bleeding.

                  faqs

                  Frequently asked questions about Unituxin (dinutuximab)

                  What other anticancer medications will I receive with Unituxin (dinutuximab) to help treat neuroblastoma?
                  Your oncology team will give you a few other medications to help Unituxin (dinutuximab) work better. For example, you’ll also receive granulocyte-macrophage colony-stimulating factor (GM-CSF), which is a cytokine. It works by boosting the number of white blood cells (WBCs) that Unituxin (dinutuximab) can recruit to help kill cancer cells. Another example is isotretinoin, a medication that helps neuroblastoma cells grow into healthy cells. Taking isotretinoin makes it less likely for the cancer to come back after treatment. Ask your oncologist if you've questions about other medications you'll receive during treatment.
                  How well does Unituxin (dinutuximab) work for neuroblastoma?
                  A clinical study compared how well Unituxin (dinutuximab) worked (in combination with GM-CSF, IL-2, and isotretinoin) with the standard treatment at the time (isotretinoin alone). Results showed that 20% more children who received Unituxin (dinutuximab) experienced event free survival, meaning their cancer either didn’t come back or get worse, after 2 years compared to children who received isotretinoin alone. And after 5 years, more children who improved with Unituxin (dinutuximab) stayed free of cancer and relapse compared to children who received isotretinoin alone. Talk with your provider if you have more questions about what results you might expect from Unituxin (dinutuximab) treatment.
                  How long does Unituxin (dinutuximab) infusions take?
                  Each infusion of Unituxin (dinutuximab) takes at least 10 hours, but can take up to 20 hours. The infusion is started at a slow rate and can gradually be changed and given faster if you don't experience any major side effects or reactions. You’ll be receiving the infusions at the hospital and will have to be admitted to the hospital for at least 4 days, perhaps longer, depending on how your body responds. Be sure to pack everything you need, like glasses, comfortable clothes, lotion, and some activities to help you pass the time. Also, bring some snacks in case you get hungry and don’t like the hospital food.
                  Will Unituxin (dinutuximab) cause infusion reactions?
                  Yes, you can expect to have infusion-related reactions, such as breathing problems, swelling, or nausea, during or after receiving Unituxin (dinutuximab). Sometimes, these reactions can be serious or life-threatening. You’ll stay in the hospital while receiving Unituxin (dinutuximab) so your care team can monitor you for these reactions. Your provider will give you pre-medications before each Unituxin (dinutuximab) dose to lower the risk of serious reaction. For example, you’ll probably receive acetaminophen (Tylenol) to help with fever, as well as an antihistamine and a corticosteroid to help ease swelling or rash.
                  Will Unituxin (dinutuximab) cause pain?
                  Yes, many people report pain while getting Unituxin (dinutuximab) infusions. This is because the medication can affect healthy nerve cells and pain fibers as a side effect and cause pain in different parts of the body, including the bones, hands, and feet. Your provider will give medications, such as morphine, before and during Unituxin (dinutuximab) infusions to help with the pain. They’ll also slow or stop the infusion if the pain is severe. Usually, the pain goes away a few days after the infusion. But sometimes, it can last longer. Talk with your provider to learn more about how you can manage your pain during and after each infusion.
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                  What are the risks and warnings for Unituxin (dinutuximab)?

                  Unituxin (dinutuximab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                  risk-warning

                  Infusion reactions

                  Unituxin (dinutuximab) commonly causes infusion reactions. Reactions can happen during the infusion or up to 24 hours afterwards. Most of the time, these reactions are mild, but sometimes, these reactions can be serious and need more medical attention.To lower the risk of these reactions, your provider will give you medications before starting the infusion. You’ll stay in the hospital during the Unituxin (dinutuximab) infusions so that your care team can monitor you closely for symptoms. If you do have a reaction, your care team might stop the infusion to provide treatment and restart at a slower rate. But if your reaction is very serious, then your provider will likely ask you to stop Unituxin (dinutuximab) permanently. Notify your provider right away if you experience symptoms of infusion-related reactions including rash, swelling, or breathing problems.

                  risk-warning

                  Pain (neurotoxicity)

                  Most people experience pain during Unituxin (dinutuximab) infusions. The pain is caused by Unituxin (dinutuximab) binding to nerve cells and pain fibers.This can affect many areas of the body, including the stomach, arms, legs, and nerves. To help with pain, your provider will give you medications, such as opioid pain medications, with Unituxin (dinutuximab) infusion. Sometimes, they might also slow the infusion to help. Pain also typically lessened with each cycle. But if the pain still isn’t controlled, your provider might recommend stopping this medication.

                  Unituxin (dinutuximab) can also cause transverse myelitis, which is inflammation of the spinal cord. This is very rare, but can lead to weakness of the legs or arm, pain, feelings of numbness or tingling, or inability to control urination. You should notify your provider right away if you have these symptoms because you’ll need to stop the medication.

                  risk-warning

                  Brain-related changes

                  Rarely, people have reported a very serious brain condition called posterior reversible encephalopathy syndrome (PRES) after receiving Unituxin (dinutuximab). This condition is caused by swelling and narrowing of blood vessels in the brain and leads to serious symptoms. Get medical help right away if you have sudden severe headaches, confusion, vision loss, or vision changes.

                  risk-warning

                  Capillary leak syndrome

                  Some people taking Unituxin (dinutuximab) experienced capillary leak syndrome, a condition where fluids from blood vessels leak into the surrounding tissues. Your healthcare team will be monitoring your vital signs, how much fluids you drink, how much urine you make, and body weight closely while in the hospital. Notify your provider right away if you notice any swelling, feeling lightheaded, dizzy, or weak.

                  risk-warning

                  Vision changes

                  Though not a common side effect, some people have reported eye problems after starting Unituxin (dinutuximab). These changes include blurry vision, dilated pupils, vision changes, and sensitivity to light. These eye problems are usually temporary and get better on their own after about 4 days. But sometimes, they can also be permanent. Let your provider know right away if you notice vision changes because they might ask you to stop taking Unituxin (dinutuximab). Depending on how serious the vision problems are, your provider might restart Unituxin (dinutuximab) for you but at a lower dose.

                  risk-warning

                  Difficulty urinating

                  • Risk factors: Taking opioid pain medications

                    It’s very rare, but Unituxin (dinutuximab) can cause nerve damage and make it difficult for you to urinate or fully empty the bladder. If you have trouble urinating, your provider will likely ask you to slowly stop taking the opioid pain medications first to see if this helps, since they can also cause this side effect. If it doesn’t, your provider might recommend you stop taking Unituxin (dinutuximab).

                    risk-warning

                    Low blood pressure

                    Unituxin (dinutuximab) can cause low blood pressure. You will receive intravenous fluids before your Unituxin (dinutuximab) infusion to help prevent this from happening. Your healthcare team will be checking your blood pressure throughout the infusion to make sure it's within safe range. Let the team know if you feel symptoms of low blood pressure, such as dizziness, lightheadedness, or nausea. If your blood pressure is very low, your provider might need to slow down the rate of the infusion or stop the treatment altogether.

                    risk-warning

                    Lower blood cell counts (risk of infection and bleeding)

                    Unituxin (dinutuximab) can cause your red blood cells, white blood cells, and platelet counts to drop. This can raise your risk for anemia, serious infections, and bleeding or bruising. Your provider will monitor your blood counts through lab work. Let your provider know as soon as possible if you experience chills, fever, fast heartbeat, tiredness, or bleeding and bruising that doesn’t go away.

                    risk-warning

                    Electrolyte changes

                    Some people have experienced changes in electrolyte levels after Unituxin (dinutuximab) infusions. Your provider will monitor your electrolyte levels daily with blood draws while you’re receiving infusions. Tell your provider if you notice any symptoms of electrolyte problems, such as fast or abnormal heartbeat or muscle cramps.

                    risk-warning

                    Harm to unborn baby

                    Unituxin (dinutuximab) can cause harm to unborn babies. If you’re able to become pregnant, your provider will have you do a pregnancy test before starting treatment. Use effective birth control while taking this medication and for at least 2 months after your last dose.

                    dosage

                    Unituxin (dinutuximab) dosage forms

                    Typical dosing for Unituxin (dinutuximab)

                    Your child’s oncologist will determine their dose based on your child’s body surface area (BSA), which takes into account their weight and height. This medication is typically given by a healthcare team in a clinic or hospital setting.

                    • The typical dosing of Unituxin (dinutuximab) is 17.5 mg/m2 infused daily through the veins, over 10-20 hours. It’s given 4 days in a row, toward the beginning or middle of each 24- to 32-day cycle. Your child can receive this medication for a maximum of 5 cycles.

                    Your child’s provider will also prescribe other medications, such as granulocyte macrophage-colony stimulating factor (GM-CSF) and isotretinoin, with Unituxin (dinutuximab) treatment. In addition, they'll receive medications before and during each Unituxin (dinutuximab) infusion to help with side effects.

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                    References

                    Best studies we found

                    American Cancer Society. (2019). Cytokines and their side effects.

                    American Cancer Society. (2021). Immunotherapy for neuroblastoma.

                    American Cancer Society. (2021). Retinoid therapy for neuroblastoma.

                    View All References (18)

                    American Cancer Society. (2023). Treatment of neuroblastoma by risk group.

                    American Cancer Society. (2024). Infusion or immune reactions.

                    Jiang, T., Zhou, C., & Ren, S. (2016). Role of IL-2 in cancer immunotherapy. Oncoimmunology.

                    Lee, K. M. C., et al. (2020). GM-CSF: A promising target in inflammation and autoimmunity. ImmunoTargets and Therapy.

                    National Cancer Institute. (n.d.). Event-free survival.

                    National Cancer Institute. (n.d.). Granulocyte-macrophage colony-stimulating factor.

                    National Cancer Institute. (2024). Neuroblastoma treatment (PDG®)–Patient version.

                    National Institute of Neurological Disorders and Stroke. (2024). Transverse myelitis

                    National Organization for Rare Disorders. (2020). Systemic capillary leak syndrome.

                    Nazha, B., et al. (2020). Disialoganglioside GD2 expression in solid tumors and role as a target for cancer therapy. Frontiers in Oncology.

                    Sait, S., et al. (2017). Anti-GD2 immunotherapy for neuroblastoma. Expert Review of Anticancer Therapy.

                    Triplett, J. D., et al. (2022). Posterior reversible encephalopathy syndrome (PRES): Diagnosis and management. Practical Neurology.

                    United Therapeutics Corp. (2017). Understanding antibody therapy: Treatment for pediatric high-risk neuroblastoma.

                    United Therapeutics Corporation. (2024). Unituxin- dinutuximab injection [package insert]. DailyMed.

                    United Therapeutics Corporation. (2024). Unituxin- dinutuximab injection [package insert]. DailyMed.

                    Wang, L. (2022). Study confirms dinutuximab extends life for children with high-risk neuroblastoma. National Cancer Institute.

                    Yu, A. L., et al. (2010). Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. The New England Journal of Medicine.

                    Yu, A. L., et al. (2021). Long-term follow-up of a phase iii study of ch14.18 (dinutuximab) + cytokine immunotherapy in children with high-risk neuroblastoma: COG study ANBL0032. Clinical Cancer Research.

                    GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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