Unituxin
Generic name: dinutuximab [ DIN-ue-TUX-i-mab ]
Drug class: Miscellaneous antineoplastics
What is Unituxin?
Unituxin is used with other medicines to treat neuroblastoma (a rare cancer of the nervous system) in children.
Unituxin is usually given after the child has had some improvement from other treatments.
Unituxin may also be used for purposes not listed in this medication guide.
Unituxin side effects
Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.
Some side effects may occur during the injection or up to 24 hours afterward. Tell your child's caregiver if the child seems dizzy or light-headed, or has a skin rash, chest tightness, wheezing, trouble breathing, or swelling in the face.
Capillary leak syndrome is a rare but serious side effect. Call your doctor right away if your child has signs of this condition: stuffy or runny nose followed by tiredness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.
Unituxin can damage red blood cells, which may cause irreversible kidney failure. Call your doctor right away if your child has unusual bruising or bleeding, pale skin, confusion, tiredness or irritability, stomach pain, bloody diarrhea, red or pink urine, swelling, rapid weight gain, and little or no urination.
Also call your doctor at once if the child has:
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sudden vision loss or vision changes;
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headache, confusion, thinking problems, seizure;
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severe dizziness or fainting;
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vomiting, diarrhea, feeling very ill;
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nerve problems--sharp or shooting pain, numbness or tingling, burning or cold feeling, weakness, loss of movement, problems with walking or daily activities, loss of bladder or bowel control;
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low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
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signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle pain or weakness, leg cramps, numbness or tingling, feeling jittery, irregular heartbeats, fluttering in your chest, or a choking feeling.
Common side effects of Unituxin may include:
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capillary leak syndrome;
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a reaction to the infusion;
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feeling light-headed;
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pain;
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low blood cell counts;
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an electrolyte imbalance;
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vomiting, diarrhea;
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rash; or
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abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Warnings
Call your doctor at once if your child has severe or worsening pain, numbness, tingling, weakness, or problems with walking or daily activities.
Some side effects may occur during the injection or up to 24 hours afterward, including dizziness, skin rash, chest tightness, wheezing, trouble breathing, or swelling in the face.
Before taking this medicine
Your child should not be treated with Unituxin if you are allergic to it.
Tell your doctor if the child has ever had:
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any type of bacterial, fungal, or viral infection;
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an eye disorder or vision problems;
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bone marrow suppression;
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an electrolyte imbalance (such as low blood levels of potassium, sodium, or calcium);
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liver or kidney disease; or
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urination problems.
How is Unituxin given?
Unituxin is injected into a vein.
Unituxin is injected slowly over 10 to 20 hours.
Unituxin is given in a 28-day treatment cycle. Your child will receive this injection only on certain days of the cycle.
Your doctor will decide how many cycles your child should receive.
Your child may be given other medicines to help prevent certain side effects.
Your child will be watched for at least 4 hours to make sure he or she does not have a reaction to the medicine.
Your child may need frequent medical tests and treatment may be delayed based on the results.
What happens if I miss a dose?
In a medical setting your child is not likely to miss a dose.
What happens if I overdose?
In a medical setting an overdose would be treated quickly.
What should I avoid after receiving Unituxin?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Unituxin?
Other drugs may affect Unituxin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Unituxin Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Unituxin.
Unituxin (dinutuximab) - United Therapeutics Corporation
Formulation type | Strength |
---|---|
Single-Dose Vial | 17.5 mg/5 mL (3.5 mg/mL) |
More about Unituxin (dinutuximab)
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- FDA approval history
- Drug class: miscellaneous antineoplastics
- Breastfeeding
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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