UNITUXIN

DINUTUXIMAB (din ue tux i mab) treats neuroblastoma, a cancer that occurs in nerve cells. It works by slowing down the growth of cancer cells. It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.
Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Your condition will be monitored carefully while you are receiving this medication.
This medication may make you feel generally unwell. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.
Tell your care team right away if you have any change in your eyesight.
This medication can cause serious allergic reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Be sure to follow the directions from your care team.
This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.
Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 2 months after the last dose. A reliable form of contraception is recommended while taking this medication and for 2 months after the last dose. Talk to your care team about effective forms of contraception.
Do not breast-feed while taking this medication.

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

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 these to your care team if they continue or are bothersome):
-Diarrhea
-Loss of appetite
-Nausea
-Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.