Dinutuximab Solution for injection

What is this medicine?

DINUTUXIMAB (din ue tux i mab) is a monoclonal antibody that targets a specific protein within cancer cells and stops the cancer cells from growing. It is used to treat neuroblastoma in children.

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

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• infection

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• lung or breathing disease,

• pregnancy

• breast-feeding

• an unusual or allergic reaction to dinutuximab, other medicines, foods, dyes, or preservatives

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

Overdosage: If you think you've 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.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Interactions have not been studied.

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.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Tell your doctor or health care professional right away if you have any change in your eyesight.

This medicine can cause serious allergic reactions. To reduce your risk you may need to take medicine before treatment with this medicine. Take your medicine as directed.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 2 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blood in the urine

• changes in vision including blurred vision and sensitivity to light

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• pain, tingling, numbness in the hands or feet

• seizures

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• signs and symptoms of low potassium like muscle cramps or muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat

• swelling of the ankles, feet, hands

• tiredness

• weight gain

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• loss of appetite

• 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.

Where should I keep my medicine?

This drug is given in a hospital or clinic and 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.