dinutuximab

What is the most important information I should know about dinutuximab?

What is dinutuximab?

Dinutuximab is used with other medicines to treat neuroblastoma (a rare cancer of the nervous system) in children.

Dinutuximab is usually given after the child has had some improvement from other treatments.

Dinutuximab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving dinutuximab?

Tell your doctor if the child has ever had:

• any type of bacterial, fungal, or viral infection;
• an eye disorder or vision problems;
• bone marrow suppression;
• low blood pressure;
• an electrolyte imbalance (such as low blood levels of potassium, sodium, or calcium);
• liver or kidney disease; or
• urination problems.

How is dinutuximab given?

Dinutuximab is injected into a vein.

This medicine is injected slowly over 10 to 20 hours.

Dinutuximab 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 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 dinutuximab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of dinutuximab?

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.

Dinutuximab 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.

• sudden vision loss or vision changes;
• headache, confusion, thinking problems, seizure;
• severe dizziness or fainting;
• vomiting, diarrhea, feeling very ill;
• 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;
• 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
• 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 may include:

• capillary leak syndrome;
• a reaction to the infusion;
• feeling light-headed;
• pain;
• low blood cell counts;
• an electrolyte imbalance;
• vomiting, diarrhea;
• rash; or
• 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.

What other drugs will affect dinutuximab?

Other drugs may affect dinutuximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about dinutuximab.