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.

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.

Dinutuximab is injected into a vein.

dinutuximab 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 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.

Usual Pediatric Dose for Neuroblastoma:

17.5 mg/m2/day IV over 10 to 20 hours for 4 consecutive days for a maximum of 5 cycles:
-Infuse on days 4, 5, 6, and 7 during cycles 1, 3, and 5 (cycles 1, 3, and 5 are 24 days in duration).
-Infuse on days 8, 9, 10, and 11 during cycles 2 and 4 (cycles 2 and 4 are 32 days in duration).

Rate of Infusion:
-Initiate at 0.875 mg/m2/hour for 30 minutes. Gradually increase as tolerated to a maximum rate of 1.75 mg/m2/hour.

Comments:
REQUIRED PRE-TREATMENT AND GUIDELINES FOR PAIN MANAGEMENT IV HYDRATION:
1) Hydration:
-Administer 0.9% sodium chloride 10 mL/kg IV over one hour just prior to initiating each infusion.
2) Analgesics:
-Administer morphine 50 mcg/kg IV immediately prior to infusion and then continue as a morphine drip at an infusion rate of 20 to 50 mcg/kg/hour during and for 2 hours following completion of therapy.
-Administer additional 25 mcg/kg to 50 mcg/kg IV doses of morphine as needed for pain up to once every 2 hours followed by an increase in the morphine infusion rate in stable patients.
-Consider using fentanyl or hydromorphone if morphine is not tolerated.
-If pain is inadequately managed with opioids, consider use of gabapentin or lidocaine in conjunction with IV morphine.
3) Antihistamines and Antipyretics:
-Administer an antihistamine such as diphenhydramine (0.5 to 1 mg/kg; maximum dose 50 mg) IV over 10 to 15 minutes starting 20 minutes prior to initiation of therapy and as tolerated every 4 to 6 hours during therapy.
-Administer acetaminophen (10 to 15 mg/kg; maximum dose 650 mg) 20 minutes prior to each infusion and every 4 to 6 hours as needed for fever or pain. -Administer ibuprofen (5 to 10 mg/kg) every 6 hours as needed for control of persistent fever or pain.

Use: In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy

Your child should not be treated with dinutuximab if you are allergic to it.

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.

In a medical setting your child is not likely to miss a dose.

In a medical setting an overdose would be treated quickly.

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

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.

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.

Also call your doctor at once if the child has:

• 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 of dinutuximab 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.

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.