Dinutuximab

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

Dinutuximab is typically given after the child has shown some improvement from other treatments.

Dinutuximab may also be used for reasons not mentioned in this medication guide.

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 specific days of the cycle.

Your doctor will determine how many cycles your child should have.

Your child may receive other medicines to help prevent some side effects.

Your child will be monitored for at least 4 hours to ensure he or she does not have a reaction to the medicine.

Your child may need regular medical tests, and treatment may be delayed based on the results.

Call your doctor right away if your child has severe or worsening pain, numbness, tingling, weakness, or issues with walking or daily activities.

Some side effects may happen during the injection or within 24 hours after, such as dizziness, skin rash, chest tightness, wheezing, trouble breathing, or swelling in the face.

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.

Get emergency medical help if your child shows signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Some side effects may happen during the injection or within 24 hours afterward. Inform your child's caregiver if your child feels 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. Contact your doctor immediately if your child shows signs of this condition: a stuffy or runny nose followed by tiredness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

Dinutuximab can harm red blood cells, which may lead to irreversible kidney failure. Call your doctor right away if your child experiences 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 contact your doctor immediately if your child has:

• sudden vision loss or vision changes;
• headache, confusion, problems with thinking, seizure;
• severe dizziness or fainting;
• vomiting, diarrhea, feeling very ill;
• nerve issues—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 the 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. Contact your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

In a medical setting, your child is unlikely to miss a dose.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

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