When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to dinutuximab or if you are pregnant.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for 2 months after the last dose.
• Tell your doctor if you are breastfeeding, or if you have eye problems, nerve problems, or any type of infection.
• This medicine may cause the following problems:
  
  • Infusion reactions (You may receive other medicines to help prevent a reaction.)
  • Peripheral neuropathy
  • Capillary leak syndrome
  • Low blood pressure
  • Low levels of electrolytes such as potassium, sodium, or calcium
  • Nerve problems in your eyes
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, double vision, sensitivity to light
• Confusion, weakness, and muscle twitching
• Decrease in how much or how often you urinate
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Fever, chills, cough, sore throat, and body aches
• Lightheadedness, dizziness, or fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Severe pain
• Trouble breathing
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, vomiting
• Swelling in your hands, ankles, or feet
• Swollen, red skin patches or bumps

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088