Dinutuximab Injection

Brand Name(s): Unituxin^®

IMPORTANT WARNING:

Dinutuximab injection may cause serious or life-threatening reactions that may occur while the medication is being given or up to 24 hours afterward. A doctor or nurse will watch your child closely while receiving the infusion and for at least 4 hours afterwards to provide treatment in case of a serious reaction to the medication. Your child may be given other medications before and while receiving dinutuximab to prevent or manage reactions to dinutuximab. Tell your doctor immediately if your child experiences any of the following symptoms during your infusion or up to 24 hours after your infusion: hives; rash; itching; reddening of the skin; fever; chills; difficulty breathing or swallowing; swelling of the face, throat, tongue, or lips; dizziness; faintness; or a fast heartbeat.

Dinutuximab injection can cause damage to nerves that may result in pain or other symptoms. Your child may receive pain medication before, during, and after the dinutuximab infusion. Tell your child's doctor or other health care provider(s) immediately if they experience any of the following symptoms during and after the infusion: severe or worsening pain, particularly in the stomach, back, chest, muscles or joints or numbness, tingling, burning, or weakness in the feet or hands.

Keep all appointments with your child's doctor and the laboratory. Your doctor may order certain tests to check your child's response to dinutuximab injection.

WHY is this medicine prescribed?

Dinutuximab injection is used in combination with other medications to treat neuroblastoma (a cancer that begins in nerve cells) in children who have responded to other treatments. Dinutuximab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dinutuximab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 10 to 20 hours by a doctor or nurse in a medical facility or infusion center. It is usually given for 4 consecutive days within a treatment cycle for up to 5 cycles.

Be sure to tell the doctor how your child is feeling during the treatment. Your child's doctor may decrease the dose, or stop the treatment for a while or permanently if your child experiences side effects to the medication.

What SPECIAL PRECAUTIONS should I follow?

Before receiving dinutuximab injection,

• tell your doctor and pharmacist if your child is allergic to dinutuximab, any other medications, or any of the ingredients in dinutuximab injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products your child is taking or plans to take. Your doctor may need to change the doses of medications or monitor your child carefully for side effects.

• tell your doctor if it is possible that your child could become pregnant. Dinutuximab injection may harm the fetus. If needed, your child should use birth control to prevent pregnancy during treatment with dinutuximab and for up to 2 months after treatment. Talk to your doctor about types of birth control that will work. If your child becomes pregnant while using dinutuximab injection, call your doctor.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive dinutuximab, call your child's doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Dinutuximab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vomiting
• diarrhea
• nausea
• decreased appetite
• weight gain

Some side effects can be serious. If your child experiences any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• fever, chills, and other signs of infection
• blurred vision
• changes in vision
• sensitivity to light
• drooping eyelids
• seizures
• muscle cramps
• rapid heartbeat
• fatigue
• blood in urine
• unusual bleeding or bruising
• vomit that is bloody or looks like coffee grounds
• stool that contains bright red blood or is black and tarry
• pale skin
• swelling of the hands, feet, ankles, or lower legs
• shortness of breath
• fainting, dizziness or lightheadedness

Dinutuximab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.