Dinutuximab, Injection

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KEY POINTS

• This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat neuroblastoma in children.
• This medicine may cause serious side effects that can be severe or life-threatening. These include infusion reactions and nervous system problems. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Your child may get serious infections more easily when receiving this medicine.
• Keep all appointments for tests to see how this medicine affects your child.
• Tell all healthcare providers who treat your child about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); monoclonal antibody

Generic and brand names: dinutuximab, injection; Unituxin

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat neuroblastoma in children. It is used with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if your child has ever had:

• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Nervous system problems such as seizures, trouble speaking, loss of balance, or confusion

Tell your healthcare provider if your child has an infection or has infections that keep coming back. Also, tell your healthcare provider if your child has recently had a vaccination or is scheduled to receive any kind of vaccination. It is best to have vaccines up to date before starting treatment with this medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine and for 2 months after the last dose of this medicine. Talk with your healthcare provider about effective birth control. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

The infusions are given by a healthcare provider. Your child will be watched carefully after receiving each dose to make sure that he does not have a serious reaction. Be sure to keep all appointments for these infusions and for blood tests to find out how this medicine affects your child.

Your provider may tell you to give your child certain medicines before each infusion to help reduce any side effects. Follow your healthcare provider's directions exactly.

What if I miss a dose?

Do not miss an appointment for an infusion. If you miss an appointment for an infusion, contact your healthcare provider to reschedule your appointment.

What should I watch out for?

This medicine may cause severe or life-threatening infusion reactions. Most of these reactions happen during or within 24 hours after an infusion of this medicine. Your healthcare provider will give your child other medicines and intravenous fluids to help decrease the risk of these reactions. Contact your healthcare provider right away if your child has any signs of an infusion reaction such as facial or lip swelling, itching or hives, trouble breathing, lightheadedness or dizziness.

This medicine commonly causes severe nerve problems or pain (such as in the legs, arms, stomach, chest, joints, back, or nerves). Your healthcare provider will give your child a narcotic pain medicine, or other pain medicine, before, during, and after each infusion. Contact your healthcare provider right away if your child has severe or worsening pain, or any numbness, burning, tingling, or weakness.

This medicine may cause a serious problem called capillary leak syndrome. Talk with your healthcare provider about this and what symptoms you should look for in your child.

Your child may get serious infections more easily when receiving this medicine. Keep your child away from people with colds, flu, or other infections. Contact your healthcare provider right away if your child develops a fever or ANY other symptoms of infection. Also, your child should not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause serious eye problems. Contact your healthcare provider right away if your child has blurry vision, double vision, droopy eyelids, unequal pupil size, or sensitivity to light.

This medicine may cause dizziness, confusion, or seizures. Your child should not or operate machinery while receiving this medicine.

Your child needs to have exams and blood tests regularly to see how this medicine affects him. Keep all appointments.

If your child needs emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist your child is receiving this medicine.

What are the possible side effects?

Along with its needed effects, this medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your child’s body adjusts to the medicine. Tell your healthcare provider if your child has any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fever and chills; cough; sore throat; severe nausea and vomiting; unusual tiredness or weakness; dizziness or fainting; face swelling; severe or worsening pain; numbness, tingling, burning, or weakness; severe headache; wheezing or trouble breathing; seizures; trouble talking or slurred speech; severe confusion; loss of balance; blurry vision, double vision, vision loss, droopy eyelids, unequal pupil size, or sensitivity to light; blood in the urine; decreased or increased urination; increased thirst or more hungry; unexplained swelling; fast or pounding heartbeat; muscle cramps; unusual bruising or bleeding.

Other: Mild diarrhea, nausea, and vomiting.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Natalizumab (Tysabri)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.