Naxitamab Injection

What is this medication?

NAXITAMAB (nax it a mab) is a monoclonal antibody. It is used to treat neuroblastoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): DANYELZA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• high blood pressure
• an unusual or allergic reaction to naxitamab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care provider in a hospital or clinic setting.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 1 year of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your doctor or health care provider if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been completed.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine.

This drug can cause serious infusion reactions. To reduce the risk, your health care provider may give you other medicines to take before receiving this one. Be sure to follow the directions from your health care provider.

Do not become pregnant while taking this medicine or for 2 months after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. There is a potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 2 months after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• breathing problems
• blurred vision
• bone pain
• changes in vision
• chest pain
• confusion
• dizziness
• facial flushing
• fast heartbeat
• feeling faint or lightheaded
• increase in blood pressure
• muscle weakness
• pain, tingling, numbness in the hands or feet
• seizures
• sensitive to light
• severe headaches
• stomach pain
• trouble passing urine or change in the amount of urine
• trouble speaking

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• anxious
• decreased appetite
• diarrhea
• nausea, vomiting
• pain, redness or irritation at site where injected
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medicine is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.