Danyelza - Naxitamab Injection

What is this medication?

NAXITAMAB (nax IT a mab) treats neuroblastoma, a cancer that occurs in nerve cells. It works by slowing down the growth of cancer cells. It is a monoclonal antibody.

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:

• Heart disease
• High blood pressure
• An unusual or allergic reaction to naxitamab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year 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 care team if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been studied.

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 medication.

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

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 2 months after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 2 months after the last dose. Talk to your care team about effective forms of contraception.

Do not breastfeed while taking this medication or for 2 months after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Heart muscle inflammation—unusual weakness or fatigue, shortness of breath, chest pain, fast or irregular heartbeat, dizziness, swelling of the ankles, feet, or hands
• Increase in blood pressure
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Pain, tingling, or numbness in the hands or feet
• Severe back pain, numbness or weakness of the hands, arms, legs, or feet, loss of coordination, loss of bowel or bladder control
• Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
• Trouble passing urine

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

• Cough
• Diarrhea
• Fatigue
• Loss of appetite
• Nausea
• Vomiting

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 medication 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.