naxitamab-gqgk 4 mg/mL intravenous solution

Generic name:
Naxitamab - injection

Pronunciation
(nax-IT-a-mab)

Brand name(s)
Danyelza

Infusion reactions (rarely fatal) may happen during the infusion of this drug and for 24 hours afterward. Your doctor may prescribe other medications (such as an antihistamine, corticosteroid, H2 blocker, and acetaminophen) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of infusion reactions such as rash, flushing, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, wheezing, chest discomfort/pain. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Naxitamab can cause serious nervous system problems. Pain is common and can be severe. Tell your doctor right away if you have pain in the abdomen, bones, neck, legs, or arms. Your doctor should prescribe medications to help prevent and relieve pain before and during treatment with this medication.

Rarely, this medication may cause a condition called reversible posterior leukoencephalopathy syndrome-RPLS, also known as posterior reversible encephalopathy syndrome-PRES. Get medical help right away if you develop headache that doesn't go away, seizures, sudden vision changes, mental/mood changes (such as confusion).

This medication is used to treat a certain type of cancer (neuroblastoma in bone or bone marrow). Naxitamab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

See also Warning section.

Read the Patient Information Leaflet if available from your pharmacist before you start using naxitamab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually on days 1, 3, and 5 of each treatment cycle. A treatment cycle is usually every 4 or every 8 weeks. The injection is given by a health care professional, usually over 30 to 60 minutes.

The dosage and treatment schedule are based on your medical condition, weight, and response to treatment.

See also Warning section.

Tiredness, nausea, vomiting, diarrhea, dizziness, lightheadedness, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

There have been rare reports of swelling of the heart muscle (myocarditis) that has occurred within days of receiving this medication. If you notice any of the following symptoms, tell your doctor right away:

• chest pain
• shortness of breath
• irregular/fast heartbeat

Tell your doctor right away if you have any serious side effects, including:

• numbness/tingling (including in the arms or legs)
• weakness in the arms or legs
• trouble urinating
• vision changes (such as blurred vision, decreased vision)

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using naxitamab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high blood pressure
• heart disease

Naxitamab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using naxitamab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be at greater risk for a certain heart problem (myocarditis) while using this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using naxitamab. Naxitamab may harm an unborn baby. Your doctor may order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 2 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts, blood pressure, blood chemistry such as potassium, sodium, phosphate) should be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.