naxitamab

What is the most important information I should know about naxitamab?

Tell your caregiver if you have any of these side effects during the injection: feeling dizzy or light-headed, itching, warmth or tingling, shortness of breath, noisy breathing, or swelling in your face.

What is naxitamab?

Naxitamab in used to treat high-risk neuroblastoma (a rare form of cancer) in adults and children at least 1 year old.

Naxitamab is used in combination with another medicine that causes your body to produce certain blood cells that help fight the cancer and protect you from infection.

Naxitamab is given after other cancer treatments did not work well, or have stopped working.

Naxitamab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Naxitamab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving naxitamab?

Tell your doctor if you have ever had high blood pressure.

You may need to have a negative pregnancy test before starting this treatment.

How is naxitamab given?

Naxitamab is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take 30 to 60 minutes to complete.

Naxitamab is usually given in a 28-day treatment cycle, repeated every 4 or 8 weeks. You may need to use the medicine only during the first week of each cycle. Your doctor will determine how long to treat you with this medicine.

You will be watched closely for at least 2 hours after the injection to make sure you do not have an allergic reaction or certain side effects.

You may need frequent blood tests to be sure this medicine is not causing harmful effects. Your blood pressure will also need to be checked often.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving naxitamab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of naxitamab?

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, itchy, warm or tingly, short of breath, or if you have a cough, noisy breathing, or swelling in your face.

• severe pain anywhere in your body;
• numbness, tingling, or burning pain in your hands or feet;
• severe headache, confusion, thinking problems, weakness, vision loss;
• a seizure;
• painful or difficult urination;
• cold symptoms --such as runny or stuffy nose, sneezing, sore throat, cough, low fever, and not feeling well;
• eye problems --blurred vision, trouble focusing, dilated pupils, unequal pupil size, being more sensitive to light;
• high blood pressure --headache, nausea, vomiting, dizziness, vision changes, nosebleeds, chest pain, fast or pounding heartbeats, pounding in your neck or ears; or
• low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting, diarrhea, loss of appetite;
• low blood cell counts, or other abnormal lab tests;
• skin rash or hives;
• swelling;
• headache, fever, feeling tired;
• fast heart rate;
• feeling anxious or irritable;
• cough; or
• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect naxitamab?

Other drugs may affect naxitamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about naxitamab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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