Naxitamab-gqgk Injection

pronounced as (nax it' a mab)

Brand Name(s): Danyelza®

Why is this medicine prescribed?

Naxitamab-gqgk injection is used in combination with another medication in adults and children 1 year of age and older to treat neuroblastoma (a cancer that begins in nerve cells) in the bone or bone marrow that has returned or that did not respond to a previous treatment, but who have responded to other treatments. Naxitamab-gqgk injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Naxitamab-gqgk comes as a solution (liquid) to be injected intravenously (into a vein) over 30 to 60 minutes by a doctor or nurse in a medical facility or infusion center. It is usually given on days 1, 3, and 5 of a 28 day treatment cycle and it may be repeated based on your response. After the initial treatment, your doctor may prescribe additional treatment cycles every 8 weeks.

Your doctor will probably treat you with other medications before and during each dose to help prevent certain side effects. Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of naxitamab-gqgk during your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with naxitamab-gqgk.

What special precautions should I follow?

Before receiving naxitamab-gqgk,

  • tell your doctor and pharmacist if you are allergic to naxitamab-gqgk, any other medications, or any of the ingredients in naxitamab-gqgk injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had hypertension or urinary retention (sudden inability to urinate).
  • tell your doctor if you are pregnant or plan to become pregnant. You must take a pregnancy test before starting treatment. You should use effective birth control during your treatment and for 2 months after your final dose. If you become pregnant while receiving naxitamab-gqgk, call your doctor. Naxitamab-gqgk may harm the fetus.
  • tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with naxitamab-gqgk and for 2 months after your final dose.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

If you miss an appointment to receive naxitamab-gqgk, call your doctor as soon as possible.

What side effects can this medicine cause?

Naxitamab-gqgk may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • vomiting
  • nausea
  • diarrhea
  • loss of appetite
  • anxiety
  • tiredness
  • cough, runny nose, fever, or other signs of infection

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • severe headache, racing or irregular heartbeat, chest pain, dizziness, shortness of breath, nose bleeds, or fatigue

Naxitamab-gqgk may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( ) or by phone (1-800-332-1088).

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure at certain times in your treatment cycle and order certain tests to check your body's response to naxitamab-gqgk.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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