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Danyelza (Naxitamab): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
40 mg/10 mL
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Danyelza

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

DANYELZA may cause serious side effects, including:

  • Serious infusion-related reactions.DANYELZA can cause serious infusion-related reactions that require immediate medical attention. Infusion-related reactions are common with DANYELZA. Tell your healthcare provider right away if you get any signs or symptoms during or after your DANYELZA infusion, including:
  • swelling of your face, eyes, lips, mouth, or tongue
  • itching
  • redness on your face (flushing)
  • skin rash or hives
  • trouble breathing
  • cough or wheezing
  • noisy high-pitched breathing
  • feeling faint or dizziness (low blood pressure)
  • Nervous system problems. Talk to your healthcare provider right away if you have new symptoms or worsening of nervous system problems, including:
  • Severe pain from nerves (neuropathic pain),including pain in the belly (abdomen), bone, neck, legs or arms. Pain is common with DANYELZA and can be severe.
  • Inflammation of the spinal cord.Signs or symptoms may include:
  • weakness in your legs or arms
  • bladder and bowel problems
  • pain in back, legs, or stomach (abdomen)
  • numbness
  • tingling
  • burning sensation
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS – also known as Posterior Reversible Encephalopathy Syndrome - PRES).PRES is a condition that affects the brain. Your healthcare provider will monitor your blood pressure and check for any neurologic symptoms after your DANYELZA infusion. Signs or symptoms of PRES may include:
  • severe headache
  • vision changes
  • changes in mental status, such as confusion, disorientation, or decreased alertness
  • difficulty speaking
  • weakness in your arms or legs
  • seizures
  • Numbness, tingling, or burning sensation in the arms or legs.
  • Nervous system problems of the eye.Signs or symptoms may include:
  • unequal pupil size
  • blurred vision
  • trouble focusing your eyes
  • larger pupil size (dilated)
  • decreased ability to see
  • sensitivity to light
  • Problems urinating or emptying your bladder (prolonged urinary retention).

What is DANYELZA?

DANYELZA is a prescription medicine used in combination with a medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF) to treat children 1 year of age and older and adults with high-risk neuroblastoma in the bone or bone marrow that:

  • has come back (relapsed) or that did not respond to previous treatment (refractory), and
  • has shown a partial response, minor response, or stable disease to prior therapy.

It is not known if DANYELZA is safe and effective in children younger than 1 year of age.

Do not receive DANYELZA if youhave had a severe allergic reaction to naxitamab-gqgk, the active ingredient in DANYELZA .Ask your healthcare provider if you are not sure.

Before receiving DANYELZA, tell your healthcare provider about all your medical conditions, including if you:

  • have high blood pressure
  • have heart disease

  • are pregnant or plan to become pregnant. DANYELZA may harm your unborn baby.

  • Your healthcare provider will do a pregnancy test before you start treatment with DANYELZA.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 2 monthsafter your last dose of DANYELZA. Talk to your healthcare provider about birth control choices that may be right for you during this time.
  • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with DANYELZA.
  • are breastfeeding or plan to breastfeed. It is not known if DANYELZA passes into your breast milk. Do not breastfeed during treatment and for 2 monthsafter your last dose of DANYELZA.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive DANYELZA?

  • Your healthcare provider will give you DANYELZA into your vein through an intravenous (I.V.) line over 30 or 60 minutes.
  • DANYELZA is given on Days 1, 3, and 5 of each treatment cycle.
  • DANYELZA is used with another medicine called GM-CSF. You can ask your healthcare provider for information about GM-CSF.
  • DANYELZA treatment cycles are usually repeated every 4 or 8 weeks. Your healthcare provider will decide how many treatment cycles you need.
  • Your healthcare provider will give you certain medicines before and during your DANYELZA infusion to help decrease your risk of getting pain, infusion-related reactions, and nausea or vomiting.
  • Your healthcare provider may slow down your infusion rate, temporarily stop DANYELZA infusion, or permanently stop treatment with DANYELZA if you have certain side effects.
  • You will be monitored for side effects for at least 2 hours after each DANYELZA infusion.
  • If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What are the possible side effects of DANYELZA?

DANYELZA may cause serious side effects, including:

  • See " What is the most important information I should know about DANYELZA?"
  • Swelling of the heart (myocarditis).Myocarditis has happened in adolescents ages 12 to 18 within days of receiving DANYELZA. Tell your healthcare provider if you get any signs or symptoms of myocarditis, including:
  • chest pain
  • shortness of breath
  • irregular heartbeat or feel like your heart is racing
  • High blood pressure (hypertension).High blood pressure is common in people who receive DANYELZA. Your blood pressure will be monitored during your DANYELZA infusion, and at least each day on Days 1 to 8 of each DANYELZA treatment cycle. Tell your healthcare provider right away if you get any signs or symptoms of high blood pressure, including:
  • headaches
  • seizures
  • nausea or vomiting
  • chest pain
  • dizziness
  • visual changes
  • shortness of breath
  • feeling that your heart is pounding or racing (palpitations)
  • nose bleeds
  • Decreased blood pressure (orthostatic hypotension) that can be severe and require hospitalization.You may feel dizzy, lightheaded, or pass out (faint) when you rise too quickly from a sitting or lying position. Your healthcare provider will monitor your blood pressure before you start and during treatment with DANYELZA.

The most common side effects of DANYELZA include:

  • fast heart rate
  • vomiting
  • cough
  • nausea
  • decreased white blood cell, red blood cell, and platelet counts
  • diarrhea
  • decreased appetite
  • tiredness
  • skin rashes
  • decreased level of potassium, sodium, and phosphate in the blood
  • hives
  • fever
  • headache
  • injection site reaction
  • swelling of the body or only in one part of the body
  • anxiety
  • irritability
  • increased liver function blood tests
  • decreased blood sugar level
  • decreased calcium levels in the blood
  • decreased protein levels (albumin) in the blood

These are not all of the possible side effects of DANYELZA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DANYELZA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about DANYELZA that is written for health professionals.

What are the ingredients in DANYELZA?

Active ingredient:naxitamab-gqgk

Inactive ingredients:citric acid anhydrous, poloxamer 188, sodium chloride, sodium citrate, Water for Injection.

Manufactured by: BTG International Inc., West Conshohocken, PA 19428

U.S. License number 1861

For more information, go to www.DANYELZA.com or call +1-877-377-3784

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761171 · View the label on DailyMed

Revision date stated in the text: May 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Danyelza

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Glycolipid Disialoganglioside-directed Antibody
Active ingredient Naxitamab 40 mg/10 mL
Dosage form Injection
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) Y-MABS THERAPEUTICS INC
FDA approval BLA 761171Biologics License Application (BLA) Approved November 25, 2020
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
40 mg/10 mL – 10 ml in 1 vial, single-dose / 1 in 1 carton NDC 50633-230-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.