Prescribing Information Visit Healthcare Professional Website Important Safety Information
Intended for US audiences only.
Prescribing Information Visit Healthcare Professional Website Important Safety Information

DANYELZA®, Y-mAbs Therapeutics, and the logos for DANYELZA and Y-mAbs Connect are registered trademarks of Y-mAbs Therapeutics, Inc. © 2024 Y-mAbs Therapeutics, Inc. All rights reserved.

Standing
with
you in
the fight

Navigating high-risk neuroblastoma
isn't easy,
but you're not alone. Learn
how DANYELZA may
help support
your child's treatment journey.

Other caregivers have been in your shoes before. See how they navigated the HRNB journey

Community

Being a strong advocate for yourself:
Erin Opens Up

Erin shares her personal journey and offers
actionable advice for caregivers.

Luke's Family Luke's Family

What to expect from DANYELZA

Science

It's important to know what to potentially expect during DANYELZA treatment

Your child will be given DANYELZA intravenously (IV) by healthcare professionals on days 1, 3, and 5 of a 28-day cycle. Five days before receiving their first infusion of DANYELZA, your child will also start another medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF can be given at home and helps the body make white blood cells, so the immune system is stronger during treatment.

Starting 5 days before treatment with DANYELZA, your care team may also prescribe a 12-day course of gabapentin to help reduce pain during treatment, which can also be given at home.

Discussion Guide Documents

Each treatment cycle of DANYELZA is 28 days long and your care team will determine if infusions in an outpatient setting may be an option. Since every child reacts differently, the number of treatment cycles will depend on your child's response.

Once your care team notices an initial response to treatment, DANYELZA will be given for at least another five 28-day cycles.

Discussion Guide Documents Discussion Guide Documents

A complete response is when the patient shows no physical evidence of disease on examination or imaging tests after treatment. Complete response is sometimes phrased as "no evidence of disease" and abbreviated NED.

A partial response is when a person's cancer is reduced by at least 50% after treatment.

Side effects and how to manage them

Resources

Helping you understand side effects and how best to manage them

We can help you to gain a better understanding of side effects and how they're best handled. Based on the clinical studies of DANYELZA®, some side effects can be expected. Your care team will monitor your child closely throughout treatment and will have a plan to help manage any side effects, as needed.

We've grouped the side effects below under pain- and nervous system-related side effects. We've also listed a few medicines that might help with the pain.

Please note: DANYELZA can cause serious infusion-related reactions, which are common with this treatment, and may require immediate medical attention. Signs and symptoms of infusion-related reactions are listed below. Speak with your care team right away if your child experiences any of these side effects while on DANYELZA.

It's possible to prepare for infusion-related reactions. Your child's care team will offer the following pre-medications:

Steroids (eg, methylprednisolone): Given by IV between 30 minutes and 2 hours before the first DANYELZA infusion. If your child had a severe reaction before, these medicines may be given at the next infusion or cycle.
Fever reducers (eg, acetaminophen): Given 30 minutes before the infusion.
Antihistamines (eg, diphenhydramine): Given 30 minutes before the infusion.
Medicine for nausea/vomiting (eg, antiemetics and H2 antagonists): Given 30 minutes before the infusion to help reduce nausea and vomiting.
Doctor with child

Your child's care team is more than just doctors and nurses; it also includes a variety of specialists and therapists dedicated to supporting your whole journey.

More help and resources

Resources

Support and Research Groups

We understand that HRNB can sometimes feel like a constant battle for a caregiver. That's why we're always here with the help and resources you can count on.

From support groups providing you with information, logistical assistance, and emotional support throughout your child's neuroblastoma treatment journey to research groups giving you access to helpful resources; you'll find all the help you need here.

Support Groups:

Arms Wide Open Childhood Cancer Foundation

awoocf.org

The Arms Wide Open Childhood Cancer Foundation is committed to funding pediatric cancer research, supporting families, both financially and emotionally, educating the general public, raising awareness, uniting the childhood cancer community, giving children with cancer a platform to share their voice, and working to ensure children who survive childhood cancer thrive.

Children's Neuroblastoma Cancer Foundation (CNCF)

cncfhope.org

The premier source for neuroblastoma information and resources, the CNCF is composed of families like yours committed to finding a cure for neuroblastoma through research, education, awareness, and advocacy.

The EVAN Foundation

theevanfoundation.org

While spreading smiles and hope, the Evan foundation drives change in the fight against neuroblastoma.

Isabella Santos Foundation (ISF)

isabellasantosfoundation.org

Established in memory of Isabella Santos, whose desire was to beat cancer, grow her hair, and live her dreams, ISF is dedicated to improving rare pediatric cancer treatment options to increase survival rates of kids with cancer.

Solving Kids' Cancer

solvingkidscancer.org

Solving Kids' Cancer focuses on aggressive childhood cancers with low survival rates by helping accelerate new, next-generation treatments.

Research Groups:

Coalition Against Childhood Cancer (CAC2)

cac2.org

CAC2 is a collaborative network of international nonprofits, corporations, where individuals that advance a variety of childhood cancer causes.

ClinicalTrials.gov

ClinicalTrials.gov

A database of privately and publicly funded clinical studies conducted around the world, where individuals can search key terms such as "neuroblastoma".

National Cancer Institute (NCI)

cancer.gov/about-nci

The federal government's principal agency for cancer research and training.

New Approaches to Neuroblastoma Therapy (NANT)

nant.org

Established in 2000, NANT is the only international clinical trials consortium focused on developing new treatments and biomarkers for relapsed/refractory high-risk neuroblastoma to improve outcome. High-risk neuroblastoma remains a challenge, despite improvements seen with intensive chemotherapy, isotretinoin, and immunotherapy.

Glossary of Important Terms

Resources

Glossary of Important Terms

Antibody

A protein made by white blood cells in response to a foreign substance in the body. This substance, called an antigen, causes an immune response in the body. Each antibody is made to bind to one specific type of antigen and destroy it. Antibodies help the body fight cancer, infection, or other diseases.

Anti-drug antibody

An antibody that binds to a specific drug after repeated administration.

Bone marrow

The soft, sponge-like tissue in the center of most bones. It produces white blood cells, red blood cells, and platelets.

Complete response

When the patient shows no physical evidence of disease on examination or imaging tests after treatment. Complete response is sometimes phrased as "no evidence of disease" and abbreviated NED.

Consolidation therapy

Treatment used to kill any cancer cells that may be left in the body after initial treatment. Consolidation can include treatments like chemotherapy, radiation, stem cell transplant, etc.

Curie score

A numbering system that divides the body into 9 skeletal sections with a tenth soft-tissue section that measures the extent of neuroblastoma with involvement present in the body.

Duration of response (DOR)

The amount of time patients maintain their complete or partial response, without the cancer growing or spreading.

Efficacy

The measurement of how well a medicine works to produce a desired effect.

GD2

A disialoganglioside molecule found on neuroblastoma cells and certain nerve cells.

GM-CSF

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a medication given with DANYELZA® to help the body's immune system during cancer treatment.

High risk

Neuroblastoma is generally considered high risk when the cancer cannot be surgically removed and it has spread to other parts of the body.

Humanized

A way of describing immunotherapies that are made to more closely resemble antibodies that are naturally present in the human body.

Immune system

A system of cells, tissues, organs, and the substances they make that help the body fight infections and other diseases.

Immunotherapy

A type of medicine that uses substances to stimulate or suppress the immune system to help the body fight the disease.

Incomplete response

This may refer to: stable disease, when the cancer stays the same; partial response, when the cancer is reduced by at least 50% after treatment; and minor response, when the cancer is reduced in some places but not all.

Induction therapy

An initial attempt to treat the cancer that often includes chemotherapy and surgery.

Infusion

A way to put fluids, including drugs, into the bloodstream. It is often called an intravenous infusion, which means an infusion into a vein.

IV (intravenous)

IV usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein.

Maintenance therapy

Attempts to treat the cancer throughout the body with medications after initial treatment. These medications may include chemotherapy, hormonal therapy, targeted therapy, or immunotherapy.

MIBG

A meta-iodobenzylguanidine (MIBG) scan is a procedure that helps detect the presence of neuroblastoma and its location in the body.

Outpatient

A term that refers to medical care that can be completed without a patient staying in a hospital overnight.

Overall response rate (ORR)

The percentage of patients in a study who have either a complete or partial response to treatment.

Partial response (PR)

This is when a person's cancer is reduced by at least 50% after treatment.

Refractory

A term used to describe cancer that does not respond completely to treatment.

Relapsed

A term used to describe cancer that has returned following a period of improvement as a result of treatment.

Remission

A decrease or disappearance of cancer signs and symptoms.

Download Glossary

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

IMPORTANT SAFETY INFORMATION

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).

Do not receive DANYELZA if you have 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 months after 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 months after 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.

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 12-18 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.

Please click for full Prescribing Information and Patient Information for DANYELZA including Boxed Warning on serious infusion-related reactions and nervous system problems, and talk to your doctor.