In relapsed or refractory high-risk neuroblastoma
(HRNB)
in the bone and/or bone marrowIf your child had an incomplete response*
to induction or relapse therapy, DANYELZA
could make a difference

* Incomplete response is defined as partial response, minor response, or stable disease to prior therapy.

Ready to ask your care team about DANYELZA?
If your child’s induction or relapse therapy did not result in a complete response, you still have options.
To be a confident advocate for your child, your first and best move is to know the facts. Don't be afraid to ask your care team all your HRNB questions, especially when it comes to treatment decisions.
Meet DANYELZA
An immunotherapy?Immunotherapy is a type of medicine that uses substances to stimulate or suppress the immune system to help the body fight a disease. for relapsed or refractory high-risk?Neuroblastoma is considered high risk when the cancer cannot be surgically removed and has spread to other parts of the body. neuroblastoma
Although decisions about changes in treatment can be overwhelming, it's possible to feel prepared for what comes next.
In HRNB, cancer may still be in your child’s bones or bone marrow?Bone marrow is the soft, sponge-like tissue in the center of most bones. It produces white blood cells, red blood cells, and platelets. if they:
Had an incomplete response?This may refer to: stable disease, when the cancer stays the same; partial response, when the cancer is reduced in all places it was originally present; and minor response, when the cancer is reduced in some places but not all. to induction (initial) therapy?Induction therapy is an initial attempt to treat the cancer and often includes chemotherapy and surgery. (chemotherapy +/- surgery)
OR
Had an incomplete response to relapse therapy?Relapsed is a term used to describe cancer that has returned following a complete response to previous treatment. (if the disease comes back)
Switching therapies? Ask if DANYELZA could be the right next step.
What Makes DANYELZA Different?
DANYELZA is:
The only FDA-approved option specifically for relapsed or refractory?Refractory is a term used to describe cancer that does not respond completely to initial treatment. HRNB
A humanized immunotherapy?Humanized is a way of describing immunotherapies that are made to more closely resemble antibodies that are naturally present in the human body., meaning it more closely resembles antibodies?An antibody is 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. Antibody therapies use antibodies to help the body fight cancer, infection, or other diseases. found in the body
A possible option for treatment in the outpatient?Outpatient refers to medical care that can be completed without a patient staying in a hospital overnight. setting, based on what your child's doctor decides
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.
DANYELZA may cause serious side effects, 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)
- weakness in your legs or arms
- bladder and bowel problems
- pain in back, legs, or stomach (abdomen)
- numbness
- tingling
- burning sensation
- severe headache
- vision changes
- changes in mental status, such as confusion, disorientation, or decreased alertness
- difficulty speaking
- weakness in your arms or legs
- seizures
- unequal pupil size
- blurred vision
- trouble focusing your eyes
- larger pupil size (dilated)
- decreased ability to see
- sensitivity to light
- 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.
DANYELZA may cause serious side effects, including:
- chest pain
- shortness of breath
- irregular heartbeat or feel like your heart is racing
- headaches
- seizures
- nausea or vomiting
- chest pain
- dizziness
- visual changes
- shortness of breath
- feeling that your heart is pounding or racing (palpitations)
- nose bleeds
- 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
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.
DANYELZA may cause serious side effects, 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)
- weakness in your legs or arms
- bladder and bowel problems
- pain in back, legs, or stomach (abdomen)
- numbness
- tingling
- burning sensation
- severe headache
- vision changes
- changes in mental status, such as confusion, disorientation, or decreased alertness
- difficulty speaking
- weakness in your arms or legs
- seizures
- unequal pupil size
- blurred vision
- trouble focusing your eyes
- larger pupil size (dilated)
- decreased ability to see
- sensitivity to light
- 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.
DANYELZA may cause serious side effects, including:
- chest pain
- shortness of breath
- irregular heartbeat or feel like your heart is racing
- headaches
- seizures
- nausea or vomiting
- chest pain
- dizziness
- visual changes
- shortness of breath
- feeling that your heart is pounding or racing (palpitations)
- nose bleeds
- 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
DANYELZA®, Y-mAbs®, Y-mAbs Connect®, and the logos for DANYELZA® and Y-mAbs Connect® are registered trademarks of Y-mAbs Therapeutics, Inc. The logo for Y-mAbs Therapeutics, Inc. is a trademark for Y-mAbs Therapeutics, Inc.
© 2024 Y-mAbs Therapeutics, Inc. All rights reserved. August 2024 NAX-000346_v4