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.
Meet DANYELZA
An immunotherapy? for relapsed or refractory high-risk? 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? if they:
Had an incomplete response? to induction (initial) therapy? (chemotherapy +/- surgery)
OR
Had an incomplete response to relapse therapy? (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? HRNB
A humanized immunotherapy?, meaning it more closely resembles antibodies? found in the body
A possible option for treatment in the outpatient? 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