Preparing for Treatment | DANYELZA® (naxitamab-gqgk)

Preparing for treatment

DANYELZA® was studied in an outpatient setting

Your child’s doctor will decide whether or not your child needs to stay overnight in the hospital

DANYELZA is given intravenously (IV) by a team of healthcare professionals. They will closely monitor your child for pain and other side effects throughout the process, as well as for some time after the infusion is complete. This will happen whether DANYELZA is administered in an inpatient or outpatient setting.

Each treatment cycle is 28 days long

The graphic below explains what happens during the first 10 days of each treatment cycle.

DANYELZA Treatment Cycle

Before DANYELZA Infusion Iconbefore

What to expect before
each infusion

  • DANYELZA is used with another medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF can be given at home and starts 5 days before the first DANYELZA infusion
  • Preventive pain medicine (eg, gabapentin) may also be given at home starting 5 days before the first DANYELZA infusion

Be sure to ask your doctor if these medicines can be picked up at your local pharmacy

During DANYELZA Infusion Iconduring

What to expect at the treatment center on infusion days

  • On Day 1 of Cycle 1, the DANYELZA infusion will be 60 minutes. The rest of the DANYELZA infusions will be 30-60 minutes, as tolerated
  • Your child will be monitored for at least 2 hours following each DANYELZA infusion
  • Your child will receive additional medicines before and during DANYELZA infusions to help manage side effects such as pain, infusion-related reactions, and nausea/vomiting. Ask your doctor about these additional medicines

See more details about managing side effects in the section below

After DANYELZA Infusion Iconafter

What to expect after
each infusion

Make sure you monitor your child’s blood pressure through 8 days after Day 1 of each treatment cycle

  • Since every child is different, it’s difficult to know exactly how many treatment cycles your child may need
  • Once your child’s doctor sees an initial response to treatment, DANYELZA will be given for another 5 cycles every 4 weeks. From there, your doctor may repeat treatment cycles every 8 weeks
  • Your child’s doctor will continue monitoring your child’s response to determine if treatment should continue. They will stop treatment if your child’s disease progresses or if they cannot tolerate the side effects
DANYELZA Caregiver, Spencer

“The ability to perform this treatment outpatient really helped our family.”

–Spencer, actual DANYELZA caregiver

Managing side effects before and during DANYELZA treatment

Because some side effects are to be expected during DANYELZA treatment, there are recommendations that your child’s care team will follow to help manage them. Your child’s care team will give your child certain medicines before and during DANYELZA infusions to help manage pain and infusion-related reactions.

For more details about safety, see the serious side effects >

Managing Pain Icon

Managing pain

Pain is common with DANYELZA and can be severe. Your child will likely experience pain during the infusion. In the clinical studies, pain usually lasted less than a day, but in some cases, it lasted longer. Your child’s care team may give your child the following medicines based on their condition:

  • Preventive pain medicine (eg, gabapentin). Given for 12 days starting 5 days before the first DANYELZA infusion in each cycle
  • Other pain medicine (eg, opioids). Given approximately an hour before infusion and may be administered by IV as needed for additional pain during the infusion
  • Anesthetic (eg, ketamine). Given if the pain is not adequately controlled by opioids. This may make your child sleepy during the infusion
Managing Infusion Related Reactions Icon

Managing infusion-related reactions

DANYELZA can cause severe infusion-related reactions that require immediate medical attention. Signs and symptoms may include swelling, itching, skin redness, rash, or hives, breathing problems, and feeling faint or dizzy. DANYELZA can also cause fever, nausea, or vomiting during or after the infusion. Your child’s care team may give your child the following medicines based on their condition:

  • Corticosteroids (eg, methylprednisolone). Given by IV between 30 minutes and 2 hours prior to the first DANYELZA infusion. These medicines will also be given for subsequent infusions if a severe reaction occurred with a previous infusion or cycle
  • Antihistamines (eg, diphenhydramine). Given 30 minutes before infusion to help reduce allergic reaction
  • Fever reducers (eg, acetaminophen). Given 30 minutes before infusion to help control fever
  • Medicine for nausea/vomiting (eg, antiemetics and H2 antagonists). Given 30 minutes before infusion to help reduce nausea and vomiting

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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)

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.

DANYELZA is approved based on two clinical studies that looked at reducing tumor size. DANYELZA is still being studied to confirm the study results and the clinical benefit of treatment.

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)

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.

DANYELZA is approved based on two clinical studies that looked at reducing tumor size. DANYELZA is still being studied to confirm the study results and the clinical benefit of treatment.

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
  • 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?”
  • 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

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.