Danyelza
Danyelza (naxitamab or naxitamab-gqgk) is an anti-GD2 monoclonal antibody. It’s used to treat advanced, high-risk neuroblastoma, a type of cancer that mostly affects children. Danyelza (naxitamab) is infused through the veins daily for a few days during each 4- or 8-week treatment cycle. Some of the most common side effects of Danyelza (naxitamab) include pain and infusion-related reactions, like fever and breathing difficulties.
What is Danyelza (naxitamab)?
What is Danyelza (naxitamab) used for?
- Advanced, high-risk neuroblastoma in the bone or bone marrow that didn’t respond well to other medications (in people ages 1 year and older)
How Danyelza (naxitamab) works
Danyelza (naxitamab) is an anti-GD2 monoclonal antibody. It finds and attaches to GD2, which are markers on the surface of cells, including healthy cells. But neuroblastoma cells have a lot more of them. When Danyelza (naxitamab) attaches to the cancer cells, it signals the immune cells to destroy them.
Your provider will give you another medication called granulocyte-macrophage colony-stimulating factor (GM-CSF) to help your body make more immune cells, so that there are more to attack the cancer.
Drug facts
Side effects of Danyelza (naxitamab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Pain (up to 100%)
- Infusion-related reaction (up to 100%)
- Fast heartbeat (84%)
- Lower blood cell counts (up to 74%)
- Lower potassium levels (63%)
- Vomiting (60%)
- Cough (60%)
- Diarrhea (56%)
- High blood pressure (44%)
- Changes in liver labs (42%)
- Rash (32%)
- Burning, numbness, or pain in the hands and feet (32%)
Less Common Side Effects
- Headache
- Swelling
- Tiredness
- Fever
- Runny nose
- Vision changes
- Being less alert
- Constipation
Danyelza (naxitamab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infusion-related reactions: hives, low blood pressure, lip and face swelling, breathing problems, wheezing, weakness, dizziness, chest pain, rash, flushing
- Serious brain-related condition: severe headaches, seizures, confusion, changes in vision, difficulty staying awake, trouble speaking
- Spinal cord inflammation: Weakness in the legs or arms, back pain, tingling or numbing feelings, needing to urinate more often, and constipation
- Dangerously high blood pressure: dizziness, headaches, blurry vision, chest pain, ringing or buzzing in the ears
The following Danyelza (naxitamab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision such as blurry vision, seeing halos around lights, vision loss
- Heart muscle inflammation—unusual weakness or fatigue, shortness of breath, chest pain, fast or irregular heartbeat, dizziness, swelling of the ankles, feet, or hands
- Increase in blood pressure
- Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
- Pain, tingling, or numbness in the hands or feet
- Severe back pain, numbness or weakness of the hands, arms, legs, or feet, loss of coordination, loss of bowel or bladder control
- Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
- Trouble passing urine
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Danyelza (naxitamab)
Pros
- Doesn't usually require admission into the hospital, can typically receive at an infusion center or clinic
- Short infusion time (30-60 minutes)
Cons
- Can cause serious infusion-related reactions, rash and breathing problems
- Can be painful to receive
Pharmacist tips for Danyelza (naxitamab)
- You’ll need to receive another medication called GM-CSF daily for 5 days before your first Danyelza (naxitamab) dose. This medication helps Danyelza (naxitamab) work better to fight cancer. Ask your provider where you need to go to receive GM-CSF infusions. If appropriate, you might be able to receive the doses at home.
- Danyelza (naxitamab) can cause nerve pain. Your provider might prescribe gabapentin (Neurontin) for you to take starting 5 days prior to the infusions. If so, be sure to pick your prescription up from the pharmacy.
- Danyelza (naxitamab) is given as an infusion into your vein by trained medical staff in a clinic or infusion center. The entire process of receiving a dose can take about half a day. Consider bringing a book, games, or something to help pass the time. Be sure to bring snacks in case you get hungry and water to stay hydrated.
- Make sure you know when your infusions are scheduled and mark the dates on your calendar so you don’t miss a dose. Typically, you’ll receive Danyelza (naxitamab) during the first few days of every 4-week cycle. But if your cancer is well-controlled after a few cycles, your provider might give you Danyelza (naxitamab) less often (every 8 weeks, instead of every 4 weeks).
- Let your care team know right away if you have any breathing problems, swelling, or dizziness during the Danyelza (naxitamab) infusion. These reactions can be serious and your provider will need to slow down your infusion and treat your symptoms right away.
- Let your provider know right away if you have trouble urinating after receiving Danyelza (naxitamab). This is likely a side effect related to the opioid medications your provider prescribed to ease pain from the infusions. But rarely, difficulty urinating can be caused by nerve damage from Danyelza (naxitamab). If you’ve trouble urinating, your provider will stop the opioid medications to see if that helps; if it does, they might ask you to stop Danyelza (naxitamab) treatment.
- Danyelza (naxitamab) can cause vision changes, including blurry vision and sensitivity to light. Usually, these side effects should get better after a couple of weeks. If not, your provider might ask you to stop Danyelza (naxitamab) treatment to prevent further damage.
Common questions about Danyelza (naxitamab)
A clinical study showed that Danyelza (naxitamab) worked well to treat neuroblastoma for 45% of people who received the medication. Most of these people had a complete response, meaning the exams and scans after treatment didn’t find any signs of tumor. And others had a partial response, meaning scans showed their tumors shrank at least half in size. In addition, the study also showed Danyelza (naxitamab) continued to prevent tumors from growing or spreading for 6 months or longer for 30% of people who initially improved with treatment. Talk with your provider if you have more questions about what results you might expect from Danyelza (naxitamab) treatment.
Before you receive Danyelza (naxitamab), your provider will give you a medication called GM-CSF, such as Leukine (sargramostim). GM-CSF is important because it helps Danyelza (naxitamab) better fight against cancer cells by boosting the amount of immune cells you have to attack the cancer. You’ll receive GM-CSF as a daily infusion for 5 days before your first dose of Danyelza (naxitamab).
Yes, you can expect to have infusion-related reactions, such as breathing problems, swelling, or nausea, during or after receiving Danyelza (naxitamab). Sometimes, these reactions can be serious or life-threatening. To lower your risk of such reactions, your provider will give you pre-medications before each Danyelza (naxitamab) dose. You’ll likely receive acetaminophen (Tylenol) to help with fever, and an antihistamine and corticosteroid to help ease swelling or rash. You might also receive antiemetics to control nausea and vomiting. Let your care team know right away if you have symptoms of infusion reactions because they might need to temporarily slow or stop your infusion to give you medical treatment.
Yes, pain is a common side effect of Danyelza (naxitamab). It can affect different parts of the body, including the bone, nerves, and hands and feet. Your provider might prescribe a 2-week treatment with gabapentin (Neurontin) starting 5 days before Danyelza (naxitamab) infusions to help with nerve pain. They might also give you IV opioid medications on the day of Danyelza (naxitamab) treatment to ease pain during the infusion. Typically, the pain should go away within a day after the infusion. But sometimes, it can last up to 2 months. Talk with your provider to learn more about how you can manage your pain during and after each infusion.
You might be at the infusion center for at least half the day for each Danyelza (naxitamab) infusion, so please plan accordingly. The Danyelza (naxitamab) infusion itself only takes about 30 minutes to an hour. But your provider will need to give you pre-medications 1-2 hours before an infusion to ease pain and prevent infusion-related reactions, such as swelling or breathing problems. After your infusion is complete, your care team will ask you to stay for about 2 hours to monitor you for infusion reactions. Be sure to dress comfortably and bring activities to help you pass the time. Also, bring snacks in case you get hungry and water to help you stay hydrated.
Usually, you will continue Danyelza (naxitamab) as long as your tumor isn’t growing or spreading. Typically, you’ll continue to receive cycles of treatment until your provider no longer sees the tumor on scans or until scans show that the tumor has shrunk by at least half. After that, your provider might space out your doses to every 8 weeks instead of every 4 weeks, depending on how well the medication is controlling your cancer. But your provider might ask you to stop treatment with Danyelza (naxitamab) if you experience serious side effects, such as severe pain, rash, or trouble breathing.
Danyelza (naxitamab) was given accelerated approval for neuroblastoma in 2020. The FDA Accelerated Approval Program allows a medication to be approved faster than usual if the medication helps fill an unmet medical need or treats a serious condition. The manufacturer is still required to complete clinical studies to confirm that the medication is beneficial and safe. Otherwise, it could lose its approval status and be removed from the market. The full approval depends on the results of the clinical trial.
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Risks and warnings for Danyelza (naxitamab)
Danyelza (naxitamab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Infusion-related reactions
Danyelza (naxitamab) commonly causes infusion reactions, typically within 30 minutes to 24 hours of starting the first infusion. Most of the time, the reactions are mild. But sometimes, these reactions can be serious and need more medical attention. To lower the risk of these reactions, your provider will give you medications, such as acetaminophen (Tylenol), an antihistamine, and a corticosteroid, before starting the infusion. If you do have a reaction, your care team might stop the infusion and treat you with medications and restart at a slower rate. To be safe, you’ll need to stay for about 2 hours after the infusion is complete so your care team can provide treatment in case of a reaction. Notify your provider right away if you experience symptoms such as rash, dizziness, and trouble breathing.
Pain
Danyelza (naxitamab) can commonly cause pain. The pain can affect different parts of the body, including the nerves, stomach, bone, neck, legs, or arms. Most of the time, the pain starts during the Danyelza (naxitamab) infusion and lasts for a few days afterward, though sometimes it can last as long as 2 months later. To prevent nerve pain, your provider might ask you to start gabapentin (Neurontin) a few days before the infusion. They’ll also provide you with other pain medications, such as opioids, on the day of your infusion to manage pain if it’s more severe. If your pain is hard to control, your provider might ask you to consider stopping this medication.
Danyelza (naxitamab) can also cause transverse myelitis, which is inflammation of the spinal cord. This is very rare, but can cause weakness of the legs or arm, pain, feelings of numbness or tingling, or increased urge to use the toilet. You should notify your provider right away if these symptoms occur. You’ll have to stop taking the medication.
Brain-related changes
Rarely, people have reported a very serious brain condition called posterior reversible encephalopathy syndrome (PRES) after taking Danyelza (naxitamab). It typically happened between 2-7 days after they finished the first cycle of treatment. Get medical help right away if you have sudden severe headaches, sudden confusion, sudden vision loss or vision changes, behavioral changes, or seizures.
Vision changes
About a quarter of people had changes in the eye after starting Danyelza (naxitamab). These changes included blurry vision, dilated pupils, vision changes, and sensitivity to light. On average, the symptoms lasted almost 3 weeks. Your provider might ask you to stop taking Danyelza (naxitamab) if you have severe vision problems and lasts longer than 2 weeks.
Vision changes
Risk factor: Taking opioid pain medications
It's very rare, but Danyelza (naxitamab) can make it difficult for you to urinate or fully empty the bladder. This side effect typically starts on the day of an infusion and can last for up to 3 weeks later. If you've trouble urinating, your provider will likely ask you to slowly stop taking any opioid medications to see if this helps. If this doesn't help, your provider might recommend you stop taking Danyelza (naxitamab).
High blood pressure
Danyelza (naxitamab) can raise your blood pressure typically on the day of the infusion and up to 9 days after. If you already have high blood pressure, you won’t be able to receive this medication unless your blood pressure is under control, It’s important to check and write down your blood pressure at least daily for the first 8 days after each Danyelza (naxitamab) infusion. Most of the time, you won’t notice any symptoms if your blood pressure is high. Notify your provider right away if you have symptoms of dangerously high blood pressure, including dizziness, headaches, blurry vision, chest pain, slow or fast heartbeat, or buzzing in the ears.
Harm to unborn or breastfeeding baby
Based on how it works in the body, Danyelza (naxitamab) will likely harm unborn babies. If you’re able to become pregnant, your provider will have you take a pregnancy test before starting treatment. Use effective birth control while taking this medication and for at least 2 months after your last dose.
There’s not enough information to know whether Danyelza (naxitamab) is found in breast milk or will cause harm to breastfed babies. But because of the possible risk of harm, you’re recommended to avoid breastfeeding during and for at least 2 months after the last Danyelza (naxitamab) dose.
Danyelza (naxitamab) dosage
Typical dosage for Danyelza (naxitamab)
Your child’s provider will determine their dose based on your child’s body weight.
- Adults and children ages 1 years and older: The typical dose is 3 mg/kg daily (up to 150 mg) infused through the veins over 30 to 60 minutes once a day. It’s typically given on Days 1, 3, and 5 of each 4-week cycle.
Your child’s provider will also give GM-CSF before the start of Danyelza (naxitamab) treatment. In addition, your child will receive medications before and during each Danyelza (naxitamab) infusion to help with side effects.
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