Danyelza is a prescription medicine used to treat high-risk neuroblastoma (a rare form of cancer) in adults and children at least 1 year old.

Danyelza is used in combination with another medicine called granulocyte-macrophage colony-stimulating factor (GM-CSF) that causes your body to produce certain blood cells that help fight the cancer and protect you from infection.

Danyelza is given after other cancer treatments did not work well, or have stopped working.

Danyelza was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Danyelza can cause serious side effects. Call your doctor at once if you have pain or a severe headache, numbness or tingling, weakness, problems with speech or thought, vision problems, painful urination, fast or pounding heartbeats, chest pain, or a seizure.

Tell your caregiver if you have any of these side effects during the injection: feeling dizzy or light-headed, itching, warmth or tingling, shortness of breath, noisy breathing, or swelling in your face.

Before taking this medicine

You should not be treated with Danyelza if you are allergic to naxitamab.

To make sure Danyelza is safe for you, tell your doctor if you have ever had: high blood pressure.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Danyelza if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Danyelza is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take 30 to 60 minutes to complete.

Danyelza is usually given in a 28-day treatment cycle, repeated every 4 or 8 weeks. You may need to use the medicine only during the first week of each cycle. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

You will be watched closely for at least 2 hours after the injection to make sure you do not have an allergic reaction or certain side effects.

You may need frequent blood tests to be sure this medicine is not causing harmful effects. Your blood pressure will also need to be checked often.

You should not be treated with Danyelza if you are allergic to naxitamab.

To make sure Danyelza is safe for you, tell your doctor if you have ever had: high blood pressure.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Danyelza if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Call your doctor for instructions if you miss an appointment for your Danyelza injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Danyelza: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, itchy, warm or tingly, short of breath, or if you have a cough, noisy breathing, or swelling in your face.

Call your doctor at once if you have:

• severe pain anywhere in your body;

• numbness, tingling, or burning pain in your hands or feet;

• severe headache, confusion, thinking problems, weakness, vision loss;

• a seizure;

• painful or difficult urination;

• cold symptoms - such as runny or stuffy nose, sneezing, sore throat, cough, low fever, and not feeling well;

• eye problems - blurred vision, trouble focusing, dilated pupils, unequal pupil size, being more sensitive to light;

• high blood pressure - headache, nausea, vomiting, dizziness, vision changes, nosebleeds, chest pain, fast or pounding heartbeats, pounding in your neck or ears; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Danyelza side effects may include:

• nausea, vomiting, diarrhea, loss of appetite;

• low blood cell counts, or other abnormal lab tests;

• skin rash or hives;

• swelling;

• headache, fever, feeling tired;

• fast heart rate;

• feeling anxious or irritable;

• cough; or

• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with naxitamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.