Naxitamab-gqgk (nax-IT-a-mab - gqgk)

Treats neuroblastoma.

Brand Name(s):

Danyelza

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the IV will remain in place for 30 to 60 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will also give you other medicines (including allergy medicine, fever medicine, steroids) to help prevent infusion-related reactions, pain, and nausea and vomiting.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 2 months after your last dose.
• Do not breastfeed during treatment and for at least 2 months after your last dose.
• Tell your doctor if you have eye problems, nerve problems, spinal cord problems, trouble urinating, or high blood pressure.
• This medicine may cause the following problems:
  • Infusion-related reactions
  • Nerve pain (including pain in the stomach, bone, neck, legs, or arms)
  • Swelling of the spinal cord
  • Reversible posterior leukoencephalopathy syndrome
  • Peripheral neuropathy (nerve problem)
  • Nerve problems in your eyes
  • Urinary retention (problem urinating or emptying the bladder)
  • Myocarditis (swelling of the heart)
  • High or low blood pressure
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision, changes in vision, sensitivity to light
• Change in how much or how often you urinate, difficult or painful urination
• Chest pain, fast, pounding, or uneven heartbeat, trouble breathing
• Fever, chills, cough, sore throat, body aches
• Lightheadedness or fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe headache, seizures
• Severe pain in the stomach, bone, neck, legs, or arms
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, decreased appetite
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088