Generic Name: naxitamab-gqgk
Trade Name: Danyelza

How is Danyelza used? Danyelza is approved for the treatment of children 1 year of age and older as well as adults with high-risk neuroblastoma in the bone or bone marrow that has relapsed or is refractory and has shown a partial response, minor respone or stable disease to prior therapy. Danyelza is approved in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF).

Danyelza labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and or life-threatening side effects including serious infusion-related reactions and severe neurotoxicity including severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS).

What is the mechanism of action? Danyelza is a type of immunotherapy drug known as a monoclonal antibody. It works by helping the body’s immune system to find and destroy cancer cells. Danyelza targets ganglioside GD2 which is over expressed on neuroblastoma cells and other cells of neuroectodermal origin, including the CNS and peripheral nerves.

How is Danyelza given (administered)? Danyelza is administered into a vein (intravenous). Patients will be monitored during infusion for infusion-related reactions.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Danyelza. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Your blood pressure will be monitored during treatment with Danyelza.

What are the common side effects of Danyelza in combination with chemotherapy?

  • Fast heart rate
  • Decreased potassium, sodium and phosphate levels
  • Anxiety/Irritability
  • Vomiting
  • Cough
  • Nausea
  • Decreased blood cell counts (red, white and/or platelets)
  • Diarrhea
  • Decreased appetite
  • Tiredness
  • Skin rashes
  • Hives
  • Fever
  • Headache
  • Injection site reaction
  • Swelling
  • Increased liver function blood tests
  • Decreased blood sugar level
  • Decreased calcium levels
  • Decreased protein levels

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Maintain adequate rest and nutrition.

Are there any special precautions patients should be aware of before starting treatment?

  • It is important that patients inform their physician of any pre-existing conditions including high blood pressure and if you are pregnant or plan on becoming pregant.
  • Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
  • Patients should check with their physician before starting any new drug or supplement.
  • Talk to your doctor if you or your partner are pregnant or planning to become pregnant. Danyelza can cause fetal harm. Females should use an effective method of birth control during treatment and for two months after the last dose of Danyelza.
  • Do not breastfeed during treatment or for two months after the last dose of Danyelza.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor right away if you experience the following:

  • Symptoms of infusion-related reactions: swelling of face/eyes/lips/mouth/tongue, itching, flushing, ski rash or hives, trouble breathing, cough or wheezing, noise high-pitched breathing, feeling faint or dizzy
  • Symptoms of nervous system problems: severe pain, inflammation of the spinal cord, RPLS, numbness/tingling/burning in the arms or legs, nervous system problems of the eyes, problems urinating.
  • Symptoms of high blood pressure: headaches, seizures, nausea/vomiting, chest pain, dizziness, visual changes, shortness of breath, heart palpitations, nose bleeds

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated 04/21.

Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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