Naxitamab-gqgk

What Is naxitamab-gqgk?

• Naxitamab-gqgk (Danyelza) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF).

What are the uses of this medicine?

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.

How does this medicine work?

Naxitamab-gqgk binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, naxitamab-gqgk was able to bind to cell surface GD2 and induce complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC).

Who Should Not Use this medicine ?

• Danyelza cannot be used in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• The recommended dosage of Danyelza is 3 mg/kg/day (up to 150 mg/day), administered as an intravenous infusion after dilution on Days 1, 3, and 5 of each treatment cycle.
• Treatment cycles are repeated every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks.
• Subsequent cycles may be repeated every 8 weeks.
• Administer GM-CSF subcutaneously prior to and during each treatment cycle as recommended.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• This medicine is avaialable as Injection: 40 mg/10 mL (4 mg/mL) clear to slightly opalescent and colorless to slightly yellow solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Danyelza

What side effects can this medication cause?

Common possible side effects and laboratory abnormalities of this medicine include:

• pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability
• decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased alanine aminotransferase, decreased glucose, decreased calcium, decreased albumin, decreased sodium, and decreased phosphate

What special precautions should I follow?

• Permanently discontinue this medication if Peripheral neuropathy, neurological disorders of the eye, and prolonged urinary retention have also occurred.
• Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.
• Monitor blood pressure during and after infusion as recommended.
• Withhold, reduce infusion rate, or discontinue based on severity.
• Danyelza can cause serious infusion reactions requiring urgent intervention including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction or interruption of Danyelza infusion.
• Permanently discontinue Danyelza in patients who develop transverse myelitis.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, Danyelza may cause fetal harm when administered to pregnant women.
• There are no available data on the use of Danyelza in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Danyelza, in combination with GM-CSF have been established in pediatric patients 1 year of age and older.
• Safety and effectiveness have not been established in pediatric patients younger than 1 year of age.

What should I know about storage and disposal of this medication?

• Store Danyelza vial refrigerated at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light until time of use.

Naxitamab-gqgk Resources
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• Dailymed label info on Naxitamab-gqgk
• FDA Naxitamab-gqgk

Naxitamab-gqgk Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski