Naxitamab-Gqgk: uses, dosing, side effects & brands
Naxitamab-Gqgk is a medicine sold in the U.S. under one brand, for neuroblastoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Neuroblastoma
- Available as
- Injectable
- Sold as
- Danyelza
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How naxitamab-gqgk is dosed
From the FDA label for Danyelza (application BLA761171). Other naxitamab-gqgk products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. Discontinue DANYELZA and GM-CSF for disease progression or unacceptable toxicity. Administer GM-CSF subcutaneously prior to and during each treatment cycle as recommended. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of DANYELZA is 3 mg/kg/day (up to 150 mg/day) on Days 1, 3, and 5 of each treatment cycle, administered as an intravenous infusion after dilution [see Dosage and Administration (2.4 and 2.5) ] in combination with GM-CSF subcutaneously as shown in Table 1. Refer to the GM-CSF Prescribing Information for recommended dosing information. 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. Discontinue DANYELZA and GM-CSF for disease progression or unacceptable toxicity. Administer pre-infusion medications and supportive treatment, as appropriate, during infusion. [see Dosage and Administration (2.2) ] The recommended dosage regimen for each treatment cycle is described below and in…
Naxitamab-Gqgk side effects
The following clinically significant adverse reactions are also described elsewhere in the labeling: Serious Infusion-Related Reactions [see Warnings and Precautions (5.1) ] Neurotoxicity [see Warnings and Precautions (5.2) ] Myocarditis [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Orthostatic Hypotension [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥25%) are infusion-related reaction, 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 ( 6.1 ). The most common Grade 3 or 4 laboratory abnormalities (≥5%) are 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 ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact BTG International Inc., Inc, at + 1-877-377-3784 , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the…
Who shouldn’t take naxitamab-gqgk
DANYELZA is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ]. History of severe hypersensitivity reaction to naxitamab-gqgk. ( 4 )
Every naxitamab-gqgk product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Danyelza.
What people report to the FDA about naxitamab-gqgk
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2 reports naming naxitamab-gqgk, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- blood pressure increased1 reports
- hypernatraemia1 reports
- hypertension1 reports
Read these as a signal, not a rate. A report does not mean naxitamab-gqgk caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is naxitamab-gqgk?
Danyelza (Naxitamab-Gqgk) is a medication used to treat Neuroblastoma.
Can you take naxitamab-gqgk with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run naxitamab-gqgk against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does naxitamab-gqgk come in?
Across the brands we track, naxitamab-gqgk is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic naxitamab-gqgk?
We do not currently list a generic-labelled naxitamab-gqgk product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Naxitamab-Gqgk: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/naxitamab-gqgk
- MLA
- “Naxitamab-Gqgk: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/naxitamab-gqgk.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for naxitamab-gqgk on DailyMed (NIH) ↗ — including its boxed warning in full.