Daily Medication Pearl: Danyelza (Naxitamab-gqgk)

Naxitamab-gqgk (Danyelza) is for the treatment of pediatric and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

Medication Pearl of the Day: Danyelza (Naxitamab-gqgk)

Indication: Naxitamab-gqgk (Danyelza) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

Insight:

  • Dosing:The recommended dosage of naxitamab-gqgk 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.
  • Dosage forms: Injection: 40 mg/10 mL (4 mg/mL) in a single-dose vial.
  • Adverse events: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.
  • Mechanism of action: 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 and antibody dependent cell-mediated cytotoxicity.
  • Manufacturer: Y-mAbs Therapeutics

Source:

DANYELZA (naxitamab-gqgk) Label (fda.gov)