naxitamab-gqgk (Danyelza)

Indications

• in combination with GM-CSF, for treatment of children >= 1 year of age & adults with relapsed or refractory high-risk neuroblastoma in bone or bone marrow with prior response to therapy

Contraindications

• pregnancy

Dosage

• 3 mg/kg/day (up to 150 mg/day) IV infusion after dilution on days 1,3 & 5 of each treatment cycle.
• treatment cycles repeated every 4 weeks until complete or partial response, followed by 5 additional cycles every 4 weeks
• subsequent cycles may be repeated every 8 weeks

40 mg/10 mL injection

Monitor

• blood pressure during & after infusion

Adverse effects

• most common (> 25%)
  • 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, & irritability
• hypertension
• serious infusion reactions
  • cardiac arrest, anaphylaxis, hypotension, bronchospasm, & stridor
• neurotoxicity
  • severe neuropathic pain
  • transverse myelitis
  • reversible posterior leukoencephalopathy syndrome

• drug adverse effects of pharmaceutical monoclonal antibodies

Mechanism of action

• GD2-binding monoclonal antibody

More general terms

• antineoplastic monoclonal antibody