Naxitamab-gqgk
Class: Antineoplastic Agents
Brands: Danyelza
Warning
Warning: Serious Infusion-related Reactions And Neurotoxicity
See full prescribing information for complete boxed warning
Serious Infusion-related Reactions: Naxitamab-gqgk can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each naxitamab-gqgk infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue naxitamab-gqgk based on severity.
Neurotoxicity: Naxitamab-gqgk can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue naxitamab-gqgk based on the adverse reaction and severity.
Introduction
Naxitamab-gqgk is a glycolipid disialoganglioside (GD2)-binding monoclonal antibody antineoplastic agent.
Uses for Naxitamab-gqgk
Naxitamab-gqgk has the following uses:
Naxitamab-gqgk is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), 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.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Naxitamab-gqgk Dosage and Administration
General
Naxitamab-gqgk is available in the following dosage form(s) and strength(s):
Concentrate for injection: 40 mg/10 mL (4 mg/mL) in a single-dose vial.
Dosage
It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Pediatric Patients
Dosage and Administration
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. 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 pre-infusion medications and supportive treatment, as appropriate, during infusion.
Administer GM-CSF subcutaneously prior to and during each treatment cycle as recommended. Refer to the GM-CSF prescribing information for recommended dosing information.
Consult manufacturer’s labeling for recommended dosage modifications for adverse reactions. Discontinue naxitamab-gqgk and GM-CSF for disease progression or unacceptable toxicity.
Adults
Dosage and Administration
The recommended dosage of naxitamab-gqgk is 3 mg/kg/day (up to 150 m...
