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FDA Labeling Changes
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Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14)].
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Unituxin (dinutuximab) is a chimeric monoclonal antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa. Unituxin binds to the glycolipid disialoganglioside (GD2). Dinutuximab is produced in the murine myeloma cell line, SP2/0.
Unituxin is a sterile, preservative-free, clear/colorless to slightly opalescent solution for intravenous infusion. Unituxin is supplied in single-use vials of 17.5 mg/5mL. Each vial contains 3.5 mg/mL of dinutuximab, histidine (20mM), polysorbate 20 (0.05%), sodium chloride (150 mM), and water for injection; hydrochloric acid is added to adjust pH to 6.8.