Unituxin（dinutuximab）

Unituxin is a GD2-binding monoclonal antibody indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA) as first-line treatment for pediatric patients with high-risk neuroblastoma who have achieved at least a partial response prior to multidrug, multimodal therapy.

Dosage and Administration
17.5 mg/m2/day as a diluted intravenous infusion over 10 to 20 hours for 4 consecutive days for up to 5 cycles.

Dosage Forms and Strengths
Injection: 17.5 mg/5 mL (3.5 mg/mL) in a single-use vial.

Contraindications
History of hypersensitivity reaction to dinutuximab.

Warnings and Precautions
⑴ Capillary leak syndrome and hypotension: Prehydration and close monitoring of patients are required during treatment. Depending on severity, manage by interruption, infusion rate reduction, or permanent discontinuation.
⑵ Infection: Interrupt until resolution of systemic infection.
⑶ Ocular neurological disorders: interrupt for dilated pupils with sluggish light reflex or other visual disturbances and permanently discontinue for recurrent ocular disease or blindness. (5.6)
⑷ Myelosuppression: Monitor peripheral blood counts during Unituxin treatment.
⑸ Electrolyte abnormalities: Closely monitor serum electrolytes.
⑹ Atypical hemolytic uremic syndrome: Permanently discontinue Unituxin and initiate supportive management.
⑺ Embryofetal toxicity: May cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.

Adverse Reactions
The most common adverse drug reactions (≥ 25%) are pain, fever, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. The most common serious adverse reactions (≥ 5%) were infection, infusion reaction, hypokalemia, hypotension, pain, pyrexia, and capillary leak syndrome.