• CNS cancers

Unituxin Generic Name & Formulations

General Description

Dinutuximab 3.5mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

GD2-binding monoclonal antibody.

How Supplied

Single-dose vial (5mL)—1

Generic Availability


Unituxin Indications


In combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of children with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Unituxin Dosage and Administration


Not applicable.


Confirm adequate hematologic, respiratory, hepatic, and renal function prior to each course. Hydrate and premedicate with antihistamines, analgesics (eg, IV opioids), and antipyretics prior to each dose: see full labeling. Give via IV infusion over 10–20 hours for 4 consecutive days; max 5 cycles. Initial rate: 0.875mg/m2/hr for 30mins; may gradually increase as tolerated up to max 1.75mg/m2/hr. Cycles 1, 3, and 5 (24-day cycle): 17.5mg/m2/day on Days 4–7. Cycles 2 and 4 (32-day cycle): 17.5mg/m2/day on Days 8–11. Dose modifications: see full labeling.

Unituxin Contraindications

Not Applicable

Unituxin Boxed Warnings

Boxed Warning

Serious infusion reactions. Neurotoxicity.

Unituxin Warnings/Precautions


Risk of serious infusion reactions; monitor during and at least 4 hours after completion of each infusion; interrupt or permanently discontinue if severe or prolonged infusion reactions occur. Have resuscitative medications and equipment available. Risk of serious neurotoxicity including severe neuropathic pain and peripheral neuropathy. Permanently discontinue if life-threatening infusion reactions, Grade 3 pain unresponsive to max supportive measures, Grade 4 sensory neuropathy or Grade 3 sensory neuropathy that interferes with daily activities for more than 2 weeks, Grade ≥2 peripheral motor neuropathy, recurrent signs of eye disorders or vision loss, urinary retention that persists following opioid discontinuation, transverse myelitis, signs/symptoms of RPLS, signs of atypical hemolytic uremic syndrome occurs. Interrupt or discontinue if symptomatic or severe capillary leak syndrome, symptomatic hypotension, systolic BP less than lower limit of normal for age or decreased by >15% compared to baseline develops. Monitor for systemic infection; temporarily discontinue until resolves. Monitor BP, peripheral blood counts during therapy, and serum electrolytes daily. Renal or hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥2 months after the last dose. Pregnancy. Nursing mothers: not recommended.

Unituxin Pharmacokinetics

See Literature

Unituxin Interactions

Unituxin Adverse Reactions

Adverse Reactions

Pain, pyrexia, infusion reactions, hypotension, hyponatremia, hypokalemia, hypocalcemia, hypoalbuminemia, increased ALT/AST, vomiting, diarrhea, capillary leak syndrome, urticaria, infections, bone marrow suppression (eg, thrombocytopenia, anemia, neutropenia, lymphopenia).

Unituxin Clinical Trials

See Literature

Unituxin Note

Not Applicable

Unituxin Patient Counseling

See Literature