Unituxin Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Generic Availability
NO
Unituxin Indications
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
Adult
Not applicable.
Children
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
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
Not Applicable
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