Generic Name and Formulations:
Dinutuximab 3.5mg/mL; soln for IV infusion after dilution; preservative-free.
United Therapeutics Corp.
Indications for UNITUXIN:
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.
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.
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. Pregnancy; avoid. Use effective contraception during therapy and for at least 2 months after last dose. Nursing mothers: not recommended.
GD2-binding monoclonal antibody.
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).
Single-use vial (5mL)—1
Clinical Pain Advisor Articles
- Deaths After Nonfatal Opioid Overdose: Causes and Risk Factors
- Treatment for Opioid Use Disorder Associated With Reduced Risk for Opioid-Related Deaths
- Opioid-Free Analgesia Use for Postsurgical Pain Limited
- Clonidine May Not Improve Post-Cesarean Delivery Analgesia
- No Added Value With Liposomal Bupivacaine Following TKA With Peripheral Nerve Block
- Recommendations for Perioperative Pain Management in Patients With Opioid Tolerance
- Vertebroplasty Comparable With Placebo for Acute Vertebral Compression Fractures
- Capsaicin 8% Patch May Be Effective in Neuropathic Pain
- Detox vs Medication-Assisted Treatment for Opioid Use Disorder in Pregnancy: Expert Roundtable
- Prior Authorization Policy May Help Reduce Long-Acting Opioid Use
- Opioid-Related Deaths Represent Significant Public Health Burden
- Addressing Confidentiality Concerns With Electronic Access to Pediatric Medical Records
- Opioid-Related Adverse Events Common After Invasive Procedures
- Diagnosis and Treatment of Migraine in Children Should Consider Atopy
- Led by AG Sessions, DOJ Declines to Defend ACA Against Federal Lawsuit