Unituxin

Pediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent therapy, with GM-CSF, IL-2, and isotretinoin.

17.5 mg/m2/day IV over 10-20 hours for 4 consecutive days per cycle, up to 5 cycles. Premedicate with opioid analgesics.

Injection: 17.5 mg/5 mL (3.5 mg/mL) single-dose vial

History of anaphylaxis to dinutuximab.

• Pain: Severe neuropathic pain very common. Premedicate with IV morphine.
• Infusion Reactions: Including anaphylaxis. Premedicate and monitor.
• Capillary Leak Syndrome: Life-threatening cases reported.
• Hypotension: Manage with fluids and vasopressors.
• Neurological Toxicity: Including peripheral neuropathy.

Pain (85%), Pyrexia (72%), Thrombocytopenia (66%), Lymphopenia (62%), Infusion Reactions (52%), Hypotension (46%), Hypokalemia (43%), Increased ALT (40%), Anemia (39%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

No formal drug interaction studies conducted.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Dinutuximab is a chimeric monoclonal antibody binding disialoganglioside GD2, highly expressed on neuroblastoma cells, inducing cell lysis through CDC and ADCC.

Half-life: ~10 days. Volume of distribution: ~5.4 L.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• ANBL0032 — Immunotherapy including dinutuximab vs isotretinoin in high-risk neuroblastoma. Phase III, n=226.
  🔬 NCT00026312 ↗ 📄 Primary Publication ↗

Consult the prescribing information for complete indication details and associated tumor types.