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Dinutuximab

Serious Infusion Reactions and Neuropathy

Infusion Reactions

  • Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with Unituxin. Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion. Immediately interrupt Unituxin for severe infusion reactions and permanently discontinue Unituxin for anaphylaxis (2.2, 2.3, 5.1).

Neuropathy

  • Unituxin causes severe neuropathic pain in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. In clinical studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies of Unituxin and related GD2-binding antibodies, severe motor neuropathy was observed in adults. Resolution of motor neuropathy was not documented in all cases. Discontinue Unituxin for severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy (2.2, 2.3, 5.2).

Patient Counseling Information

Package Inserts

Dinutuximab

Additional Information

Updated January 2018