quired intravenous hydration and premedication with antihistamines, analgesics, and antipyretics.
In connection with the Unituxin approval, United Therapeutics agreed to certain postmarketing requirements (PMRs) and certain postmarketing commitments (PMCs). PMRs and PMCs are studies that sponsors conduct after FDA approval to gather additional information about a product's safety, efficacy, or optimal use. PMRs are required studies, whereas a sponsor voluntarily commits to conduct PMCs.
About Unituxin
Unituxin (dinutuximab) is a disialoganglioside, GD2-binding chimeric monoclonal antibody (formerly called ch14.18) indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. The safety and effectiveness of Unituxin was eva luated in a randomized, open-label, multicenter trial conducted in pediatric patients with high-risk neuroblastoma. All patients had received prior therapy consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and radiation therapy to residual soft tissue disease.
Important Safety Information for Unituxin
Boxed WARNING
•Serious Infusion Reactions
•Serious and potentially life threatening infusion reactions (facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension) 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
•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
•Severe (Grade 3) peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma
•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
CONTRAINDICATIONS
Unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab.
WARNINGS AND PRECAUTIONS
•Serious Infusion Reactions
•Serious infusion reactions requiring urgent intervention including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin included facial and upper airway edema, dyspnea, bronchospasm, stridor, urticaria, and hypotension. Infusion reactions generally occurred during or within 24 hours of completing the Unituxin infusion. Due to overlapping signs and symptoms, it was not possible to dist |
