BOX WARNING
Infusion Reactions: Severe infusion reactions occurred with the administration of ERBITUX in approximately 3% of patients, rarely with fatal outcome (<1 in 1000). Approximately 90% of severe infusion reactions were associated with the first infusion of ERBITUX. Severe infusion reactions are characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension (see WARNINGS and ADVERSE REACTIONS). Severe infusion reactions require immediate interruption of the ERBITUX infusion and permanent discontinuation from further treatment. (See WARNINGS: Infusion Reactions and DOSAGE AND ADMINISTRATION: Dose Modifications.)
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