Table 3.

Recommendations for the management of IRRs.

IRR	Action
Grade 1 or 2	The infusion should be paused. When the patient’s condition is stable, the infusion may be restarted at the investigator’s discretion. Restart infusion rate at half of that employed before the interruption. Subsequently, the infusion rate may be increased at the investigator’s discretion
Grade 2 or higher event of laryngeal edema Grade 2 or higher event of bronchospasm that does not respond to systemic therapy and does not resolve within 6 h from onset	Patient must be withdrawn from treatment
Grade 3 or higher	Infusion must be stopped and the patient must be observed carefully until resolution of the IRR
If the intensity of the IRR remains at grade 3 or 4 after 2 h	Patient must be withdrawn from treatment
If the intensity of the IRR decreases to grade 1 or 2 within 2 h	Infusion may be restarted at the investigator’s discretion. Upon restart, the infusion rate should be half of that employed before the interruption. Subsequently, the infusion rate may be increased at the investigator’s discretion
If the intensity of the IRR returns to grade 3 or 4 after restart of the infusion	The procedure described above may be repeated at the investigator’s discretion
If the intensity of the IRR increases to grade 3 or 4 for a third time	Patient must be withdrawn from treatment

IRR, infusion-related reaction.