Signs, symptoms, grading, and management

Infusion-related adverse reactions (OPDIVO IV only)

Signs and symptoms of infusion-related reactions may include1

  • Itching or rash
  • Shortness of breath or wheezing
  • Dizziness
  • Fever
  • Chills or shaking
  • Flushing
  • Feel like passing out
  • Back or neck pain

Management considerations for infusion-related reactions for OPDIVO
and OPDIVO & YERVOY1,2

  • When OPDIVO (nivolumab) is administered in combination with YERVOY (ipilimumab), if OPDIVO is withheld or discontinued, YERVOY should also be withheld or discontinued
  • OPDIVO or OPDIVO + YERVOY can cause severe infusion-related reactions
  • Mild or moderate symptoms (Grade 1 or 2)*: Interrupt or slow the rate of infusion
  • Severe or life-threatening symptoms (Grade 3 or 4)*: Permanently discontinue treatment

*In trials that evaluated OPDIVO as a single agent or in combination with YERVOY, toxicity was graded per NCI CTCAE V4 or V5.1

NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

OPDIVO Select Important Safety Information

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

OPDIVO® (nivolumab) vial icon
Dosing Information

Find the appropriate dosing information for your patients in any approved regimen.

OPDIVO® (nivolumab) dosing guide icon
OPDIVO Dosing Guide

A guide to dosing across all indications.
 

Clipboard with patient info icon
Patient Monitoring Checklist

A convenient, printable tool to help nurses identify signs and symptoms of immune-mediated adverse reactions. 

References:

  1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. YERVOY [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.


1506-US-2400610  11/24