Indications

Full Prescribing Information

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Medication Guide

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Treatment modifications to manage adverse reactions

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Manage and monitor adverse reactions1,2

View signs, symptoms, and immune-mediated adverse reaction management information

Lung icon
Pneumonitis
Colon icon
Colitis
Liver icon
Hepatitis and hepatotoxicity
Thyroid icon
Endocrinopathies
Kidneys icon
Nephritis with renal dysfunction
Skin icon
Dermatologic conditions
Other immune-mediated adverse reactions
Infusion-related reactions

These are not all the possible organ systems that may be affected.1,2

YERVOY® (ipilimumab) may be associated with eye problems with signs and symptoms that include blurry vision, double vision or other vision problems, and eye pain or redness.2

Complications of allogeneic hematopoietic stem cell transplantation (HSCT), such as graft-versus-host disease, can be fatal, and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with OPDIVO or YERVOY.1,2

Dose modifications for OPDIVO and OPDIVO-based combinations1,2

No dose reduction for OPDIVO or YERVOY is recommended.

In general, withhold OPDIVO and YERVOY for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue OPDIVO and YERVOY for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, persistent moderate (Grade 2) or severe (Grade 3) reactions lasting 12 weeks or longer after last YERVOY dose (excluding endocrinopathy), or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for OPDIVO or OPDIVO-based combinations for adverse reactions that require management different from these general guidelines are discussed in the two tables below.

When OPDIVO is administered in combination with YERVOY, withhold or permanently discontinue both OPDIVO and YERVOY for an adverse reaction meeting these dose modification guidelines.

Recommended dose modifications for adverse reactions in patients treated with OPDIVO1

ADVERSE REACTION SEVERITY DOSE MODIFICATION
Pneumonitis Grade 2 Withhold*
Grade 3 or 4 Permanently discontinue
Colitis
For colitis in patients treated with combination therapy with ipilimumab, please see the table below
Grade 2 or 3 Withhold*
Grade 4 Permanently discontinue
Hepatitis with no tumor involvement of liver
For liver enzyme elevations in patients treated with combination therapy with ipilimumab, please see the table below
AST/ALT increases to >3 times and ≤8 times the ULN
OR
Total bilirubin increases to >1.5 times and ≤3 times the ULN
Withhold*
AST/ALT increases to >8 times the ULN
OR
Total bilirubin increases to >3 times the ULN
Permanently discontinue
Hepatitis with tumor involvement of the liver
For liver enzyme elevations in patients treated with combination therapy with ipilimumab, please see the table below
Baseline AST/ALT is >1 and ≤3 times the ULN and increases to >5 and ≤10 times the ULN
OR
Baseline AST/ALT is >3 and ≤5 times the ULN and increases to >8 and ≤10 times the ULN
Withhold*
AST/ALT increases to >10 times the ULN
OR
Total bilirubin increases to >3 times the ULN
Permanently discontinue
Endocrinopathies Grade 3 or 4 Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with renal dysfunction Grade 2 or 3 increased blood creatinine Withhold*
Grade 4 increased blood creatinine Permanently discontinue
Exfoliative dermatologic conditions Suspected SJS, TEN, or DRESS Withhold
Confirmed SJS, TEN, or DRESS Permanently discontinue
Myocarditis Grade 2, 3, or 4 Permanently discontinue
Neurological toxicities Grade 2 Withhold*
Grade 3 or 4 Permanently discontinue
Infusion-related reactions Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue

*Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
If AST and ALT are less than or equal to the ULN at baseline, withhold or permanently discontinue OPDIVO based on recommendations for hepatitis with no liver involvement.
Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved.

DRESS=drug rash with eosinophilia and systemic symptoms; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis.

Recommended dose modifications for adverse reactions in patients treated with OPDIVO combination therapy1,2

OPDIVO in combination with YERVOY
ADVERSE REACTION SEVERITY DOSE MODIFICATION
Pneumonitis Grade 2 Withhold*
Grade 3 or 4 Permanently discontinue
Colitis Grade 2 Withhold*
Grade 3 or 4 Permanently discontinue
Hepatitis with no tumor involvement of the liver
OR
Hepatitis with tumor involvement of the liver/non-HCC
AST/ALT increases to >3 times and ≤5 times the ULN
OR
Total bilirubin increases to ≥1.5 times and ≤3 times the ULN
Withhold*
AST/ALT >5 times the ULN
OR
Total bilirubin >3 times the ULN
Permanently discontinue
Hepatitis with tumor involvement of the liver/HCC Baseline AST/ALT is >1 and ≤3 times the ULN and increases to >5 and ≤10 times the ULN
OR
Baseline AST/ALT is >3 and ≤5 times the ULN and increases to >8 and ≤10 times the ULN
Withhold*
AST/ALT increases to >10 times the ULN
OR
Total bilirubin increases to >3 times the ULN
Permanently discontinue
Endocrinopathies Grade 3 or 4 Withhold until clinically stable or permanently discontinue depending on severity
Nephritis with renal dysfunction Grade 2 or 3 increased blood creatinine Withhold*
Grade 4 increased blood creatinine Permanently discontinue
Exfoliative dermatologic conditions Suspected SJS, TEN, or DRESS Withhold
Confirmed SJS, TEN, or DRESS Permanently discontinue
Myocarditis Grade 2, 3, or 4 Permanently discontinue
Neurological toxicities Grade 2 Withhold*
Grade 3 or 4 Permanently discontinue
Infusion-related reactions Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue

*Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
If AST and ALT are less than or equal to the ULN at baseline, withhold or permanently discontinue OPDIVO in combination with YERVOY based on recommendations for hepatitis with no liver involvement.
Depending on clinical severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement. Resume once acute symptoms have resolved.

OPDIVO in combination with CABOMETYX
ADVERSE REACTION SEVERITY DOSE MODIFICATION
Liver enzyme elevations ALT or AST >3 times ULN but ≤10 times ULN with concurrent total bilirubin <2 times ULN Withhold* both OPDIVO and CABOMETYX until adverse reactions recover to Grades 0-1
ALT or AST >10 times ULN or >3 times ULN with concurrent total bilirubin ≥2 times ULN Permanently discontinue* both
OPDIVO and CABOMETYX

*Consider corticosteroid therapy for hepatic adverse reactions if OPDIVO is withheld or discontinued when administered in combination with CABOMETYX.
After recovery, rechallenge with one or both of OPDIVO and CABOMETYX may be considered. If rechallenging with CABOMETYX with or without OPDIVO, refer to CABOMETYX Prescribing Information.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; HCC=hepatocellular carcinoma; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.

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Preparation and Administration

Find instructions for preparation, administration, infusion, and storage.

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IMAR Guide

A quick reference guide to immune-mediated adverse reactions (IMARs) associated with treatment.

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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-2400488 08/24