Signs and symptoms of hepatitis may include1
- Yellowing of the skin or the whites of the eyes
- Severe nausea or vomiting
- Pain on the right side of the stomach area (abdomen)
- Dark urine (tea colored)
- Bleeding or bruising more easily than normal
Management considerations for immune-mediated hepatitis1
CONSIDERATIONS | FOR PATIENTS WITH HEPATITIS AND NO TUMOR INVOLVEMENT OF LIVER |
FOR PATIENTS WITH HEPATITIS AND TUMOR INVOLVEMENT OF LIVER WITHOUT HCC |
FOR PATIENTS WITH HEPATITIS AND TUMOR INVOLVEMENT OF LIVER OR HCC |
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Dose modification with Opdualag | Withhold treatment* if AST/ALT increases to >3x and ≤8x ULN or total bilirubin increases to >1.5x and ≤3x ULN. Permanently discontinue treatment if AST or ALT increases to more than 8 times ULN regardless of baseline or total bilirubin increases to more than 3 times ULN. |
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Management | Administer 1 to 2 mg/kg/day prednisone or equivalent until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. |
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Follow-up | Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. |
In a trial that evaluated Opdualag, toxicity was graded per NCI CTCAE V5.0.1
*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.1
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
Dosing Schedule
Learn more about the dosing schedule for this fixed-dose combination therapy.
Patient Monitoring
Checklist
A convenient, printable tool to help nurses identify signs and symptoms of immune-mediated adverse reactions.
Reference:
- Opdualag [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.