Management of some adverse reactions may require temporary interruption or permanent discontinuation.
Management of some adverse reactions may require temporary interruption or permanent discontinuation.
Severe and fatal immune-mediated adverse reactions
Monitor and assess
General dose modifications
General corticosteroid management
Modify treatment based on severity
Withhold* | Permanently discontinue |
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For Grade 2 | For Grade 3 or 4 |
*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 less (or equivalent) within 12 weeks of initiating corticosteroids. |
Modify treatment based on severity
Withhold* | Permanently discontinue |
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For Grade 2 or 3 | For Grade 4 |
*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 less (or equivalent) within 12 weeks of initiating corticosteroids. |
Liver enzyme elevations in patients being treated with BAVENCIO as monotherapy:
Modify treatment based on severity
Withhold* | Permanently discontinue | |
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Hepatitis with no tumor involvement of the liver | For AST or ALT increases >3 and up to 8 times ULN, or total bilirubin increases >1.5 and up to 3 times ULN | For AST or ALT >8 times ULN or total bilirubin >3 times ULN |
Hepatitis with tumor involvement of the liver† | If baseline AST or ALT is >1 and up to 3 times ULN and increases to >5 and up to 10 times ULN, or baseline AST or ALT is >3 and up to 5 times ULN and increases to >8 and up to 10 times ULN | For AST or ALT increases to >10 times ULN, or total bilirubin increases to >3 times ULN |
*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 less (or equivalent) within 12 weeks of initiating corticosteroids. †If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue BAVENCIO based on recommendations for hepatitis where there is no tumor involvement of the liver. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. |
Modify treatment based on severity
Grade 2 or higher | Grade 3-4 |
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Initiate symptomatic treatment, including hormone replacement, as clinically indicated | Withhold BAVENCIO for adrenal insufficiency until clinically stable, or permanently discontinue depending on severity |
Modify treatment based on severity
Any grade | Grade 3-4 |
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Initiate hormone replacement, as clinically indicated | Withhold BAVENCIO until clinically stable, or permanently discontinue depending on severity |
Modify treatment based on severity
Any grade hypothyroidism or hyperthyroidism | Grade 3-4 |
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Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism, as clinically indicated | Withhold BAVENCIO until clinically stable, or permanently discontinue depending on severity |
Modify treatment based on severity
Hyperglycemia |
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Initiate treatment with insulin, as clinically indicated. Withhold BAVENCIO until clinically stable, or permanently discontinue depending on severity |
Modify treatment based on severity
Withhold* | Permanently discontinue |
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For Grade 2 or 3 increased blood creatinine | For Grade 4 increased blood creatinine |
*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 less (or equivalent) within 12 weeks of initiating corticosteroids. |
Modify treatment based on severity
Withhold* | Permanently discontinue |
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For suspected Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS) | For confirmed SJS, TEN, or DRESS |
*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 less (or equivalent) within 12 weeks of initiating corticosteroids. |
For myocarditis, permanently discontinue BAVENCIO for Grade 2, Grade 3, or Grade 4 adverse reactions |
For neurological toxicities, withhold* BAVENCIO for Grade 2 and permanently discontinue for Grade 3 or Grade 4 adverse reactions |
*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 less (or equivalent) within 12 weeks of initiating corticosteroids. |
Modify treatment based on severity
Grade 1-2 | Grade 3-4 |
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Interrupt or slow the rate of infusion | Stop the infusion and permanently discontinue BAVENCIO |
Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT