Bavencio (avelumab) for Cancer Treatment: Interactions & Warnings

Treatment-Related Adverse Reaction Severity of Adverse Reactions Dose Modification Pneumonitis Grade 2 pneumonitis Withhold
Bavencio.
Resume Bavencio in patients with complete or partial resolution (Grade 0 to 1) of pneumonitis after corticosteroid taper. Grade 3 or 4 pneumonitis or recurrent Grade 2 pneumonitis Permanently discontinue. Hepatitis. For
Bavencio in combination with axitinib, see below. Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal Withhold
Bavencio.
Resume Bavencio in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper. AST or ALT more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal Permanently discontinue. Colitis Grade 2 or 3 diarrhea or colitis Withhold Bavencio.
Resume
Bavencio in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper. Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis Permanently discontinue. Endocrinopathies (including but not limited to hypothyroidism,
hyperthyroidism, adrenal insufficiency, hyperglycemia) Grade 3 or 4 Withhold
Bavencio.
Resume Bavencio in patients with complete or partial resolution (Grade 0 to 1) of endocrinopathies after corticosteroid taper. Nephritis and Renal Dysfunction Serum creatinine more than 1.5 and up to 6 times the upper limit of normal Withhold
Bavencio.
Resume Bavencio in patients with complete or partial resolution (Grade 0 to 1) of nephritis and renal dysfunction after corticosteroid taper. Serum creatinine more than 6 times the upper limit of normal Permanently discontinue. Other immune-mediated adverse reactions (including but not limited to myocarditis, pancreatitis, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, bullous dermatitis, For any of the following:

• Moderate or severe clinical signs or symptoms of an immune-mediated adverse reaction not described above
• Grade 3 or 4 endocrinopathies

Withhold
Bavencio pending clinical evaluation.
Resume Bavencio in patients with complete or partial resolution (Grade 0 to 1) of other immunemediated adverse reactions after corticosteroid taper. Stevens Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN),
rhabdomyolysis, myasthenia gravis, histiocytic necrotizing lymphadenitis,
demyelination, vasculitis, hemolytic anemia, hypophysitis, iritis, and
encephalitis)* For any of the following:

• Life-threatening adverse reaction (excluding endocrinopathies)
• Recurrent severe immune-mediated adverse reaction
• Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks
• Persistent Grade 2 or 3 immune-mediated adverse reactions lasting 12 weeks or longer

Permanently discontinue. Infusion-related reaction Grade 1 or 2 Interrupt or slow the rate of infusion. Grade 3 or 4 Permanently discontinue. * Observed with
Bavencio or with other anti-PD-1/PD-L1 monoclonal antibodies.