|Adverse reactions||Combined (N = 163)|
|Skin and subcutaneous tissue|
|General disorders and administration site|
|Musculoskeletal and connective tissue|
|Metabolism and nutrition|
Warnings and Precautions for LIBTAYO include severe and fatal immune-mediated adverse reactions such as immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and other immune-mediated adverse reactions; infusion-related reactions; and embryo-fetal toxicity. Monitor for symptoms and signs of immune-mediated adverse reactions.
For more information on Warnings and Precautions, see additional Important Safety Information below and in Section 5 of the full Prescribing Information.
|Laboratory abnormalities||Combined (N = 163)|
|Grade 3-4, %a|
|Increased aspartate aminotransferase||3|
The safety of LIBTAYO was evaluated in 534 patients
with advanced solid malignancies, including
163 patients with advanced CSCC.