|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.
LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.