LIBTAYO demonstrated a favorable safety profile in patients with advanced CSCC in clinical studies1
Adverse reactions in ≥10% of patients with mCSCC or laCSCC who were not candidates for curative surgery
or curative radiation and who received LIBTAYO in Study 1423 and Study 15401
- The most common Grade 3-4 adverse reactions (≥2%) were cellulitis, anemia, hypertension, pneumonia, musculoskeletal pain, fatigue, pneumonitis, sepsis, skin infection, and hypercalcemia1
- LIBTAYO was permanently discontinued due to adverse reactions in 8% of patients1
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Adverse reactions resulting in permanent discontinuation were pneumonitis, cough, pneumonia, encephalitis, aseptic meningitis, hepatitis, arthralgia, muscular weakness, neck pain, soft tissue necrosis, complex regional
pain syndrome, lethargy, psoriasis, rash maculopapular, proctitis, and confusional state1
- Serious adverse reactions occurred in 35% of patients1
- Serious adverse reactions that occurred in at least 2% of patients were pneumonitis, cellulitis, sepsis, and pneumonia1
Warnings and Precautions for LIBTAYO1
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; complications of allogeneic HSCT; 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.
Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation
receiving LIBTAYO in Study 1423 and Study 15401