LIBTAYO demonstrated a favorable safety profile in Study 16201*
Adverse reactions in ≥10% of patients receiving LIBTAYO in Study 16201
-
Serious ARs occurred in 32% of patients. Serious ARs that occurred in >1.5% (at least 2 patients) were
urinary
tract infection, colitis, acute kidney injury, adrenal insufficiency, anemia, infected neoplasm, and
somnolence1
-
Fatal ARs occurred in 1.5% of patients who received LIBTAYO, including acute kidney injury and
cachexia1
- Permanent discontinuation of LIBTAYO due to an AR occurred in 13% of patients1
-
ARs resulting in permanent discontinuation of LIBTAYO in >1.5% (at least 2 patients) were colitis and general
physical health deterioration1
-
Dosage delays of LIBTAYO due to an AR occurred in 34% of patients. ARs which required dosage interruption in
>2% of patients (at least 3 patients) included blood creatinine increased, diarrhea, colitis, fatigue,
headache, pneumonitis, and urinary tract infection1
-
The most common ARs reported in at least 15% of patients were fatigue, musculoskeletal pain, diarrhea, rash,
pruritus, and upper respiratory tract infection1
-
The most common Grade 3 or 4 ARs (>2%) were hypertension, colitis, fatigue, urinary tract infection,
pneumonia, increased blood pressure, hypokalemia and visual impairment1
-
The most common (>3%) laboratory abnormality worsening from baseline to Grade 3 or 4 was
hyponatremia1
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.1
For more information on Warnings and Precautions, see additional Important Safety Information throughout and in Section 5 of the full Prescribing Information.
Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients
receiving LIBTAYO in Study 16201*