LIBTAYO demonstrated a favorable safety profile in Study 16201*

Adverse reactions in ≥10% of patients receiving LIBTAYO in Study 16201


Adverse reactions in ≥10% of patients receiving LIBTAYO in Study 1620
  • *Of the 132 patients in the safety analysis of study 1620, 84 patients had laBCC.1
  • 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
  • Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.
  • Fatigue is a composite term that includes fatigue, asthenia, and malaise.1
  • Musculoskeletal pain is a composite term that includes arthralgia, back pain, myalgia, pain in extremity, musculoskeletal pain, neck pain, musculoskeletal stiffness, musculoskeletal chest pain, musculoskeletal discomfort, and spinal pain.1
  • §Rash is a composite term that includes rash maculo-papular, rash, dermatitis, dermatitis acneiform, erythema, rash pruritic, dermatitis bullous, dyshidrotic eczema, pemphigoid, rash erythematous, and urticaria.1
  • ||Upper respiratory tract infection is a composite term that includes upper respiratory tract infection, nasopharyngitis, rhinitis, sinusitis, pharyngitis, respiratory tract infection, and viral upper respiratory tract infection.1
  • Dyspnea is a composite term that includes dyspnea and dyspnea exertional.1
  • #Hypertension is a composite term that includes hypertension and hypertensive crisis.1

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*

Grade 3 or 4 laboratory abnormalities
  • Toxicity graded per NCI CTCAE v4.03.1
  • *Of the 132 patients in the safety analysis of Study 1620, 84 patients had laBCC.1
  • **Percentages are based on the number of patients with at least 1 postbaseline value available for that parameter.2
  • BCC=basal cell carcinoma; HHI=hedgehog inhibitor; HSCT=hematopoietic stem cell transplantation; NCI CTCAE=National Cancer Institute Common Terminology for Adverse Events.

References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Data on file. Regeneron Pharmaceuticals, Inc.