LIBTAYO demonstrated a favorable safety profile in patients with advanced cutaneous squamous cell carcinoma (CSCC) in clinical studies1,2

Adverse reactions in ≥10% of patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation receiving LIBTAYO in Studies 1423 and 15401

Adverse reactions Combined (N = 163)
All grades,
%
Grade 3-4,
%
Skin and subcutaneous tissue
Rasha 25 1.2
Pruritusb 15 0
Gastrointestinal
Diarrheac 22 0.6
Nausea 19 0
Constipation 12 0.6
General disorders and administration site
Fatigued 29 2
Musculoskeletal and connective tissue
Musculoskeletal paine 17 3
Metabolism and nutrition
Decreased appetite 10 0
  • a Rash is a composite term that includes rash maculopapular, rash, dermatitis, rash generalized, dermatitis bullous, drug eruption, erythema, rash erythematous, rash macular, rash pruritic, and skin reaction.
  • b Pruritus is a composite term that includes pruritus and pruritus allergic.
  • c Diarrhea is a composite term that includes diarrhea and colitis.
  • d Fatigue is a composite term that includes fatigue and asthenia.
  • e Musculoskeletal pain is a composite term that includes musculoskeletal pain, back pain, myalgia, neck pain, and pain in extremity.

  • LIBTAYO was permanently discontinued due to adverse reactions in 5% of patients
  • Adverse reactions resulting in permanent discontinuation were pneumonitis, autoimmune myocarditis, hepatitis, aseptic meningitis, complex regional pain syndrome, cough, and muscular weakness
  • Serious adverse reactions occurred in 28% of patients
  • Serious adverse reactions that occurred in at least 2% of patients were cellulitis, sepsis, pneumonia, pneumonitis, and urinary tract infection


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; 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 metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation receiving LIBTAYO in Studies 1423 and 15401

Laboratory abnormalities Combined (N = 163)
Grade 3-4, %a
Chemistry
Increased aspartate aminotransferase 3
Increased INR 2
Hypoalbuminemia 1
Hematology
Lymphopenia 7
Anemia 2
Electrolytes
Hypophosphatemia 4
Hyponatremia 3
Hypercalcemia 1
  • a Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.
  • INR, international normalized ratio.
The safety of LIBTAYO was evaluated in 534 patients with advanced solid malignancies, including 163 patients with advanced CSCC.
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
  2. Migden MR et al. N Engl J Med. 2018;379(4):341-351.