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.

Indication and Usage

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.

  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.