Recommended dosage modifications for adverse reactions1

Withhold or discontinue LIBTAYO to manage adverse reactions as described in the table below. No dose reduction of LIBTAYO is recommended.

Adverse reaction Severitya LIBTAYO dosage modification
Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1)]
Pneumonitis Grade 2 Withholdb
Grade 3 or 4 Permanently discontinue
Colitis Grade 2 or 3 Withholdb
Grade 4 Permanently discontinue
Hepatitis If AST or ALT increases to more than 3 and up to 10 times the upper limit of normal (ULN) or if total bilirubin increases up to 3 times the ULN Withholdb
If AST or ALT increases to more than 10 times the ULN or total bilirubin increases to more than 3 times the ULN Permanently discontinue
Endocrinopathies Grade 2, 3, or 4 Withhold if clinically necessary
Other immune-mediated adverse reactions involving a major organ Grade 3 Withholdb
Grade 4 Permanently discontinue
Recurrent or persistent immune-mediated adverse reactions
  • Recurrent Grade 3 or 4
  • Grade 2 or 3 persistent for 12 weeks or longer after last LIBTAYO dose
  • Requirement for 10 mg per day or greater prednisone or equivalent lasting 12 weeks or longer after last LIBTAYO dose
Permanently discontinue
Other adverse reactions
Infusion-related reactions [see Warnings and Precautions (5.1)] Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue
  • a Toxicity was graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0.
  • b Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.

  • ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; ULN, upper limit of normal.
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.