Recommended dosage modifications for adverse reactions1

No dose reduction for LIBTAYO is recommended. In general, withhold LIBTAYO for severe (Grade 3) imARs. Permanently discontinue LIBTAYO for life-threatening (Grade 4) imARs, recurrent severe (Grade 3) imARs that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids.

Dosage modifications for LIBTAYO for adverse reactions that require management different from these general guidelines are summarized in the table below.


Adverse reaction Severity* LIBTAYO dosage modifications
Immune-mediated adverse reactions [see Warnings and Precautions 5.1]
Pneumonitis Grade 2 Withhold
Grade 3 or 4 Permanently discontinue
Colitis Grade 2 or 3 Withhold
Grade 4 Permanently discontinue
Hepatitis with no tumor involvement
of the liver
If AST or ALT increases to more than 3 and up to 8 times the ULN or if total bilirubin increases to more than 1.5 and up to 3 times the ULN Withhold
If AST or ALT increases to more than 8 times the ULN or total bilirubin increases to more than 3 times the ULN Permanently discontinue
Hepatitis with tumor involvement
of the liver
If baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN Withhold
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 3 or 4 Withhold until clinically stable or permanently
discontinue depending on severity
Nephritis with renal dysfunction Grade 2 or 3 increased blood creatinine Withhold
Grade 4 increased blood creatinine Permanently discontinue
Exfoliative dermatologic conditions Suspected SJS, TEN, or DRESS Withhold
Confirmed SJS, TEN, or DRESS Permanently discontinue
Myocarditis Grade 2, 3, or 4 Permanently discontinue
Neurological toxicities Grade 2 Withhold
Grade 3 or 4 Permanently discontinue
Other adverse reactions
Infusion-related reactions [see Warnings and
Precautions 5.2
]
Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue

  • *Based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0.1
  • Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.1
  • If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue LIBTAYO based on recommendations for hepatitis with no liver involvement.
  • ALT=alanine aminotransferase; AST=aspartate aminotransferase; DRESS=drug rash with eosinophilia and systemic symptoms; imARs=immune-mediated adverse reactions; SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.

Reference: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.