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