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What is Libtayo, and how does it work?
Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
It is not known if Libtayo is safe and effective in children.
What are the side effects of Libtayo?
The most common side effects of Libtayo include
These are not all the possible side effects of Libtayo.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Libtayo?
Recommended Dosage
The recommended dosage of Libtayo is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
Dosage Modifications For Adverse Reactions
Withhold or discontinue
Libtayo to manage adverse reactions as described in Table 1. No dose reduction of
Libtayo is recommended.
Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse ReactionSeverityaLibtayo Dosage ModificationsSevere and Fatal
Immune-Mediated Adverse Reactions PneumonitisGrade 2WithholdbGrades 3 or 4Permanently discontinueColitisGrades 2 or 3WithholdbGrade 4Permanently discontinueHepatitisIf 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.WithholdbIf AST or ALT increases to more than 10 times the ULN or total bilirubin increases to more than 3 times the ULNPermanently discontinueEndocrinopathiesGrades 2, 3, or 4Withhold if clinically necessaryOther immune-mediated adverse reactions involving a major organGrade 3WithholdbGrade 4Permanently discontinueRecurrent 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 discontinueOther Adverse Reactions
Infusion-related reactions Grade 1 or 2Interrupt or slow the rate of infusionGrade 3 or 4Permanently discontinuea Toxicity graded per 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.
What drugs interact with Libtayo?
No Information Provided
Is Libtayo safe to use while pregnant or breastfeeding?
- Based on its mechanism of action, Libtayo can cause fetal harm when administered to a pregnant woman.
- There are no available data on the use of Libtayo in pregnant women.
- There is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the breastfed child or on milk production.
- Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of
Libtayo.