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 ReactionSeveritya Libtayo Dosage Modifications
Severe and Fatal Immune-Mediated Adverse Reactions
PneumonitisGrade 2Withholdb
Grades 3 or 4Permanently discontinue
ColitisGrades 2 or 3Withholdb
Grade 4Permanently discontinue
HepatitisIf 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 ULNPermanently discontinue
EndocrinopathiesGrades 2, 3, or 4Withhold if clinically necessary
Other immune-mediated adverse reactions involving a major organGrade 3Withholdb
Grade 4Permanently 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 Grade 1 or 2Interrupt or slow the rate of infusion
Grade 3 or 4Permanently discontinue
a 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.

SLIDESHOW

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Summary

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. The most common side effects of Libtayo include tiredness, rash, diarrhea, muscle or bone pain, and nausea.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 12/3/2020
References
All sections courtesy of the U.S. Food and Drug Administration