What is Libtayo, and how does it work?
What are the side effects of Libtayo?
What is the dosage for Libtayo?
What drugs interact with Libtayo?
Is Libtayo safe to use while pregnant or breastfeeding?

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

tiredness,
rash,
diarrhea,
muscle or bone pain, and
nausea.

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 Reaction	Severity^a	Libtayo Dosage Modifications
Severe and Fatal Immune-Mediated Adverse Reactions
Pneumonitis	Grade 2	Withholdb
Pneumonitis	Grades 3 or 4	Permanently discontinue
Colitis	Grades 2 or 3	Withholdb
Colitis	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
Hepatitis	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	Grades 2, 3, or 4	Withhold if clinically necessary
Other immune-mediated adverse reactions involving a major organ	Grade 3	Withhold^b
	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	Grade 1 or 2	Interrupt or slow the rate of infusion
Infusion-related reactions	Grade 3 or 4	Permanently 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

Skin Cancer Symptoms, Types, Images See Slideshow

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.