What is Libtayo, and how does it work?
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?
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||Severitya||Libtayo Dosage Modifications|
|Severe and Fatal Immune-Mediated Adverse Reactions|
|Grades 3 or 4||Permanently discontinue|
|Colitis||Grades 2 or 3||Withholdb|
|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|
|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||Withholdb|
|Grade 4||Permanently discontinue|
|Recurrent or persistent immune mediated adverse reactions||Permanently discontinue|
|Other Adverse Reactions|
|Infusion-related reactions||Grade 1 or 2||Interrupt or slow the rate of infusion|
|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.
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.
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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Melanoma is a type of skin cancer which begins in skin cells called melanocytes and affects more than 53,600 people in the United States each year. These melanocytes can grow together to form benign moles which, after a change in size, shape, or color can be a sign of melanoma. Caused by sun exposure, early detection becomes extremely important to avoid a spread to other areas of the body. Diagnosis is confirmed through a biopsy of the abnormal skin and treatment depends on the extent and characteristics of the patient. Metastatic melanoma is melanoma that has spread to various organs.
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Skin cancer is the abnormal and uncontrolled growth of skin cells. Skin cancer usually arises on skin exposed to the sun, such as the face, lips, ears, scalp, neck, chest, arms and hands and on the legs, especially in women. Malignant melanoma is a highly aggressive skin cancer that tends to spread to other parts of the body. All other types of skin cancers have the potential to be locally invasive and spread to other parts of the body. Nonmelanoma skin cancers are comparatively less aggressive.
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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.