HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LIBTAYO safely and effectively. See full prescribing information for LIBTAYO.
LIBTAYO � (cemiplimab-rwlc) injection, for intravenous use
Initial U.S. Approval: 09/2018
INDICATIONS AND USAGE
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of LIBTAYO is 350 mg as an intravenous infusion over 30 minutes every 3 weeks. (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Severe and Fatal Immune-Mediated Adverse Reactions: Immune-mediated adverse reactions can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions and immune-mediated nephritis and renal dysfunction. Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver and thyroid function, at baseline and periodically during treatment. Withhold or permanently discontinue LIBTAYO and administer corticosteroids based on the severity of reaction. (2.2, 5.1)
Infusion-Related Reactions: Interrupt, slow the rate of infusion or permanently discontinue based on severity of reaction. (2.2, 5.2)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. (5.3, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 20%) were fatigue, rash and diarrhea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-877-542-8296 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2019