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LIBTAYO product information

Indications

LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.1

LIBTAYO is indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.1

LIBTAYO is indicated for the first-line treatment of patients with non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, and is1:

  • Locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or1
  • Metastatic1

Storage and handling1

LIBTAYO (cemiplimab-rwlc) Injection is a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles.

Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Protect from light. Do not freeze or shake.

Reimbursement and customer support

LIBTAYOhcp.com or 1.877.LIBTAYO (1.877.542.8296),(1.877.542.8296), select option 1.

Authorized specialty distributors

Contracted specialty pharmacy

Regeneron and Sanofi do not recommend the use of any particular distributor or specialty pharmacy.

Product information
How supplied 350-mg/7-mL (50 mg/mL) solution in a single-dose vial
Quantity and units per case 1 vial per carton/24 cartons per case
NDC 61755-008-01 (350 mg/7 mL)
HCPCS codes J9119 - Injection, cemiplimab-rwlc, 1 mg
GTIN 00361755008013 (350-mg/7-mL case)
00361755008018 (350-mg/7-mL carton)
UPC 361755008018 (350 mg/7 mL)

The following permanent J-code can be used for billing and other administrative purposes: J9119, Injection,
cemiplimab-rwlc, 1 mg
Coding requirements may vary by payer; please verify coding requirements before submitting claims.

LIBTAYO resources and support for you and your patients

LIBTAYO product information sheet
LIBTAYO dosage and immune-mediated adverse reactions (imARs) guide

Reference: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron PharmaceuticaIs, Inc., and sanofi-aventis U.S. LLC.