LIBTAYO product information


LIBTAYO is an FDA-approved 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

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 or 1.877.LIBTAYO (1.877.542.8296),(1.877.542.8296), option 1

Authorized specialty distributors

Contracted 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 J9999 – not otherwise classified, antineoplastic drugs
J3590 – unclassified biologics
C9044 – injection, cemiplimab-rwlc, 1 mg
GTIN 00361755008013 (350-mg/7-mL case)
00361755008018 (350-mg/7-mL carton)
UPC 361755008018 (350 mg/7 mL)

Effective April 1, 2019, the following
C-code is available

for administrative
and billing

purposes specific to LIBTAYO: C9044, Injection,
cemiplimab-rwlc, 1 mg
Coding requirements may vary by

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
LIBTAYO patient discussion guide
LIBTAYO patient discussion guide (Spanish)
LIBTAYO patient wallet card
  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.