Recommended dosage1

LIBTAYO (cemiplimab-rwlc) packaging

Preparation and administration1

  • Visually inspect for particulate matter and discoloration prior to administration. LIBTAYO is a clear–to–slightly opalescent, colorless–to–pale yellow solution that may contain trace amounts of translucent-to-white particles. Discard the vial if the solution is cloudy, is discolored, or contains extraneous particulate matter other than trace amounts of translucent-to-white particles.
  • Preparation
    • Do not shake
    • Withdraw 7 mL from a vial and dilute with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to a final concentration between 1 mg/mL to 20 mg/mL
    • Mix diluted solution by gentle inversion. Do not shake
    • Discard any unused medicinal product or waste material
    Storage of infusion solution
    • Store at room temperature up to 25°C (77°F) for no more than 8 hours from the time of preparation to the end of the infusion or at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of preparation to the end of infusion
    • Allow the diluted solution to come to room temperature prior to administration
    • Do not freeze
    Administration
    • Administer by intravenous infusion over 30 minutes through an intravenous line containing a sterile, in-line or add-on 0.2-micron to 5-micron filter
    How supplied/storage and handling
    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. It is supplied in a carton containing 1 single-dose vial of:
    • 350 mg/7 mL (50 mg/mL) (NDC 61755-008-01)
    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.
    1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.