LIBTAYO has straightforward dosing1



Treatment should be continued
until disease progression or
unacceptable toxicity1

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.

Preparation1

  • 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 infusion1

  • 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

Administration1

  • 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 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. 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.

  • IV=intravenous; NDC=national drug code; Q3W=every 3 weeks.

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