Treatment should be continued until disease progression or unacceptable toxicity.
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.
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
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
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.