Dosing

LIBTAYO® (cemiplimab-rwlc) logo

LIBTAYO has straightforward dosing1

LIBTAYO dosing protocol is a fixed 350-mg dose from a single-dose vial.

A fixed 350 mg dose from a single-dose vial

LIBTAYO is given as an IV infusion over 30 minutes.

An IV infusion over 30
minutes

LIBTAYO is given every 3 weeks.

Every 3 weeks
 

Treatment should be continued until disease progression or unacceptable toxicity1

LIBTAYO 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
  • Refer to the Prescribing Information for the chemotherapy agents administered in combination with LIBTAYO for additional recommended dosing information, as appropriate

How LIBTAYO is 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.