Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
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Libtayo Injection Dosage

Drug Detail:Libtayo (Cemiplimab-rwlc [ se-mip-li-mab ])

Generic Name: CEMIPLIMAB 50mg in 1mL

Dosage Form: injection

Drug Class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Recommended Dosage

The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Dosage Modifications for Adverse Reactions

Withhold or discontinue LIBTAYO to manage adverse reactions as described in Table 1. No dose reduction of LIBTAYO is recommended.

Table 1: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity* LIBTAYO Dosage Modifications
*
Toxicity graded per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
†
Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.
Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)]
Pneumonitis Grade 2 Withhold†
Grades 3 or 4 Permanently discontinue
Colitis Grades 2 or 3 Withhold†
Grade 4 Permanently discontinue
Hepatitis If AST or ALT increases to more than 3 and up to 10 times the upper limit of normal (ULN) or if total bilirubin increases up to 3 times the ULN. Withhold†
If AST or ALT increases to more than 10 times the ULN or total bilirubin increases to more than 3 times the ULN Permanently discontinue
Endocrinopathies Grades 2, 3, or 4 Withhold if clinically necessary
Other immune-mediated adverse reactions involving a major organ Grade 3 Withhold†
Grade 4 Permanently discontinue
Recurrent or persistent immune mediated adverse reactions
  • Recurrent Grade 3 or 4
  • Grade 2 or 3 persistent for 12 weeks or longer after last LIBTAYO dose
  • Requirement for 10 mg per day or greater prednisone or equivalent lasting 12 weeks or longer after last LIBTAYO dose
 Permanently discontinue
Other Adverse Reactions
Infusion-related reactions [see Warnings and Precautions (5.2)] Grade 1 or 2 Interrupt or slow the rate of infusion
Grade 3 or 4 Permanently discontinue

Preparation and Administration

  • 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, 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.
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