Libtayo Injection Dosage
Generic name: CEMIPLIMAB 50mg in 1mL
Dosage form: injection
Drug class: Anti-PD-1 monoclonal antibodies
Medically reviewed by Drugs.com. Last updated on Mar 10, 2023.
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.
Adverse Reaction | Severity* | LIBTAYO Dosage Modifications |
---|---|---|
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 |
|
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.
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