From the FDA Drug Label
The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity.
Dosing Schedule for Cemiplimab (Libtayo):
- The dosing schedule for cemiplimab is every 3 weeks.
- The recommended dose is 350 mg administered as an intravenous infusion.
- Treatment should continue until disease progression, unacceptable toxicity, or up to 24 months for certain indications 1, 1, 1.
From the Research
Cemiplimab (Libtayo) is typically administered as an intravenous infusion at a dose of 350 mg every 3 weeks until disease progression or unacceptable toxicity occurs. This dosing schedule is based on the most recent and highest quality study, which demonstrated substantial antitumor activity and an acceptable safety profile in patients with advanced cutaneous squamous cell carcinoma 2. The infusion is usually given over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2-5 micron pore size). Patients should be monitored during and after the infusion for signs of infusion-related reactions, which may require dose interruption or discontinuation. Before starting treatment, patients should undergo baseline laboratory tests including liver and thyroid function tests, as cemiplimab can cause immune-mediated adverse reactions affecting multiple organ systems. Dose modifications may be necessary for immune-mediated adverse reactions, with temporary interruption or permanent discontinuation depending on the severity of the reaction.
Some key points to consider when administering cemiplimab include:
- The importance of monitoring patients for signs of infusion-related reactions
- The need for baseline laboratory tests to assess liver and thyroid function
- The potential for immune-mediated adverse reactions and the need for dose modifications
- The use of a fixed dose of 350 mg every 3 weeks, rather than a weight-based dosing regimen, which has been shown to be effective and safe in clinical trials 3, 4.
Overall, the dosing schedule of cemiplimab every 3 weeks is supported by the most recent and highest quality evidence, and is considered a safe and effective treatment option for patients with advanced cutaneous squamous cell carcinoma.