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.
The typical dosing schedule for cemiplimab (Libtayo) is every 3 weeks.
- This applies to various indications, including locally advanced or metastatic basal cell carcinoma, locally advanced or metastatic cutaneous squamous cell carcinoma, and non-small cell lung cancer.
- The dosage is consistent across these indications, with 350 mg administered as an intravenous infusion every 3 weeks 1.
From the Research
Cemiplimab (Libtayo) is typically administered at a dose of 350 mg intravenously every 3 weeks. This is the standard dosing schedule for most indications including advanced cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer. The medication is given as an intravenous infusion over 30 minutes through a 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 for infusion-related reactions during and after administration. This 3-week interval allows for appropriate drug concentration to be maintained in the body while the patient's immune system is activated against cancer cells. Cemiplimab works as a PD-1 inhibitor, blocking the interaction between PD-1 and its ligands to restore anti-tumor immune responses. Treatment typically continues until disease progression or unacceptable toxicity occurs, with regular monitoring for immune-mediated adverse reactions which may require dose modifications or temporary discontinuation.
Some studies have explored alternative dosing schedules, such as every 4 weeks 2, but the standard and most widely accepted schedule remains every 3 weeks, as supported by the majority of clinical trials and studies, including those published in reputable journals such as the Journal for Immunotherapy of Cancer 3 and The Lancet. Oncology 4. The population pharmacokinetic characteristics of cemiplimab also support the use of a fixed dose of 350 mg every 3 weeks 5.
Key points to consider when administering cemiplimab include:
- Monitoring for infusion-related reactions
- Regular assessment for immune-mediated adverse reactions
- Dose modifications or temporary discontinuation as needed
- Treatment continuation until disease progression or unacceptable toxicity
- Use of a fixed dose of 350 mg every 3 weeks as the standard schedule.
Overall, the evidence from various studies, including 3, 4, and 5, supports the use of cemiplimab at a dose of 350 mg intravenously every 3 weeks as the standard dosing schedule for most indications.