Cemiplimab is a monoclonal antibody targeting PD-1, indicated for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) that cannot be cured by surgery or radiotherapy.

How to Use Cemiplimab

Administration Regimen

Standard Dose: The recommended dose is 350mg, administered via intravenous infusion over 30 minutes, once every 3 weeks, until disease progression or the occurrence of intolerable toxicity.

Dosage Form and Specification: The injection is a colorless to pale yellow clear solution supplied in single-dose vials, with a concentration of 350mg/7mL (50mg/mL).

Key Points for Infusion Operation

Dilution Requirement: Withdraw 7mL of the drug solution and dilute it with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 1-20mg/mL. Gently invert and mix the diluted solution; shaking is avoided.

Infusion Filtration: Intravenous tubing equipped with a 0.2-5 micrometer sterile filter must be used for infusion.

Stability: The diluted solution can be stored at room temperature (≤25°C) for no more than 8 hours, or at refrigerated temperature (2-8°C) for no more than 24 hours. It must be brought to room temperature before use.

Management of Missed Infusions

If a scheduled infusion day is missed, the infusion should be administered as soon as possible, and the original once-every-3-week schedule should be resumed. No dose adjustment is required.

Dose Adjustment of Cemiplimab

Dose Adjustment for Immune-Mediated Adverse Reactions

Pneumonitis: Discontinue administration for Grade 2 adverse reactions; permanently discontinue treatment for Grade 3-4 adverse reactions.

Colitis/Hepatitis: Discontinue administration for Grade 2-3 adverse reactions; permanently discontinue treatment for Grade 4 adverse reactions.

Endocrine Disorders (e.g., thyroid dysfunction, diabetes): Discontinue administration based on the severity of symptoms; permanently discontinue treatment if necessary.

Other Organ Toxicities (e.g., nephritis, skin diseases): Discontinue administration for Grade 3 adverse reactions; permanently discontinue treatment for Grade 4 adverse reactions.

Principles for Corticosteroid Therapy

For immune-related adverse reactions of Grade ≥2, corticosteroids (e.g., prednisone 1-2mg/kg/day) are required. After symptoms subside to Grade ≤1, the dose should be gradually tapered.

Use of Cemiplimab in Special Populations

Pediatric Patients

The efficacy has not been established, and its use is not recommended.

Pregnancy and Lactation

Pregnancy: It may cause fetal harm. Pregnancy status must be confirmed before medication use. Effective contraception is required during treatment and for 4 months after the last dose.

Lactation: Breastfeeding is prohibited during treatment and for 4 months after discontinuing the drug.

Hepatic and Renal Impairment

No dose adjustment is required for patients with mild to moderate hepatic or renal impairment; data on patients with severe hepatic impairment are insufficient.