Cemiplimab is a PD-1 inhibitor indicated for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation therapy. As an immune checkpoint inhibitor, it activates the immune system to combat tumors but may also trigger immune-related adverse reactions.

Precautions for Cemiplimab Administration

Indication and Contraindication

Cemiplimab is indicated for:

Metastatic CSCC (including lymph node or distant metastasis).

Locally advanced CSCC (incurable by surgery or radiation therapy).

Currently, there are no explicit contraindications for this drug, but caution is required regarding the risk of severe immune-related adverse reactions.

Administration Regimen

Recommended Dose: 350 mg administered intravenously over 30 minutes, once every 3 weeks.

Preparation Requirements: Dilute with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a concentration of 1–20 mg/mL; avoid shaking. The diluted solution must be used within 8 hours at room temperature or within 24 hours when refrigerated (2–8°C).

Infusion Management: Infuse via an intravenous line equipped with a 0.2–5 micrometer filter.

Administration in Special Populations

Pregnant Women: May cause fetal immune rejection, leading to miscarriage or stillbirth. Confirm pregnancy status before administration; effective contraceptive measures must be used during treatment and for at least 4 months after the last dose.

Lactating Women: Breastfeeding is recommended to be avoided for at least 4 months after discontinuing the drug.

Elderly Patients: No dose adjustment is required, but close monitoring for adverse reactions is necessary.

Prevention of Immune-Related Adverse Reactions

Be alert to the following symptoms that may indicate immune-related adverse reactions:

Pneumonitis: New or worsening cough, chest pain, dyspnea.

Colitis: Diarrhea, bloody stools, abdominal pain.

Hepatitis: Jaundice, elevated transaminases.

Endocrine Disorders: Thyroid dysfunction, adrenal insufficiency, diabetes mellitus.

Cemiplimab Administration Monitoring

Baseline Assessment

Laboratory Tests: Liver function (AST/ALT), thyroid function, creatinine, complete blood count.

Imaging Assessment: Baseline measurement of tumor burden (per RECIST 1.1 criteria).

Patient Medical History: Screen for autoimmune diseases, infections (e.g., hepatitis B, tuberculosis), and history of organ transplantation.

Monitoring for Immune-Related Adverse Reactions

Pneumonitis: Conduct regular chest imaging examinations; immediately withhold the drug and consider corticosteroid treatment if symptoms occur.

Hepatitis: Monitor liver function every 3 weeks; withhold administration if AST/ALT elevates to 3 times the upper limit of normal.

Endocrine Abnormalities: Monitor thyroid function (TSH, free T4), blood glucose, and electrolytes.

Management of Infusion Reactions

Approximately 0.2% of patients may experience severe infusion reactions (e.g., chills, dyspnea).

Closely monitor patients during the first infusion; if a reaction occurs, reduce the infusion rate or discontinue the drug permanently.

Efficacy Assessment

Evaluate tumor response via imaging (CT/MRI) and clinical examinations every 8 weeks. Continue treatment until disease progression or intolerable toxicity occurs.

Patient Education and Long-Term Management

Self-Monitoring: Instruct patients to report symptoms such as rash, persistent diarrhea, and dyspnea.

Vaccination: Avoid live vaccines (e.g., measles vaccine) until 3 months after the end of treatment.

Follow-Up Plan: Long-term follow-up is required even after drug discontinuation, as some immune reactions may occur delayed.