Cemiplimab is a programmed death receptor-1 (PD-1) blocking antibody that activates the immune system to fight against tumors by inhibiting the PD-1/PD-L1 pathway.

Indications of Cemiplimab

Core Indications

It is indicated for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), specifically including:

Metastatic CSCC (lymph node or distant metastasis)

Locally advanced CSCC (cannot be cured by radical surgery or radiotherapy)

Application Conditions

Patients with active autoimmune diseases, a history of organ transplantation, or previous treatment with PD-1/PD-L1 inhibitors must be excluded.

Treatment should be continued until disease progression or the occurrence of intolerable toxicity.

Specifications and Properties of Cemiplimab

Dosage Form and Specifications

Injection: 350mg/7mL (50mg/mL), supplied in single-dose vials.

Properties

Cemiplimab Injection is a clear to slightly opalescent, colorless to pale yellow solution, which may contain trace amounts of translucent to white particles.

The pH value of the solution is 6, and the main active ingredient is cemiplimab-rwlc with a molecular weight of approximately 146 kDa.

Physicochemical Characteristics

pH Value: 6.0 (L-histidine buffer system)

Excipients: Contains sucrose (50mg/mL), L-proline, polysorbate 80 (2mg/mL), and no preservatives.

Precautions

A visual inspection is required before use. If the solution is turbid, discolored, or contains foreign particles other than trace translucent to white particles, the vial should be discarded.

A special reminder: This drug must not be shaken, so as to avoid affecting its efficacy.

Storage Methods of Cemiplimab

Storage of Unopened Products

Temperature: 2°C–8°C (refrigerated storage), protected from light in the original packaging.

Prohibited Operations: Freezing, shaking, or direct exposure to light.

Storage After Preparation

Diluent: Must be diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a concentration of 1–20mg/mL.

Time Limit: At room temperature (≤25°C): Infusion must be completed within 8 hours.

Refrigerated Storage (2°C–8°C): Infusion must be completed within 24 hours.

Other Requirements: The diluted solution must be brought to room temperature before infusion, and re-freezing is prohibited.