Cemiplimab is an important immunotherapeutic drug classified as a programmed death receptor-1 (PD-1) blocking antibody. As a major breakthrough in the field of cancer immunotherapy in recent years, this drug has demonstrated favorable efficacy in the treatment of specific types of skin cancer.

Indications of Cemiplimab

Treatment of Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)

Cemiplimab is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC).

Patients in this category typically present with tumors that have spread to lymph nodes or distant organs, indicating that the disease has progressed to an advanced stage.

Treatment of Locally Advanced Cutaneous Squamous Cell Carcinoma (CSCC)

In addition to metastatic disease, the drug is also indicated for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (CSCC).

A characteristic of these patients is that the tumor has progressed to an advanced stage in the local area, but no distant metastasis has occurred yet.

Eligibility Criteria for Patients

Patients eligible for Cemiplimab must meet specific criteria—they are not suitable for curative surgery or curative radiation therapy.

This restrictive criterion highlights the drug’s role as an alternative when existing treatment methods cannot offer a potential cure, providing a new treatment option for this patient population.

Dosage Form, Strength, and Characteristics of Cemiplimab

Dosage Form and Strength

Cemiplimab is available as an injectable formulation in two strength packages: one is a single-dose vial containing 250mg/5mL (50mg/mL), and the other is a single-dose vial containing 350mg/7mL (50mg/mL).

Physical Characteristics

The drug solution appears clear to slightly opalescent and is colorless to pale yellow in color.

The solution may contain trace amounts of translucent to white particles; this is a normal phenomenon and does not affect the drug quality.

Solution Properties

The drug solution is a sterile preparation with a pH of approximately 6.

The solution contains multiple excipients, including L-histidine, sucrose, L-proline, and polysorbate 80. These components work together to maintain the drug’s stability and bioavailability.

Healthcare professionals should visually inspect the drug solution before administration. If the solution is turbid, discolored, or contains foreign substances other than those described above, the vial should be discarded.

Storage and Handling of Cemiplimab

Routine Storage Conditions

Unopened vials of Cemiplimab must be stored under refrigeration, with the temperature maintained within the range of 2°C to 8°C (36°F to 46°F).

The drug should be kept in its original packaging and protected from light to prevent drug degradation caused by direct sunlight exposure.

Special Precautions

Two points require special attention during storage: freezing is strictly prohibited and vigorous shaking should be avoided.

Freezing may cause denaturation and inactivation of the protein-based drug, while vigorous shaking may affect the molecular structure of the drug.

Storage of Reconstituted Solution

The reconstituted drug solution also has strict storage requirements.

The reconstituted solution should not be stored at room temperature (not exceeding 25°C/77°F) for more than 8 hours.

If stored under refrigeration (2°C to 8°C), the total storage time (from reconstitution to the end of infusion) should not exceed 24 hours.

Before use, the refrigerated reconstituted solution needs to be warmed to room temperature, but any artificial heating methods to accelerate the warming process are prohibited.

Transportation Requirements

When the drug needs to be transported, it is essential to maintain the recommended refrigeration conditions throughout the entire process. Professional pharmaceutical cold chain transportation equipment should be used, and temperature changes during transportation should be monitored to prevent drug inactivation caused by temperature exceeding the allowable range.