Cemiplimab is an important immunotherapeutic agent classified as a programmed death receptor-1 (PD-1) blocking antibody. As a significant 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 for Cemiplimab

Treatment of Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)

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

Such patients 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 has not yet metastasized to distant sites.

Eligibility Criteria for Patients

Patients eligible for cemiplimab must meet specific criteria: they are not suitable for curative surgery or curative radiotherapy.

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

Dosage Form, Strength, and Properties of Cemiplimab

Dosage Form and Strength

Cemiplimab is available as an injectable formulation in two strength packages:

A single-dose vial containing 250 mg/5 mL (50 mg/mL)

A single-dose vial containing 350 mg/7 mL (50 mg/mL)

Physical Properties

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, which is a normal phenomenon and does not affect the drug quality.

Solution Characteristics

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 collectively maintain the stability and bioavailability of the drug.

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

Storage and Handling of Cemiplimab

Routine Storage Conditions

Unopened cemiplimab vials 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 severe shaking should be avoided.

Freezing may cause denaturation and inactivation of the protein-based drug, while severe 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.