Cemiplimab is an immune checkpoint inhibitor antibody targeting PD-1, used in the treatment of various advanced or metastatic tumors. Mastering the proper usage and dosage is crucial for exerting the drug's efficacy and reducing adverse reactions. 

Dosage of cemipalimab (Cemiplimab)

This article will outline its recommended dosage, administration methods, and dosage adjustment principles to provide scientific references for clinical practice and patients.

1. Patient Selection (NSCLC)

Patients with locally advanced or metastatic NSCLC who are suitable for monotherapy with cemiplimab should be selected based on the PD-L1 expression level of tumor cells.

2. Recommended Dosage

CSCC and BCC: 350 mg, administered via intravenous infusion once every 3 weeks, until disease progression, occurrence of unacceptable toxicity, or for a maximum duration of 24 months (whichever comes first).

NSCLC: 350 mg, administered via intravenous infusion once every 3 weeks, until disease progression or occurrence of unacceptable toxicity.

Combination with Chemotherapy: Please refer to the prescribing information of the chemotherapeutic drugs used in combination.

3. Dosage Adjustment for Adverse Reactions

It is not recommended to reduce the dosage of cemiplimab. Generally, the dosage adjustment principles are as follows:

For grade 3 immune-mediated adverse reactions, administration should be withheld.

For grade 4 or life-threatening immune-mediated adverse reactions, recurrent grade 3 reactions requiring systemic immunosuppressive therapy, or patients in whom the corticosteroid dosage cannot be reduced to a prednisone-equivalent dosage of 10 mg/day or less within 12 weeks after initiating steroid use, permanent discontinuation of the drug is required.

Specific dosage adjustment recommendations are as follows:

Immune-mediated Pneumonitis: Withhold for grade 2; permanently discontinue for grade 3 or 4.

Immune-mediated Colitis: Withhold for grade 2 or 3; permanently discontinue for grade 4.

Immune-mediated Hepatitis: The decision to withhold or permanently discontinue the drug depends on whether there is liver tumor involvement and the degree of transaminase/bilirubin elevation.

Immune-mediated Endocrinopathies: Withhold or permanently discontinue for grade 3 or 4, depending on the severity.

Immune-mediated Nephritis: Withhold for grade 2 or 3 serum creatinine elevation; permanently discontinue for grade 4.

Cutaneous Adverse Reactions (e.g., SJS, TEN, DRESS): Withhold if suspected; permanently discontinue if confirmed.

Myocarditis: Permanently discontinue for grade 2, 3, or 4.

Neurological Toxicity: Withhold for grade 2; permanently discontinue for grade 3 or 4.

Infusion-related Reactions: Interrupt or slow down the infusion rate for grade 1 or 2; permanently discontinue for grade 3 or 4.

4. Preparation and Administration

Visually inspect for particulates or discoloration before administration.

Withdraw 7 mL from each vial and dilute with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration of 1–20 mg/mL.

Gently invert to mix; do not shake.

The diluted solution can be stored at room temperature (≤25°C) for no more than 8 hours, or at 2–8°C for no more than 10 days.

Use an intravenous infusion line with a 0.2–5 micrometer filter, and the infusion time should be 30 minutes.

During the treatment with cemiplimab, strictly following the principles of usage, dosage, and dosage adjustment can effectively improve efficacy and reduce risks. Patients should undergo regular follow-ups, pay attention to physical reactions, and communicate with doctors to adjust the treatment plan if necessary, so as to achieve the best therapeutic effect.