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Cemiplimab Dosage

Medically reviewed by Drugs.com. Last updated on Nov 30, 2018.

Applies to the following strengths: 350 mg/7 mL

Usual Adult Dose for Squamous Cell Carcinoma

350 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity

Use: For the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Data not available

Dose Adjustments

Dose Modifications for Adverse Reactions:
PNEUMONITIS:
-Grade 2: Withhold therapy; resume therapy if resolved to Grade 1 or less after corticosteroid taper.
-Grade 3 or 4: Permanently discontinue therapy.
COLITIS:
-Grade 2 or 3: Withhold therapy; resume therapy if resolved to Grade 1 or less after corticosteroid taper.
Grade 4: Permanently discontinue therapy.
HEPATITIS:
-If AST or ALT increases to more than 3 and up to 10 times the upper limit of normal (ULN) or if total bilirubin increases up to 3 x ULN: Withhold therapy; resume therapy if resolved to Grade 1 or less after corticosteroid taper.
-If AST or ALT increases to more than 10 x ULN or total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy.
ENDOCRINOPATHIES:
-Grade 2, 3, or 4: Withhold if clinically necessary.
ADVERSE REACTIONS INVOLVING A MAJOR ORGAN:
-Grade 3: Withhold therapy; resume therapy if resolved to Grade 1 or less after corticosteroid taper.
-Grade 4: Permanently discontinue therapy.
RECURRENT OR PERSISTENT IMMUNE MEDIATED ADVERSE REACTIONS:
-Recurrent Grade 3 or 4 OR Grade 2 or 3 persistent for 12 weeks or longer after last dose OR requirement for 10 mg per day or greater prednisone or equivalent lasting 12 weeks or longer after last dose: Permanently discontinue therapy.
INFUSION-RELATED REACTIONS:
-Grade 1 or 2: Interrupt or slow the rate of infusion.
-Grade 3 or 4: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:
-None

This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:
-Store in a refrigerator at 2C to 8C (36F to 46F) in the original carton.
-Protect from light.
-Do not freeze or shake.

Reconstitution/preparation techniques:
-Visually inspect for particulate matter and discoloration prior to administration.
-This drug should be a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles. Discard the vial if the solution is cloudy, discolored or contains particulate matter.
-Withdraw 7 mL from a vial and dilute with 0.9% sodium chloride injection or 5% dextrose injection, USP to a final concentration between 1 mg/mL to 20 mg/mL.
-Mix diluted solution by gentle inversion. Do not shake.
-Discard any unused product.

IV compatibility:
-Compatible with 0.9% sodium chloride injection or 5% dextrose injection.

Patient advice:
-This drug can harm a developing fetus. Use effective contraception during therapy and for at least 4 months after.
-Do not breastfeed during therapy and for at least 4 months after.
-Report adverse reactions to your healthcare provider promptly.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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