Cemiplimab Dosage

Medically reviewed by Drugs.com. Last updated on Dec 2, 2022.

Usual Adult Dose for Basal Cell Carcinoma

350 mg IV every 3 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Uses:

• 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
• For the treatment of patients with locally advanced or metastatic basal cell carcinoma who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate

Usual Adult Dose for Squamous Cell Carcinoma

350 mg IV every 3 weeks
Duration of therapy: Until disease progression, unacceptable toxicity, or up to 24 months

Uses:

• 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
• For the treatment of patients with locally advanced or metastatic basal cell carcinoma who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate

Usual Adult Dose for Non-Small Cell Lung Cancer

350 mg IV every 3 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Selection of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for treatment with this drug as a single agent should be based on programmed death ligand-1 (PD-L1) expression on tumor cells.
• For information on US FDA-approved tests for the detection of PD-L1 expression: www.fda.gov/companiondiagnostics
• The manufacturer product information for coadministered agents should be consulted for recommended dosing information, as appropriate.

Uses:

• In combination with platinum-based chemotherapy, for the first-line treatment of patients with NSCLC with no epidermal growth factor receptor (EGFR), anaplastic lymphoma receptor tyrosine kinase (ALK), or ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) aberrations and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic
• As a single agent, for the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression (tumor proportion score at least 50%) as determined by a US FDA-approved test, with no EGFR, ALK, or ROS1 aberrations, and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic

Renal Dose Adjustments

Renal dysfunction: Data not available

If Immune-Mediated Nephritis with Renal Dysfunction Develops During Therapy:

• Grade 2 or 3 increased blood creatinine: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to less than 10 mg/day (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 4 increased blood creatinine: This drug should be permanently discontinued.

Comments:

• Renal dysfunction (CrCl at least 21 mL/min [determined by Cockcroft-Gault]) had no clinically significant effect on the exposure of this drug.

Liver Dose Adjustments

Liver dysfunction: Data not available

If Immune-Mediated Hepatitis with No Tumor Involvement of the Liver Develops During Therapy:

• AST or ALT increases to greater than 3 to 8 times the upper limit of normal (3 to 8 x ULN) or total bilirubin increases to greater than 1.5 to 3 x ULN: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to less than 10 mg/day (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• AST or ALT increases to greater than 8 x ULN or total bilirubin increases to greater than 3 x ULN: This drug should be permanently discontinued.

If Immune-Mediated Hepatitis with Tumor Involvement of the Liver Develops During Therapy:

• Baseline AST and ALT up to ULN: This drug should be withheld or permanently discontinued based on recommendations for hepatitis with no liver involvement.
• Baseline AST or ALT greater than 1 to 3 x ULN and increases to greater than 5 to 10 x ULN or baseline AST or ALT greater than 3 to 5 x ULN and increases to greater than 8 to 10 x ULN: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to less than 10 mg/day (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• AST or ALT increases to greater than 10 x ULN or total bilirubin increases to greater than 3 x ULN: This drug should be permanently discontinued.

Comments:

• Mild to moderate liver dysfunction (total bilirubin greater than 1 to 3 x ULN) had no clinically significant effect on the exposure of this drug.
• This drug has not been studied in patients with severe liver dysfunction (total bilirubin greater than 3 x ULN).

Dose Adjustments

No dose reduction for this drug is recommended.

General Guidelines:

• For severe (grade 3) immune-mediated adverse reactions: This drug should be withheld.
• For life-threatening (grade 4) immune-mediated adverse reactions, recurrent severe (grade 3) immune-mediated reactions that require systemic immunosuppressive therapy, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of starting steroids: This drug should be permanently discontinued.

Dosage Modifications for Immune-Mediated Adverse Reactions:
Colitis:

• Grade 2 or 3: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to less than 10 mg/day (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 4: This drug should be permanently discontinued.

Endocrinopathies:

• Grade 3 or 4: This drug should be withheld until clinically stable or permanently discontinued depending on severity.

Exfoliative Dermatologic Conditions:

• Suspected Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS): This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to less than 10 mg/day (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Confirmed SJS, TEN, or DRESS: This drug should be permanently discontinued.

Infusion-Related Reactions:

• Grade 1 or 2: This drug should be interrupted or the rate of infusion slowed.
• Grade 3 or 4: This drug should be permanently discontinued.

Myocarditis:

• Grade 2, 3, or 4: This drug should be permanently discontinued.

Neurological Toxicities:

• Grade 2: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to less than 10 mg/day (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 3 or 4: This drug should be permanently discontinued.

Pneumonitis:

• Grade 2: This drug should be withheld.
• Complete or partial resolution (grade 0 or 1) after corticosteroid taper: This drug should resume.
• If no complete or partial resolution within 12 weeks of starting steroids or inability to reduce prednisone to less than 10 mg/day (or equivalent) within 12 weeks of starting steroids: This drug should be permanently discontinued.
• Grade 3 or 4: This drug should be permanently discontinued.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer by IV infusion over 30 minutes through an IV line containing a sterile, in-line or add-on 0.2 to 5 micron filter.

Storage requirements:

• Before dilution: Store vials in a refrigerator at 2C to 8C (36F to 46F) in original carton.
• Protect from light.
• Do not freeze or shake.
• Diluted solution: Store at room temperature up to 25C (77F) for no more than 8 hours from time of preparation to end of infusion or at 2C to 8C (36F to 46F) for no more than 24 hours from time of preparation to end of infusion.
• Allow to come to room temperature before administration.
• Do not freeze.

Reconstitution/preparation techniques:

• This drug should be diluted prior to IV administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP

Monitoring:

• Endocrine: Thyroid function (at baseline and periodically during therapy)
• General: For signs/symptoms of infusion-related reactions
• Hepatic: Liver enzymes (at baseline and periodically during therapy)
• Immunologic: For signs/symptoms of underlying immune-mediated adverse reactions
• Metabolic: For hyperglycemia or other signs/symptoms of diabetes
• Renal: Creatinine (at baseline and periodically during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Contact health care provider immediately for signs/symptoms of pneumonitis (including new/worsening cough, chest pain, or shortness of breath).
• Contact health care provider immediately for signs/symptoms of colitis (including diarrhea, blood/mucus in stools, or severe abdominal pain).
• Contact health care provider immediately for signs/symptoms of hepatitis.
• Contact health care provider immediately for signs/symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, or type 1 diabetes mellitus.
• Contact health care provider immediately for signs/symptoms of nephritis.
• Contact health care provider immediately if a new rash develops.
• Contact health care provider immediately for signs/symptoms of infusion-related reactions.
• Contact health care provider immediately if signs/symptoms of post-allogeneic hematopoietic stem cell transplantation complications or solid organ transplant rejection develop.
• Inform health care provider of a known/suspected pregnancy.
• Patients of childbearing potential: Use effective contraception during therapy and for at least 4 months after the last dose.
• Do not breastfeed during therapy and for at least 4 months after the last dose.

Frequently asked questions

• What type of drug is Libtayo?

Further information

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

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