Cemiplimab

Indications

Cemiplimab is used for: Indicated for patients with, metastatic cutaneous squamous cell carcinoma (CSCC), or locally advanced CSCC who are not candidates for curative surgery or curative radiation

Adult Dose

Adult Intravenous Cutaneous Squamous Cell Carcinoma Indicated for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation 350 mg IV q3Weeks infused over 30 min Continue until disease progression or unacceptable toxicity Hepatic impairment Mild: No clinically important effect on the exposure of cemiplimab observed Moderate or severe: Not studied

Child Dose

Renal Dose

Renal impairment Mild or moderate: No clinically important effect on the exposure of cemiplimab observed CrCl <25 mL/min: Not studied

Administration

IV Preparation Visually inspect for particulate matter and discoloration; solution should appear clear to slightly opalescent, colorless to pale yellow and may contain trace amounts of translucent-to-white particles Discard if solution is cloudy, discolored, or contains extraneous particulate matter other than trace amounts of translucent-to-white particles Do not shake Withdraw 350 mg (7 mL) from vial and dilute with 0.9% NaCl or D5W to a final concentration between 1-20 mg/mL Mix diluted solution by gentle inversion; do not shake Discard unused drug or waste material IV Administration Infuse over 30 minutes through an IV line containing a sterile, in-line or add-on 0.2 to 5-micron filter

Contra Indications

Precautions

May cause a wide variety of immune-mediated adverse effects Cemiplimab binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, hypophysitis, hypothyroidism or hyperthyroidism, type 1 diabetes mellitus, nephritis, and dermatologic reactions reported during clinical trials Other immune-mediated adverse reactions involving other systems (eg, neurological, cardiovascular, ocular) were also reported in <1% of patients or were reported with other PD-1/PD-L1 blockers Evaluate clinical chemistries, including liver tests and thyroid function tests, at baseline and periodically during treatment; institute medical management promptly to include specialty consultation as appropriate Lactation There are no data regarding distribution into human milk, or the drug’s effect on breastfed children or on milk production Because of potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose

Pregnancy-Lactation

Pregnancy Based on its mechanism of action, cemiplimab can cause fetal harm when administered to pregnant women Verify pregnancy status in females of reproductive potential before initiating Advise women of the potential risk to a fetus Contraception Advise females of reproductive potential to use effective contraception during treatment with for at least 4 months after last dose Lactation There are no data regarding distribution into human milk, or the drug’s effect on breastfed children or on milk production Because of potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose

Interactions

Adverse Effects

Side effects of Cemiplimab : >10% (All Grades) Fatigue (29%) Rash (25%) Diarrhea (22%) Nausea (19%) Musculoskeletal pain (17%) Pruritus (15%) Constipation (12%) 1-10% (All Grades) Decreased appetite (10%) Immune-mediated pneumonitis (2.4%) Immune-mediated hepatitis (2.1%) Immune-mediated dermatologic reactions (1.7%) 1-10% (Grades 3-4) Lymphopenia (7%) Hypothyroidism (6%) Hypophosphatemia (4%) Hyponatremia (3%) Musculoskeletal pain (3%) Increased AST (3%) Increased INR (2%) Anemia (2%) Fatigue (2%) Hyperthyroidism (1.5%) Rash (1.2%) Hypoalbuminemia (1%) Hypercalcemia (1%) <1% Infusion-related reactions Diarrhea, Grades 3-4 Constipation, Grades 3-4 Immune-mediated colitis, all grades Immune-mediated nephritis, all grades Adrenal insufficiency Hypophysitis Diabetes mellitus type 1

Mechanism of Action

Monoclonal antibody that targets checkpoint inhibitor PD-1 (programmed death 1) and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway-mediated inhibition of the immune response, including antitumor immune response, thereby decreasing tumor growth Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production