Cemiplimab

Metastatic cutaneous squamous cell carcinoma (CSCC), Locally advanced CSCC who are not candidates for curative surgery or curative radiation

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 every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months. Basal Cell Carcinoma Indicated for advanced basal cell carcinoma (laBCC) OR metastatic basal carcinoma (BCC) in patients who either were previously treated with OR not candidates for a hedgehog pathway inhibitor 350 mg every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months. Non-Small Cell Lung Cancer Single-agent Indicated for first-line treatment of locally advanced (ie, patient not a candidate for surgery or chemoradiation) OR metastatic non-small cell lung cancer (NSCLC) in tumors having high PD-L1 expression [Tumor Proportion Score (TPS) > 50%], with no EGFR, ALK, or ROS1 aberrations 350 mg every 3 weeks until disease progression or unacceptable toxicity. Combination therapy with platinum-based chemotherapy Indicated in combination with platinum-based chemotherapy for first-line treatment of adults with NSCLC with no EGFR, ALK, or ROSI aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic Cemiplimab 350 mg IV every 3 weeks PLUS Platinum-based chemotherapy q3Weeks for 4 cycles Continue until disease progression or unacceptable toxicity

Renal impairment CrCl >21 mL/min: No dosage adjustment necessary

Hepatic impairment Mild-to moderate (total bilirubin >1-3x ULN): No dosage adjustment necessary Severe: Not studied

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

Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. Withhold or permanently discontinue Cemiplimab based on the severity of reaction. Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction. Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. Monitoring Parameters Monitor for signs and symptoms of infusion- and immunerelated side-effects Monitor liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.

Not Classi 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

>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

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