Cemiplimab-rwlc

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# Overview
Cemiplimab-rwlc is a programmed death receptor-1 (PD-1) blocking antibody that is FDA approved 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.   Common adverse reactions include fatigue, rash and diarrhea.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
Indication
- Cemiplimab-rwlc is indicated 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.
Dosage
- The recommended dosage of cemiplimab-rwlc is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding cemiplimab-rwlc Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.

### NonGuideline-Supported Use
There is limited information regarding cemiplimab-rwlc Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
The safety and effectiveness of cemiplimab-rwlc have not been established in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding cemiplimab-rwlc Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.

### NonGuideline-Supported Use
There is limited information regarding cemiplimab-rwlc Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.

# Contraindications
None.

# Warnings
- Cemiplimab-rwlc is a monoclonal antibody that belongs to a class of drugs that 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. Important immune-mediated adverse reactions listed under Warnings and Precautions may not be inclusive of all possible immune-mediated reactions.
- Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies.
- Early identification and management are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor for symptoms and signs of immune-mediated adverse reactions. 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.
- In general, withhold cemiplimab-rwlc for Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions. Permanently discontinue cemiplimab-rwlc for Grade 4 and certain Grade 3 immune-mediated adverse reactions. For Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions, administer corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy until improvement to Grade 1 or less followed by a corticosteroid taper over one month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Institute hormone replacement therapy for endocrinopathies as warranted.
Immune-Mediated Pneumonitis
- Immune-mediated pneumonitis occurred in 2.4% of 534 patients receiving cemiplimab-rwlc, including Grade 5 (0.2%), Grade 3 (0.7%) and Grade 2 (1.3%). Pneumonitis led to permanent discontinuation of cemiplimab-rwlc in 1.3% of patients. Systemic corticosteroids were required in all patients with pneumonitis, including 85% who received prednisone  40 mg per day or equivalent. Pneumonitis resolved in 62% of patients.
Immune-Mediated Colitis
- Immune-mediated colitis occurred in 0.9% of 534 patients receiving cemiplimab-rwlc, including Grade 3 (0.4%) and Grade 2 (0.6%). Colitis led to permanent discontinuation of cemiplimab-rwlc in 0.2% of patients. Systemic corticosteroids were required in all patients with colitis, including 60% who received prednisone  40 mg per day or equivalent. Colitis resolved in 80% of patients.
Immune-Mediated Hepatitis
- Immune-mediated hepatitis occurred in 2.1% of 534 patients receiving cemiplimab-rwlc, including Grade 5 (0.2%), Grade 4 (0.2%), and Grade 3 (1.7%). Hepatitis led to permanent discontinuation of cemiplimab-rwlc in 0.9% of patients. Systemic corticosteroids were required in all patients with hepatitis, including 91% who received prednisone  40 mg per day or equivalent. Hepatitis resolved in 64% of patients.
Immune-Mediated Endocrinopathies 
Adrenal Insufficiency
- Adrenal insufficiency occurred in 0.4% of 534 patients receiving cemiplimab-rwlc, including Grade 3 (0.2%), and Grade 2 (0.2%).
Hypophysitis
- Hypophysitis, which can result in hypopituitarism, occurred in 0.2% of 534 patients receiving cemiplimab-rwlc, which consisted of one patient with Grade 3 hypophysitis.
Hypothyroidism
- Hypothyroidism occurred in 6% of 534 patients receiving cemiplimab-rwlc, including Grade 3 (0.2%) and Grade 2 (5.6%). No patients discontinued hormone replacement therapy.
Hyperthyroidism
- Hyperthyroidism occurred in 1.5% of 534 patients receiving cemiplimab-rwlc, including Grade 3 (0.2%) and Grade 2 (0.4%). Hyperthyroidism resolved in 38% of patients.
Type 1 Diabetes Mellitus
- Type 1 diabetes mellitus, which can present with diabetic ketoacidosis, occurred in 0.7% of 534 patients, including Grade 4 (0.4%) and Grade 3 (0.4%). Type 1 diabetes mellitus led to permanent discontinuation of cemiplimab-rwlc in 0.2% of patients.
Immune-Mediated Nephritis with Renal Dysfunction
- Immune-mediated nephritis occurred in 0.6% of 534 patients receiving cemiplimab-rwlc, including Grade 3 (0.4%) and Grade 2 (0.2%). Nephritis led to permanent discontinuation of cemiplimab-rwlc in 0.2% of patients. Systemic corticosteroids were required in all patients with nephritis, including 67% who received prednisone  40 mg per day or equivalent. Nephritis resolved in all patients.
Immune-Mediated Dermatologic Adverse Reactions
- Immune-mediated dermatologic reactions, including erythema multiforme and pemphigoid, occurred in 1.7% of 534 patients receiving cemiplimab-rwlc, including Grade 3 (1.1%) and Grade 2 (0.6%). In addition, SJS and TEN have been observed with cemiplimab-rwlc and with other products in this class. Systemic corticosteroids were required in all patients with dermatologic reactions, including 89% who received prednisone  40 mg per day or equivalent. Dermatologic reactions resolved in 33% of patients. Approximately 22% of patients had recurrence of dermatologic reactions after re-initiation of cemiplimab-rwlc.
Other Immune-Mediated Adverse Reactions
- The following clinically significant immune-mediated adverse reactions occurred at an incidence of < 1% in 534 patients who received cemiplimab-rwlc or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.
- Neurological: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome / myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.
- Cardiovascular: Myocarditis, pericarditis, vasculitides.
- Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada like syndrome, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.
- Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis.
- Musculoskeletal and Connective Tissue: Myositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
- Hematological and Immunological: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.
- Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients receiving cemiplimab-rwlc. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue cemiplimab-rwlc based on severity of reaction.
- Based on its mechanism of action, cemiplimab-rwlc can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with cemiplimab-rwlc and for at least 4 months after the last dose.

# Adverse Reactions

## Clinical Trials Experience
- Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- The data described in WARNINGS AND PRECAUTIONS reflect exposure to cemiplimab-rwlc in 534 patients in two open-label, single-arm, multicohort studies (Study 1423 and Study 1540), including 98 patients with metastatic (nodal or distant) CSCC, 65 patients with locally advanced CSCC, and 371 patients with other advanced solid tumors. Cemiplimab-rwlc as a single agent or in combination with chemotherapy or radiation was administered intravenously at doses of 1 mg/kg every 2 weeks (n=27), 3 mg/kg every 2 weeks (n=446), 3 mg/kg every 3 weeks (n=12), 10 mg/kg every 2 weeks (n=6), 200 mg every 2 weeks (n=20) or 350 mg every 3 weeks (n=23). Among the 534 patients, 38% were exposed for  6 months and 16% were exposed for  12 months.
- The data described below reflect exposure to cemiplimab-rwlc in 163 patients with advanced CSCC (metastatic or locally advanced disease) in Study 1423 and Study 1540 . Patients received cemiplimab-rwlc 1 mg/kg every 2 weeks (n=1), 3 mg/kg every 2 weeks (n=139) or 350 mg every 3 weeks (n=23) as an intravenous infusion until disease progression, unacceptable toxicity, or completion of planned treatment. The median duration of exposure was 20 weeks (3 days to 1.4 years).
- The safety population characteristics were: median age of 71 years (38 to 96 years), 85% male, 96% white, and ECOG performance score (PS) of 0 (44%) or 1 (56%).
- The most common adverse reactions reported in at least 20% of patients were fatigue, rash and diarrhea. The most common Grade 3-4 adverse reactions ( 2%) were cellulitis, sepsis, hypertension, pneumonia, musculoskeletal pain, skin infection, urinary tract infection and fatigue. Cemiplimab-rwlc was permanently discontinued due to adverse reactions in 5% of patients; adverse reactions resulting in permanent discontinuation were pneumonitis, autoimmune myocarditis, hepatitis, aseptic meningitis, complex regional pain syndrome, cough, and muscular weakness. Serious adverse reactions occurred in 28% of patients. Serious adverse reactions that occurred in at least 2% of patients were cellulitis, sepsis, pneumonia, pneumonitis and urinary tract infection.
- Table 2 summarizes the adverse reactions that occurred in  10% of patients and Table 3 summarizes Grade 3 and 4 laboratory abnormalities worsening from baseline in  1% of patients receiving cemiplimab-rwlc.

## Immunogenicity
- As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to cemiplimab-rwlc in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
- Anti-drug antibodies (ADA) were tested in 398 of 534 patients who received cemiplimab-rwlc and the incidence of cemiplimab-rwlc treatment-emergent ADAs was 1.3% using an electrochemiluminescent (ECL) bridging immunoassay; 0.3% were persistent ADA responses. In the patients who developed anti-cemiplimab-rwlc antibodies, there was no evidence of an altered pharmacokinetic profile of cemiplimab-rwlc.

## Postmarketing Experience
There is limited information regarding Cemiplimab-rwlc Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Cemiplimab-rwlc Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
Risk Summary
- Based on its mechanism of action, cemiplimab-rwlc can cause fetal harm when administered to a pregnant woman. There are no available data on the use of cemiplimab-rwlc in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, cemiplimab-rwlc has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus.
- In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Animal Data
- Animal reproduction studies have not been conducted with cemiplimab-rwlc to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering cemiplimab-rwlc during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to cemiplimab-rwlc may increase the risk of developing immune-mediated disorders or altering the normal immune response.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cemiplimab-rwlc in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Cemiplimab-rwlc during labor and delivery.

### Nursing Mothers
Risk Summary
- There is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the breastfed child or on milk production. Because of the 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 of cemiplimab-rwlc.

### Pediatric Use
- The safety and effectiveness of cemiplimab-rwlc have not been established in pediatric patients.

### Geriatic Use
- Of the 163 patients with metastatic and locally advanced CSCC who received cemiplimab-rwlc in clinical studies, 72% were 65 years or older and 37% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

### Gender
There is no FDA guidance on the use of Cemiplimab-rwlc with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Cemiplimab-rwlc with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Cemiplimab-rwlc in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Cemiplimab-rwlc in patients with hepatic impairment.

### Females of Reproductive Potential and Males
Pregnancy Testing
- Verify pregnancy status in females of reproductive potential prior to initiating cemiplimab-rwlc.
Contraception
- Cemiplimab-rwlc can cause fetal harm when administered to a pregnant woman.
Females
- Advise females of reproductive potential to use effective contraception during treatment with cemiplimab-rwlc and for at least 4 months after the last dose.

### Immunocompromised Patients
There is no FDA guidance one the use of Cemiplimab-rwlc in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- The recommended dosage of cemiplimab-rwlc is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
- Withhold or discontinue cemiplimab-rwlc to manage adverse reactions as described in Table 1. No dose reduction of cemiplimab-rwlc is recommended.
- Visually inspect for particulate matter and discoloration prior to administration. Cemiplimab-rwlc is 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 extraneous particulate matter other than trace amounts of translucent to white particles.
Preparation
- Do not shake.
- Withdraw 7 mL from a vial and dilute with 0.9% Sodium Chloride Injection, USP 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 medicinal product or waste material.
Storage of Infusion Solution
- Store at room temperature up to 25C (77F) for no more than 8 hours from the time of preparation to the end of the infusion or at 2C to 8C (36F to 46F) for no more than 24 hours from the time of preparation to the end of infusion.
- Allow the diluted solution to come to room temperature prior to administration.
- Do not freeze.
Administration
- Administer by intravenous infusion over 30 minutes through an intravenous line containing a sterile, in-line or add-on 0.2-micron to 5-micron filter.

### Monitoring
There is limited information regarding Cemiplimab-rwlc Monitoring in the drug label.

# IV Compatibility
- Cemiplimab-rwlc is administered as an intravenous infusion.

# Overdosage
There is limited information regarding Cemiplimab-rwlc overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
- 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. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.
- Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

## Structure
There is limited information regarding Cemiplimab-rwlc Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Cemiplimab-rwlc Pharmacodynamics in the drug label.

## Pharmacokinetics
- Cemiplimab-rwlc pharmacokinetic (PK) data were collected in 505 patients with various solid tumors, including 135 patients with CSCC. The PK of cemiplimab-rwlc was linear and dose proportional in the dose range of 1 mg/kg to 10 mg/kg administered intravenously every two weeks and 350 mg intravenously administered every three weeks.
- After a dose of 350 mg cemiplimab-rwlc administered intravenously every 3 weeks, median steady-state concentrations (CV%) of cemiplimab-rwlc ranged between a maximum concentration (Cmax,ss) of 166 mcg/mL (28%) and a minimum concentration (Cmin,ss) of 59 mcg/mL (48%). Steady-state exposure is achieved after approximately 4 months of treatment.
Distribution
- The volume of distribution of cemiplimab-rwlc at steady state is 5.3 L (25%).
Elimination
- Cemiplimab-rwlc clearance (CV%) after the first dose is 0.32 L/day (39%) and decreases over time by 34%, resulting in a steady-state clearance (CLss) (CV%) of 0.21 L/day (39%). The elimination half-life (CV%) at steady state is 19 days (30%).
Specific Populations
- The following factors have no clinically important effect on the exposure of cemiplimab-rwlc: age (27 to 96 years), sex, body weight (31 to 156 kg), race (White, Black, Asian and other), cancer type, albumin level (22 to 48 g/L), renal function (creatinine clearance determined by Cockcroft-Gault 25 mL/min or greater) and hepatic function (total bilirubin 0.35 to 45 mol/L). Cemiplimab-rwlc has not been studied in patients with moderate or severe hepatic impairment.

## Nonclinical Toxicology
- No studies have been performed to assess the potential of cemiplimab-rwlc for carcinogenicity or genotoxicity.
- In a 3-month repeat-dose toxicology study in sexually mature cynomolgus monkeys, there were no cemiplimab-rwlc-related effects on fertility parameters (menstrual cycle, semen analysis, or testicular measurements) or in male or female reproductive organs at doses up to the highest dose tested, 50 mg/kg/week (approximately 5.5 to 25.5 times the human exposure based on AUC at the clinical dose of 350 mg once every 3 weeks).
- In animal models, inhibition of PD-L1/PD-1 signaling increased the severity of some infections and enhanced inflammatory responses. M. tuberculosisinfected PD-1 knockout mice exhibit markedly decreased survival compared with wild-type controls, which correlated with increased bacterial proliferation and inflammatory responses in these animals. PD-L1 and PD-1 knockout mice and mice receiving PD-L1 blocking antibody have also shown decreased survival following infection with lymphocytic choriomeningitis virus.

# Clinical Studies
- The efficacy of cemiplimab-rwlc in patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who were not candidates for curative surgery or curative radiation was evaluated in two open-label, multi-center, non-randomized, multicohort studies: Study 1423 (NCT02383212) and 1540 (NCT02760498). Both studies excluded patients with autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with antiPD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B or hepatitis C; or ECOG performance score (PS)  2.
- Patients received cemiplimab-rwlc 3 mg/kg intravenously every 2 weeks for up to 48 weeks in Study 1423 or up to 96 weeks in Study 1540. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment. Tumor response assessments were performed every 8 weeks. The major efficacy outcome measures were confirmed objective response rate (ORR), as assessed by independent central review (ICR) and ICR-assessed duration of response. For patients with metastatic CSCC without externally visible target lesions, ORR was determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). For patients with externally visible target lesions (locally advanced and metastatic CSCC), ORR was determined by a composite endpoint that integrated ICR assessments of radiologic data (RECIST 1.1) and digital medical photography (WHO criteria). The efficacy analysis was conducted when all patients had the opportunity for at least 6 months of follow-up.
- A total of 26 patients with CSCC were enrolled in Study 1423 and 82 patients were enrolled in Study 1540. Of these 108 patients, 75 had metastatic CSCC and 33 had locally advanced CSCC. The median age was 71 years (38 to 96 years); 85% were male; 97% were White; 43% had ECOG PS 0 and 57% had ECOG PS 1; 50% received at least one prior anti-cancer systemic therapy; 96% received prior cancer-related surgery; and 79% received prior radiotherapy. Among patients with metastatic CSCC, 69% had distant metastases and 31% had only nodal metastases.
- Efficacy results are presented in Table 4.

# How Supplied
- Cemiplimab-rwlc injection is a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles. It is supplied in a carton containing 1 single-dose vial of:
350 mg/7 mL (50 mg/mL) (NDC 61755-008-01)
- 350 mg/7 mL (50 mg/mL) (NDC 61755-008-01)

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

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
Immune-Mediated Adverse Reactions
- Advise patients that cemiplimab-rwlc can cause immune-mediated adverse reactions including the following:
- Pneumonitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of pneumonitis, including new or worsening symptoms of cough, chest pain, or shortness of breath.
- Colitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of colitis, including diarrhea, blood or mucus in stools, or severe abdominal pain.
- Hepatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatitis.
- Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, or type 1 diabetes mellitus.
- Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.
- Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately if they develop a new rash.
Infusion-Related Reactions
- Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions.
Embryo-Fetal Toxicity
- Advise females of reproductive potential that cemiplimab-rwlc can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy.
- Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose of cemiplimab-rwlc.
Lactation
- Advise female patients not to breastfeed while taking cemiplimab-rwlc and for at least 4 months after the last dose.

# Precautions with Alcohol
Alcohol-Cemiplimab-rwlc interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

# Brand Names
Libtayo

# Look-Alike Drug Names
There is limited information regarding Cemiplimab-rwlc Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price