{ "query": "cemiplimab", "ingredient": "cemiplimab", "slug": "cemiplimab", "rxcui": "2058826", "brands": [], "names": [ "cemiplimab" ], "classes": [ { "id": "L01FF", "name": "PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors" } ], "alternatives": [ "atezolizumab", "avelumab", "dostarlimab", "durvalumab", "nivolumab", "pembrolizumab", "retifanlimab", "tislelizumab", "toripalimab" ], "label": { "route_mode": "INTRAVENOUS", "route_counts": { "INTRAVENOUS": 1 }, "boxed_warning": "", "indications_and_usage": "is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. ( 1.1 ) for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation. ( 1.1 , 14.1 ) Basal Cell Carcinoma (BCC) for the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. ( 1.2 ) Non-Small Cell Lung Cancer (NSCLC) in combination with platinum\u2010based chemotherapy for the first\u2010line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is: locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. ( 1.3 ) as single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) \u226550%] as determined ...", "contraindications": "None. None. ( 4 )", "warnings_and_cautions": "Immune-Mediated Adverse Reactions ( 5.1 ) 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. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue LIBTAYO based on the severity of reaction. ( 2.3 ) Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction. ( 2.3 , 5.2 ) 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. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.4...", "warnings": "", "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling. Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] Most common adverse reactions (\u226515%): LIBTAYO as a single agent in mCSCC or laCSCC, m BCC or laBCC, and NSCLC with high PD-L1 expression : Fatigue, musculoskeletal pain, rash, diarrhea, and anemia. ( 6.1 ) LIBTAYO as a single agent in adjuvant CSCC at high risk of recurrence: Rash and pruritus. ( 6.1 ) LIBTAYO in combination with platinum-based chemotherapy in NSCLC: Alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-877-542-8296 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. ...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Indications and Usage ( 1.1 ) 10/2025 Dosage and Administration ( 2.2 ) 10/2025 Warnings and Precautions ( 5.1 ) 8/2026", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Advise patients that LIBTAYO can cause immune-mediated adverse reactions including the following [see Warnings and Precautions (5.1) ] : 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. Other Immune-M...", "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: October 2025 MEDICATION GUIDE LIBTAYO \u00ae (Lib-TIE-oh) (cemiplimab-rwlc) injection What is the most important information I should know about LIBTAYO? LIBTAYO is a medicine that may treat certain types of cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems. cough shortness of breath chest pain Intestinal problems. diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems. yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your st...", "clinical_studies": "14.1 Cutaneous Squamous Cell Carcinoma (CSCC) Advanced CSCC The efficacy of LIBTAYO in patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) 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 Study 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 anti\u2013PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B or hepatitis C; or ECOG PS \u22652. Patients received LIBTAYO 3 mg/kg intravenously every 2 weeks for up to 48 weeks in Study 1423 or up to 96 weeks (Groups 1 and 2), or 350 mg every 3 weeks for up to 54 weeks (Group 3) in Study 1540. Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment. Tumor response assessments were performed every 8 or 9 weeks. The major efficacy outcome measures were confirmed objective response rate (ORR), de...", "brand_name": "LIBTAYO", "manufacturer": "Regeneron Pharmaceuticals, Inc.", "application_number": "BLA761097", "pharm_class_epc": [], "route": [ "INTRAVENOUS" ], "effective_time": "20260831", "set_id": "4347ae1f-d397-4f18-8b70-03897e1c054a", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 1349, "serious": 1303, "death": 242, "hospitalization": 793, "primary_suspect": 1345, "top_reactions": [ [ "Fatigue", 81 ], [ "Off Label Use", 69 ], [ "Drug Ineffective", 64 ], [ "Pyrexia", 54 ], [ "Pneumonitis", 49 ], [ "Dyspnoea", 48 ], [ "Pneumonia", 48 ], [ "Diarrhoea", 45 ], [ "Disease Progression", 44 ], [ "Febrile Neutropenia", 43 ], [ "Rash", 43 ], [ "Nausea", 42 ], [ "Death", 40 ], [ "Pain", 39 ], [ "Asthenia", 38 ] ], "by_year": { "2019": 161, "2020": 129, "2021": 146, "2022": 149, "2023": 189, "2024": 160, "2025": 214, "2026": 165 }, "by_year_primary": { "2019": 161, "2020": 129, "2021": 146, "2022": 149, "2023": 189, "2024": 158, "2025": 212, "2026": 165 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 0, "nda": 0, "anda": 0, "first_approval": "", "rems": false, "rems_last": "", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [], "unapproved": false, "first_approval_fmt": "" }, "trials": { "total": 236, "completed": 35, "terminated": 34, "with_results": 25, "industry": 166, "phase3": 18, "results_share": 0.7142857142857143, "terminated_share": 0.1440677966101695 }, "pubmed": { "rct": 21, "meta": 4, "recent_rct": 21, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "cemiplimab" ], "source": "bulk-index" }, "partd": null, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "cemiplimab", "matched": "cemiplimab", "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 89, "letter": "A", "why": [ "Death appears in 2.0x the share of reports seen across all of FAERS (-6)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 39, "letter": "F", "why": [ "21 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 95, "letter": "A", "why": [ "No recalls on record since 2016", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 70, "letter": "C", "why": [ "No generic version approved: brand-only pricing (-30)", "9 same-class alternatives exist" ], "weight": 0.1 } }, "total": 77, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are fatigue, pyrexia. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over atezolizumab, avelumab, dostarlimab? What would make you pick one of those instead?", "There is no generic. Is there an older generic in the same class that works as well for my situation?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }