{ "query": "ipilimumab", "ingredient": "ipilimumab", "slug": "ipilimumab", "rxcui": "1094833", "brands": [ "Yervoy" ], "names": [ "ipilimumab" ], "classes": [], "alternatives": [], "label": { "route_mode": "INTRAVENOUS", "route_counts": { "INTRAVENOUS": 1 }, "boxed_warning": "", "indications_and_usage": "is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma \u2022 Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1) \u2022 Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (1.2) Renal Cell Carcinoma (RCC) \u2022 Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. (1.3) Colorectal Cancer \u2022 Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test in combination with nivolumab. (1.4) Hepatocellular Carcinoma \u2022 adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in combination with nivolumab. ( 1.5 ) \u2022 in combination with nivolumab in adult patients with unresectable or metastatic HCC who have...", "contraindications": "None. \u2022 None. (4)", "warnings_and_cautions": "\u2022 Severe and Fatal Immune-Mediated Adverse Reactions : Immune-mediated adverse reactions (IMAR) can occur in any organ system or tissue, including the following: immune-mediated colitis, immune-mediated hepatitis, immune-mediated dermatologic adverse reactions, immune-mediated endocrinopathies, immune-mediated pneumonitis, and immune-mediated nephritis with renal dysfunction, and can occur at any time during treatment or after discontinuation. Monitor for symptoms and signs that may be clinical manifestations of IMAR. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone level and thyroid function including at baseline and before each dose. In general, withhold YERVOY for severe (grade 3) and permanently discontinue for life-threatening (grade 4) immune-mediated adverse reactions. See Full Prescribing Information for additional dosage modifications. ( 2.3 , 5.1 ) \u2022 Infusion-Related Reactions : Discontinue for severe and life-threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions. ( 2.3 , 5.2 ) \u2022 Complications of allogeneic HSCT : Fatal and other serious comp...", "warnings": "", "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] . \u2022 Infusion-related reactions [see Warnings and Precautions (5.2) ] . Most common adverse reactions (\u226520%) with YERVOY as a single agent are fatigue, diarrhea, pruritus, rash, nausea, and headache. (6.1) Most common adverse reactions (\u226520%) with YERVOY in combination with nivolumab are fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia, headache, hypothyroidism, constipation, decreased weight, and dizziness. (6.1) Most common adverse reactions (\u226520%) with YERVOY in combination with nivolumab and platinum-doublet chemotherapy are fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Indications and Usage ( 1 ) 6/2026 Dosage and Administration (2) 6/2026 Warnings and Precautions (5) 8/2026", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Advise patients that YERVOY can cause immune-mediated adverse reactions including the following [see Warnings and Precautions (5.1) ] : \u2022 Immune-Mediated Diarrhea or Colitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of diarrhea or colitis. \u2022 Immune-Mediated Hepatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatitis. \u2022 Immune-Mediated Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately if they develop a new rash. \u2022 Immune-Mediated Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypophysitis, adrenal insufficiency, hypothyroidism, hyperthyroidism, and diabetes mellitus. \u2022 Immune-Mediated Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening symptoms of pneumonitis. \u2022 Immune-Mediated Nephritis with Renal Dysfunction: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis. Infusion...", "spl_medguide": "MEDICATION GUIDE YERVOY \u00ae (yur-voi) (ipilimumab) injection Read this Medication Guide before you start receiving YERVOY and before each infusion. There may be new information. If your healthcare provider prescribes YERVOY in combination with nivolumab, also read the Medication Guide that comes with nivolumab. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about YERVOY? YERVOY is a medicine that may treat certain cancers by working with your immune system. YERVOY 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 may 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. Some of these problems may happen more often when YERVOY is used in combination with nivolumab. Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including: Intestinal problems. \u2022...", "clinical_studies": "14.1 Unresectable or Metastatic Melanoma The efficacy of YERVOY was investigated in a Study MDX010-20, a randomized (3:1:1), double-blind, double-dummy trial (NCT00094653) that included patients with unresectable or metastatic melanoma previously treated with one or more of the following: aldesleukin, dacarbazine, temozolomide, fotemustine, or carboplatin. The trial enrolled only patients with HLA-A2*0201 genotype; this HLA genotype facilitates the immune presentation of the investigational peptide vaccine. The trial excluded patients with active autoimmune disease or those receiving systemic immunosuppression for organ transplantation. Patients were randomized to YERVOY administered at a dose of 3 mg/kg as an intravenous infusion every 3 weeks for 4 doses with an investigational peptide vaccine with incomplete Freund\u2019s adjuvant - gp100 administered at a dose of 2 mg peptide by deep subcutaneous injection every 3 weeks for 4 doses; gp100 administered at a dose of 2 mg by deep subcutaneous injection every 3 weeks for 4 doses as a single agent with a placebo; or YERVOY administered at a dose of 3 mg/kg by intravenous infusion every 3 weeks for 4 doses with a placebo. The major effica...", "brand_name": "YERVOY", "manufacturer": "E.R. Squibb & Sons, L.L.C.", "application_number": "BLA125377", "pharm_class_epc": [ "CTLA-4-directed Blocking Antibody [EPC]" ], "route": [ "INTRAVENOUS" ], "effective_time": "20260820", "set_id": "2265ef30-253e-11df-8a39-0800200c9a66", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 39882, "serious": 35651, "death": 8829, "hospitalization": 18165, "primary_suspect": 39863, "top_reactions": [ [ "Death", 4098 ], [ "Malignant Neoplasm Progression", 3501 ], [ "Diarrhoea", 2669 ], [ "Off Label Use", 2494 ], [ "Colitis", 2056 ], [ "Pyrexia", 1915 ], [ "Rash", 1644 ], [ "Fatigue", 1539 ], [ "Intentional Product Use Issue", 1347 ], [ "Nausea", 1237 ], [ "Immune-Mediated Enterocolitis", 1122 ], [ "Decreased Appetite", 1041 ], [ "Hypophysitis", 1007 ], [ "Dyspnoea", 948 ], [ "Pneumonia", 931 ] ], "by_year": { "2019": 4276, "2020": 3614, "2021": 4099, "2022": 4409, "2023": 3218, "2024": 3248, "2025": 2534, "2026": 1576 }, "by_year_primary": { "2019": 4276, "2020": 3614, "2021": 4099, "2022": 4409, "2023": 3217, "2024": 3242, "2025": 2528, "2026": 1570 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [], "recall_total": 0, "drugsfda": { "applications": 1, "nda": 0, "anda": 0, "first_approval": "20110325", "rems": false, "rems_last": "20150316", "labeling_supplements": 0, "labeling_recent": 0, "sponsors": [ "BRISTOL MYERS SQUIBB" ], "unapproved": false, "first_approval_fmt": "03/25/2011" }, "trials": { "total": 987, "completed": 419, "terminated": 179, "with_results": 292, "industry": 555, "phase3": 88, "results_share": 0.6968973747016707, "terminated_share": 0.18135764944275581 }, "pubmed": { "rct": 237, "meta": 44, "recent_rct": 128, "cochrane": [] }, "payments": { "year": "2024", "usd": 5.02, "records": 1, "by_name": [ [ "Yervoy", 5.02 ] ], "names_checked": [ "ipilimumab", "Yervoy" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 623, "beneficiaries": 203, "spend": 12091035.96, "by_brand": [ { "brand": "Yervoy", "claims": 623, "per_claim": 19407.762376, "is_generic": false } ], "per_claim": 19407.762375601927 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "ApplicationRejected", "name": "ipilimumab", "matched": "ipilimumab", "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 84, "letter": "B", "why": [ "Death appears in 2.4x the share of reports seen across all of FAERS (-11)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 71, "letter": "C", "why": [ "237 randomized trials and 44 systematic reviews/meta-analyses indexed in PubMed", "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 $5 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 40, "letter": "F", "why": [ "No generic version approved: brand-only pricing (-30)", "No same-class alternatives found: little leverage to switch (-30)" ], "weight": 0.1 } }, "total": 80, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are death, malignant neoplasm progression, diarrhoea. 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?", "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.)" ] }