{
 "query": "vedolizumab",
 "ingredient": "vedolizumab",
 "slug": "vedolizumab",
 "rxcui": "1538097",
 "brands": [
  "Entyvio"
 ],
 "names": [
  "vedolizumab"
 ],
 "classes": [
  {
   "id": "L04AG",
   "name": "Monoclonal antibodies"
  }
 ],
 "alternatives": [
  "alemtuzumab",
  "anifrolumab",
  "axatilimab",
  "belimumab",
  "efalizumab",
  "emapalumab",
  "inebilizumab",
  "muromonab-cd3",
  "natalizumab",
  "ocrelizumab",
  "ofatumumab",
  "rozanolixizumab",
  "sibeprenlimab",
  "teprotumumab",
  "ublituximab"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 1,
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). ( 1 ) moderately to severely active Crohn's disease (CD). ( 1 )",
  "contraindications": "is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1) ] . Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. ( 4 )",
  "warnings_and_cautions": "Infusion-Related Reactions and Hypersensitivity Reactions : Discontinue ENTYVIO and initiate appropriate treatment if serious reactions occur. ( 5.1 ) Infections : Treatment with ENTYVIO should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, ENTYVIO should not be administered until the infection resolves. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) : Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. ( 5.3 ) 5.1 Infusion-Related Reactions and Hypersensitivity Reactions Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate [see Adverse Reactions (6.1 , 6.2) ]. These reactions may occur with the first or subsequent infusions of ENTYVIO and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of EN...",
  "warnings": "",
  "adverse_reactions": "The following topics are also discussed in detail in the Warnings and Precautions section: Infusion-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Liver Injury [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence \u22653% and \u22651% higher than placebo) are: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities. ( 6.1 ) Adverse reactions with subcutaneous ENTYVIO are similar to those reported with intravenous ENTYVIO with the exception of injection site reactions reported with subcutaneous ENTYVIO. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration Important Administration Information ( 2.1 ) 2/2026 Warnings and Precautions Infections ( 5.2 ) 2/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infusion-Related and Hypersensitivity Reactions Instruct patients to report immediately if they experience symptoms consistent with a hypersensitivity reaction during or following an infusion of ENTYVIO [see Warnings and Precautions (5.1) ] . Infections Inform patients that they may be more likely to develop infections when taking ENTYVIO. Instruct patients to tell their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions (5.2) ] . Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received some integrin receptor antagonist and systemic immunosuppressant products. Instruct patients to report if they experience any new onset or worsening of neurological signs and symptoms immediately, as these could be indicative of PML [see Warnings and Precautions (5.3) ]. Liver Injury Inform patients that elevated transaminase levels with or without elevated bilirubin has occurred in patients who received ENTYVIO. Instruct patients to report promptly any sympto...",
  "spl_medguide": "MEDICATION GUIDE ENTYVIO \u00ae (en ti' vee oh) (vedolizumab) for injection, for intravenous use ENTYVIO \u00ae (en ti' vee oh) (vedolizumab) injection, for subcutaneous use ENTYVIO \u00ae (en ti' vee oh) PEN (vedolizumab) injection, for subcutaneous use This Medication Guide has been approved by the U.S. Food and Drug Administration VMB245 R12 Revised: 2/2026 What is the most important information I should know about ENTYVIO? ENTYVIO may cause serious side effects, including: Infusion-related and serious allergic reactions. These reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing). Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have symp...",
  "clinical_studies": "14.1 Clinical Studies in Ulcerative Colitis Intravenous Administration The safety and efficacy of intravenous ENTYVIO were evaluated in two randomized, double-blind, placebo-controlled trials (UC Trials I and II) in adult patients with moderately to severely active ulcerative colitis (UC) defined as Mayo score of 6 to 12 with endoscopy subscore of two or three. The Mayo score ranges from 0 to 12 and has four subscales that are each scored from zero (normal) to three (most severe): stool frequency, rectal bleeding, findings on endoscopy, and physician global assessment. An endoscopy subscore of two is defined by marked erythema, lack of vascular pattern, friability, and erosions; an endoscopy subscore of three is defined by spontaneous bleeding and ulceration. Enrolled patients in the U.S. had over the previous five-year period an inadequate response or intolerance to immunomodulator therapy (i.e., azathioprine or 6-mercaptopurine) and/or an inadequate response, loss of response, or intolerance to a TNF blocker. Outside the U.S., prior treatment with corticosteroids was sufficient for entry if over the previous five-year period the patients were corticosteroid dependent (i.e., unabl...",
  "brand_name": "ENTYVIO",
  "manufacturer": "Takeda Pharmaceuticals America, Inc.",
  "application_number": "BLA761133",
  "pharm_class_epc": [
   "Integrin Receptor Antagonist [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS",
   "INTRAVENOUS"
  ],
  "effective_time": "20260429",
  "set_id": "6e94621c-1a95-4af9-98d1-52b9e6f1949c",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 85742,
  "serious": 74333,
  "death": 4219,
  "hospitalization": 25134,
  "primary_suspect": 85718,
  "top_reactions": [
   [
    "Off Label Use",
    22326
   ],
   [
    "Colitis Ulcerative",
    15631
   ],
   [
    "Crohn^S Disease",
    11371
   ],
   [
    "Drug Ineffective",
    9920
   ],
   [
    "Diarrhoea",
    8706
   ],
   [
    "Abdominal Pain",
    7454
   ],
   [
    "Fatigue",
    6308
   ],
   [
    "Haematochezia",
    6142
   ],
   [
    "Frequent Bowel Movements",
    5261
   ],
   [
    "Arthralgia",
    4741
   ],
   [
    "Malaise",
    4329
   ],
   [
    "Nausea",
    4165
   ],
   [
    "Headache",
    4121
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    4036
   ],
   [
    "Product Dose Omission Issue",
    3817
   ]
  ],
  "by_year": {
   "2019": 5520,
   "2020": 7469,
   "2021": 10540,
   "2022": 9445,
   "2023": 11049,
   "2024": 12188,
   "2025": 11224,
   "2026": 5190
  },
  "by_year_primary": {
   "2019": 5519,
   "2020": 7469,
   "2021": 10540,
   "2022": 9441,
   "2023": 11043,
   "2024": 12183,
   "2025": 11221,
   "2026": 5185
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 3,
  "nda": 0,
  "anda": 0,
  "first_approval": "20140520",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "TAKEDA PHARMS USA"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/20/2014"
 },
 "trials": {
  "total": 217,
  "completed": 101,
  "terminated": 26,
  "with_results": 50,
  "industry": 117,
  "phase3": 36,
  "results_share": 0.49504950495049505,
  "terminated_share": 0.11981566820276497
 },
 "pubmed": {
  "rct": 45,
  "meta": 51,
  "recent_rct": 19,
  "cochrane": [
   {
    "pmid": "37458279",
    "title": "Vedolizumab for induction and maintenance of remission in Crohn's disease",
    "year": "2023"
   },
   {
    "pmid": "25105240",
    "title": "Vedolizumab for induction and maintenance of remission in ulcerative colitis",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 30029706.37,
  "records": 59568,
  "by_name": [
   [
    "Entyvio",
    30029706.37
   ]
  ],
  "names_checked": [
   "vedolizumab",
   "Entyvio"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 18679,
  "beneficiaries": 3697,
  "spend": 156882357.49,
  "by_brand": [
   {
    "brand": "Entyvio",
    "claims": 14773,
    "per_claim": 8749.0445434,
    "is_generic": false
   },
   {
    "brand": "Entyvio Pen",
    "claims": 3906,
    "per_claim": 7074.4297107,
    "is_generic": false
   }
  ],
  "per_claim": 8398.862759783715
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.5x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 56,
   "letter": "D",
   "why": [
    "45 randomized trials and 51 systematic reviews/meta-analyses indexed in PubMed",
    "2 independent Cochrane review(s) exist",
    "Only 50% of completed registered trials posted results (-8)"
   ],
   "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": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $30,029,706 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "15 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are colitis ulcerative, crohn^s disease. 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 alemtuzumab, anifrolumab, axatilimab? 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?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}