{
 "query": "vibegron",
 "ingredient": "vibegron",
 "slug": "vibegron",
 "rxcui": "2472254",
 "brands": [
  "Gemtesa"
 ],
 "names": [
  "vibegron"
 ],
 "classes": [
  {
   "id": "G04BD",
   "name": "Drugs for urinary frequency and incontinence"
  }
 ],
 "alternatives": [
  "darifenacin",
  "emepronium",
  "fesoterodine",
  "flavoxate",
  "mirabegron",
  "oxybutynin",
  "propiverine",
  "solifenacin",
  "terodiline",
  "tolterodine",
  "trospium"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). ( 1.2 ) 1.1 Overactive Bladder in Adults GEMTESA \u00ae is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. 1.2 Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia (BPH) GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).",
  "contraindications": "is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Do not use if prior hypersensitivity reaction to vibegron or any components of the product. ( 4 )",
  "warnings_and_cautions": "Urinary Retention : Monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, in whom the risk of urinary retention may be greater. If urinary retention develops, discontinue GEMTESA. ( 5.1 ) Angioedema : Angioedema of the face and/or larynx has been reported with GEMTESA. ( 5.2 ) 5.1 Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention [see Adverse Reactions ( 6.1 )] . 5.2 Angioedema Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involve...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reaction is described elsewhere in the labeling: Urinary retention [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (\u22652%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America, Inc. at 1-833-876-8268 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. Overactive Bladder in Adults The safety of GEMTESA was evaluated in a 12-week, double-blind, placebo- and active-controlled study (Study 3003) in patients with OAB [see Clinical Studies ( 14.1 )] . A total of 545 patients received GEMTESA. The majority of the patients were White (78%) and female (85%) with a mean age of 60 years (range 18 to 93 years). Adverse reactions that were reported in Study 3003 at an incidence greate...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage, Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia ( 1.2 ) 12/2024 Contraindications ( 4 ) 10/2024 Warnings and Precautions, Angioedema ( 5.2 ) 10/2024",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Urinary Retention Inform patients that GEMTESA has been associated with urinary retention. Inform patients that the risk of urinary retention may be increased in patients taking muscarinic antagonist medications for the treatment of OAB. Instruct patients to contact their healthcare provider if they experience symptoms consistent with urinary retention while taking GEMTESA [see Warnings and Precautions ( 5.1 )] . Angioedema Inform patients that GEMTESA may cause angioedema. Advise patients to immediately discontinue GEMTESA and seek medical attention if angioedema associated with upper airway swelling occurs as this may be life-threatening [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 ) ]. Administration Instructions Advise patients that GEMTESA tablets can be swallowed whole with a glass of water or may be crushed, mixed with a tablespoon of applesauce and taken immediately with a glass of water [see Dosage and Administration ( 2.1 )]. Manufactured for and Distributed by: Sumitomo Pharma America, Inc. Marlborough, MA 01752 is a trademark of Sumitomo Pharma Co., Ltd., used under...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Overactive Bladder in Adults The efficacy of GEMTESA was evaluated in a 12-week, double-blind, randomized, placebo-controlled, and active-controlled trial (Study 3003, NCT03492281) in patients with OAB (urge urinary incontinence, urgency, and urinary frequency). Patients were randomized 5:5:4 to receive either GEMTESA 75 mg, placebo, or active control orally, once daily for 12 weeks. For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 urge urinary incontinence (UUI) per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. Urge urinary incontinence was defined as leakage of urine of any amount because the patient felt an urge or need to urinate immediately. The study population included OAB medication-na\u00efve patients as well as patients who had received prior therapy with OAB medications. The co-primary endpoints were change from baseline in average daily number of micturitions and average daily number of UUI episodes at week 12. Additional endpoints included change from baseline in average daily number of \u201cneed to urinate immediately\u201d (...",
  "brand_name": "GEMTESA",
  "manufacturer": "Sumitomo Pharma America, Inc.",
  "application_number": "NDA213006",
  "pharm_class_epc": [
   "beta3-Adrenergic Agonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250401",
  "set_id": "25f21d25-14f8-4fda-91f6-7aa8b68aa1c8",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7986,
  "serious": 2418,
  "death": 403,
  "hospitalization": 895,
  "primary_suspect": 7978,
  "top_reactions": [
   [
    "Drug Ineffective",
    1083
   ],
   [
    "Diarrhoea",
    399
   ],
   [
    "Headache",
    376
   ],
   [
    "Urinary Tract Infection",
    349
   ],
   [
    "Urinary Retention",
    310
   ],
   [
    "Death",
    287
   ],
   [
    "Fatigue",
    287
   ],
   [
    "Inability To Afford Medication",
    266
   ],
   [
    "Nausea",
    259
   ],
   [
    "Constipation",
    246
   ],
   [
    "Drug Effect Less Than Expected",
    233
   ],
   [
    "Fall",
    221
   ],
   [
    "Dizziness",
    217
   ],
   [
    "Urinary Incontinence",
    215
   ],
   [
    "Pollakiuria",
    210
   ]
  ],
  "by_year": {
   "2019": 9,
   "2020": 19,
   "2021": 228,
   "2022": 189,
   "2023": 1841,
   "2024": 1999,
   "2025": 2275,
   "2026": 1414
  },
  "by_year_primary": {
   "2019": 9,
   "2020": 19,
   "2021": 228,
   "2022": 188,
   "2023": 1841,
   "2024": 1999,
   "2025": 2268,
   "2026": 1414
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20201223",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 1,
  "labeling_recent": 1,
  "sponsors": [
   "SUMITOMO PHARMA AM"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/23/2020"
 },
 "trials": {
  "total": 16,
  "completed": 10,
  "terminated": 2,
  "with_results": 9,
  "industry": 12,
  "phase3": 8,
  "results_share": 0.9,
  "terminated_share": 0.125
 },
 "pubmed": {
  "rct": 24,
  "meta": 10,
  "recent_rct": 19,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 1530215.19,
  "records": 53492,
  "by_name": [
   [
    "Gemtesa",
    1530215.19
   ]
  ],
  "names_checked": [
   "vibegron",
   "Gemtesa"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1361795,
  "beneficiaries": 320270,
  "spend": 945088935.3,
  "by_brand": [
   {
    "brand": "Gemtesa",
    "claims": 1361795,
    "per_claim": 694.00235373,
    "is_generic": false
   }
  ],
  "per_claim": 694.0023537316556
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5681,
  "fills": 1361795,
  "per_million": 4171.699852033529,
  "ratio": 1.5066000552458025,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 96,
   "letter": "A",
   "why": [
    "4,172 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-4)",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "24 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-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": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,530,215 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, headache, urinary tract infection. How would we recognize and handle those?",
  "Why this one over darifenacin, emepronium, fesoterodine? 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.)"
 ]
}