{
 "query": "umeclidinium",
 "ingredient": "umeclidinium",
 "slug": "umeclidinium",
 "rxcui": "1487514",
 "brands": [
  "Incruse"
 ],
 "names": [
  "umeclidinium",
  "umeclidinium bromide"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "RESPIRATORY (INHALATION)",
  "route_counts": {
   "RESPIRATORY (INHALATION)": 3,
   "ORAL": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 )",
  "contraindications": "Umeclidinium ELLIPTA is contraindicated in the following conditions: \u2022 Severe hypersensitivity to milk proteins [see Warnings and Precautions ( 5.3 )] \u2022 Hypersensitivity to umeclidinium or any of the excipients [see Warnings and Precautions ( 5.3 ), Description ( 11 )] \u2022 Severe hypersensitivity to milk proteins. ( 4 ) \u2022 Hypersensitivity to any ingredient. ( 4 )",
  "warnings_and_cautions": "\u2022 Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. ( 5.1 ) \u2022 If paradoxical bronchospasm occurs, discontinue Umeclidinium ELLIPTA and institute alternative therapy. ( 5.2 ) \u2022 Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.4 ) \u2022 Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.5 ) 5.1 Deterioration of Disease and Acute Episodes Umeclidinium ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. Umeclidinium ELLIPTA has not been studied in subjects with acutely deteriorating COPD. The initiation of Umeclidinium ELLIPTA in this setting is not appropriate. Umeclidinium ELLIPTA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Umeclidinium ELLIPTA has not been studied in the relief of acute symptoms an...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in greater detail in other sections: \u2022 Paradoxical bronchospasm [see Warnings and Precautions ( 5.2 )] \u2022 Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.4 )] \u2022 Worsening of urinary retention [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence \u22652% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the 8 clinical trials conducted to support initial approval of Umeclidinium ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4 randomize...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Not for Acute Symptoms Inform patients that Umeclidinium ELLIPTA is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta 2 -agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used. Instruct patients to seek medical attention immediately if they experience any of the following: \u2022 Decreasing effectiveness of inhaled, short-acting beta 2 -agonists \u2022 Need for more inhalations than usual of inhaled, short-acting beta 2 -agonists \u2022 Significant decrease in lung function as outlined by the physician Tell patients they should not stop therapy with Umeclidinium ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation. [See Warnings and Precautions ( 5.1 ).] Paradoxical Bronchospasm As with other inhaled medicines, Umeclidinium ELLIPTA can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue Umeclidinium ELLIPTA and contact their healthc...",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of umeclidinium 62.5 mcg were evaluated in 3 dose-ranging trials, 2 placebo-controlled clinical trials (one 12-week trial and one 24-week trial), and a 12-month long\u2011term safety trial. The efficacy of umeclidinium ELLIPTA is based primarily on the dose\u2011ranging trials in 624 subjects and the 2 placebo-controlled confirmatory trials in 1,738 subjects with COPD, including chronic bronchitis and/or emphysema. [See Clinical Studies ( 14.1 , 14.2 ).] The safety and efficacy of umeclidinium ELLIPTA in combination with an ICS/LABA were also evaluated in four 12-week clinical trials. The efficacy of umeclidinium ELLIPTA in combination with an ICS/LABA is based on 1,637 subjects with COPD. [See Clinical Studies ( 14.3 ).] Evidence of efficacy for umeclidinium ELLIPTA on COPD exacerbations was established by the efficacy of the umeclidinium component as part of a fixed-dose combination with an ICS/LABA, as assessed in a 12-month trial in 10,355 subjects. [See Clinical Studies ( 14.3 ).] 14.1 Dose-Ranging Trials Dose selection for umeclidinium in COPD was supported by a 7-day, randomized, double-blind, placebo-controlled, crossover trial evaluating 4 doses of umeclidini...",
  "brand_name": "Umeclidinium Ellipta",
  "manufacturer": "Prasco Laboratories",
  "application_number": "NDA205382",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251106",
  "set_id": "763388a5-cc89-4c25-8562-521df679b7e8",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 2",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 11234,
  "serious": 7012,
  "death": 1015,
  "hospitalization": 3725,
  "primary_suspect": 11212,
  "top_reactions": [
   [
    "Dyspnoea",
    2574
   ],
   [
    "Asthma",
    1873
   ],
   [
    "Wheezing",
    1344
   ],
   [
    "Cough",
    1272
   ],
   [
    "Therapeutic Product Effect Incomplete",
    1078
   ],
   [
    "Drug Ineffective",
    1057
   ],
   [
    "Pneumonia",
    874
   ],
   [
    "Chronic Obstructive Pulmonary Disease",
    853
   ],
   [
    "Loss Of Personal Independence In Daily Activities",
    826
   ],
   [
    "Obstructive Airways Disorder",
    757
   ],
   [
    "Condition Aggravated",
    745
   ],
   [
    "Productive Cough",
    622
   ],
   [
    "Nausea",
    614
   ],
   [
    "Off Label Use",
    596
   ],
   [
    "Fatigue",
    571
   ]
  ],
  "by_year": {
   "2019": 1435,
   "2020": 1481,
   "2021": 1392,
   "2022": 990,
   "2023": 865,
   "2024": 928,
   "2025": 789,
   "2026": 430
  },
  "by_year_primary": {
   "2019": 1435,
   "2020": 1481,
   "2021": 1390,
   "2022": 986,
   "2023": 861,
   "2024": 926,
   "2025": 779,
   "2026": 430
  }
 },
 "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": "20140430",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 3,
  "labeling_recent": 1,
  "sponsors": [
   "GLAXO GRP ENGLAND"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/30/2014"
 },
 "trials": {
  "total": 115,
  "completed": 96,
  "terminated": 7,
  "with_results": 69,
  "industry": 98,
  "phase3": 41,
  "results_share": 0.71875,
  "terminated_share": 0.06086956521739131
 },
 "pubmed": {
  "rct": 63,
  "meta": 14,
  "recent_rct": 8,
  "cochrane": [
   {
    "pmid": "28631387",
    "title": "Umeclidinium bromide versus placebo for people with chronic obstructive pulmonary disease (COPD)",
    "year": "2017"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "umeclidinium",
   "Incruse"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 852329,
  "beneficiaries": 185597,
  "spend": 375858547.52,
  "by_brand": [
   {
    "brand": "Incruse Ellipta",
    "claims": 852329,
    "per_claim": 440.9782461,
    "is_generic": false
   }
  ],
  "per_claim": 440.97824609980415
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "umeclidinium",
  "matched": "umeclidinium",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2135,
  "fills": 852329,
  "per_million": 2504.901276385058,
  "ratio": 0.9046394839617712,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,505 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "63 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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": 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": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma, wheezing, cough. How would we recognize and handle those?",
  "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.)"
 ]
}