Vilanterol

ANORO ELLIPTA ANORO ELLIPTA contains both umeclidinium and vilanterol. The mechanisms of action described below for the individual components apply to ANORO ELLIPTA.

• ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.ICD-10: J44.9, J45.909

• ANORO ELLIPTA is contraindicated in: • patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients [see Warnings and Precautions (5.6), Description (11)] . • use of a long-acting beta 2 -adrenergic agonist (LABA), including vilanterol, one of the active ingredients in ANORO ELLIPTA, without an inhaled corticosteroid (ICS), in patients with asthma [see Warnings and Precautions (5.1)] .contraindicated

The recommended dosage of ANORO ELLIPTA for maintenance treatment of COPD is 62.5 mcg umeclidinium and 25 mcg vilanterol (1 actuation of ANORO ELLIPTA 62.5/25 mcg) once daily by oral inhalation. • ANORO ELLIPTA should be used at the same time every day. Do not use ANORO ELLIPTA more than 1 time every 24 hours. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] . • For oral inhalation only. ( 2 ) • Maintenance treatment of COPD: 1 actuation of ANORO ELLIPTA once daily administered by oral inhalation. ( 2 )

• LABA monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) • Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. ( 5.2 ) • Do not use in combination with additional therapy containing a LABA because of risk of overdose. ( 5.3 ) • If paradoxical bronchospasm occurs, discontinue ANORO ELLIPTA and institute alternative therapy. ( 5.5 ) • Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. ( 5.7 ) • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. ( 5.8 ) • 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. ( 5.9 ) • 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. ( 5.10 ) • Be alert to hypokalemia and hyperglycemia. ( 5.11 ) 5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death The safety and effectiveness of ANORO ELLIPTA in patients with asthma have not been established. ANORO ELLIPTA is not indicated for the treatment of asthma [see Contraindications ( 4 )] . Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death.

The following clinically significant adverse reactions are described elsewhere in labeling: • Serious asthma-related events–hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] • Paradoxical bronchospasm [see Warnings and Precautions ( 5.5 )] • Cardiovascular effects [see Warnings and Precautions ( 5.7 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.9 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence ≥1% and more common than placebo) are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 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. The clinical program for ANORO ELLIPTA included 8,138 subjects with COPD in four 6‑month lung function trials, one 12-month long-term safety study, and 9 other trials of shorter duration. A total of 1,124 subjects have received at least 1 dose of ANORO ELLIPTA (umeclidinium/vilanterol 62.5/25 mcg), and 1,330 subjects have received a higher dose of umeclidinium/vilanterol (125/25 mcg).

8.1 Pregnancy Risk Summary There are insufficient data on the use of ANORO ELLIPTA or its individual components, umeclidinium and vilanterol, in pregnant women to inform a drug-associated risk. (See Clinical Considerations.) In animal reproduction studies, umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effects on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled dose (MRHDID). Vilanterol administered via inhalation to pregnant rats and rabbits produced no fetal structural abnormalities at exposures approximately 70 times the MRHDID. (See Data.) The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery: ANORO ELLIPTA should be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility. Data Animal Data: The combination of umeclidinium and vilanterol has not been studied in pregnant animals.

Metabolism

Linear pharmacokinetics was observed for umeclidinium (62.5 to 500 mcg) and vilanterol (25 to 100 mcg). Absorption Umeclidinium: Umeclidinium plasma levels may not predict therapeutic effect.

ANORO ELLIPTA contains both umeclidinium and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to ANORO ELLIPTA. Treatment of overdosage consists of discontinuation of ANORO ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage. Umeclidinium High doses of umeclidinium may lead to anticholinergic signs and symptoms. Vilanterol The expected signs and symptoms with overdosage of vilanterol are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis).

• May 10, 2013NDANDA204275Glaxo Grp Ltd
• Dec 18, 2013NDANDA203975Glaxosmithkline
• Sep 18, 2017NDANDA209482Glaxosmithkline

1. 1Dyspnoea13,25415%
2. 2Drug Ineffective8,3909.5%
3. 3Cough6,8537.7%
4. 4Wrong Technique In Device Usage Process6,8527.7%
5. 5Product Complaint5,6476.4%
6. 6Asthma5,5756.3%
7. 7Product Dose Omission Issue5,5706.3%
8. 8Pneumonia4,4905.1%
9. 9Wheezing3,6194.1%
10. 10Death3,4853.9%
11. 11Fatigue3,3253.8%
12. 12Off Label Use3,0123.4%
13. 13Chronic Obstructive Pulmonary Disease2,9593.3%
14. 14Headache2,8313.2%
15. 15Malaise2,5832.9%

The 10 most recently updated of 132 ClinicalTrials.gov registrations naming Vilanterol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma
  Withdrawn · Phase 3 · Interventional · 0 enrolled · Sandoz
  NCT07223294updated 2026-05-12
• Immuno-inflammatory Response of Erdosteine in COPD
  Not yet recruiting · Interventional · 30 enrolled · Pierachille Santus, MD, PhD
  NCT07329946updated 2026-04-29
• Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD
  Suspended · Interventional · 100 enrolled · Medical University of Bialystok
  NCT07541378updated 2026-04-21
• VENTURI (VENTilation Using Respiratory Imaging)
  Recruiting · Phase 2 · Interventional · 20 enrolled · University of Alabama at Birmingham
  NCT07282886updated 2026-04-13
• Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
  Active not recruiting · Phase 4 · Interventional · 1,366 enrolled · GlaxoSmithKline
  NCT06372496updated 2026-03-24
• Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study
  Completed · Phase 4 · Interventional · 22 enrolled · Thammasat University
  NCT06905483updated 2026-02-02
• To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD
  Completed · Phase 4 · Interventional · 463 enrolled · GlaxoSmithKline
  NCT05535972updated 2025-12-11
• Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations
  Completed · Phase 4 · Interventional · 80 enrolled · Baylor Research Institute
  NCT05292053updated 2025-11-21
• A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
  Recruiting · Phase 3 · Interventional · 292 enrolled · GlaxoSmithKline
  NCT05757102updated 2025-10-07
• 129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation
  Not yet recruiting · Phase 4 · Interventional · 60 enrolled · Western University, Canada
  NCT07192016updated 2025-09-25

Frequently asked questions

How does Vilanterol work?

ANORO ELLIPTA ANORO ELLIPTA contains both umeclidinium and vilanterol. The mechanisms of action described below for the individual components apply to ANORO ELLIPTA.

What is Vilanterol used for?

According to FDA labeling, Vilanterol carries indications including: ANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Vilanterol?

Vilanterol is classified as beta2-Adrenergic Agonist, Adrenergic beta2-Agonists, Bronchodilation, Decreased Histamine Release.

What are the brand names for Vilanterol?

Vilanterol is marketed under brand names including Anoro, Breo, Trelegy.

What are the contraindications for Vilanterol?

Vilanterol labeling lists contraindications including: ANORO ELLIPTA is contraindicated in: • patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients [see Warnings and Precautions (5.6), Description (11)] . • use of a long-acting beta 2 -adrenergic agonist (LABA), including vilanterol, one of the active ingredients in ANORO ELLIPTA, without an inhaled corticosteroid (ICS), in patients with asthma [see Warnings and Precautions (5.1)] .. Always consult the full prescribing information and a clinician.