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Vilanterol Trifenatate

Class: Selective beta-2-Adrenergic Agonists
VA Class: RE102
Chemical Name: α,α-Diphenylbenzeneacetic acid compd. with (α1R) - α1 - [[[6 - [2 - [(2,6 - dichlorophenyl)methoxy]ethoxy]hexyl]amino]methyl] - 4 - hydroxy - 1,3 - benzenedimethanol (1:1)
Molecular Formula: C24H33Cl2NO5•C20H16O2
CAS Number: 503070-58-4
Brands: Anoro Ellipta, Breo Ellipta (combination)

Warning(s)

  • Increased risk of asthma-related death with long-acting β2-adrenergic agonists.1 8 9 16 (See Asthma-related Death under Cautions.)

  • Increased risk of asthma-related death considered class effect of long-acting β2-adrenergic agonists, including vilanterol.1 16

  • Safety and efficacy of vilanterol/umeclidinium fixed-combination therapy in patients with asthma not established; not indicated for treatment of asthma.16

Introduction

Bronchodilator; a relatively selective, long-acting β2-adrenergic agonist.1 2 3 4 5 6 16 18

Uses for Vilanterol Trifenatate

Bronchospasm in COPD

Vilanterol/fluticasone or vilanterol/umeclidinium fixed-combination therapy: Long-term maintenance treatment of airflow obstruction associated with COPD, including chronic bronchitis and emphysema.1 2 3 6 16 17 18

Vilanterol/fluticasone fixed-combination therapy: Reduction of COPD exacerbations in patients with a history of exacerbations.1

Vilanterol/fluticasone or vilanterol/umeclidinium fixed-combination therapy: Not indicated for treatment of acute bronchospasm (i.e., as rescue therapy for treatment of acute episodes of bronchospasm).1 16

Other Uses

Vilanterol/umeclidinium fixed-combination therapy: Not indicated for treatment of asthma; safety and efficacy in asthma not established.16

Vilanterol Trifenatate Dosage and Administration

Administration

Administer vilanterol in fixed combination with fluticasone by oral inhalation only using a specific preloaded inhaler (Breo Ellipta) that delivers powdered vilanterol/fluticasone in fixed combination from foil-wrapped blisters.1

Administer vilanterol in fixed combination with umeclidinium by oral inhalation only using a specific preloaded inhaler (Anoro Ellipta) that delivers powdered vilanterol/umeclidinium in fixed combination from foil-wrapped blisters.16

Administer vilanterol in fixed combination with fluticasone or umeclidinium once daily at the same time every day.1 16

Oral Inhalation

Oral Inhalation Administration

Before first use of either the Breo Ellipta or Anoro Ellipta inhaler, remove device from foil tray; discard enclosed desiccant out of reach of children and pets.1 16 Write date the tray is opened and inhaler is to be discarded (6 weeks after opening) on label.1 16 Do not open inhaler cover until immediately before use; to avoid wasting doses, do not close cover again until dose is inhaled.1 16

Open cover fully to expose the mouthpiece and expect to hear a click.1 16 If dose counter does not advance when click is heard, inform clinician that dose is not properly prepared.1 16

Before inhaling dose, exhale completely; do not exhale into mouthpiece of inhaler.1 16 Place mouthpiece between lips and inhale deeply through inhaler with a steady, even breath; do not inhale through nose.1 16 Do not block air vent on inhaler during inhalation.1 16 Remove inhaler from mouth, hold the breath for about 3–4 seconds (or as long as comfortable), then exhale slowly and gently.1 16

Do not administer another dose even if delivery of dose not perceived.1 16 After dose is administered, close inhaler by sliding cover over mouthpiece as far as possible.1 16

After inhalation of vilanterol/fluticasone in fixed combination, rinse mouth with water without swallowing.1

Routine cleaning of inhaler is not necessary; may clean mouthpiece with dry tissue if desired.1 16

Dosage

Available as vilanterol trifenatate; dosage expressed in terms of vilanterol.1 16

Each foil-wrapped blister in the Breo Ellipta inhaler device contains 40 mcg of vilanterol trifenatate (equivalent to 25 mcg of vilanterol) or 100 mcg of fluticasone furoate (in separate blisters).1 In vitro, each pair of blisters from the inhaler delivered 22 mcg of vilanterol and 92 mcg of fluticasone furoate.1 Precise amount of drug delivered to lungs depends on factors (e.g., patient's inspiratory flow).1

Breo Ellipta inhaler delivers 30 doses (or 14 doses for the sample or institutional package).1

Each foil-wrapped blister in the Anoro Ellipta inhaler device contains 40 mcg of vilanterol trifenatate (equivalent to 25 mcg of vilanterol) or 74.2 mcg of umeclidinium bromide (equivalent to 62.5 mcg of umeclidinium) (in separate blisters).16 In vitro, each pair of blisters from the inhaler delivered 22 mcg of vilanterol and 55 mcg of umeclidinium.16 Precise amount of drug delivered to lungs depends on factors (e.g., patient's inspiratory flow).16

Anora Ellipta inhaler delivers 30 doses (or 7 doses for the sample or institutional package).16

Adults

COPD
Vilanterol/Fluticasone Fixed-combination Therapy
Oral Inhalation

25 mcg of vilanterol and 100 mcg of fluticasone furoate (1 inhalation) once daily.1

Vilanterol/Umeclidinium Fixed-combination Therapy
Oral Inhalation

25 mcg of vilanterol and 62.5 mcg of umeclidinium (1 inhalation) once daily.16

Prescribing Limits

Adults

COPD
Vilanterol/Fluticasone Fixed-combination Therapy
Oral Inhalation

Do not administer more than once every 24 hours.1

Vilanterol/Umeclidinium Fixed-combination Therapy
Oral Inhalation

Do not administer more than once every 24 hours.16

Special Populations

When vilanterol is used in fixed combination with fluticasone furoate, dosage requirements for fluticasone should be considered.1 When vilanterol is used in fixed combination with umeclidinium bromide, dosage requirements for umeclidinium should be considered.16

Hepatic Impairment

Vilanterol/fluticasone fixed-combination therapy: No dosage adjustment required.1 (See Absorption under Pharmacokinetics.)

Vilanterol/umeclidinium fixed-combination therapy: No dosage adjustment required in patients with moderate hepatic impairment; not studied in patients with severe hepatic impairment.16 (See Absorption under Pharmacokinetics.)

Renal Impairment

No dosage adjustment required.1 16

Geriatric Patients

No dosage adjustment required.1 16 (See Geriatric Use under Cautions.)

Cautions for Vilanterol Trifenatate

Contraindications

  • Known hypersensitivity to vilanterol or any ingredient in the formulation.1 16

  • Known severe hypersensitivity to milk proteins.1 16

Warnings/Precautions

Warnings

Use of Fixed Combinations

When used in fixed combination with fluticasone or umeclidinium, consider the cautions, precautions, contraindications, and interactions associated with fluticasone or umeclidinium.1 16

Asthma-related Death

Increased risk of asthma-related death reported with long-acting β2-adrenergic agonists (e.g., vilanterol).1 8 16 (See Boxed Warning.) Data from clinical trials also suggest that long-acting β2-adrenergic agonists increase the risk of asthma-related hospitalization in children and adolescents.8

Large safety study (Salmeterol Multicenter Asthma Research Trial [SMART]) showed an increase in asthma-related deaths in patients receiving salmeterol.1 9 16 Increased risk of asthma-related death with salmeterol considered class effect of long-acting β2-adrenergic agonists, including vilanterol.1 16 However, no adequate studies conducted to determine whether rate of asthma-related death is increased in patients receiving vilanterol.1 16

Not known whether death rate is increased in patients with COPD receiving long-acting β2-adrenergic agonists, including vilanterol.1 16

Other Warnings and Precautions

Deterioration of Disease and Acute Episodes

Do not initiate vilanterol in fixed combination with fluticasone or umeclidinium in patients with acutely deteriorating COPD, which may be life-threatening.1 16

Do not use for relief of acute symptoms.1 16 Not studied in patients with acute symptoms; do not use extra doses of the drug in such situations.1 16 Use a short-acting, inhaled β2-agonist as needed for acute symptoms.1 16

When initiating therapy, discontinue regular use of short-acting oral or inhaled β2-agonists and use only for relief of acute COPD symptoms.1 16

Failure to respond to a previously effective dosage of vilanterol in fixed combination with fluticasone or umeclidinium or to a supplemental short-acting, inhaled β2-agonist may indicate worsening COPD.1 16 Immediately reevaluate the patient and treatment regimen.1 16 Do not use extra or increased dosages in such situations.1 16

Excessive Use and Use With Other Long-acting β2-Adrenergic Agonists

Possible fatalities and/or adverse cardiovascular effects reported in association with excessive use of inhaled sympathomimetic drugs.1 16

Do not use vilanterol in fixed combination with fluticasone or umeclidinium more frequently or at dosages higher than recommended or concomitantly with other preparations containing long-acting β2-adrenergic agonists, since overdosage may result.1 16

Do not use vilanterol in fixed combination with fluticasone or umeclidinium with another preparation containing a long-acting β2-agonist for any reason.1 16

Paradoxical Bronchospasm

Possible acute, life-threatening paradoxical bronchospasm may occur.1 16 If paradoxical bronchospasm occurs, immediately treat patient with an inhaled, short-acting bronchodilator; discontinue therapy with vilanterol in fixed combination with fluticasone or umeclidinium; and institute alternative therapy.1 16

Sensitivity Reactions

Hypersensitivity reactions may occur.1 16 Anaphylactic reactions reported following oral inhalation of other powder preparations containing lactose in patients with severe milk protein allergy.1 16 (See Contraindications under Cautions.)

Postmarketing reports of hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria when used in fixed combination with fluticasone.1

Cardiovascular Effects

Possible clinically important increases in pulse rate, systolic or diastolic BP, and also reports of cardiac arrhythmias; may require discontinuance of drug.1 16

ECG changes (e.g., flattening of T wave, prolongation of QTc interval, ST-segment depression) reported with β2-agonists; clinical importance unknown.1 16

Administration of large dosages of orally inhaled vilanterol (4 times the recommended dosage) in combination with fluticasone in healthy individuals resulted in clinically important prolongation of the QTc interval.1

Use vilanterol with caution in patients with cardiovascular disorders (e.g., coronary insufficiency, cardiac arrhythmias, hypertension).1 16

No clinically important effects on heart rate, QTc, or BP observed in patients with COPD receiving vilanterol alone or in combination with fluticasone in clinical trials.1

No clinically important effects on cardiac rhythm observed in patients with COPD or on QTc in healthy individuals receiving vilanterol in combination with umeclidinium bromide in clinical trials.16 19

Metabolic and Electrolyte Effects

Use with caution in patients with thyrotoxicosis.1 16

IV albuterol (IV preparation not commercially available in US) reported to aggravate preexisting diabetes mellitus and ketoacidosis.1 16 β2-Adrenergic agonists may produce transient hyperglycemia in some patients.1 16

Clinically important hypokalemia (usually transient and not requiring supplementation) may occur in some patients receiving β2-adrenergic agonists; may result in adverse cardiovascular effects.1 16 (See Cardiovascular Effects under Cautions.)

Changes in serum glucose or potassium concentrations not observed in patients with COPD receiving vilanterol in fixed combination with fluticasone or umeclidinium in clinical trials of 6 or 12 months' duration.1 16

Nervous System Effects

Use with caution in patients with seizure disorders and in those unusually responsive to sympathomimetic amines.1 16

Specific Populations

Pregnancy

Category C.1 16

May interfere with uterine contractility.1 16 Carefully weigh benefit versus risk in labor.1 16

Lactation

Not known whether distributed into milk; other β2-adrenergic agonists distributed into human milk.1 16 Use caution.1 16

Pediatric Use

Not indicated for use in pediatric patients.1 16 Safety and efficacy not established.1 16

Geriatric Use

No overall differences in safety and efficacy observed between geriatric and younger adults.1 16 No evidence of age-related differences from other clinical experience but increased sensitivity cannot be ruled out.1 16 (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Vilanterol exposure not substantially altered in patients with hepatic impairment.1 16

Vilanterol/fluticasone in fixed combination: Use with caution in patients with moderate or severe hepatic impairment.1 Dosage adjustment not required in patients with hepatic impairment.1 (See Absorption under Pharmacokinetics.)

Vilanterol/umeclidinium in fixed combination: Dosage adjustment not required in patients with moderate hepatic impairment; not studied in patients with severe hepatic impairment.16 (See Absorption under Pharmacokinetics.)

Renal Impairment

Vilanterol exposure not substantially increased in patients with severe renal impairment (Clcr <30 mL/minute).1 16 Dosage adjustment not required.1 16

Common Adverse Effects

Vilanterol/fluticasone in fixed combination: Nasopharyngitis,1 2 3 headache,1 2 3 upper respiratory tract infection,1 2 3 oropharyngeal candidiasis.1 2 3

Vilanterol/umeclidinium in fixed combination: Pharyngitis,16 sinusitis,16 lower respiratory tract infection,16 constipation,16 diarrhea,16 extremity pain,16 muscle spasms,16 neck pain,16 chest pain.16

Interactions for Vilanterol Trifenatate

Substrate of CYP3A4 and P-glycoprotein (P-gp).1 7 16

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes and/or the P-glycoprotein Transport System

Potent inhibitors of CYP3A4: Potential pharmacokinetic interaction (increased vilanterol concentrations).1 7 16 Use caution with long-term concomitant therapy.1 16

Potent inhibitors of P-gp: Clinically important effects on pharmacokinetics unlikely.1 16

Drugs that Prolong the QT Interval

Potential pharmacologic interaction (increased risk of ventricular arrhythmias and possible potentiation of vilanterol effects on cardiovascular system).1 16 Use extreme caution during concomitant therapy or within 2 weeks of discontinuance of such agents.1 16

Specific Drugs

Drug

Interaction

Comments

β-Adrenergic blocking agents

Potential antagonism of pulmonary effects resulting in severe bronchospasm in patients with COPD1 16

Avoid concomitant use if possible; if concomitant therapy required, consider cautious use of cardioselective β-blocker1 16

Antidepressants, tricyclic

Possible potentiation of vilanterol effects on cardiovascular system1 16

Use extreme caution during concomitant therapy or within 2 weeks following discontinuance of a tricyclic antidepressant1 16

Antiretrovirals, HIV protease inhibitors (indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)

Possible increased vilanterol exposure1 7 16

Use caution with long-term concomitant therapy1 16

Azole antifungals (itraconazole, ketoconazole, voriconazole)

Increased vilanterol exposure1 7 16

Use concomitantly with caution1 16

Conivaptan

Possible increased vilanterol exposure1 16

Use caution with long-term concomitant therapy1 16

Diuretics, non-potassium-sparing

Potential additive hypokalemia and/or ECG changes, especially when recommended β-agonist dosage exceeded1 16

Clinical importance unknown; use concomitantly with caution1 16

Macrolide antibiotics (clarithromycin, telithromycin, troleandomycin)

Possible increased vilanterol exposure1 7 16

Use caution with long-term concomitant therapy1 16

MAO inhibitors

Possible potentiation of vilanterol effects on cardiovascular system1 16

Use extreme caution during concomitant therapy or within 2 weeks following discontinuance of an MAO inhibitor1 16

Nefazodone

Possible increased vilanterol exposure1 16

Use caution with long-term concomitant therapy1 16

Sympathomimetic agents

Additive pharmacologic effects1 16

Avoid concomitant use1 16

Verapamil

Pharmacokinetic interaction unlikely1 16

Dosage adjustment of vilanterol not recommended1 16

Vilanterol Trifenatate Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral inhalation;15 absolute bioavailability of vilanterol in fixed combination with fluticasone is approximately 27%, principally due to absorption of drug delivered to the lungs.1

Oral bioavailability of the swallowed portion of an inhaled dose is low (<2% for vilanterol in fixed combination with fluticasone) because of extensive first-pass metabolism.1 6 7 16

Peak plasma concentrations reached within 5–15 minutes following oral inhalation.1 15 16

Steady-state concentrations achieved after 6 days of once-daily dosing of vilanterol/fluticasone fixed-combination therapy and within 14 days of once-daily dosing of vilanterol/umeclidinium fixed-combination therapy.1 16

Onset

Vilanterol/fluticasone in fixed combination: Median time to onset (defined as a 100-mL increase from baseline in FEV1) 16 minutes.1

Vilanterol/umeclidinium in fixed combination: Median time to onset 27 minutes.16

Duration

Bronchodilation generally persists for 24 hours.4 5 6

Special Populations

Vilanterol/fluticasone in fixed combination: No clinically important changes in peak concentrations or AUC of vilanterol, but increased exposure of fluticasone observed in patients with mild, moderate, or severe hepatic impairment.1 (See Hepatic Impairment under Cautions.)

Vilanterol/umeclidinium in fixed combination: No clinically important changes in peak concentrations or AUC of vilanterol or umeclidinium in patients with moderate hepatic impairment.16 (See Hepatic Impairment under Cautions.)

Distribution

Extent

Not known whether distributed into human milk.1 16

Plasma Protein Binding

Approximately 94%.1 16

Elimination

Metabolism

Extensively metabolized, mainly by CYP3A4.1 6 16

Elimination Route

Excreted mainly as metabolites in urine (70%) and feces (30%) following oral administration.1 6 16

Half-life

Effective half-life for vilanterol in fixed combination with fluticasone: 21.3 hours following oral inhalation of multiple doses in patients with COPD.1

Effective half-life of vilanterol in fixed combination with umeclidinium: 11–19 hours following oral inhalation of multiple doses in healthy individuals.16 19

Special Populations

No clinically important differences in pharmacokinetics based on age, race, or gender.1 16

Possible increased exposure in patients with severe renal impairment.1 16

Stability

Storage

Oral Inhalation

20–25°C (may be exposed to 15–30°C) in a dry place away from direct heat or sunlight.1 16

Keep inhaler in sealed tray until immediately before use.1 16 Discard inhaler after every blister used or 6 weeks after removal of inhaler from foil tray, whichever comes first.1 16

Actions

  • Synthetic sympathomimetic amine.1 2 3 4 5 6

  • Relatively selective, long-acting β2-adrenergic agonist.1 2 3 4 5 6 16 18

  • Functional selectivity of vilanterol in vitro similar to that of salmeterol; clinical importance unknown.1 5 16 18

  • Increases concentrations of cyclic adenosine-3′,5′-monophosphate (cAMP), resulting in relaxation of bronchial smooth muscle.1 5 16 18

  • Appears to inhibit release of mediators of immediate hypersensitivity from cells, especially mast cells.1 16 18

Advice to Patients

  • When used in fixed combination with fluticasone or umeclidinium, importance of informing patients of important cautionary information about fluticasone or umeclidinium.1 16

  • Provide copy of the manufacturer's patient information (medication guide) and instructions for use to all patients each time drug is dispensed.1 16 Importance of instructing patients to read the medication guide prior to initiation of therapy and each time prescription is refilled.1 16

  • Importance of informing patients that long-acting β2-adrenergic agonists (including vilanterol) increase the risk of asthma-related death.1 16

  • Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the inhalation delivery systems.1 16

  • Importance of not using vilanterol to relieve acute COPD symptoms; do not use extra doses for such symptoms.1 16

  • Importance of adherence to dosing schedules, including not altering the dose or frequency of use unless otherwise instructed by a clinician.1 16

  • Importance of advising patients that if a dose is missed, to take the dose as soon as it is remembered; importance of not doubling the dose or taking more than one dose in a 24-hour period.1 16

  • Importance of all patients being provided with and instructed in the use of a short-acting, inhaled β2-adrenergic agonist as treatment for acute COPD symptoms.1 16

  • Importance of discontinuing regular use of short-acting, inhaled β2-agonists when initiating vilanterol-containing preparations and using short-acting, inhaled β2-agonists to relieve acute symptoms.1 16

  • Importance of contacting a clinician immediately if symptoms worsen, the short-acting inhaled β2-agonist becomes less effective or more inhalations than usual are required, or clinically important decrease in lung function occurs.1 16

  • Importance of advising patients receiving vilanterol-containing preparations not to use additional vilanterol or other long-acting, inhaled β2-agonists for any reason.1 16

  • Importance of patients not discontinuing therapy without medical supervision, since symptoms may recur after discontinuance.1 16

  • Importance of informing patients of adverse effects associated with β2-agonists (e.g., palpitations, chest pain, rapid heart rate, tremor, nervousness).1 16

  • Importance of advising patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur following administration of vilanterol in fixed combination with fluticasone and instructing patients to discontinue the drug if such reactions occur.1

  • Importance of advising patients with severe milk protein allergy to avoid use of vilanterol-containing preparations.1 16

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 16

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., cardiac disease, hypertension, seizures, thyroid disease, diabetes mellitus, allergies to drugs or food).1 16

  • Importance of informing patients of other important precautionary information.1 16 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Vilanterol Trifenatate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Powder for inhalation

25 mcg (of vilanterol) with Fluticasone Furoate 100 mcg per inhalation

Breo Ellipta

GlaxoSmithKline

Powder for inhalation

25 mcg (of vilanterol) with Umeclidinium Bromide 62.5 mcg (of umeclidinium) per inhalation

Anoro Ellipta

GlaxoSmithKline

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Date published: March 12, 2015
Last reviewed: November 04, 2015
Date modified: February 08, 2016

References

1. GlaxoSmithKline. Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for oral inhalation use prescribing information. Research Triangle Park, NC; 2014 Sept.

2. Martinez FJ, Boscia J, Feldman G et al. Fluticasone furoate/vilanterol (100/25; 200/25 μg) improves lung function in COPD: a randomised trial. Respir Med. 2013; 107:550-9. [PubMed 23332861]

3. Kerwin EM, Scott-Wilson C, Sanford L et al. A randomised trial of fluticasone furoate/vilanterol (50/25 μg; 100/25 μg) on lung function in COPD. Respir Med. 2013; 107:560-9. [PubMed 23352226]

4. Hanania NA, Feldman G, Zachgo W et al. The efficacy and safety of the novel long-acting β2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest. 2012; 142:119-27. [PubMed 22241764]

5. Slack RJ, Barrett VJ, Morrison VS et al. In vitro pharmacological characterization of vilanterol, a novel long-acting β2-adrenoceptor agonist with 24-hour duration of action. J Pharmacol Exp Ther. 2013; 344:218-30. [PubMed 23131596]

6. Harrell AW, Siederer SK, Bal J et al. Metabolism and disposition of vilanterol, a long-acting β(2)-adrenoceptor agonist for inhalation use in humans. Drug Metab Dispos. 2013; 41:89-100. [PubMed 23043183]

7. Kempsford R, Allen A, Bal J et al. The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjects. Br J Clin Pharmacol. 2013; 75:1478-87. [PubMed 23116485]

8. Food and Drug Administration. FDA drug safety communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called long-acting beta-agonists (LABAs). Rockville, MD; 2010 Jun 2. Available from FDA website. Accessed 2013 Nov 22.

9. Food and Drug Administration. FDA drug safety communication: New safety requirements for long-acting inhaled asthma medications called long-acting beta-agonists (LABAs). Rockville, MD; 2010 Feb 18. Available from FDA website. Accessed 2013 Nov 22.

10. Food and Drug Administration. FDA drug safety communication: FDA requires post-market safety trials for long-acting beta-agonists (LABAs). Rockville, MD; 2011 Apr 15. Available from FDA website. Accessed 2013 Nov 22.

15. Nakahara N, Wakamatsu A, Kempsford R et al. The safety, pharmacokinetics and pharmacodynamics of a combination of fluticasone furoate and vilanterol in healthy Japanese subjects. Int J Clin Pharmacol Ther. 2013; 51:660-71. [PubMed 23735179]

16. GlaxoSmithKline. Anoro Ellipta (umeclidinium and vilanterol inhalation powder) prescribing information. Research Triangle Park, NC; 2014 May.

17. Donohue JF, Maleki-Yazdi MR, Kilbride S et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013; 107:1538-46. [PubMed 23830094]

18. Scott LJ, Hair P. Umeclidinium/Vilanterol: first global approval. Drugs. 2014; 74:389-95. [PubMed 24532124]

19. Kelleher D, Tombs L, Preece A et al. A randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects. Pulm Pharmacol Ther. 2014; 29:49-57. [PubMed 25020273]

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