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Fluticasone furoate and vilanterol: Drug information

Fluticasone furoate and vilanterol: Drug information
(For additional information see "Fluticasone furoate and vilanterol: Patient drug information" and see "Fluticasone furoate and vilanterol: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Breo Ellipta
Brand Names: Canada
  • Breo Ellipta
Pharmacologic Category
  • Beta2 Agonist;
  • Beta2-Adrenergic Agonist, Long-Acting;
  • Corticosteroid, Inhalant (Oral)
Dosing: Adult
Asthma, maintenance/controller

Asthma, maintenance/controller: Oral inhalation: Note: Individualize daily fluticasone dose based on severity of symptoms. Patients receiving fluticasone/vilanterol should not use additional salmeterol or vilanterol products. Safety: The recommended number of inhalations per dose is based on the vilanterol component; do NOT adjust the number of inhalations to change the corticosteroid dose; use an alternative inhaler (Ref).

Dry powder inhaler (fluticasone furoate 100 mcg/vilanterol 25 mcg or fluticasone furoate 200 mcg/vilanterol 25 mcg): Oral inhalation: 1 inhalation once daily (maximum dose: 1 inhalation [fluticasone furoate 200 mcg/vilanterol 25 mcg] once daily).

Chronic obstructive pulmonary disease, maintenance

Chronic obstructive pulmonary disease, maintenance: Note: Use of long-acting beta agonist and inhaled corticosteroid is not encouraged. In patients with persistent exacerbations on dual long-acting bronchodilator therapy or elevated eosinophil count (Group E), consider triple therapy (inhaled corticosteroid, long-acting beta agonist, and long-acting muscarinic antagonist). In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).

Dry powder inhaler (fluticasone furoate 100 mcg/vilanterol 25 mcg per actuation): Oral inhalation: 1 inhalation once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Mild impairment: There are no dosage adjustments provided in the manufacturer's labeling.

Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, systemic fluticasone exposure may be increased up to threefold in patients with hepatic impairment; use with caution and monitor closely.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Fluticasone furoate and vilanterol: Pediatric drug information")

Asthma, maintenance therapy

Asthma, maintenance therapy:

Note: The maximum dose is based on the vilanterol component; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher fluticasone dose per inhalation must be prescribed; if asthma symptoms occur between doses, a rescue medication (eg, short-acting beta2-agonist) should be used for immediate relief. Do not administer more than 1 inhalation once daily.

Children ≥5 to <12 years: Fluticasone furoate 50 mcg/vilanterol 25 mcg: Oral inhalation: 1 inhalation once daily.

Children ≥12 years and Adolescents ≤17 years: Fluticasone furoate 100 mcg/vilanterol 25 mcg: Oral inhalation: 1 inhalation once daily.

Adolescents ≥18 years: Note: Initial dose prescribed should be based upon asthma severity, previous therapy, and risk of exacerbation; titrate to lowest effective dose once symptoms controlled.

Fluticasone furoate 100 mcg/vilanterol 25 mcg: Oral inhalation: 1 inhalation once daily. If inadequate response, consider the higher dose combination.

Fluticasone furoate 200 mcg/vilanterol 25 mcg: Oral inhalation: 1 inhalation once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Altered kidney function:

Children ≥5 years and Adolescents: Oral inhalation: No dosage adjustment necessary.

Dosing: Hepatic Impairment: Pediatric

Children ≥5 years and Adolescents: Oral inhalation:

Mild impairment: There are no dosage adjustments provided in the manufacturer's labeling.

Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied in pediatric patients; however, in adults, systemic fluticasone exposure may be increased up to 3-fold in patients with moderate to severe hepatic impairment; use with caution and monitor closely.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults unless otherwise indicated. Also see Fluticasone (Oral Inhalation) monograph.

1% to 10%:

Cardiovascular: Extrasystoles (≥2%), hypertension (≥3%), supraventricular extrasystole (≥2%), ventricular premature contractions (≥2%)

Gastrointestinal: Oral candidiasis (2% to 5%; including oropharyngeal candidiasis), upper abdominal pain (≥2%)

Infection: Influenza (3%)

Nervous system: Headache (children, adolescents, and adults: 3% to 8%), voice disorder (2%)

Neuromuscular & skeletal: Arthralgia (≥2%), back pain (≥2%), bone fracture (2%)

Respiratory: Acute sinusitis (≥2%), allergic rhinitis (children and adolescents: 4%), bronchitis (≤2%), cough (1% to 2%), nasopharyngitis (children, adolescents, and adults: 6% to 10%), oropharyngeal pain (2%), pharyngitis (≥2%), pneumonia (6% to 7%), respiratory tract infection (≥2%), rhinitis (children and adolescents: 3%), sinusitis (1% to 2%), upper respiratory tract infection (children, adolescents, and adults: 2% to 7%), viral respiratory tract infection (children and adolescents: 3%)

Miscellaneous: Fever (≥2%)

Postmarketing:

Cardiovascular: Palpitations, tachycardia

Endocrine & metabolic: Hyperglycemia

Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema)

Nervous system: Nervousness, tremor

Neuromuscular & skeletal: Muscle spasm

Respiratory: Paradoxical bronchospasm

Contraindications

Hypersensitivity to fluticasone, vilanterol, or any component of the formulation; severe hypersensitivity to milk proteins; primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Fluticasone may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, including adrenal crisis, in patients sensitive to these effects. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled corticosteroids; deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic steroids to a less systemically available inhaled corticosteroid. Adult patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fluticasone/vilanterol does not provide the systemic steroid dose needed to treat patients having trauma, surgery, or infections. Do not use this product to transfer patients from oral corticosteroid therapy. Observe patients carefully for any evidence of systemic corticosteroid effects; particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. If systemic corticosteroid withdrawal effects occur (eg, fatigue, lassitude, weakness, nausea, vomiting, hypotension), taper fluticasone/vilanterol slowly and other treatments for management of asthma or chronic obstructive pulmonary disease (COPD) symptoms should be considered.

• Asthma-related deaths: Use of long-acting beta-2 agonists (LABAs) as monotherapy (without inhaled corticosteroids) has been associated with an increased risk of asthma-related death, asthma-related hospitalizations in pediatric and adolescent patients, and an increased risk of severe exacerbations (SMART 2006; Walters 2007). Data from large randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma-related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Current asthma guidelines recommend the use of an as-needed low dose inhaled corticosteroid with formoterol as the preferred reliever agent (GINA 2023).

• Bronchospasm: Paradoxical bronchospasm, which may be life threatening, may occur with use of inhaled bronchodilating agents; reaction should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue fluticasone/vilanterol and institute alternative therapy.

• Hypersensitivity: Severe hypersensitivity, including anaphylaxis, angioedema, rash and urticaria may occur; discontinue fluticasone/vilanterol if a hypersensitivity reaction occurs.

• Immunosuppression: Use increases susceptibility to infections (eg, chickenpox and measles, sometimes more serious or even fatal, in susceptible children or adults using corticosteroids). Avoid exposure in such patients who have not had these diseases or been properly immunized. Use with caution (if at all) in patients with tuberculosis (TB) infection (latent TB) or disease (active TB) of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

• Lower respiratory infections: An increase in the incidence of pneumonia and other lower respiratory tract infections (some fatal) have been reported in patients with COPD following use; monitor COPD patients closely since pneumonia symptoms may overlap symptoms of exacerbations.

• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing fluticasone/vilanterol therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.

• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

Disease-related concerns:

• Asthma: Appropriate use: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Not to be used in status asthmaticus. For acute asthma exacerbations, budesonide/formoterol is preferred as a reliever; however, short-acting beta-2 agonists (SABAs) may be used. In patients presenting to primary care or acute care facility, SABAs are recommended for the acute management of exacerbations (GINA 2023).

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, antiseizure medications, oral corticosteroids); high doses and/or long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease, especially coronary insufficiency, arrhythmias, and hypertension; beta-agonists may cause elevation in blood pressure, heart rate, and increase risk of arrhythmias; may also cause ECG changes (eg, flattening of the T wave, QTc prolongation, ST segment depression).

• Chronic obstructive pulmonary disease: Appropriate use: Do not use for acute episodes of COPD. Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Data are not available to determine if LABA use increases the risk of death in patients with COPD. Do not increase daily dose.

• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.

• Hepatic impairment: Fluticasone exposure may be increased up to threefold in patients with hepatic impairment; use with caution in patients with moderate or severe impairment and monitor closely.

• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium.

• Ocular disease: Use with caution in patients with increased intraocular pressure, cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use of inhaled corticosteroids. Consider routine eye exams in chronic users.

• Seizure disorders: Use with caution in patients with seizure disorders.

• Thyrotoxicosis: Use with caution in patients with thyrotoxicosis.

Special populations:

• Pediatric: Data from controlled clinical trials suggest LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Lactose: May contain lactose; anaphylactic reactions have been reported in patients with severe milk protein allergy using other lactose-containing powder products.

Other warnings/precautions:

• Discontinuation of systemic corticosteroids: Withdraw systemic corticosteroid therapy with gradual tapering of dose (eg, adult patients on prednisone may decrease dose by 2.5 mg weekly during inhaled corticosteroid therapy). Monitor lung function, beta-agonist use, asthma and COPD symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal. Allergic conditions (eg, eosinophilic conditions, rhinitis, eczema, arthritis, conjunctivitis) may be unmasked when transitioning from systemic to inhaled corticosteroid therapy.

• Patient information: Patients must be instructed to use short-acting beta-2 agonist (eg, albuterol) for acute asthma or COPD symptoms and to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of inhaled short-acting beta2-agonist may indicate deterioration of asthma or COPD, and medical evaluation to assess treatment regimen must not be delayed.

Dosage Forms Considerations

Inhaler contains 2 foil strips and each strip contains 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (50, 100 or 200 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose. Packaging with 60 blisters provides 30 inhalations and packaging with 28 blisters provides 14 inhalations.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Breo Ellipta: Fluticasone furoate 50 mcg and vilanterol 25 mcg per actuation (60 ea); Fluticasone furoate 100 mcg and vilanterol 25 mcg per actuation (28 ea, 60 ea); Fluticasone furoate 200 mcg and vilanterol 25 mcg per actuation (28 ea, 60 ea) [contains milk protein]

Generic: Fluticasone furoate 100 mcg and vilanterol 25 mcg per actuation (60 ea); Fluticasone furoate 200 mcg and vilanterol 25 mcg per actuation (60 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Aerosol powder (Breo Ellipta Inhalation)

50-25 mcg/INH (per each): $8.14

100-25 mcg/ACT (per each): $6.72

200-25 mcg/ACT (per each): $6.72

Aerosol powder (Fluticasone Furoate-Vilanterol Inhalation)

100-25 mcg/ACT (per each): $7.29

200-25 mcg/ACT (per each): $7.29

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Breo Ellipta: Fluticasone furoate 100 mcg and vilanterol 25 mcg per actuation (28 ea, 60 ea); Fluticasone furoate 200 mcg and vilanterol 25 mcg per actuation (28 ea, 60 ea) [contains milk protein]

Administration: Adult

Oral inhalation: Dry powder inhaler: Administer at the same time each day. Do not use more than one inhalation in 24 hours; may cause adverse effects. Discard device 6 weeks after it is removed from the foil tray or when the dose counter reads “0” (whichever comes first). Do not open the cover of the inhaler until ready for use; each time cover is opened, 1 dose of medicine is prepared. Exhale fully before taking one long, steady, deep breath through the mouthpiece (do not breathe through nose); hold breath for 3 to 4 seconds and exhale slowly and gently. Patient should rinse mouth with water after inhalation and expectorate rinse solution.

Administration: Pediatric

Oral inhalation: Dry powder inhaler: Do not use with a spacer or volume holding chamber. Administer at the same time each day. After removing inhaler from tray, write the "Tray opened" and "Discard" dates on the inhaler label. The "Discard" date is 6 weeks from date of opening the tray. Do not shake inhaler. When ready to use, prepare the dose by fully opening cover of inhaler to expose the mouthpiece. Do not open the cover of the inhaler until ready for use; each time cover is opened and a click is heard, 1 dose of medicine is prepared. After exhaling fully (with mouth pointed away from inhaler), put mouthpiece in mouth and close lips firmly around mouthpiece, then take one long, steady, deep breath in through the mouthpiece (do not breathe through nose); hold breath for 3 to 4 seconds and exhale slowly and gently. Patient should rinse mouth with water after inhalation and expectorate rinse solution. The mouthpiece may be wiped with a dry tissue if it needs to be cleaned; do not take inhaler apart or wash or place any part of inhaler in water. The dose indicator will turn red when less than 10 doses remain, and the pharmacy should be contacted for a refill. Discard inhaler 6 weeks after it has been removed from the foil tray or when the dose counter reads “0” (whichever comes first).

Use: Labeled Indications

Asthma, maintenance/controller: Maintenance treatment of asthma in adults and pediatric patients ≥5 years of age.

Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Fluticasone 100 mcg/vilanterol 25 mcg is the only strength indicated for the treatment of COPD.

Limitations of use: Not indicated for the relief of acute bronchospasm.

Medication Safety Issues
Sound-alike/look alike issues:

Breo Ellipta may be confused with Anoro Ellipta, Arnuity Ellipta, Incruse Ellipta, and Trelegy Ellipta; Ellipta is the inhaler delivery system trademark not a medication.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Risk X: Avoid combination

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Fluticasone (Oral Inhalation). Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Oral Inhalation). Management: Consider alternatives to this combination if possible. Coadministration of fluticasone propionate and strong CYP3A4 inhibitors is not recommended. If combined, monitor patients for systemic corticosteroid adverse effects (eg, adrenal suppression). Risk D: Consider therapy modification

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Risk X: Avoid combination

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Nirmatrelvir and Ritonavir: May increase the serum concentration of Fluticasone (Oral Inhalation). Risk C: Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Theophylline Derivatives: Beta2-Agonists may enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies using this combination.

Beta-agonists have the potential to affect uterine contractility if administered during labor.

Also refer to the fluticasone monograph for additional information.

Breastfeeding Considerations

It is not known if sufficient quantities of fluticasone or vilanterol are absorbed following inhalation to produce detectable amounts in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; bone mineral density (at baseline and periodically thereafter); blood pressure, heart rate; serum potassium (hypokalemic patients) and glucose (diabetic patients); ocular changes (intraocular pressure, cataracts); signs/symptoms of oral or systemic infection, hypercortisolism, or adrenal suppression

Mechanism of Action

Fluticasone: A corticosteroid with anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.

Vilanterol: A long-acting beta2-agonist, relaxes bronchial smooth muscle by selective action on beta2-receptors with little effect on heart rate.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Fluticasone and vilanterol: Absorbed primarily via lungs; minimal GI absorption due to presystemic metabolism.

Distribution: IV: Fluticasone: 661 L; Vilanterol: 165 L.

Protein binding: Fluticasone: >99%; Vilanterol: 94%.

Metabolism: Fluticasone and vilanterol: Hepatic via CYP3A4 to inactive metabolites.

Bioavailability: Oral inhalation: Fluticasone: 15.2%; Vilanterol: 27.3%.

Half-life elimination: Plasma elimination phase following repeat dosing: Fluticasone: 24 hours; Vilanterol: 21.3 hours (chronic obstructive pulmonary disease); 16 hours (asthma).

Time to peak: Plasma concentrations: Fluticasone: 0.5 to 1 hour; Vilanterol: 10 minutes.

Excretion: Urine: (<2% fluticasone; ~70% vilanterol); feces (>90% fluticasone; ~30% vilanterol).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Relvar ellipta;
  • (AT) Austria: Relvar;
  • (AU) Australia: Breo ellipta;
  • (BE) Belgium: Relvar ellipta | Relvar ellipta abacus;
  • (BR) Brazil: Relvar ellipta;
  • (CH) Switzerland: Relvar ellipta;
  • (CO) Colombia: Relvar ellipta;
  • (DE) Germany: Relvar ellipta | Revinty ellipta;
  • (DO) Dominican Republic: Relvar ellipta;
  • (EC) Ecuador: Relvar ellipta;
  • (ES) Spain: Relvar ellipta | Revinty ellipta;
  • (FI) Finland: Relvar ellipta;
  • (FR) France: Relvar ellipta | Revinty ellipta;
  • (GB) United Kingdom: Relvar ellipta | Revinty ellipta;
  • (GR) Greece: Relvar ellipta | Revinty ellipta;
  • (HK) Hong Kong: Relvar ellipta;
  • (HR) Croatia: Relvar ellipta;
  • (HU) Hungary: Relvar ellipta;
  • (IE) Ireland: Relvar ellipta;
  • (IT) Italy: Relvar ellipta | Revinty ellipta;
  • (KE) Kenya: Relvar ellipta;
  • (KR) Korea, Republic of: Relvar ellipta;
  • (KW) Kuwait: Relvar ellipta;
  • (LB) Lebanon: Relvar ellipta;
  • (LU) Luxembourg: Relvar ellipta;
  • (MA) Morocco: Relvar ellipta;
  • (MX) Mexico: Relvare;
  • (MY) Malaysia: Relvar ellipta;
  • (NG) Nigeria: Relvar ellipta;
  • (NL) Netherlands: Relvar ellipta;
  • (NO) Norway: Relvar ellipta;
  • (NZ) New Zealand: Breo ellipta;
  • (PE) Peru: Relvar ellipta;
  • (PH) Philippines: Relvar ellipta;
  • (PK) Pakistan: Relvar ellipta;
  • (PL) Poland: Relvar ellipta;
  • (PR) Puerto Rico: Breo ellipta;
  • (PT) Portugal: Relvar ellipta | Revinty ellipta;
  • (QA) Qatar: Relvar Ellipta;
  • (RO) Romania: Relvar ellipta;
  • (RU) Russian Federation: Relvar ellipta;
  • (SA) Saudi Arabia: Relvar ellipta;
  • (SE) Sweden: Relvar ellipta;
  • (SG) Singapore: Relvar ellipta;
  • (SI) Slovenia: Relvar ellipta;
  • (SK) Slovakia: Relvar ellipta;
  • (TH) Thailand: Relvar ellipta;
  • (TR) Turkey: Relvar ellipta | Revinty ellipta;
  • (TW) Taiwan: Relvar ellipta;
  • (UG) Uganda: Relvar ellipta;
  • (UY) Uruguay: Relvar ellipta;
  • (ZA) South Africa: Relvar ellipta
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  2. Breo Ellipta (fluticasone/vilanterol) [prescribing information]. Durham, NC: GlaxoSmithKline; May 2023.
  3. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/2023-gina-main-report/. Updated 2023. Accessed August 23, 2023.
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  5. 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(4):560-9. [PubMed 23352226]
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Topic 89424 Version 273.0

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