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Fluticasone and Vilanterol

Medically reviewed by Drugs.com. Last updated on Jul 22, 2020.

Pronunciation

(floo TIK a sone & VYE lan ter ol)

Index Terms

  • Fluticasone Furoate and Vilanterol
  • Fluticasone/Vilanterol
  • Vilanterol and Fluticasone
  • Vilanterol and Fluticasone Furoate

Dosage Forms

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]

Brand Names: U.S.

  • Breo Ellipta

Pharmacologic Category

  • Beta2 Agonist
  • Beta2-Adrenergic Agonist, Long-Acting
  • Corticosteroid, Inhalant (Oral)

Pharmacology

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.

Use: Labeled Indications

Asthma: Treatment of asthma in patients ≥18 years.

Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce exacerbations of COPD in patients with a history of exacerbations

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.

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

Dosing: Adult

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.

Asthma: Oral inhalation: Note: The recommended starting dose is based upon asthma severity and previous asthma therapy (including inhaled corticosteroid dosage). Titrate to the lowest effective dose (step down) once asthma is well controlled after 2 to 3 months (GINA 2020).

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

COPD: Oral inhalation: Dry powder inhaler: One inhalation (fluticasone furoate 100 mcg/vilanterol 25 mcg) once daily (maximum: 1 inhalation [fluticasone furoate 100 mcg/vilanterol 25 mcg] 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: Geriatric

Refer to adult dosing.

Administration

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.

Storage

Store between 20°C and 25°C (68°F and 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Store in a dry place away from heat and sunlight. Store inside the unopened foil tray prior to initial use. Discard 6 weeks after opening the foil tray or after the labeled number of inhalations have been used, whichever comes first.

Drug Interactions

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

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

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

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. 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. Monitor therapy

Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). 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. Monitor therapy

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

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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. Consider therapy modification

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

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

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

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Oral Inhalation). Consider therapy modification

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

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

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

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

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

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

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

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

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

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

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

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. 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. 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. Consider therapy modification

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

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

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

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification

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

Procarbazine: May enhance the adverse/toxic effect of Sympathomimetics. Management: Consider alternatives to this combination when possible. Procarbazine prescribing information states that this combination should be avoided. Consider therapy modification

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. Monitor therapy

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

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

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

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

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

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

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

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

Adverse Reactions

Also see fluticasone (oral inhalation) monograph.

1% to 10%:

Cardiovascular: Hypertension (≥3%), extrasystoles (≥2%), supraventricular extrasystole (≥2%), ventricular premature contractions (≥2%)

Central nervous system: Headache (5% to 8%), voice disorder (2%)

Gastrointestinal: Oropharyngeal candidiasis (2% to 5%), upper abdominal pain (≥2%)

Infection: Influenza (≥3%)

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

Respiratory: Nasopharyngitis (6% to 10%), pneumonia (2% to 7%), upper respiratory tract infection (2% to 7%), acute sinusitis (≥2%), allergic rhinitis (≥2%), oropharyngeal pain (≥2%), pharyngitis (≥2%), rhinitis (≥2%), viral respiratory tract infection (≥2%), cough (≥1%), sinusitis (≥1%), bronchitis

Miscellaneous: Fever (≥2%)

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, hyperglycemia, hypersensitivity reaction, muscle spasm, nervousness, palpitations, paradoxical bronchospasm, skin rash, tachycardia, tremor, urticaria

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. 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 COPD symptoms should be considered.

• Asthma-related deaths: The use of long-acting beta-2 agonists (LABAs) as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART 2006; Walters 2007); additional data from other clinical trials suggests risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, 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 (aged 4 to 11 years) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Current guidelines recommend the use of an as-needed low-dose inhaled corticosteroid with formoterol for patients with infrequent symptoms (GINA 2020).

• Bone density: Long-term use of inhaled corticosteroids may affect bone mineral density.

• Bronchospasm: Can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, fluticasone/vilanterol should be discontinued immediately and alternative therapy should be instituted.

• 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 active or quiescent tuberculosis infections 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: Infections with Candida albicans in the mouth and throat (thrush) have been reported with use.

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. In patients presenting to primary care or acute care facility, short-acting beta-2 agonists are recommended for the acute management of exacerbations (GINA 2020).

• 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).

• 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.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• 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, 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 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 COPD, and medical evaluation to assess treatment regimen must not be delayed.

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

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy (refer to the fluticasone, oral inhalation monograph for additional details). Beta-agonists have the potential to affect uterine contractility if administered during labor. Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants).

Patient Education

What is this drug used for?

• It is used to treat COPD (chronic obstructive pulmonary disease).

• It is used to treat asthma.

• This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flu-like symptoms

• Common cold symptoms

• Change in voice

• Back pain

• Joint pain

• Stuffy nose

• Runny nose

• Sore throat

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.

• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat.

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss.

• Severe headache

• Bone pain

• Severe loss of strength and energy

• Tremors

• Fast heartbeat

• Severe dizziness

• Passing out

• Chest pain

• Anxiety

• Thrush

• Eye pain

• Vision changes

• Severe eye irritation

• Mouth pain

• Mouth irritation

• Trouble breathing

• Wheezing

• Coughing after use

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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