Fluticasone and Vilanterol
(floo TIK a sone & VYE lan ter ol)
- Fluticasone Furoate and Vilanterol
- Vilanterol and Fluticasone
- Vilanterol and Fluticasone Furoate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Powder, for oral inhalation:
Breo Ellipta: Fluticasone furoate 100 mcg and vilanterol 25 mcg per actuation (28s, 60s) [contains lactose; blister pack]
Breo Ellipta: Fluticasone furoate 200 mcg and vilanterol 25 mcg per actuation (28s, 60s) [contains lactose; blister pack]
Brand Names: U.S.
- Breo Ellipta
- Beta2 Agonist
- Beta2-Adrenergic Agonist, Long-Acting
- Corticosteroid, Inhalant (Oral)
Fluticasone is 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.
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
Asthma: Oral inhalation: One inhalation (fluticasone 100 mcg/vilanterol 25 mcg or fluticasone 200 mcg/vilanterol 25 mcg) once daily (maximum: 1 inhalation [fluticasone 200 mcg/vilanterol 25 mcg] once daily). Recommended starting dose is determined according to asthma severity. For patients not adequately controlled on the lower combination dose, consider the higher dose combination. Reevaluate treatment regimen if previously effective dose does not provide adequate improvement in asthma control.
Chronic obstructive pulmonary disease (COPD): Oral inhalation: One inhalation (fluticasone 100 mcg/vilanterol 25 mcg) once daily (maximum: 1 inhalation [fluticasone 100 mcg/vilanterol 25 mcg] once daily)
Refer to adult dosing.
Dosing: Renal Impairment
No dosage adjustment necessary.
Dosing: Hepatic Impairment
US labeling: No dosage adjustment necessary. Use with caution in moderate or severe impairment; systemic fluticasone exposure may be increased up to threefold.
Mild impairment: No dosage adjustment necessary.
Moderate or severe impairment: Maximum dose: One inhalation (fluticasone 100 mg/vilanterol 25 mcg) once daily.
Oral inhalation: 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.
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.
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy
Aprepitant: May increase the serum concentration of CYP3A4 Substrates. 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
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). 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
Cobicistat: May increase the serum concentration of Fluticasone (Oral Inhalation). Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Oral Inhalation). Management: Use of orally inhaled fluticasone propionate with strong CYP3A4 inhibitors is not recommended. Use of orally inhaled fluticasone furoate with strong CYP3A4 inhibitors should be done with caution. Monitor patients using such a combination more closely. Consider therapy modification
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination
Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination
Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
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
Long-Acting Beta2-Agonists: May enhance the adverse/toxic effect of other Long-Acting Beta2-Agonists. Avoid combination
Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy
Loop Diuretics: Corticosteroids (Orally Inhaled) 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
Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates. 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
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification
Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy
Stiripentol: May increase the serum concentration of CYP3A4 Substrates. 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
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
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
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tipranavir: May increase the serum concentration of Fluticasone (Oral Inhalation). Avoid combination
Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Also see fluticasone (oral inhalation) monograph.
1% to 10%:
Cardiovascular: Hypertension (≥3%), peripheral edema (≥3%), extrasystoles (≥2%), supraventricular extrasystole (≥2%), ventricular premature contractions (≥2%)
Central nervous system: Headache (5% to 8%)
Gastrointestinal: Oropharyngeal candidiasis (2% to 5%), diarrhea (≥3%), upper abdominal pain (≥2%)
Infection: Influenza (≥3%)
Neuromuscular & skeletal: Arthralgia (2% to ≥3%), back pain (2% to ≥3%), bone fracture (2%)
Respiratory: Nasopharyngitis (6% to 10%), upper respiratory tract infection (≥2% to 7%), pneumonia (2% to 7%), oropharyngeal pain (2% to ≥3%), pharyngitis (2% to ≥3%), chronic obstructive pulmonary disease (≥3%), cough (1% to ≥3%), sinusitis (1% to ≥3%), bronchitis (<1% to ≥3%), acute sinusitis (≥2%), allergic rhinitis (≥2%), rhinitis (≥2%), viral respiratory tract infection (≥2%), voice disorder (2%)
Miscellaneous: Fever (2% to ≥3%)
<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, glaucoma, hypersensitivity reaction, palpitations, paradoxical bronchospasm, tachycardia
Concerns related to adverse effects:
• Adrenal suppression: Fluticasone may cause hypercorticism 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: [US Boxed Warning]: Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death; fluticasone and vilanterol should only be used in patients not adequately controlled on other long-term asthma control medication (ie, inhaled corticosteroid) or whose disease severity requires initiation of treatment with both an inhaled corticosteroid and a LABA. Data from a placebo-controlled trial that compared the safety of another LABA (salmeterol) with placebo added to asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol; this finding is considered a class effect of LABAs, including vilanterol. Assess patients at regular intervals once asthma control is maintained on combination therapy to determine if step-down therapy is appropriate (without loss of asthma control), and the patient can be maintained on an inhaled corticosteroid only. LABAs are not appropriate in patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. Data are not available to determine whether the rate of death in patients with COPD is increased by LABA.
• 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.
• Acute bronchospasm: Do not use for acute bronchospasm. Short-acting beta2-agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments.
• Asthma: Appropriate use: Patients with asthma should only use fluticasone/vilanterol if not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or if asthma severity clearly requires initiation of treatment with both an inhaled corticosteroid and a LABA. Assess patients at regular intervals and, if possible, step down therapy (eg, discontinue fluticasone/vilanterol) without loss of asthma control; maintain patient on long-term asthma control medication, such as an inhaled corticosteroid. Do not use fluticasone/vilanterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
• 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; beta2-agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Hepatic impairment: Use with caution in patients with moderate or severe hepatic impairment; monitor closely.
• Hypokalemia: Use with caution in patients with hypokalemia; beta2-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.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Pediatric: [US Boxed Warning]: 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: Contains lactose; anaphylactic reactions have been reported in patients with severe milk protein allergy using other lactose-containing powder products.
• Appropriate use: Do not use for acute episodes of COPD or asthma. Do not initiate in patients with significantly worsening, potentially life-threatening, or acutely deteriorating COPD or asthma. Therapy should not be used more than once daily; do not exceed recommended dose. Do not use with other long-acting beta2-agonists; clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
• 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 beta2-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.
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, hypercorticism, or adrenal suppression
Pregnancy Risk Factor
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.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience flu-like symptoms, change in voice, rhinorrhea, or pharyngitis. Have patient report immediately to prescriber signs of infection, signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), severe headache, bone pain, severe nausea, vomiting, loss of strength and energy, irritability, tremors, tachycardia, severe dizziness, passing out, angina, arrhythmia, redness or white patches in mouth or throat, eye pain, vision changes, or difficulty breathing, wheezing, or coughing after use (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about fluticasone/vilanterol
- Other brands: Breo Ellipta