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 2022).
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).
Chronic obstructive pulmonary disease, maintenance: Note: Depending on symptoms and exacerbation risk, may use a single long-acting bronchodilator (long-acting beta-2 agonists [LABA] or long-acting muscarinic antagonist [LAMA]) or dual-acting bronchodilator (LABA and LAMA), with or without an inhaled corticosteroid. In addition, a short-acting bronchodilator is used for symptom relief (GOLD 2022).
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.
No dosage adjustment necessary.
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.
Refer to adult dosing.
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]
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)
Yes
Inhaler contains 2 foil strips and each strip contains 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (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.
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]
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Breo Ellipta:http://www.fda.gov/downloads/Drugs/DrugSafety/UCM352347.pdf
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.
Asthma: Treatment of asthma in patients ≥18 years.
Chronic obstructive pulmonary disease, maintenance: 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.
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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
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
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).
• 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 2022).
• 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.
Refer to individual components.
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.
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination
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
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. 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
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).
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 continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
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
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.
See individual agents.
Aerosol powder (Breo Ellipta Inhalation)
100-25 mcg/ACT (per each): $6.34
200-25 mcg/ACT (per each): $6.34
Aerosol powder (Fluticasone Furoate-Vilanterol Inhalation)
100-25 mcg/ACT (per each): $7.29
200-25 mcg/ACT (per each): $7.29
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