Exacerbation Data

BREO is for adult patients with asthma uncontrolled on a long-term control medication (eg, ICS) or whose disease warrants an ICS/LABA (inhaled corticosteroid/long-acting beta₂-adrenergic agonist). BREO is NOT indicated for the relief of acute bronchospasm.

EXACERBATION DATA

BREO is the only ICS/LABA proven to reduce exacerbations without a second daily dose.

Proven to reduce the RISK and RATE of exacerbations^*

In a 24- to 76-week study of patients with a history of asthma exacerbations^*

Time to First Asthma Exacerbation

20% reduction in risk of exacerbations

WITH BREO 100/25 (n=1009) vs FF mcg (n=1010) HAZARD RATIO=0.795; P=0.036

Annual Rate of Asthma Exacerbations

25% reduction in rate of exacerbations

PER PATIENT PER YEAR WITH BREO 100/25 (n=1009) vs FF 100 mcg (n=1010) BREO 0.14 vs FF 0.19; P=0.014

*Asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or on an inpatient hospitalization or ED visit due to asthma that required systemic corticosteroids.

24- to 76-week study: Patients with an asthma exacerbation history

Design: 24- to 76-week, randomized, double-blind, event-driven trial that evaluated the long-term safety and efficacy of BREO 100/25 compared with FF 100 mcg (each administered once daily in the evening). Patients with a history of 1 or more asthma exacerbations in the prior year that required treatment with oral/systemic corticosteroids or ED visit or inpatient hospitalization, and who were being treated with a low- to high-dose ICS or low- to mid-dose ICS/LABA entered a 2-week run-in period during which LABA treatment was stopped. Patients who reported symptoms and/or rescue beta₂‑agonist use during the 2-week run-in period were randomized to receive treatment, which varied in duration from 24 to 76 weeks, as the study was stopped when 330 events had occurred. An event was defined as a patient experiencing an asthma exacerbation.

Asthma exacerbation criteria: a deterioration of asthma that required the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or ED visit due to asthma that required systemic corticosteroids.

Patients who experienced 1 or more exacerbations: BREO 100/25, n=154; FF 100 mcg, n=186. The total number of exacerbation events was 200 for BREO and 271 for FF 100 mcg. Management of all exacerbations required use of systemic/oral corticosteroids.

Patients: 2019 patients with asthma aged 12 years and older^† (mean age: 42 years). At baseline, patients had a mean percent predicted FEV₁ of 72%.

^†BREO is approved for use in patients ≥18 years of age.

Primary endpoint: time to first asthma exacerbation.

Secondary endpoint: rate of asthma exacerbations (per patient per year).

SHOW LESS

Bateman ED, O’Byrne PM, Busse WW, et al. Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone. Thorax. 2014;69(4):312-319.

CONTRAINDICATIONS

BREO is contraindicated for primary treatment of status asthmaticus or other acute episodes of chronic obstructive pulmonary disease (COPD) or asthma where intensive measures are required.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BREO is contraindicated for primary treatment of status asthmaticus or other acute episodes of chronic obstructive pulmonary disease (COPD) or asthma where intensive measures are required.

BREO is contraindicated in patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients.

WARNINGS AND PRECAUTIONS

LABA monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.
BREO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.
BREO is not a rescue medication and should not be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta₂-agonist.
BREO should not be used more often or at higher doses than recommended, or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
Oropharyngeal candidiasis has occurred in patients treated with BREO. Advise patients to rinse the mouth with water without swallowing after inhalation.
Use caution in patients who use corticosteroids as they are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
Particular care is needed for patients transferred from systemic corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to BREO.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, discontinue BREO slowly.
Caution should be exercised when considering the coadministration of BREO with ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
If paradoxical bronchospasm occurs, discontinue BREO immediately and institute alternative therapy.
Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of BREO. Discontinue BREO if such reactions occur.
Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, BREO may need to be discontinued. BREO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Decreases in bone mineral density have been observed with long‐term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, 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, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care.
Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with COPD or asthma following the long-term administration of inhaled corticosteroids. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use BREO long term.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Increased blood glucose levels have been reported. Also, be alert to hypokalemia.
Orally inhaled corticosteroids may reduce growth velocity in children and adolescents.

ADVERSE REACTIONS

In a 12-week trial, adverse reactions (≥2% incidence and more common than placebo) reported in subjects taking BREO 100/25 (and placebo) were: nasopharyngitis, 10% (7%); headache, 5% (4%); oropharyngeal pain, 2% (1%); oral candidiasis, 2% (0%); and dysphonia, 2% (0%). In a separate 12-week trial, adverse reactions (≥2% incidence) reported in subjects taking BREO 200/25 (or BREO 100/25) were: headache, 8% (8%); nasopharyngitis, 7% (6%); influenza, 3% (3%); upper respiratory tract infection, 2% (2%); oropharyngeal pain, 2% (2%); sinusitis, 2% (1%); bronchitis, 2% (<1%); and cough, 1% (2%).
Additional adverse reactions (≥2% incidence) reported in subjects taking BREO 200/25 in a 24-week trial included viral respiratory tract infection, pharyngitis, pyrexia, and arthralgia; and with BREO 100/25 or 200/25 in a 12-month trial included pyrexia, back pain, extrasystoles, upper abdominal pain, respiratory tract infection, allergic rhinitis, pharyngitis, rhinitis, arthralgia, supraventricular extrasystoles, ventricular extrasystoles, acute sinusitis, and pneumonia.
In a 24- to 76-week trial of subjects with ≥1 asthma exacerbations in the past year, asthma-related hospitalizations occurred in 1% of subjects taking BREO 100/25. No asthma-related deaths or intubations were observed.

DRUG INTERACTIONS

Caution should be exercised when considering the coadministration of BREO with ketoconazole and other known strong CYP3A4 inhibitors. See prior Warning and Precaution regarding CYP3A4 inhibitors.
BREO should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
Use beta-blockers with caution as they not only block the pulmonary effect of beta-agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD or asthma.
Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.

USE IN SPECIFIC POPULATIONS

BREO is not indicated for children and adolescents; the safety and efficacy in patients aged ≤17 years have not been established.
Use BREO with caution in patients with moderate or severe hepatic impairment. Fluticasone furoate systemic exposure increased by up to 3-fold in subjects with hepatic impairment. Monitor for corticosteroid-related side effects.

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20% reduction in risk of exacerbations

25% reduction in rate of exacerbations

Study Design:

CONTRAINDICATIONS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

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