Important Safety Information for BREO ELLIPTA (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
• Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids
because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids
to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to BREO ELLIPTA.
• 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 ELLIPTA slowly.
• Caution should be exercised when considering the coadministration of BREO ELLIPTA with long-term ketoconazole and other known
strong CYP3A4 inhibitors (e.g., 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 ELLIPTA and institute alternative therapy.
• 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 ELLIPTA may need to be discontinued. BREO ELLIPTA should be used with caution in patients with cardiovascular disorders,
especially coronary insufficiency, cardiac arrhythmias, and hypertension.
• Decreases in bone mineral density (BMD) 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 (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care. Since
patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating
BREO ELLIPTA and periodically thereafter.
• Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with COPD following the long-term
administration of inhaled corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a
history of increased intraocular pressure, glaucoma, and/or cataracts.
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are
unusually responsive to sympathomimetic amines.
• Be alert to hypokalemia and hyperglycemia.
• The most common adverse reactions (≥3% and more common than placebo) reported in two 6-month clinical trials with BREO ELLIPTA (and
placebo) were nasopharyngitis, 9% (8%); upper respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%).
• In addition to the events reported in the 6-month studies, adverse reactions occurring in ≥3% of the subjects treated with
BREO ELLIPTA in two 1-year studies included COPD, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain,
arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.
• Caution should be exercised when considering the coadministration of BREO ELLIPTA with long-term ketoconazole and other known strong
CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin,
troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
• BREO ELLIPTA 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 the effect of
adrenergic agonists, such as vilanterol, on the cardiovascular system may be potentiated by these agents.
• 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 reversible obstructive airways disease.
• Use with caution in patients taking non–potassium-sparing diuretics, as electrocardiographic changes and/or hypokalemia
associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.
USE IN SPECIFIC POPULATIONS
• Use BREO ELLIPTA with caution in patients with moderate or severe hepatic impairment. Fluticasone furoate exposure may increase in these
patients. Monitor for systemic corticosteroid effects.
Please see Brief Summary of Prescribing Information, including
Boxed Warning, for BREO ELLIPTA on the following pages.
THE ONLY ONCE-DAILY ICS/LABA FOR
THE MAINTENANCE TREATMENT OF COPD
• Approved for long-term, once-daily, maintenance treatment
of airflow obstruction in patients with COPD
• Approved to reduce COPD exacerbations in
patients with a history of exacerbations
• Not approved for the relief of acute bronchospasm
or for the treatment of asthma
• Delivered in the ELLIPTA inhaler