WARNING: ASTHMA-RELATED DEATH
• Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, one of the active ingredients in BREO ELLIPTA,
increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase
in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all
LABAs, including vilanterol.
• The safety and efficacy of BREO ELLIPTA in patients with asthma have not been established. BREO ELLIPTA is not
indicated for the treatment of asthma.
• BREO ELLIPTA is a combination inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and/or emphysema. BREO ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
• BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
• BREO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins or who have demonstrated
hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients.
WARNINGS AND PRECAUTIONS
• BREO ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
• BREO ELLIPTA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of
bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
• BREO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other
medications containing LABAs, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported
in association with excessive use of inhaled sympathomimetic drugs. Patients using BREO ELLIPTA should not use another medicine
containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
• Oropharyngeal candidiasis has occurred in patients treated with BREO ELLIPTA. Advise patients to rinse the mouth without swallowing
following inhalation to help reduce the risk of oropharyngeal candidiasis.
• An increase in the incidence of pneumonia has been observed in subjects with COPD receiving BREO ELLIPTA. There was also an
increased incidence of pneumonias resulting in hospitalization. In some incidences these pneumonia events were fatal.
— In replicate 12-month studies of 3255 subjects with COPD who had experienced a COPD exacerbation in the previous year,
there was a higher incidence of pneumonia reported in subjects receiving BREO ELLIPTA 100/25 mcg (6% [51 of 806 subjects]),
fluticasone furoate (FF)/vilanterol (VI) 50/25 mcg (6% [48 of 820 subjects]), and FF/VI 200/25 mcg (7% [55 of 811 subjects]) than in
subjects receiving VI 25 mcg (3% [27 of 818 subjects]). There was no fatal pneumonia in subjects receiving VI or FF/VI 50/25 mcg.
There was fatal pneumonia in 1 subject receiving BREO ELLIPTA at the approved strength (100/25 mcg) and in 7 subjects receiving
FF/VI 200/25 mcg (<1% for each treatment group).
• Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as the clinical features of such
infections overlap with the symptoms of COPD exacerbations.
• Patients who use corticosteroids 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.
Use caution in patients with the above because of the potential for worsening of these infections.
The only once-daily ICS/LABA
(inhaled corticosteroid/long-acting beta2-agonist)
for the maintenance treatment of COPD.
Important Safety Information for BREO ELLIPTA