• The use of ANORO ELLIPTA is contraindicated in patients with severe hypersensitivity to milk proteins or who have
demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients.
WARNINGS AND PRECAUTIONS
• ANORO ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening
episodes of COPD.
• ANORO ELLIPTA should not be used for the relief of acute symptoms, ie, as rescue therapy for the treatment of
acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
• ANORO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in
conjunction with other medicines containing LABA, 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 ANORO ELLIPTA should not use another medicine containing a LABA (eg, salmeterol, formoterol
fumarate, arformoterol tartrate, indacaterol) for any reason.
• Caution should be exercised when considering the coadministration of ANORO ELLIPTA with long-term
ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir,
itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because
increased cardiovascular adverse effects may occur.
• If paradoxical bronchospasm occurs, discontinue ANORO 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, or symptoms. If such effects occur, ANORO ELLIPTA may need to
be discontinued. ANORO ELLIPTA should be used with caution in patients with cardiovascular disorders, especially
coronary insufficiency, cardiac arrhythmias, and hypertension.
• ANORO ELLIPTA is a combination anticholinergic/long-acting beta2-adrenergic agonist 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.
• ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
Important Safety Information for ANORO ELLIPTA
WARNING: ASTHMA-RELATED DEATH
• Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in
ANORO 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 LABA, including vilanterol.
• The safety and efficacy of ANORO ELLIPTA in patients with asthma have not been established. ANORO ELLIPTA is not indicated for the treatment of asthma.
Help Your Patients
With ANORO ELLIPTA