These highlights do not include all the information needed to use the ANORO ELLIPTA inhaler safely and effectively. See full prescribing information for ANORO ELLIPTA.
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder)
FOR ORAL INHALATION USE
Initial U.S. Approval: 2013
WARNING: ASTHMA-RELATED DEATH
See full prescribing information for complete boxed warning.
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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. (5.1)
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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. (5.1)
INDICATIONS AND USAGE
ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). (1)
Important limitations: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1, 5.2)
DOSAGE AND ADMINISTRATION
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For oral inhalation only. ( 2)
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Maintenance treatment of COPD: 1 inhalation of ANORO ELLIPTA once daily. ( 2)
DOSAGE FORMS AND STRENGTHS
Inhalation Powder. Inhaler containing 2 double-foil blister strips of powder formulation for oral inhalation. One strip contains umeclidinium 62.5 mcg per blister and the other contains vilanterol 25 mcg per blister. (3)
CONTRAINDICATIONS
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Severe hypersensitivity to milk proteins or any ingredients. ( 4)
WARNINGS AND PRECAUTIONS
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LABA increase the risk of asthma-related death. ( 5.1)
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Do not initiate in acutely deteriorating COPD or to treat acute symptoms. ( 5.2)
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Do not use in combination with an additional medicine containing LABA because of risk of overdose. ( 5.3)
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If paradoxical bronchospasm occurs, discontinue ANORO ELLIPTA and institute alternative therapy. ( 5.5)
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Use with caution in patients with cardiovascular disorders (
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