HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PERFOROMIST Inhalation Solution safely and effectively. See full prescribing information for PERFOROMIST Inhalation Solution.
 
PERFOROMIST ® (formoterol fumarate) Inhalation Solution
Initial U.S. Approval: 2001
WARNING: ASTHMA-RELATED DEATHSee full prescribing information for complete boxed warning.
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Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. (5.1)
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A placebo-controlled study with another long-acting beta2-adrenergic agonist (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. (5.1)
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The finding of an increased risk of asthma-related death with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. (4, 5.1)
INDICATIONS AND USAGE
PERFOROMIST Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:
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Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1)
Important limitations of use:
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PERFOROMIST Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2, 5.2)
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PERFOROMIST Inhalation Solution is not indicated to treat asthma. ( 1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only.
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One 20 mcg/2 mL vial every 12 hours ( 2)
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For use with a standard jet nebulizer (with a facemask or mouthpiece) connected to an air compressor ( 2)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution (unit dose vial for nebulization); 20 mcg/2 mL solution (3)

CONTRAINDICATIONS
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All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication. ( 4)
WARNINGS AND PRECAUTIONS
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Do not initiate PERFOROMIST Inhalation Solution in acutely deteriorating patients. ( 5.2)
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Do not use for relief of acute symptoms. Concomitant short-acting beta 2-agonists can be used as needed for acute relief. ( 5.2)
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Do not exceed the recommended dose. Excessive use of PERFOROMIST Inhalation Solution, or use in conjunction with other medications containing long-acting beta 2-agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3, 5.5)
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Life-threatening paradoxical bronchospasm can occur. Discontinue PERFOROMIST Inhalation Solution immediately. ( 5.4)
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Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or with sensitivity to sympathomimetic drugs. ( 5.6, 5.7)
ADVERSE REACTIONS
Most common adverse reactions (>2% and more common than placebo) are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Mylan Specialty L.P. at 1-800-429-7751 or FDA at 1-800-FDA-1088 or www.fda.gov/med