The PERFOROMIST Inhalation Solution

PERFOROMIST Inhalation Solution—an FDA-approved nebulized treatment for COPD for use with a nebulizer.

PERFOROMIST Inhalation Solution:

Begins working within minutes
Each dose lasts for 12 hours¹
Offers twice-daily dosing¹
- The morning dose provides rapid relief
- The evening dose lasts through the night

PERFOROMIST Solution should not be used to treat sudden symptoms.

In a study of 351 patients, most of those who used PERFOROMIST Solution experienced better control of their COPD, with fewer symptoms (exacerbations)*

*In the 12-week study, 78% of subjects (N=351) achieved a 15% increase from baseline FEV₁ following the first dose of PERFOROMIST Inhalation Solution 20 mcg as measured by serial FEV₁ for 12 hours post-dose; the primary efficacy analysis compared to placebo when evaluated at end point (week 12 for completers and last observation carried forward for noncompleters).

Please see full Prescribing Information, including Boxed Warning.

Approved Use

Maintenance Treatment of COPD. PERFOROMIST Inhalation Solution is approved for the long-term, twice-daily (morning and evening) use in the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information

WARNING: INCREASED RISK OF ASTHMA-RELATED DEATH

PERFOROMIST Inhalation Solution belongs to a class of medications known as long-acting beta₂-adrenergic agonists or LABAs. Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another long-acting beta₂-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta₂-adrenergic agonist), the active ingredient in PERFOROMIST Inhalation Solution. [See WARNINGS AND PRECAUTIONS.]

Important Limitations of Use

Deteriorating COPD

PERFOROMIST Inhalation Solution should not be used in patients with rapidly worsening COPD, which may be a life-threatening condition.

Asthma

PERFOROMIST Inhalation Solution is not indicated to treat asthma.

Warnings and Precautions

PERFOROMIST Inhalation Solution should not used for the relief of sudden symptoms, i.e., as rescue therapy for bronchospasm (wheezing or coughing). Sudden symptoms should be treated with a fast-acting rescue inhaler.

Excessive Use of PERFOROMIST Inhalation Solution and Use With Other Long-Acting Beta-Agonists PERFOROMIST Inhalation Solution should not be used more often, or at higher doses than recommended, or with other inhaled, long-acting beta₂-agonists, at the same time because of the risk of an overdose. Serious heart effects and fatalities have been reported with too high doses of inhaled adrenaline-like drugs.

Paradoxical Bronchospasm

As with other inhaled beta₂-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm (unexpected tightening of breathing tubes) that may be life threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be immediately stopped and a different therapy started.

Cardiovascular Effects

PERFOROMIST Inhalation Solution, like other beta₂-agonists, can produce serious heart-related effects in some patients as measured by higher pulse rate and higher blood pressure.

PERFOROMIST Inhalation Solution should be used with caution in patients with heart disease, especially coronary insufficiency, cardiac arrhythmias, and high blood pressure; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to adrenaline-like drugs.

Coexisting Conditions

PERFOROMIST Inhalation Solution, like other adrenaline-like drugs, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to adrenaline-like drugs. Doses of the related beta₂-agonist albuterol, when administered intravenously, have been reported to worsen preexisting diabetes.

Drug Interactions

MAO Inhibitors, Tricyclic Antidepressants and QTc Prolonging Drugs

PERFOROMIST Inhalation Solution, like other beta₂-agonists, should be used with extreme caution in patients being treated with certain antidepressants (monoamine oxidase inhibitors, tricyclic antidepressants), or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be increased by these agents.

Adverse Events

PERFOROMIST Inhalation Solution was studied in a 12-week, double-blind, placebo- and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). The most common adverse events reported in patients taking PERFOROMIST Inhalation Solution, and occurring more frequently than in patients taking placebo, were diarrhea (5%), nausea (5%), nasopharyngitis (3%), dry mouth (3%), dizziness (2%), and insomnia (2%).

This Web site provides useful information about chronic obstructive pulmonary disease (COPD) and the maintenance treatment of COPD with PERFOROMIST (formoterol fumarate) Inhalation Solution. Please consult with your healthcare practitioner, who is your best source for diagnosing COPD and recommending appropriate treatment.

PERFOROMIST is a registered trademark of Dey, L.P. DEY^® is a registered trademark of Dey, L.P. U.S. Patent Nos. 6,814,953 and 6,667,344.