Efficacy of PERFOROMIST^®

Rapid, Sustained and Consistent Delivery

Safety of PERFOROMIST

Review PERFOROMIST safety and tolerability data

Signs and Symptoms

Certain signs and symptoms of COPD may indicate inadequate control and the need to reevaluate treatment and delivery device.

Recognize the signs and symptoms of COPD

The Role of Nebulization with a LABA

Ease of use with a three step method, twice-daily administration — these are just two of the important features of nebulization for patients with COPD.

Review the details

Most patients with Chronic Obstructive Pulmonary Disease (COPD) have difficulty breathing and seek rapid relief. Nebulized PERFOROMIST Inhalation Solution provides long-lasting bronchodilation. It works in as soon as five minutes and lasts for 12 hours.² It is not to be used for relief of acute episodes of bronchospasm.

Sustained FEV₁ improvement over 12 hours at week 12²

A randomized, double-blind, double-dummy, placeboand active-controlled, parallel-group study in 351 moderate to severe COPD patients evaluating the safety and efficacy of PERFOROMIST Solution (20 mcg/2 mL BID) over 12 weeks. Sustained improvement was measured by serial FEV₁ for 12 hours postdose, the primary efficacy analysis compared with placebo when evaluated at end point. Seventy-eight percent of subjects achieved a 15% increase from baseline in FEV1 following the first dose of PERFOROMIST Solution, 20 mcg.

In a 12-week pivotal trial, twice-daily dosing with PERFOROMIST provided sustained and consistent bronchodilation at every time point measured throughout the study period.² There was no evidence of tachyphylaxis throughout the 12 weeks.² Tolerance to the effects of inhaled beta₂-agonists can occur with regularly scheduled, chronic use.

Learn more about the efficacy and safety of PERFOROMIST.

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Reduced the use of rescue albuterol medication

Important Safety Information

Prescribing Information

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Please see accompanying full Prescribing Information, including Boxed Warning.

Indication

PERFOROMIST^® (formoterol fumarate) Inhalation Solution is indicated for the 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.

Important Limitations for Use:

It is not indicated to treat acute deteriorations of COPD
It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta₂-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared 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 is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation Solution.
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.

Important Safety Information

PERFOROMIST Inhalation Solution like other LABAs is contraindicated in patients with asthma without use of a long term asthma control medication.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

As with other inhaled beta₂-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be discontinued immediately and alternative therapy instituted.

PERFOROMIST Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other inhaled, long-acting beta₂-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

PERFOROMIST Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

PERFOROMIST Inhalation Solution, like other beta₂-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms.

PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution. Doses of the related beta₂-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Beta agonist medications may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

PERFOROMIST Inhalation Solution, as with other beta₂-agonists, should be used with extreme caution in patients being treated with 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 potentiated by these agents.

Beta-blockers and formoterol fumarate may inhibit the effect of each other when administered concurrently. Therefore, patients with COPD should not normally be treated with beta-blockers except under certain circumstances e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD.

Concomitant treatment with Xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution is advised in the co-administration.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Understanding COPD

How to Neb

Benefits of nebulization in a variety of settings

Twice-daily Dosing

Fewer interruptions for your patients could make a significant difference in their daily routines. Twice-daily dosing with PERFOROMIST, a long-acting beta₂-agonist (LABA), provides your patients with:^1,2

Rapid relief with the morning dose to help start the day
Symptom control throughout the night with the evening dose

Reduced Need for Rescue Medication

Reducing the need for rescue medication may indicate increased symptom control.^*²

Average daily albuterol usage (puffs) over 12-week study²

^* PERFOROMIST Solution has not been demonstrated to have an impact on disease progression in patients with COPD.

^† LS mean = least squares mean, a method for determining the values of unknown quantities by minimizing the differences between predicted and observed values.

Many patients with COPD are not getting the full effect of their maintenance treatment. Consider your patients. Consider their treatment settings. Consider reevaluating the treatment strategy for your patients with COPD.