Efficacy of PERFOROMIST®

Rapid, Sustained and Consistent Delivery

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.

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Reduced the use of rescue albuterol medication
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Reduced the use of rescue albuterol medication
Important Safety Information
Prescribing Information

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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.

A randomized, double-blind, double-dummy, placebo and 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.

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.

Your patients with COPD can achieve rapid and sustained bronchodilation with twice-daily nebulization—with PERFOROMIST.2

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.

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 (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS).

Important Safety Information

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.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

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.

WARNINGS AND PRECAUTIONS

Deterioration of Disease and Acute Episodes
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, ie, as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist

Excessive Use of PERFOROMIST Inhalation Solution and Use With Other Long-Acting Beta2-Agonists
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

Paradoxical 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

Cardiovascular Effects
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 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.

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

DRUG INTERACTIONS

MAO Inhibitors, Tricyclic Antidepressants and QTc Prolonging Drugs
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

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.