About COPD

COPD: Progressive but Treatable

Airflow Limitation: Not Fully Reversible

Chronic Obstructive Pulmonary Disease (COPD) is a progressive but treatable disease that is primarily characterized by chronic airflow limitation that is not fully reversible.1 The airflow limitation is caused by disease and destruction—small airway disease (obstructive bronchiolitis) and parenchymal destruction (emphysema).1 Airflow limitation is also associated with an amplification of the inflammatory response of the lung to noxious particles and gases.1

COPD also has significant, systemic extrapulmonary effects that lead to comorbid conditions and contribute to disease severity. Your patients with COPD may be restricted from activities which results in a poor quality of life.1

COPD is differentiated from asthma, but sometimes difficult to distinguish. Airflow limitation is usually progressive and not fully reversible in patients with COPD; in contrast, airflow limitation is reversible in patients with asthma.1

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Understanding COPD
Spirometric results combined with signs and symptoms confirm the diagnosis of COPD. Find out more about this progressive but treatable disease.
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Symptoms

Symptoms of COPD include:1

  • Dyspnea — progressive, persistent and worse upon exertion
  • Cough — may be intermittent and unproductive
  • Sputum Production

It is important to keep in mind that airflow limitation may be present years before symptoms of cough and/or sputum production occur in patients.1

Spirometry for Diagnosis and Assessment

The prevalence of COPD is difficult to capture due to imprecise and varying definitions of the disease.1 In addition, it is not always recognized in its early form, so COPD may be under-diagnosed.1 Fewer than 50% of individuals with COPD, based on airflow limitation, have a diagnosis of COPD.7

Spirometry allows you to assess lung function by measuring the volume of air that your patient can expel from the lungs after maximal inspiration.1,29 In just one second, spirometry measures both Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV1) to confirm the presence of airway obstruction.1,29 GOLD guidelines recommend postbronchodilator FEV1 for the diagnosis of COPD and assessment of disease severity.1,29

Symptom Management with Bronchodilators

Bronchodilators are critical for symptom management in patients with COPD. When considering bronchodilators for the ongoing management of your patients' symptoms, it's important to consider the long-acting versus short-acting properties of any particular treatment for your patients with COPD. Bronchodilators can relieve symptoms, improve exercise tolerance and improve overall health status.1

Manage Treatment

Assessment of FEV1, FVC and symptoms are critical when developing a COPD treatment strategy. Certain signs and symptoms may indicate inadequate control and the need to reevaluate your patients. Therapy is available for patients at each stage of COPD.

GOLD guidelines: Therapy at each stage of COPD1

Consider more about COPD:

COPD is differentiated from asthma, but sometimes difficult to distinguish. Airflow limitation is usually progressive and not fully reversible in patients with COPD but is reversible in patients with asthma.

Evaluating the risk factors contributes to a successful maintenance treatment strategy.

Certain signs and symptoms may indicate inadequate control of symptoms and the need to reevaluate your patients.

Proper diagnosis and management may make the difference for certain patients in various care settings.

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.