Signs and Symptoms of COPD

Recognize and Reevaluate

Patients with Chronic Obstructive Pulmonary Disease (COPD) commonly exhibit symptoms of cough, progressive sputum production and dyspnea upon exertion.1 With COPD, airflow limitation is not fully reversible.1 Airflow limitation may be present years before symptoms of cough and/or sputum production occur in your patients.1 Certain signs or symptoms may indicate the need to reevaluate treatment and delivery device.1


Oxygen therapy may be required for patients with very severe COPD, who are experiencing chronic respiratory failure and surgical treatments.1

According to the GOLD guidelines, reducing the frequency and severity of exacerbations is now recognized as an important global initiative for treatment patients with COPD.1 Approximately 20% of patients with moderate to severe COPD have more than one exacerbation per year.5 As COPD progresses, acute exacerbations tend to become more frequent, averaging about three episodes per year.6

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 effect of bronchodilators.1

Bronchodilators can relieve symptoms, improve exercise tolerance and improve overall health status.1 GOLD guidelines recommend post-bronchodilator FEV1 for diagnosis of COPD and assessment of severity.1

GOLD guidelines: Therapy at Each Stage of COPD1

When developing a successful treatment strategy for your patients, assessment of both FEV1 and symptoms is critical.1 Certain signs and symptoms may indicate inadequate control and the need to reevaluate your patients' treatment options.

Your patients can achieve rapid and sustained bronchodilation with twice-daily nebulization.* Nebulization with PERFOROMIST® Inhalation Solution may make the difference for your patients with COPD.

* PERFOROMIST should not be used for relief of acute episodes of bronchospasm.

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.