Patients in Long-term Care Settings

Challenges Impact Medication Delivery

PERFOROMIST® Benefits for Residents and Staff

Nebulized PERFOROMIST Inhalation Solution offers symptom control in addition to other benefits for residents and staff.

Fewer Treatment Errors with Twice-Daily Nebulization3,4

Many residents with Chronic Obstructive Pulmonary Disease (COPD) in long-term care settings suffer from comorbidities which affect their cognitive, physical and breathing abilities.25,27 These primary diagnoses and comorbidities may predict potential difficulties with delivery of medication. And, as patients age, the incidence of errors in inhalation technique tends to increase.25 In fact, in a study of 316 patients with asthma or COPD, 89% of patients were unable to use their inhalers correctly.28

When one or more errors are made during treatment, an important consequence is that significant amounts of medication may fail to reach the lungs, resulting in a loss of medication efficacy.3,26 Nearly 20% of nursing home residents who have moderate to severe COPD—the number is rising each year—are the ones likely to make errors.19

When treated with twice-daily nebulization, residents in long-term care settings do not experience the errors of coordination and cooperation that occur when using MDIs or DPIs.3

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Benefits of nebulization in a variety of settings
More flexibility. Less steps to administer. No special techniques required. Coverage from NADONA 2010.
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Benefits of nebulization in a variety of settings
Important Safety Information
Prescribing Information

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Addressing Long-term Care Needs with Nebulization

COPD is prevalent in nursing homes; nearly one-fifth of nursing home residents are diagnosed with COPD.19 Common primary diagnosis of nursing home residents may predict potential difficulties with delivery of medication. It is estimated that 57% of residents have dementia and 74% have short-term memory loss.19 Nebulization addresses the needs of those in long-term care settings. It is an easy three step technique.14 Metered dose inhalers (MDIs) and dry powder inhalers (DPIs) also deliver medication but require many more steps—eight steps to administer DPI and nine for MDI.3 With several extra steps each of these inhalation devices present difficulties for residents in long-term care settings.

The requirement of tidal breathing makes it easy to administer nebulization, so residents get rapid and sustained bronchodilation with minimal effort.3 It is the easiest inhalation system for residents in long-term care settings to understand and use, which ensures compliance with therapy.3,12

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.