The Role of Nebulization with a LABA

Effective, Twice-Daily Delivery

Nebulization is an effective delivery technique for your patients with Chronic Obstructive Pulmonary Disease (COPD) who receive treatment in various care settings. Nebulizers can be used at any age across all stages of disease severity or acuity.12,13 By delivering medication through tidal breathing, nebulization requires little or no coordination or cooperation on the part of the patient.3 This provides ease in administration that is not available with other delivery methods.3 Consider an easy, effective treatment option—twice-daily nebulization for patients receiving treatment in long-term care facilities, in hospitals and at home.

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How to Neb
Patients can use nebulizers anywhere. It's an easy, 3-step process to "neb".
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"How to Neb with Perforomist®"

Patients can benefit from twice-daily nebulization—anywhere. Patients, caregivers and health care professionals follow an easy, three step process to "neb":14

  1. Twist off cap of vial and transfer PERFOROMIST Inhalation Solution to the nebulizer medicine cup (reservoir).
  2. Connect the nebulizer reservoir to the mouthpiece or mask, and connect nebulizer to the compressor.
  3. Insert mouthpiece or put on mask and turn on compressor to start nebulization.

Calm, deep, even breathing is encouraged, until there is no longer any visible mist in the nebulizer reservoir. And, treatment for your patients does not take long—under 10 minutes.

After nebulization, patients remove the mouthpiece (or mask) and the T-shaped part of reservoir cup. These two pieces should be rinsed in warm, soapy water for 30 seconds. Do not rinse tubing. Simply let these two pieces air-dry on a clean cloth or hand-dry with a lint-free cloth.

Optimal Drug Delivery

Nebulization enables medication, such as a long-acting beta2-agonist (LABA), to be delivered without the use of propellants required in a metered dose inhaler (MDI).3,13 By aerosolizing the medication, nebulization avoids clumping of particles, thus optimizing drug delivery to allow medication to reach the lungs.3,12 Generating a mist that is visible for several minutes also helps patients feel confident that they are receiving appropriate treatment.13,14 The three step process is easy for your patients to follow.14

Fewer Steps, Greater Flexibility

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 many steps, both of these inhalation devices present several difficulties.3 Improper device use with an MDI or DPI could lead to inadequate control and a shortness of breath, decline in FEV1 and exacerbations.1,4

MDI

  • Combine speed with portability, but require patients to coordinate timing of inhalation with squeezing of device3
  • Up to 70% of patients do not use MDIs properly3

DPI

  • Are breath-actuated and require a moderate to high inspiratory flow rate3
  • Patients must inhale rapidly for proper drug aerosolization—which may be difficult for someone with COPD3

It is clear to see why nebulization is noticeably easier to administer. Since all these devices effectively deliver medication when used correctly, consider the number of steps required for your patients to get symptom relief.1,3,4 Twice-daily nebulization with long acting bronchodilators also reduces the treatment burden associated with more frequent dosing with nebulized short-acting beta2-agonists (SABA) that patients use throughout the day.1

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Nebulizers: A Device Choice
Reduce the number of steps - reduce technique-related errors. The device may make the difference for certain patients.
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Nebulizers: A Device Choice
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Evolution of Nebulizers

Although nebulizer systems were bulky in the past, newer models have significantly improved.13 Today, nebulizer systems are smaller in size and can be battery operated with greater portability—which provides your patients with more flexibility.13 Nebulizers can be used effectively by anyone, anywhere, at any time.13

Nebulization: Effective in Various Care Settings

Nebulization can be particularly effective when used in various patient care settings. The ease and convenience of nebulization at home may encourage and support patient compliance with treatment.12 Long-term care facilities or hospitals providing care for elderly or other compromised patients will also find that nebulization is a very effective method of delivering medication to residents or patients who have difficulty using other devices.

Patients May Benefit from Twice-Daily Nebulized PERFOROMIST

Patients may benefit from twice-daily, nebulized PERFOROMIST as demonstrated by health status improvement in domains measured by the St. George's Respiratory Questionnaire (SGRQ). Developed and validated in COPD, the self-reported SGRQ determines the degree of health status improvement in7

  • Symptoms (frequency and severity)
  • Activity (activities that cause or are limited by breathlessness)
  • Impact (social functioning or psychological disturbances resulting from airway disease)

Patients treated with PERFOROMIST showed statistically and clinically significant improvements in total SGRQ score vs placebo (P≤.03). In addition, they also showed significant improvement in both Symptom and Impact scores (P≤.03).

Results from the SGRQ reported that patients treated with PERFOROMIST were able to be more active, although PERFOROMIST has not been demonstrated to have an impact on disease progression in patients with COPD. Patient improvement is important as the GOLD guidelines highlight increasing patient participation in everyday activities as a key goal of treatment in COPD.1

Improvement in St. George's Respiratory Questionnaire (SGRQ) as reported in the PERFOROMIST pivotal clinical trial2,7 †

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

† The SGRQ measures the health and overall well-being of patients with airway diseases and has been shown to provide reproducible and valid results. The SGRQ is a standardized, self-administered questionnaire.7

‡ As measured by 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

Easy and Effective

It only takes three steps for your patients with COPD to achieve rapid and sustained bronchodilation with twice-daily PERFOROMIST nebulization. Review patient profiles and their treatment settings:

Patient Profiles

Patient 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.