Patient Profiles

Successful Maintenance Therapy for Certain Patients

Although medication delivered by nebulizers can be effective for all patients, there are some for whom it may be particularly appropriate.

Ralph* - Breathing limitations may impair the ability of the patient to receive the full dose from a DPI

case study

"When I use my inhaler, I can't take a deep breath. Am I getting enough medicine?"

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*Not an actual patient

"When I use my inhaler, I can't take a deep breath. Am I getting enough medicine?"

Patient Description - 72-year-old male
- Retired teacher
- History of smoking: 2-3 packs/day for 50 years
Chief Complaint† - Difficulty breathing
- Unable to walk short distances
- Frequent use of rescue medication
- Trouble sleeping
Upon
Exam 		- Shortness of breath when walking to exam room
- FEV1: 45% predicted
- Upon measurement of peak inspiratory flow rate, patient cannot fully inspire to receive an adequate dose of COPD medication from his dry powder inhaler (DPI)
Diagnosis - Severe COPD

CONCLUSION

Patient is currently being treated for COPD, but symptoms have increased in the last 6 months since his previous visit.

NEXT STEPS

Consider twice-daily nebulization with PERFOROMIST® (formoterol fumarate) Inhalation Solution.

About Patients with Breathing Limitations

Patients may not be able to fully exhale or fully inspire. This breathing limitation impacts their ability to get the full dose of medication, which can lead to suboptimal drug deposition in the lung and reduced therapeutic effects. Elderly patients, in particular, have breathing limitations that reduce their ability to achieve rapid, full inspiration. Most DPI systems require moderate to high inspiratory flow rate for adequate drug delivery. With nebulization, tidal breathing is the only requirement for patients to get their full dose of medication.

†PERFOROMIST® has not been demonstrated to treat these signs and symptoms.

Janice* - Her COPD is not adequately controlled

case study

"I need to use my albuterol inhaler more and more. Why is this happening?"

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*Not an actual patient

"I need to use my albuterol inhaler more and more. Why is this happening?"

Patient Description - 53-year-old female
- Housewife
- Frequent use of albuterol
- History of smoking: 2 packs/day for 32 years
Chief Complaint† - Dyspnea when climbing stairs and cleaning house
- Feels she cannot do the same activities she could 6 months ago
Upon
Exam 		- FEV1: 60% predicted
- More frequent use of rescue albuterol
Diagnosis - Moderate COPD

CONCLUSION

Patient is currently being treated for COPD, but symptoms have increased in the last 6 months since her previous visit.

NEXT STEPS

Consider initiating twice-daily nebulization with PERFOROMIST® (formoterol fumarate) Inhalation Solution.

About Patients Uncontrolled on Rescue Medication

Patients who use excessive short-acting rescue medication for maintenance therapy may still lack control of symptoms. Twice-daily nebulization reduced the need for more frequent use of rescue medication in a clinical trial of 351 patients with moderate to severe COPD. Average daily albuterol usage (puffs per day) was reduced from approximately 2.7 to 1.25 after 12 weeks.

†PERFOROMIST® has not been demonstrated to treat these signs and symptoms.

Jose* - Prefers COPD treatment through nebulization

case study

"All I have to do is breathe normally with my nebulizer and I know I can get all of my medicine."

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*Not an actual patient

"All I have to do is breathe normally with my nebulizer and I know I can get all of my medicine."

Patient Description - 60-year-old male
- Office manager
- History of smoking: 2 packs/day for 28 years
Chief Complaint† - Shortness of breath
- When using his dry powder inhaler (DPI), patient feels he does not receive full amount of medication; some stays in his mouth
- Has had 2 recurrences of thrush
- Frequent cough, often with mucus
Upon
Exam 		- Shortness of breath
- FEV1: 69% predicted
- Patient prefers nebulization because of previous positive experience
Diagnosis - Moderate COPD

CONCLUSION

Patient is currently being treated for COPD, but symptoms have persisted in the last 6 months since his previous visit.

NEXT STEPS

Consider twice-daily nebulization with PERFOROMIST® (formoterol fumarate) Inhalation Solution.

About Patients Who Prefer Nebulization

Patients may prefer twice-daily nebulization for many reasons. Perhaps they have difficulty performing the correct inhaler technique with an MDI or DPI. They may notice increased use of short-acting beta2-agonists without sustained benefit. Based on results from the Nebulization for Easier Breathing (NEB) survey, patients are very satisfied with nebulization. The survey of 800 participants was completed in March 2009—400 participants were patients with COPD and 400 were caregivers of patients. Of the surveyed patients, 91.3% agreed that they were able to breathe easier as a result of nebulization. Patients were satisfied with their current nebulized treatment (89% of patients) and stated that nebulization helped them live more active lives (74% of patients). 25% of patients cited device immobility as a disadvantage.

†PERFOROMIST® has not been demonstrated to treat these signs and symptoms.

Marie* - Physically challenged; cannot correctly operate her inhaler

case study

"My hands hurt so much, I can’t use my inhaler right. Am I getting all the medicine I need?"

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*Not an actual patient

"My hands hurt so much, I can’t use my inhaler right. Am I getting all the medicine I need?"

Patient Description - 68-year-old female
- Librarian
- History of smoking: 2 packs/day for 28 years
Chief Complaint† - Shortness of breath when climbing stairs or walking long distances
- Trouble sleeping
- Using rescue medication multiple times per day
Upon
Exam 		- Wheezing, productive cough
- FEV1: 65% predicted
- Arthritic pain in extremities
- Difficulty holding inhaler when asked to demonstrate device usage
Comorbidities - Osteoarthritis of hands that limits dexterity
Diagnosis - Moderate COPD

CONCLUSION

Patient is currently being treated for COPD with handheld inhaler devices, but has experienced difficulty using them.

NEXT STEPS

Consider twice-daily nebulization with PERFOROMIST® (formoterol fumarate) Inhalation Solution.

About Patients Who Are Physically Challenged

Many patients with Chronic Obstructive Pulmonary Disease (COPD) are physically challenged with conditions such as arthritis, stroke, Parkinson's disease, or hearing or visual difficulties. These physical challenges impact patients' ability to perform the correct inhaler technique. Specifically, patients with physical challenges may experience difficulty and discomfort when using an MDI or DPI due to the multiple steps involved, pain from arthritis, tremors, or muscle rigidity. They may also have trouble listening to or watching device usage instructions. Nebulization only requires tidal breathing. A less than optimal inhaler technique can affect delivery, potentially compromising efficacy of the medication.

†PERFOROMIST® has not been demonstrated to treat these signs and symptoms.

Joey* - Cognitively impaired; does not comprehend or remember instructions

case study

"He just doesn’t understand how to use his inhaler; he gets confused. Is he getting enough medicine?"

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*Not an actual patient

"He just doesn’t understand how to use his inhaler; he gets confused. Is he getting enough medicine?"

Patient Description - 70-year-old male
- Former crane operator
- History of smoking: 2 packs/day for 31 years
Chief Complaint† - Dyspnea
- Inability to walk distances that were previously achievable
Upon
Exam 		- Severe shortness of breath while talking, barrel chest, and pursed-lip breathing
- FEV1: 40% predicted
- Frequent use of rescue medication
- Spouse confirms Joey’s confusion in how to utilize inhaler
- Upon device demonstration, patient has consistent difficulty remembering instructions
Comorbidities - Cognitive impairment
Diagnosis - Severe COPD

CONCLUSION

Patient is currently being treated for COPD with handheld inhaler devices, but cannot remember or comprehend instructions.

NEXT STEPS

Consider twice-daily nebulization with PERFOROMIST® (formoterol fumarate) Inhalation Solution.

About Patients Who Are Cognitively Impaired

A substantial number of patients with COPD may suffer from neurological disorders, including cognitive impairment, dementia, or short-term memory loss. Patients with COPD may also have Alzheimer's disease. Cognitive impairments limit patients' ability to understand and recall instructions of the multiple steps necessary for correct inhaler technique with an MDI or DPI. With nebulization, tidal breathing is the only requirement for patients to get their full dose of medication.

†PERFOROMIST® has not been demonstrated to treat these signs and symptoms.


*These photographs do not represent actual patients

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.

Important Limitations for Use:

  • It is not indicated to treat acute deteriorations of COPD
  • It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

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.

Important Safety Information

PERFOROMIST Inhalation Solution like other LABAs is contraindicated in patients with asthma without use of a long term asthma control medication.

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, i.e., as rescue therapy for the treatment of acute episodes of 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.

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.

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.

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, like other sympathomimetic amines, should be used with caution. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Beta agonist medications may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

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.

Beta-blockers and formoterol fumarate may inhibit the effect of each other when administered concurrently. Therefore, patients with COPD should not normally be treated with beta-blockers except under certain circumstances e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD.

Concomitant treatment with Xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution is advised in the co-administration.

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Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.