PERFOROMIST
Profiles

COPD Patient Insights

How to screen patients who may benefit from a nebulized LABA

It’s important to periodically evaluate your COPD patients’ treatment. Smoking cessation is the single most effective method for slowing disease progression.1 Despite pharmacotherapy, most patients with COPD will progress over time.1 It is important to always reassess your COPD patients.

PATIENT PROFILE I

Sarah

Sarah's Story*

  • Diagnosed with COPD 5 years ago
  • Currently on COPD maintenance therapy but finds it difficult to take deep breaths
  • FEV1 value has decreased since her last visit 6 months ago

Questions to ask Sarah:

  • Do you ever feel you can’t breathe in all the way?
  • Are you able to take in all the medicine from your current maintenance therapy?
  • How often do you use your rescue inhaler?
*Not an actual patient.

PATIENT PROFILE II

Jeff

Jeff's Story*

  • 71 years old
  • Reluctant to start COPD maintenance treatment due to cost of prescription medicines
  • Finds insurance paperwork confusing and burdensome

Questions to ask Jeff:

  • Are you taking your medicines differently than they are prescribed to save money?
  • Are you filling your prescription in a timely manner so that you always have your COPD medication available?
  • Have you not received your treatment on time recently due to problems filling out the required paperwork?
*Not an actual patient.

PATIENT PROFILE III

David

David's Story*

  • Regularly uses his nebulized SABA 4 times a day
  • His symptoms have worsened

Questions to ask David:

  • Do you use your rescue medication on a regular basis? How often?
  • Have your symptoms worsened over the last 6 months?
  • Do you have a hard time taking deep breaths?
*Not an actual patient.

PATIENT PROFILE IV

Ruth

Ruth's Story*

  • 70 years old
  • Just diagnosed with COPD
  • FEV1 value of 1.3 L
  • Symptoms undiagnosed for several years
  • Caretaker concerned patient can’t adequately manage hand-breath coordination

Questions to ask Ruth:

  • Are you aware of the various options of COPD treatment delivery devices?
  • Can you please test the following devices and tell me your preference?
*Not an actual patient.

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Important Safety Information

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.

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.

The most common adverse reactions (≥2% and more common than placebo) with PERFOROMIST are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

Prescribing Information Show More

Important Safety Information

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.

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.

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.

The most common adverse reactions (≥2% and more common than placebo) with PERFOROMIST are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

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