Safety Profile

Adverse Events Similar to Placebo

The safety profile of PERFOROMIST® was demonstrated in a 12-week trial, with the overall incidence of adverse events for PERFOROMIST comparable with placebo (51.2% vs. 57%, respectively).2,9

Incidence of specific treatment-emergent adverse events (incidence ≥2% and greater than placebo):

Side Effect Profile2,9

* The most common adverse events (reported in ≥2% of patients and occurring more frequently than with placebo).

PERFOROMIST has demonstrated a side effect profile similar to placebo with no reported tremor or agitation.9 Another important finding from the 12-week trial was the higher incidence of Chronic Obstructive Pulmonary Disease (COPD) exacerbation side effects in the placebo group (7.9%) compared with the PERFOROMIST group (4.1%).9

Cardiac Monitoring in a Clinical Trial

Cardiovascular issues are often a concern with treatment for the elderly patient population with COPD. However, clinically significant cardiac adverse events with PERFOROMIST were similar to those of placebo over 12 weeks, including QTc prolongation, cardiac arrhythmias and heart rate.8

The study was not powered to detect significant between-group differences in cardiac tolerability.8 In addition, the study excluded patients with severe cardiac abnormalities.8 PERFOROMIST, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by increased pulse rate, systolic and/or diastolic blood pressure, and/or symptoms.9

Long-term study results with PERFOROMIST were also impressive. In a 52-week study, there were no clinically relevant changes from baseline ECG measurements or Holter monitoring, including a low incidence of prolonged QTc, and no treatment-related increases in cardiac effects.15

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.

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.

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.