t (Figure 2) are shown below.
Figure 1 Mean* FEV1 at Day 1
Figure 1 Mean* FEV1 at Day 1
Figure 2 Mean* FEV1 at Endpoint after 12 Weeks of Treatment
* Figures show least-squares means adjusted for baseline FEV 1
Patients treated with PERFOROMIST Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.
Examination of age (≥ 65 or younger) and gender subgroups did not identify differences in response to PERFOROMIST Inhalation Solution. There were too few non-Caucasian subjects to assess differences in populations defined by race adequately.
In the 12 week study, 78% of subjects achieved a 15% increase from baseline FEV1 following the first dose of PERFOROMIST Inhalation Solution 20 mcg. In these subjects, the median time to onset of bronchodilation, defined as 15% increase in FEV1, was 11.7 minutes. When defined as an increase in FEV1 of 12% and 200 mL, the time to onset of bronchodilation was 13.1 minutes after dosing. The median time to peak bronchodilator effect was 2 hours after dosing.
16 HOW SUPPLIED/STORAGE AND HANDLING
PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a 2 mL sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below.
Carton of 30 individually wrapped unit dose vials, NDC 49502-605-30
Carton of 60 individually wrapped unit dose vials, NDC 49502-605-61
Storage and Handling:
Prior to dispensing to the patient: Store in a refrigerator, 2°C to 8°C (36°F to 46°F)
After dispensing to the patient: Store at 2°C to 25°C (36°F to 77°F) for up to 3 months. Protect pouch from heat.
• PERFOROMIST Inhalation Solution should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a facemask or mouthpiece.
•
Vial should always be stored in the foil pouch, and only removed IMMEDIATELY before use.
•
Do not take by mouth.
•
Contents of any partially used container should be discarded.
•
Discard the container and top after use.
•
Keep out of the reach of children
17 PATIENT COUNSELING INFORMATION
Asthma-Related Death
Patients should be informed that long acting beta agonist, such as PERFOROMIST, increase the risk of asthma-related death. All LABA, including PERFOROMIST, should not be used in patients with asthma without use of a long-term asthma control medication.
Acute Exacerbations or Deteriorations
PERFOROMIST Inhalation Solution is not indicated for relief of acute symptoms, and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist (the healthcare provider should provide the patient with such medication and instruct the patient in how it should be used). Patients should be instructed to seek medical attention if their symptoms worsen despite recommended doses of PERFOROMIST Inhalation Solution, if PERFOROMIST Inhalation Solution treatment becomes less effective, or if they need more inhalations of a short-acting beta2-agonist than usual.
Appropriate Dosing
Patients should not stop using PERFOROMIST Inhalation Solution unless told to do so by a healthcare provider because symptoms may get worse. Patients should not inhale more than the prescribed num
