te bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)].
2 DOSAGE AND ADMINISTRATION
BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg) should be administered as two inhalations taken twice daily in the morning and in the evening by the orally inhaled route only. Do not take more than two inhalations twice daily.
BEVESPI AEROSPHERE contains 120 inhalations per canister. The canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable inhalations, the color behind the number in the dose indicator display window changes to red. BEVESPI AEROSPHERE should be discarded when the dose indicator display window shows zero.
Priming BEVESPI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BEVESPI AEROSPHERE before using for the first time. To prime BEVESPI AEROSPHERE, release 4 sprays into the air away from the face, shaking well before each spray. BEVESPI AEROSPHERE must be re-primed when the inhaler has not been used for more than 7 days. To re-prime BEVESPI AEROSPHERE, release 2 sprays into the air away from the face, shaking well before each spray.
3 DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol: BEVESPI AEROSPHERE is a pressurized metered dose inhaler that delivers 9 mcg of glycopyrrolate and 4.8 mcg of formoterol fumarate per inhalation. Two inhalations equal one dose. BEVESPI AEROSPHERE contains 120 inhalations per canister. The canister has an attached dose indicator and is supplied with a white plastic actuator with an orange dust cap.
4 CONTRAINDICATIONS
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication [see WARNINGS AND PRECAUTIONS (5.1)]. BEVESPI AEROSPHERE is not indicated for the treatment of asthma.
BEVESPI AEROSPHERE is contraindicated in patients with hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product [see WARNINGS AND PRECAUTIONS (5.5)].
5 WARNINGS AND PRECAUTIONS
5.1. Asthma-Related Death
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Data from a large placebo-controlled trial in subjects with asthma showed that LABAs may increase the risk of asthma-related death. Data are not available to determine whether the rate of death in patients with COPD is increased by LABAs.
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A 28-week, placebo-controlled US trial comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in subjects receiving salmeterol (13/13,176 in subjects treated with salmeterol vs. 3/13,179 in subjects treated with placebo; RR 4.37, 95% CI: 1.25, 15.34). The increased risk of asthma-related death is considered a class effect of LABAs, including formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE.
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No trial adequate to determine whether the rate of asthma-related deaths is increased in patients treated with BEVESPI AEROSPHERE has been conducted. The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma.
5.2. Deterioration of Disease and Acute Episodes
BEVESPI AEROSPHERE should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. BEVESPI AEROSPHERE has not been studied in patients with acutely |
