Not for Acute Symptoms: Inform patients that BEVESPI AEROSPHERE is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise them to treat acute symptoms with a rescue inhaler such as albuterol. Provide patients with such medicine and instruct them in how it should be used.
Instruct patients to seek medical attention immediately if they experience any of the following:
•
Symptoms get worse
•
Need for more inhalations than usual of their rescue inhaler
 
Patients should not stop therapy with BEVESPI AEROSPHERE without physician/provider guidance since symptoms may recur after discontinuation.     
Do Not Use Additional Long-Acting Beta2-Agonists: Instruct patients to not use other medicines containing a LABA. Patients should not use more than the recommended dose of BEVESPI AEROSPHERE.

Instruct patients who have been taking inhaled, short-acting beta2-agonists on a regular basis to discontinue the regular use of these products and use them only for the symptomatic relief of acute symptoms.

Paradoxical Bronchospasm: As with other inhaled medicines, BEVESPI AEROSPHERE can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue BEVESPI AEROSPHERE.

Risks Associated With Beta2-Agonist Therapy: Inform patients of adverse effects associated with beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Worsening of Narrow Angle Glaucoma: Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Worsening of Urinary Retention: Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Instructions for Administering BEVESPI AEROSPHERE

It is important for patients to understand how to correctly administer BEVESPI AEROSPHERE [see INSTRUCTIONS FOR USE].

Inform patients to use 2 inhalations of BEVESPI AEROSPHERE orally twice daily (2 inhalations in the morning and 2 inhalations in the evening).

Instruct patients to prime BEVESPI AEROSPHERE before using it for the first time. Instruct patients to prime BEVESPI AEROSPHERE by releasing 4 sprays into the air away from their face, shaking well before each spray. Inform patients that BEVESPI AEROSPHERE must be re-primed when the inhaler has not been used for more than 7 days. Instruct patients to re-prime BEVESPI AEROSPHERE by releasing 2 sprays into the air away from their face, shaking well before each spray.

Inform patients that it is very important to clean BEVESPI AEROSPHERE 1 time each week so that medicine will not build up and block the spray through the mouthpiece [see INSTRUCTIONS FOR USE]. Instruct patients to clean BEVESPI AEROSPHERE by taking the canister out of the actuator, running warm water through the actuator, and allowing the actuator to air-dry overnight. Instr