Description

Indications 

Bevespi Aerosphere is a prescribed inhalation aerosol indicated for the long-term treatment of adults with chronic obstructive pulmonary disease-COPD, including chronic bronchitis, emphysema, or both.  

Bevespi Aerosphere is a combination of two bronchodilators: long-acting muscarinic antagonist (LAMA) glycopyrrolate and long-acting beta-agonist (LABA) formoterol fumarate, which function differently to ease the tension in the muscles encircling the airways. While one relaxes the smooth muscles around the airways, the other inhibits their constriction, resulting in complementary therapeutic effects. 

Bevespi Aerosphere is not suitable for managing sudden COPD symptoms or as a rescue inhaler and is not indicated for asthma use. A separate rescue inhaler must always be carried to address sudden symptoms. 

Uses and Dosage 

Before using Bevespi Aerosphere and with each prescription refill, thoroughly review its medication guide and patient information leaflet. Talk to your doctor or pharmacist if you have any questions or concerns. 

Bevespi Aerosphere is intended for oral inhalation use only. If the aerosol accidentally comes in contact with the eyes, rinse them thoroughly with water, and contact your healthcare provider if redness persists. 

The usual dosing regimen for Bevespi Aerosphere involves 2 puffs, twice daily, administered in the morning and evening. 

To properly use Bevespi Aerosphere, follow these steps: 

1. Prime the inhaler by removing the cap and spraying 4 times into the air away from your face, before using it for the first time. Shake well before each spray. 
2. For daily use, remove the cap and shake well before each use. 
3. Breathe out fully through your mouth. 
4. Place the mouthpiece in your mouth and tilt your head back with your tongue below the mouthpiece. 
5. Press the dose indicator while breathing in deeply and slowly, until the canister stops moving and a puff of medicine is released. Then stop pressing. 
6. After receiving the dose, remove the mouthpiece from your mouth and hold your breath for up to ten seconds or as comfortable, followed by a gentle exhale. 
7. Allow an interval of 1 minute and repeat steps 3-6 for the second dose. 
8. Immediately replace the cap over the mouthpiece after each use. 

To maintain proper functionality and prevent blockage of the mouthpiece spray, clean your inhaler once a week 

Reprime the inhaler by releasing 2 puffs into the air away from your face every after cleaning and if you have not used it for more than 7 days. Shake well before each spray. 

For optimal results, use Bevespi Aerosphere regularly at consistent times each day. Consult your doctor before increasing your dosage, using it more frequently, or discontinuing use, as doing so will not improve your condition any faster and may increase the risk of side effects. 

Inform your doctor if your condition fails to improve or deteriorates. 

Side Effects 

Listed below are the side effects associated with the use of Bevespi Aerosphere. If any of them last or worsen, tell your doctor promptly. 

Common Side Effects 

• Cough 
• Urinary tract infection 

Serious Side Effects 

• Sudden breathing problems after inhalation 
• Chest pain, increased blood pressure, fast or irregular heartbeat 
• Tremor or nervousness 
• New or exacerbated issues with the eyes, such as acute narrow-angle glaucoma. Symptoms may include: 
  • Eye pain or discomfort 
  • Nausea or vomiting 
  • Blurred vision 
  • Seeing halos or bright colors around lights 
  • Red eyes 
• New or worsened urinary retention: 
  • Difficulty urinating 
  • Painful urination 
  • Urinating frequently 
  • Urinating in a weak stream or drips 
• High blood sugar or low blood potassium 

Call your doctor right away if you experience any of the above-mentioned symptoms. 

Allergic Reactions 

In rare cases, Bevespi Aerosphere may cause a severe allergic reaction. Get emergency medical care if you experience any of the following symptoms of a serious allergic reaction: 

• Rash 
• Hives 
• Face, mouth, or tongue swelling  
• Breathing problems 

This list does not contain all the potential side effects of Bevespi Aerosphere. If you experience any other effects not mentioned above, tell your doctor promptly. 

Cautions 

Before using Bevespi Aerosphere, inform your doctor and pharmacist if you have any known hypersensitivities, especially to glycopyrrolate, formoterol, other medicines, or any ingredients present in this inhaler.  

To ensure Bevespi Aerosphere is safe for you, disclose to your physician your medical background, specifically regarding any history of: 

• Heart problems (e.g., chest pain, irregular heartbeat) 
• High blood pressure 
• Seizures 
• Overactive thyroid 
• Diabetes 
• Personal or family history of glaucoma (angle-closure type) 
• Difficulty urinating (e.g., due to an enlarged prostate) 

To avoid potential drug interactions that can impact the efficacy of Bevespi Aerosphere or lead to unfavorable reactions, inform your doctor and pharmacist of all medications you’re presently taking, such as prescription and non-prescription drugs, dietary supplements, and herbal products. 

Avoid using other anticholinergic drugs (e.g., ipratropium, tiotropium) or LABA drugs (e.g., salmeterol, vilanterol) while using Bevespi Aerosphere. 

Bevespi Aerosphere may lead to QT prolongation, which can result in a rare but severe and potentially fatal fast or irregular heartbeat and other symptoms such as severe dizziness and fainting. Immediate medical attention is necessary if such symptoms occur. 

The use of Bevespi Aerosphere during pregnancy is warranted only if its potential benefits outweigh the risks to the fetus. Women prescribed with this inhaler should promptly notify their physicians if they become pregnant. 

The excretion of glycopyrrolate and formoterol fumarate into breast milk is uncertain. Consult your physician prior to breastfeeding when using this inhaler.