Approved Uses & Safety Info
Approved Uses
Important Safety Information
Approved Uses
Once-daily BREO is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both and to treat asthma in patients aged 5 years and older. BREO 100/25 mcg is the only strength approved for COPD. BREO is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.
Important Safety Information
- BREO contains vilanterol. Long-acting beta2-adrenergic agonist (LABA) medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
- Do not use BREO to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
- It is not known if BREO is safe and effective in children younger than 5 years of age.
- Do not use BREO if you have a severe allergy to milk proteins or are allergic to any of the ingredients in BREO. Ask your healthcare provider if you are not sure.
- Do not use BREO more often than prescribed.
- Do not take BREO with other medicines that contain a LABA for any reason. Tell your healthcare provider about all the medicines you take and about all of your health conditions.
- Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need your rescue inhaler more often than usual or it does not work as well to relieve your symptoms, or if your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
- BREO can cause serious side effects, including:
- fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREO to help reduce your chance of getting thrush.
- pneumonia. People with COPD have a higher chance of getting pneumonia. BREO may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: increase in mucus (sputum) production; change in mucus color; fever; chills; increased cough; increased breathing problems.
- weakened immune system and increased chance of getting infections (immunosuppression).
- reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroids and start taking inhaled corticosteroids.
- sudden breathing problems immediately after inhaling your medicine. If this happens, stop using BREO and call your healthcare provider right away.
- serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms: rash; hives; swelling of your face, mouth, and tongue; breathing problems.
- effects on heart: increased blood pressure; a fast or irregular heartbeat, awareness of heartbeat; chest pain.
- effects on nervous system: tremor; nervousness.
- bone thinning or weakness (osteoporosis).
- slowed growth in children.
- eye problems including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using BREO.
- changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
- Common side effects of BREO 100/25 for COPD include: runny nose and sore throat; upper respiratory tract infection; headache; thrush in your mouth or throat - rinse your mouth with water without swallowing after use to help prevent this; back pain; pneumonia; bronchitis; inflammation of the sinuses; cough; mouth and throat pain; joint pain; high blood pressure; flu; fever.
- Common side effects of BREO for asthma include: runny nose and sore throat; thrush in your mouth or throat - rinse your mouth with water without swallowing after use to help prevent this; headache; flu; respiratory tract infection; bronchitis; inflammation of the sinuses; mouth and throat pain; hoarseness and voice changes; cough.
