ABOUT BREO ELLIPTA

Once-daily BREO is a prescription medicine for adults with asthma who need both an ICS (inhaled corticosteroid) and a LABA (long-acting beta2-adrenergic agonist) medicine. BREO is not for people whose asthma is well controlled on an asthma control medicine, like an ICS. BREO is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.


Once-daily BREO helps improve breathing for a full 24 hours.

BREO is the first and only once-daily inhaled asthma combination treatment—an inhaled corticosteroid (fluticasone furoate) and a long-acting beta2-adrenergic agonist (vilanterol)—that has been shown to work all day and night, for a full 24 hours. It opens up airways in the lungs for better breathing. Your results may vary.


BREO helps prevent asthma symptoms from occurring in the first place.

BREO prevents symptoms such as wheezing, cough, chest tightness, and shortness of breath and can help keep them from coming back. Your results may vary.

Taking once-daily BREO every day can also reduce the days when asthma symptoms occur and reduce the days when a rescue inhaler is needed. Your results may vary.

BREO is not a rescue medicine and should not be used to treat sudden symptoms of asthma.


BREO treats two of the main causes of asthma symptoms.

Two of the main causes of asthma symptoms are airway inflammation and airway constriction. BREO treats these two causes with a combination of two medicines:

  • Fluticasone furoate helps decrease inflammation in the lungs. Inflammation can lead to breathing problems.
  • Vilanterol opens lung airways by helping the muscles around them stay relaxed, preventing symptoms such as wheezing, coughing, chest tightness, and shortness of breath.

BREO has been shown to reduce the risk of future asthma flare-ups.

In people with a history of asthma flare-ups (or "exacerbations"), BREO has been shown to reduce the risk of future flare-ups. A flare-up is a time when asthma symptoms have worsened and are severe enough to require treatment with steroids, or also a hospital stay or emergency department visit. Your results may vary.


Talk to your doctor to see if BREO fits into your asthma treatment.

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Important Safety Information for BREO ELLIPTA

  • BREO contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO contains an 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.

Important Safety Information for BREO ELLIPTA

  • BREO contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO contains an 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.
  • BREO should not be used in children and adolescents. It is not known if BREO is safe and effective in children and adolescents younger than 18 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.
    • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye may occur.
    • reduced adrenal function (adrenal insufficiency). This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an ICS (such as BREO). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse chronic obstructive pulmonary disease symptoms, adrenal insufficiency can get worse and may cause death. Symptoms include: feeling tired; lack of energy; weakness; nausea and vomiting; low blood pressure (hypotension).
    • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop taking 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 of a serious allergic reaction: 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)
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using BREO.
    • changes in laboratory blood values: high blood sugar (hyperglycemia) and low potassium (hypokalemia).
    • slowed growth in children.
  • 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.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.