IMPORTANT SAFETY INFORMATION

BREO ELLIPTA is only approved for use in chronic obstructive pulmonary disease (COPD). BREO is NOT approved for use in asthma. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in BREO), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.
See full Important Safety Information below ▼

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Approved Uses

BREO ELLIPTA is approved for adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both. BREO ELLIPTA is a prescription medicine that is used long term as 1 inhalation 1 time each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days). BREO is not for use to treat sudden symptoms of COPD and won't replace a rescue inhaler. BREO is not for the treatment of asthma.

IMPORTANT SAFETY INFORMATION

  • BREO ELLIPTA is only approved for use in COPD. BREO is NOT approved for use in asthma.
  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as vilanterol (one of the medicines in BREO), have an increased risk of death from asthma problems. It is not known if LABA medicines increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using BREO.
  • Get emergency medical care if your breathing problems worsen quickly, or if you use your rescue inhaler but it does not relieve your breathing problems.
  • Do not use BREO to treat sudden symptoms of COPD. Always have a rescue inhaler with you to treat sudden symptoms.
  • BREO is not for the treatment of asthma. It is not known if BREO is safe and effective in people with asthma.
  • Do not use BREO if you have severe allergy to milk proteins or 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.
  • BREO can cause serious side effects, including:
    • 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
    • thrush (fungal infection) in mouth and/or throat. You may develop a yeast infection (Candida albicans) in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent thrush in your mouth and throat.
    • 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 the face, mouth, and tongue
      • breathing problems
    • sudden breathing problems immediately after inhaling your medicine
    • effects on heart
      • increased blood pressure
      • a fast and/or irregular heartbeat
      • chest pain
    • effects on nervous system
      • tremor
      • nervousness
    • reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as BREO). Symptoms include: feeling tired; lack of energy; weakness; nausea and vomiting; low blood pressure.
    • changes in laboratory blood values (sugar, potassium)
    • 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 (ocular herpes simplex) may occur.
    • bone thinning or weakness (osteoporosis)
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using BREO.
  • Common side effects of BREO include:
    • runny nose and sore throat
    • upper respiratory tract infection
    • headache
    • thrush in mouth and/or throat. Rinse your mouth without swallowing after use to help prevent this

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.

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