HOW TO USE BREO ELLIPTA

Instructions for using your BREO ELLIPTA inhaler

This demonstration is intended to complement the Patient Information for BREO ELLIPTA. For full instructions on how to use BREO ELLIPTA, and other important information, please see the complete Prescribing Information and Patient Information for BREO ELLIPTA. You can also ask your healthcare provider or pharmacist for more information.

Approved Uses

Once-daily BREO 100/25 is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. BREO is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

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.

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.
    • 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). 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 inhaled corticosteroid (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 COPD 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 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

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.