BREO ELLIPTA inhaler
BREO ELLIPTA inhaler

Welcome to the official product website for BREO for ASTHMA and BREO 100/25 for COPD

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Patient Information (PDF)

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ABOUT BREO

  • BREO for Asthma

    What is BREO used for?

    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.

    24 hours of better breathing

    BREO is a once-daily inhaled asthma combination treatment. It’s an inhaled corticosteroid (fluticasone furoate) and a long-acting beta2-adrenergic agonist (vilanterol) combined, shown to work for a full 24 hours, all day and night. Results may vary.

    Prevents asthma symptoms

    As part of your asthma maintenance plan, BREO can prevent symptoms such as wheezing, coughing, 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 reduce the days when an asthma 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 both airway inflammation and airway constriction caused by asthma with a combination of 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 asthma symptoms such as wheezing, coughing, chest tightness, and shortness of breath.

    Reduces future 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 a hospital stay or emergency room visit. Your results may vary.

    Talk to your doctor to see if BREO can help with your asthma.

  • BREO 100/25 for COPD

    What is BREO used for?

    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.

    Helps increase airflow for a full day

    BREO helps improve lung function by opening up the airways in your lungs for a full 24 hours so you can breathe better. Your results may vary.

    BREO is a combination of two medicines—an inhaled corticosteroid (ICS) medicine called fluticasone furoate, and a long-acting beta2-adrenergic agonist (LABA) medicine called vilanterol—creating the first and only once-daily ICS/LABA that helps improve lung function for a full 24 hours. Your results may vary.

    Helps reduce the number of future flare-ups if you’ve had one before

    BREO helps reduce the number of flare-ups, also called exacerbations. This is when your symptoms are worse than usual for several days and require steroids (oral or injectable), antibiotics, and/or a hospital stay. Your results may vary.

    Talk to your doctor to see if BREO can help with your COPD.

FREQUENTLY ASKED QUESTIONS

  • What are the approved uses for BREO?

    Asthma

    BREO is approved for people 18 years and older with asthma. BREO is a prescription medicine used as 1 inhalation 1 time each day to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing.

    BREO contains vilanterol. LABA (long-acting beta2-adrenergic agonist) medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO contains an ICS (inhaled corticosteroid) 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.

    BREO is not for people with asthma who are well controlled with an asthma control medicine, such as a low-to-medium dose of an ICS medicine. BREO is for adults with asthma who need both an ICS and a LABA medicine.

    BREO is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

    COPD

    BREO 100/25 is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both. BREO 100/25 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 used to relieve sudden breathing problems and won’t replace a rescue inhaler.

  • Can BREO be used to relieve sudden breathing problems?

    No. BREO does not relieve sudden symptoms of asthma, and you should not take extra doses of BREO to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

  • Is BREO approved for use in children or adolescents?

    No. 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.

  • What are the medicines in BREO and how do they work?

    BREO contains 2 medicines—an inhaled corticosteroid called fluticasone furoate, and a long-acting beta2-adrenergic agonist (LABA) called vilanterol. Fluticasone furoate helps decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. Vilanterol opens lung airways by helping the muscles around them stay relaxed, preventing symptoms.

  • When should BREO not be used?

    Do not use BREO:

    • to treat sudden, severe symptoms of asthma or COPD.
    • if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
    • if you are allergic to fluticasone furoate, vilanterol, or any of the ingredients in BREO.

  • What should I tell my healthcare provider before using BREO?

    Tell your healthcare provider about all of your medical conditions, including if you:

    • have heart problems.
    • have high blood pressure.
    • have seizures.
    • have thyroid problems.
    • have diabetes or have been told you have high blood sugar.
    • have liver problems.
    • have weak bones (osteoporosis).
    • have an immune system problem.
    • have eye problems such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision.
    • are allergic to milk proteins.
    • have any type of viral, bacterial, fungal, or parasitic infection.
    • are exposed to chickenpox or measles.
    • are pregnant or plan to become pregnant. It is not known if BREO may harm your unborn baby.
    • are breastfeeding. It is not known if the medicines in BREO pass into your breast milk and if they can harm your baby.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BREO and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

  • How should I use BREO?

    Read the step-by-step instructions for using BREO at the end of the Patient Information for BREO.

    • Do not use BREO unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
    • BREO comes in 2 different strengths. Your healthcare provider prescribed the strength that is best for you.
    • Use BREO exactly as your healthcare provider tells you to use it. Do not use BREO more often than prescribed.
    • Use 1 inhalation of BREO 1 time each day. Use BREO at the same time each day.
    • If you miss a dose of BREO, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.
    • If you take too much BREO, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
    • Do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
    • Do not stop using BREO unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
    • BREO does not relieve sudden symptoms of asthma or COPD and you should not take extra doses of BREO to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
    • Call your healthcare provider or get medical care right away if:
      • your breathing problems get worse.
      • you need to use your rescue inhaler more often than usual.
      • your rescue inhaler does not work as well to relieve your symptoms.
      • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

  • Should I stop taking BREO if my symptoms get better?

    Do not stop using BREO unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

  • What are the possible side effects of BREO?

    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). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as BREO). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.

       

      Symptoms of adrenal insufficiency 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, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using BREO.
    • high levels of blood sugar (hyperglycemia), which may cause increased thirst, frequent urination, or unexplained tiredness.
    • changes in laboratory blood levels, including low levels of potassium (hypokalemia).
    • slowed growth in children.

    Common side effects of BREO include:

    COPD:

    • 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
    • increased blood pressure
    • flu
    • fever

    These are not all the possible side effects of BREO.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Asthma:

    • 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

  • Will I taste or feel my dose of BREO after inhalation?

    You may not taste or feel the medicine, even when you are using the inhaler correctly. Do not take another dose from the inhaler even if you do not feel or taste the medicine.

  • What time should I take BREO?

    Use 1 inhalation of BREO 1 time each day. Use BREO at the same time each day. If you miss a dose of BREO, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.

  • Why is the dose counter on the inhaler important?

    Each time you fully open the cover of the inhaler (you will hear a clicking sound), a dose is ready to be inhaled. This is shown by a decrease in the number on the counter. Therefore, it is important to monitor the counter with each use to ensure there are doses remaining.

    If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in 1 inhalation.

    Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine.

    When you have fewer than 10 doses remaining in your inhaler, the left half of the counter shows red as a reminder to get a refill.

  • I thought the inhaler contained 60 doses of medicine. Why does the dose counter start at 30 rather than 60?

    Each inhaler of BREO contains 30 doses, which equals a 30-day supply. That’s why your dose counter starts at 30.

    BREO contains 2 medicines. Inside the inhaler, these 2 medicines are packaged in separate strips that each contain 30 blisters. When you open the inhaler (and hear the click), the contents of 1 blister from each strip combine to form 1 dose of BREO.

    You may see the quantity “60” mentioned in printouts about your prescription, but your inhaler provides 30 doses. The “60” refers to the number of blisters inside the inhaler and not the number of doses.

  • How will I know when the inhaler is empty?

    When the cover is closed and the counter shows “1,” you have one dose remaining. Open the cover and ensure that the counter decreases from 1 to 0. The last dose is now ready to be inhaled. After you have inhaled this last dose, no doses are remaining, and the inhaler will be empty.

  • Should I shake the inhaler?

    You do not need to shake this kind of inhaler. Read the step-by-step instructions for using BREO at the end of the Patient Information that comes with your medicine.

  • Can I eat or drink when using BREO?

    Rinse your mouth with water without swallowing after using BREO to help reduce your chance of getting thrush. After completing these steps, you may eat or drink normally.

  • How do I store BREO?

    • Store BREO at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
    • Store BREO in the unopened foil tray and only open when ready for use.
    • Safely throw away BREO in the trash 6 weeks after you open the foil tray or when the counter reads “0,” whichever comes first. Write the date you open the tray on the label on the inhaler.

    Keep BREO and all medicines out of the reach of children.

  • What are the ingredients in BREO?

    Active ingredients: fluticasone furoate, vilanterol trifenatate

    Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

  • Is BREO an anabolic steroid?

    No. BREO contains an ingredient called fluticasone furoate, which is a type of medicine called an inhaled corticosteroid (ICS). ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.

  • Can the inhaler be recycled?

    GSK cannot guarantee that BREO ELLIPTA inhalers or their contents can be fully recycled. Because waste disposal laws and regulations vary from state to state, check with your local or state goverment agency for guidance.

  • Are coupons available for BREO?

    We do not currently offer coupons for BREO.