TALK TO YOUR DOCTOR ABOUT BREO ELLIPTA

Ask your doctor if BREO is right for you

Only your healthcare provider can tell you which asthma medication is right for you. It is a good idea to assess your asthma regularly and share your assessment with your healthcare provider.

Before your visit

Before your next appointment with your healthcare provider, think about your current treatment plan and how well your asthma symptoms are controlled.

Download and print out the following Doctor Discussion Guide and write down your answers to help you and your healthcare provider have a better discussion about how well your asthma symptoms are controlled. This may help your healthcare provider determine if BREO could be right for you.

Doctor Discussion Guide

The responses to these questions are not intended to diagnose a condition or disease state and do not replace the advice of your doctor.

  1. Are you still having asthma symptoms on your current medication?
  2. How often are you using your rescue inhaler?
  3. Have you had an asthma flare-up in the past? If so, when?
  4. Do you feel in control of your asthma today? In the past month?
  5. What are your goals for asthma treatment?

A flare-up is a time when symptoms have worsened and are severe enough to require treatment with steroids, or also a hospital stay or emergency department visit.

Once-daily BREO is a prescription medicine for adults whose asthma is not well controlled on a long-term asthma control medicine, like an inhaled corticosteroid. BREO is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

IMPORTANT SAFETY INFORMATION

  • 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.

IMPORTANT SAFETY INFORMATION

  • 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 whether fluticasone furoate, the other medicine in BREO, reduces the risk of death from asthma problems seen with LABA medicines.
  • 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.
  • BREO should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.
  • When your asthma is well controlled, your healthcare provider may tell you to stop taking BREO. Your healthcare provider will decide if you can stop BREO without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
  • 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 to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
  • 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.
  • 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 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 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.
    • 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 (sugar, potassium)
    • 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.