RISKS & SIDE EFFECTS

Please review this safety information.

Below you can learn about the risks and side effects of BREO ELLIPTA. This, however, is not all the safety information, and does not replace talking with your healthcare provider about your medical condition or treatment. Please see the complete Prescribing Information including Boxed Warning and Medication Guide for BREO ELLIPTA for more information or ask your healthcare provider or pharmacist.

What is the most important information I should know about BREO ELLIPTA?

BREO can cause serious side effects, including:

  • 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. You may need different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly.
    • you use your rescue inhaler, but it does not relieve your breathing problems.
  • For people with asthma, 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.

Is BREO ELLIPTA 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.

Can BREO ELLIPTA be used to relieve sudden breathing problems?

No. BREO is not used to relieve sudden breathing problems and will not replace a rescue inhaler. 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.

Who should not use BREO ELLIPTA?

Do not use BREO ELLIPTA:

  • 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 ELLIPTA. See "What are the ingredients in BREO ELLIPTA?" below for a complete list of ingredients.

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

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.
  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • 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 ELLIPTA?

Read the step-by-step instructions for using BREO at the end of the Medication Guide.

  • 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 one 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.

What are the possible side effects with BREO ELLIPTA?

BREO can cause serious side effects, including:

  • See "What is the most important information I should know about BREO ELLIPTA?" above.
  • 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)
  • 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 inhaled corticosteroid (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
  • 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 levels, including high levels of blood sugar (hyperglycemia) and low levels of 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

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.

What are the ingredients in BREO ELLIPTA?

Active ingredients: fluticasone furoate, vilanterol trifenatate

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

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.