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 your talking to your healthcare professional 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 ELLIPTA 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 ELLIPTA), have an increased risk of death from asthma problems. It is not known whether fluticasone furoate, the other medicine in BREO ELLIPTA, reduces the risk of death from asthma problems seen with LABA medicines.
  • It is not known if LABA medicines, such as vilanterol, increase the risk of death in people with COPD.
  • Call your healthcare provider if breathing problems worsen over time while using BREO ELLIPTA. 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

Who should not use BREO ELLIPTA?

Do not use BREO ELLIPTA if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • 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 health 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 any of the ingredients in BREO ELLIPTA, any other medicines, or food products. See “What are the ingredients in BREO ELLIPTA?” below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if BREO ELLIPTA may harm your unborn baby.
  • are breastfeeding. It is not known if the medicines in BREO ELLIPTA pass into your 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 ELLIPTA 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.

What are the possible side effects with BREO ELLIPTA?

BREO ELLIPTA can cause serious side effects, including:

  • See “What is the most important information I should know about BREO ELLIPTA?”
  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREO ELLIPTA to help reduce your chance of getting thrush.
  • pneumonia. People with COPD have a higher chance of getting pneumonia. BREO ELLIPTA 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 inhaled corticosteroid (such as BREO ELLIPTA). 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 ELLIPTA 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 ELLIPTA.
  • changes in laboratory blood values (sugar, potassium)
  • slowed growth in children

Common side effects of BREO ELLIPTA 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.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with BREO ELLIPTA. Ask your healthcare provider or pharmacist for more information.

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

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. It is not known if LABA medicines increase the risk of death in people with COPD.

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 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 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.
    • 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.
    • 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).
  • 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

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.