FREQUENTLY ASKED QUESTIONS

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Here are answers to some frequently asked questions about BREO ELLIPTA. Talk to your doctor to learn more.

WHAT IS THE APPROVED USE FOR BREO FOR ASTHMA?

BREO ELLIPTA is approved for people 18 years and older with asthma. BREO is a prescription medicine used as 1 inhalation 1 time each day to control symptoms of asthma for better breathing and to prevent symptoms such as wheezing. 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. BREO is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

HOW CAN BREO HELP MY ASTHMA?

BREO is used to prevent and control symptoms of asthma, such as wheezing.

BREO is the first and only once-daily inhaled asthma combination treatment that helps patients breathe better by improving lung function for a full 24 hours. Your results may vary.

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

WHAT ARE THE MEDICINES IN BREO AND HOW DO THEY WORK?

BREO contains two 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.

CAN BREO HELP CONTROL MY ASTHMA SYMPTOMS?

Once-daily BREO combines 2 medicines in 1 inhaler to help control asthma symptoms, and to prevent them from occurring in the first place. BREO has been shown to increase symptom-free days. Your results may vary.

BREO is not a rescue medicine and should not be used to treat sudden breathing problems.

HOW DOES BREO HELP ME BREATHE BETTER?

Once-daily BREO treats two of the main causes of asthma symptoms—airway constriction and airway inflammation. BREO opens up the airways to help improve breathing for a full 24 hours. Your results may vary.

DOES BREO TREAT SUDDEN SYMPTOMS OF ASTHMA?

No. BREO is not used to relieve sudden breathing problems and does 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?

Do not use BREO if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure. Do not use BREO if you are allergic to fluticasone furoate, vilanterol, or any of the ingredients in BREO.

WHAT ARE THE INGREDIENTS IN BREO?

Active ingredients: fluticasone furoate, vilanterol

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

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.

WHERE CAN I FIND INSTRUCTIONS FOR USING BREO?

You can read the step-by-step instructions for using BREO at the end of the Medication Guide. Additionally, you can watch a demonstration here.

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.

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.
  • You may see the quantity "60" mentioned in printouts about your prescription. The reason is that each dose is a combination of the two medicines in BREO.

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.

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.

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.

HOW CAN I LEARN MORE ABOUT BREO?

If you aren't currently taking BREO for asthma, sign up for your FREE Info Kit. If you are currently taking BREO for asthma, sign up for support, helpful tips, and additional information.

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.