WARNINGS
Do not use BREO ELLIPTA:
• to treat sudden, severe symptoms of COPD or asthma.
• 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 the section ADDITIONAL INFORMATION below, for a complete list of ingredients in BREO ELLIPTA
USES
BREO ELLIPTA combines 2 medicines in 1 inhaler, an inhaled corticosteroid (ICS) medicine (fluticasone furoate), and a long-acting beta2-adrenergic agonist (LABA) medicine (vilanterol). o ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. o LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. • BREO ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler. • BREO ELLIPTA is a prescription medicine used long term (chronic) to treat people with: Chronic Obstructive Pulmonary Disease (COPD): o BREO ELLIPTA is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. o BREO ELLIPTA is used 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). Asthma: o BREO ELLIPTA is a prescription medicine used to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing. o BREO ELLIPTA contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. BREO ELLIPTA contains an ICS 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.
It is not known if BREO ELLIPTA is safe and effective in children younger than 5 years of age
HOW TO USE
How should I use BREO ELLIPTA?
Read the step-by-step instructions for using BREO ELLIPTA at the end of this Patient Information.
• Do not use BREO ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
• BREO ELLIPTA comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
• Use BREO ELLIPTA exactly as your healthcare provider tells you to use it. Do not use BREO ELLIPTA more often than prescribed.
• Children may need help to use BREO ELLIPTA.
• Use 1 inhalation of BREO ELLIPTA 1 time each day. Use BREO ELLIPTA at the same time each day.
• 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 ELLIPTA 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 ELLIPTA does not relieve sudden symptoms of COPD or asthma and you should not take extra doses of BREO ELLIPTA 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:
o your breathing problems get worse.
o you need to use your rescue inhaler more often than usual.
o your rescue inhaler does not work as well to relieve your symptoms.
o your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you
BREO ELLIPTA can cause serious side effects, including:
• 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: o increase in mucus (sputum) production o chills o change in mucus color o increased cough o fever o 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 ELLIPTA). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD or asthma symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include: o feeling tired o nausea and vomiting o lack of energy o low blood pressure (hypotension) o weakness
• sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using 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:
o rash o swelling of your face, mouth, and tongue
o hives o breathing problems
• effects on heart.
o increased blood pressure o chest pain
o a fast or irregular heartbeat, awareness of heartbeat
• effects on nervous system.
o tremor o nervousness
• bone thinning or weakness (osteoporosis).
• slowed growth in children. A child’s growth should be checked often.
• eye problems including glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using BREO ELLIPTA.
• changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
Common side effects of BREO ELLIPTA include:
COPD:
• runny nose and sore throat • bronchitis
• upper respiratory tract infection
• inflammation of the sinuses
• headache
• cough
thrush in your mouth or throat. Rinse your mouth
• mouth and throat pain with water without swallowing after use to help • joint pain prevent this.
• increased blood pressure
• back pain
• flu
• pneumonia
•fever
Asthma:
• runny nose and sore throat
• respiratory tract infection
• thrush in your mouth or throat. Rinse your mouth
• bronchitis with water without swallowing after use to help
• inflammation of the sinuses prevent this.
• mouth and throat pain
• headache
• hoarseness and voice changes •
flu
• cough
These are not all the possible side effects of BREO ELLIPTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BREO ELLIPTA for a condition for which it was not prescribed. Do not give BREO ELLIPTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about BREO ELLIPTA that is written for health professionals
OVERDOSE
If you take too much BREO ELLIPTA, 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.
MISSED DOSE
• If you miss a dose of BREO ELLIPTA, 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.
STORAGE
Store BREO ELLIPTA at room temperature between 68-degrees F and 77-degrees F (20-degrees C and 25-degrees C). Keep in a dry place away from heat and sunlight. • Store BREO ELLIPTA in the unopened tray and only open when ready for use. • Safely throw away BREO ELLIPTA in the trash 6 weeks after you open the 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 ELLIPTA and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 05/2023
Prescribing Information: revision date 11/2024
Inhibitors of Cytochrome P450 3A4
Fluticasone furoate and vilanterol are both substrates of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol. Caution should be exercised when considering the coadministration of BREO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see the sections WARNINGS and PRECAUTIONS above].
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and QTc Prolonging
Vilanterol, like other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.
Beta-Adrenergic Receptor Blocking Agents
Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, but may also produce severe bronchospasm in patients with COPD or asthma. Therefore, patients with COPD or asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.
Non–Potassium-Sparing Diuretics
The electrocardiographic changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics.
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 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 ELLIPTA may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if the medicines in BREO ELLIPTA 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 ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take
• other LABA (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol)
• 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
