Breo Ellipta (fluticasone furoate / vilanterol) is a maintenance inhaler used every day to help manage asthma and chronic obstructive pulmonary disease (COPD). It's a combination of two medications: fluticasone, a corticosteroid that reduces swelling in your lungs, and vilanterol, a long-acting beta agonist (LABA) that helps relax your airways. The typical dose is one puff by mouth once a day. Breo Ellipta (fluticasone furoate / vilanterol) isn't for sudden breathing problems or asthma attacks. Side effects include oral thrush, sore throat, and headache.
Asthma - in adults and children 5 years and older
Chronic obstructive pulmonary disease (COPD) - in adults
Breo Ellipta (fluticasone furoate / vilanterol) is a combination of two medications.
Fluticasone furoate is a corticosteroid. It works by lowering swelling and irritation in your lungs. This helps make breathing easier.
Vilanterol is a long-acting beta agonist. It relaxes the muscles in your airways. This opens up the lungs, helping air flow more easily.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
Long-term treatment for both COPD and asthma
Inhaled only once a day
Might be easier to use compared to some other dry powder inhalers
Safe for children 5 years and older for asthma
Won't work well for asthma attacks or COPD flare ups
Not safe for those severely allergic to milk proteins since it contains lactose
Can cause thrush in mouth or throat
No need to prime or shake the inhaler before use
Take Breo Ellipta (fluticasone furoate / vilanterol) at the same time every day to help prevent asthma or COPD attacks. You can take it at any time of day, but daily use is important for the medication to work well.
If you miss a dose of Breo Ellipta (fluticasone furoate / vilanterol), take it as soon as you remember. Don’t take more than one dose in a day, and never take two doses at the same time. Just take your next dose at your regular time.
Breo Ellipta (fluticasone furoate / vilanterol) isn't for sudden asthma attacks or COPD flare-ups. If you have wheezing, coughing, shortness of breath, or chest tightness, tell your prescriber right away. Always keep a rescue inhaler like albuterol with you for emergencies.
Get your routine tests done on time while you're taking Breo Ellipta (fluticasone furoate / vilanterol). These checkups help your prescriber see if the medication is working and not causing problems. Tests might include blood work, breathing tests, and eye exams.
Store Breo Ellipta (fluticasone furoate / vilanterol) at room temperature in a dry place away from heat or sunlight. Keep unused inhalers in the original foil pouch until you’re ready to use them.
Write use-by date: When you open the foil pouch, write down the use-by date (6 weeks later). Throw the inhaler away when it reaches 6 weeks or shows “0” doses, whichever happens first.
Preparing a dose: You don't need to prime or shake the inhaler before using it. Opening the cover loads 1 dose, so only open it when you’re ready to use it.
Taking a dose: Hold the inhaler flat like a hamburger and slide the cover until it clicks. Breathe out fully, then put the mouthpiece in your mouth and take a long, steady, deep breath. Try to hold your breath for 3 to 4 seconds, or as long as you comfortably can.
After use: Rinse your mouth with water and spit it out. This lowers your risk of oral thrush). Call your prescriber if you notice white patches in your mouth or throat.
Cleaning: Wipe the mouthpiece with a dry cloth once a week. Don't rinse the inhaler with water.
Breo Ellipta (fluticasone furoate / vilanterol) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Using albuterol more often | Using too much Breo Ellipta (fluticasone furoate / vilanterol)*
Don't use Breo Ellipta (fluticasone furoate / vilanterol) during an asthma attack or COPD flare-up because it won’t give quick relief. Instead, use a rescue inhaler like albuterol if you're having trouble breathing.
If you notice you’re using your rescue inhaler more often than usual, tell your pulmonologist since this might mean your condition is getting worse. Never take more doses of Breo Ellipta (fluticasone furoate / vilanterol) than prescribed since this won’t help your breathing and can raise your risk for serious side effects like heart problems, tremors, and dizziness.
Risk factors: Using too much Breo Ellipta (fluticasone furoate / vilanterol) | Using together with other LABAs
Using Breo Ellipta (fluticasone furoate / vilanterol) more often, at a higher dose than prescribed, or with other LABAs can raise your risk of overdose. Taking too much can lead to serious side effects like heart problems, and in rare cases, even death. Get medical help right away if you have symptoms like chest pain, a fast or irregular heartbeat, tremor, headache, or nervousness.
Risk factor: Not rinsing and spitting after using Breo Ellipta (fluticasone furoate / vilanterol)
Breo Ellipta (fluticasone furoate / vilanterol) contains fluticasone furoate, a steroid that can sometimes cause a mouth and throat infection called oral thrush. To help prevent thrush, rinse your mouth with water and spit it out after each dose.
If you do get thrush, your pulmonologist might prescribe an antifungal medication and ask you to pause Breo Ellipta (fluticasone furoate / vilanterol). Let them know if you notice symptoms of thrush, such as white patches in your mouth, cotton-like feeling in your mouth, pain while eating or swallowing, or loss of taste.
Risk factors: COPD
Studies show that people with COPD who use Breo Ellipta (fluticasone furoate / vilanterol) can have a higher risk of getting pneumonia. In some cases, pneumonia has led to hospitalization or even death. Symptoms of pneumonia can look a lot like a COPD flare-up, so it’s important to watch for warning signs such as fever, chills, cough with mucus, chest pain, or shortness of breath.
Risk factors: Active, chronic (long-term), or recurrent infection | Medical conditions that weaken the immune system | Taking other medications that can weaken the immune system
Breo Ellipta (fluticasone furoate / vilanterol) can make it harder for your body to fight infections. Infections like tuberculosis, chickenpox, and measles can be more serious if you're using this medication. Don't use Breo Ellipta (fluticasone furoate / vilanterol) if you have an active or ongoing infection without talking with your prescriber first. Let them know right away if you have signs of an infection, such as a fever, body aches, tiredness, vomiting, pain, chills, or nausea.
Risk factors: High doses of Breo Ellipta (fluticasone furoate / vilanterol) | Taking medications that interact with Breo Ellipta (fluticasone furoate / vilanterol) | Stressful events (e.g., surgery)
Breo Ellipta (fluticasone furoate / vilanterol) can be absorbed into your bloodstream. At the recommended dose, it usually doesn’t affect your adrenal glands, which make important stress hormones. But if you take more than prescribed or also take certain medicines that interact with Breo Ellipta (fluticasone furoate / vilanterol), you might experience adrenal insufficiency, a condition where your body doesn't make enough of its own steroid hormones.
Let your prescriber know if you feel very tired, weak, or sick to your stomach, especially after surgery or during times of stress as these could be signs of low steroid levels.
Breo Ellipta (fluticasone furoate / vilanterol) can sometimes cause paradoxical bronchospasm, which means your airways tighten instead of relax. This is rare but can be life threatening. If you notice more wheezing, shortness of breath, or coughing after using Breo Ellipta (fluticasone furoate / vilanterol), stop using it and use a rescue inhaler (like albuterol) right away. Contact your prescriber since you might need to switch to a different treatment.
Risk factors: Allergy to milk proteins (lactose)
Serious allergic reactions to Breo Ellipta (fluticasone furoate / vilanterol) are possible. These reactions can include hives, swelling of the face or throat, rash, or trouble breathing. Stop using this inhaler right away if you have any of these reactions and get medical help. Because Breo Ellipta (fluticasone furoate / vilanterol) contains lactose, people with a severe milk protein allergy shouldn't use this medication.
Risk factors: History of heart problems | Using more Breo Ellipta (fluticasone furoate / vilanterol) than recommended
Breo Ellipta (fluticasone furoate / vilanterol) can sometimes affect your heart. It might raise your heart rate or blood pressure and can cause irregular heart rhythms. Your risk is higher if you take more than prescribed or if you already have heart problems like high blood pressure or irregular heartbeats. If you notice heart-related problems, your prescriber might have you stop using this medication.
Risk factors: Using Breo Ellipta (fluticasone furoate / vilanterol) long term | Older adult | Unable to move for a long period of time | Family history of osteoporosis | Poor diet | Postmenopausal | Smoking | Using medications that can cause bone loss
If you take Breo Ellipta (fluticasone furoate / vilanterol) for a long time, you might be at risk for bone loss. It's not certain if this will lead to broken bones, but your risk is higher if you're an older adult, postmenopausal, have a poor diet, smoke, or take certain medications. Your prescriber might check your bone density regularly to help protect your bone health. If you've had broken bones or a history of osteoporosis, talk to your prescriber before starting this medication.
Children who use inhaled steroids like Breo Ellipta (fluticasone furoate / vilanterol) might grow more slowly. To help lower this risk, your child's pulmonologist will prescribe the lowest dose needed to control their asthma. Your child's care team will also check their growth regularly while they use this inhaler. If you're concerned about how Breo Ellipta (fluticasone furoate / vilanterol) might affect your child's growth, talk with your child’s pulmonologist to see if it’s the best option.
Risk factors: Long-term use of Breo Ellipta (fluticasone furoate / vilanterol) | History of eye problems like glaucoma or cataracts
Using Breo Ellipta (fluticasone furoate / vilanterol) for a long time can raise eye pressure, worsen glaucoma, or lead to cataracts. Talk to your prescriber right away if you experience blurry vision, eye discomfort, or other changes in your vision. You might need an eye exam to check for these problems.
Breo Ellipta (fluticasone furoate / vilanterol) can raise blood sugar levels. Let your prescriber know if you're feeling more thirsty or hungry than usual, confused, or urinating more often. These can be signs of high blood sugar.
Medications like Breo Ellipta (fluticasone furoate / vilanterol) can sometimes cause low potassium levels, which can affect your heart rhythm. This drop in potassium is usually short term and doesn’t require treatment. Let your care team know if you have muscle pain or weakness, muscle cramps, or abnormal heartbeat as these can be signs of low potassium.
Breo Ellipta (fluticasone furoate / vilanterol) comes in three different strengths:
Breo Ellipta 50/25 mcg - 50 mcg fluticasone furoate / 25 mcg vilanterol
Breo Ellipta 100/25 mcg - 100 mcg fluticasone furoate / 25 mcg vilanterol
Breo Ellipta 200/25 mcg - 200 mcg fluticasone furoate / 25 mcg vilanterol
Asthma:
Adults 18 years and older: The typical dose is one puff of Breo Ellipta 100/25 mcg OR Breo Ellipta 200/25 mcg by mouth once a day.
Children 12 to 17 years: The typical dose is one puff of Breo Ellipta 100/25 mcg by mouth once a day.
Children 5 to 11 years: The typical dose is one puff of Breo Ellipta 50/25 mcg by mouth once a day.
COPD:
Adults: The typical dose is one puff of Breo Ellipta 100/25 mcg by mouth once a day.
Asthma attacks
Severe episodes of asthma or COPD
Allergy to lactose or milk proteins
Asthma - in adults and children 5 years and older
Chronic obstructive pulmonary disease (COPD) - in adults
Maintenance treatment of asthma in people ages 5 years and older
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GlaxoSmithKline LLC. (2024). Breo Ellipta- fluticasone furoate and vilanterol trifenatate powder [package insert]. DailyMed.
Grant, A. C., et al. (2015). The Ellipta® Dry Powder Inhaler: Design, functionality, in vitro dosing performance and critical task compliance by patients and caregivers. Journal of Aerosol Medicine and Pulmonary Drug Delivery.
Magee, J. S., et al. (2018). Paradoxical bronchoconstriction with short-acting beta agonist. American Journal of Case Reports.
Prasco Laboratories. (2024). Fluticasone furoate and vilanterol powder. DailyMed.
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