Breo is a combination inhaler used for maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma in adults and children. It contains two active ingredients, fluticasone (an inhaled corticosteroid, or ICS) and vilanterol (a long-acting beta agonist, or LABA). Breo Ellipta (fluticasone / vilanterol) is inhaled through the mouth once per day. It's available as a lower-cost generic. Side effects can differ based on your age and your Breo Ellipta (fluticasone / vilanterol) dose, but generally include upper respiratory tract infections, sore throat, and headache.
Breo Ellipta (fluticasone / vilanterol) is a combination of two medications that work together to make it easier to breathe in people with asthma and COPD symptoms.
Fluticasone is an inhaled corticosteroid. It's thought to lower inflammation and swelling in the lungs.
Vilanterol is a long-acting beta agonist. It relaxes the muscles in your lungs to open up your airways.
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 control of asthma and COPD symptoms
Inhaled only once per day, unlike other similar inhalers which are used twice per day
Might be easier to use compared to some other dry powder inhalers
Can't use if you're severely allergic to milk proteins because it contains lactose
Need to rinse your mouth with water after each use to prevent fungal infections (thrush) in your mouth and throat
Doesn't replace your rescue inhaler
Take an inhalation of Breo Ellipta (fluticasone / vilanterol) at the same time once per day to prevent COPD or asthma attacks. You can take Breo Ellipta (fluticasone / vilanterol) at any time of the day, but you must take it every day for it to work well for you.
If you have sudden trouble breathing during an asthma attack, use your rescue inhaler. Breo Ellipta (fluticasone / vilanterol) won't treat an asthma attack as it's happening.
Call your pulmonologist if your breathing or peak flow meter results worsen. Also contact your pulmonologist if you're using your rescue inhaler more often than usual. These could be signs that your Breo Ellipta (fluticasone / vilanterol) dose is too low, or you need another long-acting medication to help manage your asthma.
Don't start any new medications while you're taking Breo Ellipta (fluticasone / vilanterol) without asking your pulmonologist or primary care provider first. Breo Ellipta (fluticasone / vilanterol) can interact with other medications, such as blood pressure medications (e.g., beta blockers) and tricyclic antidepressants. Your healthcare providers can check for interactions to make sure your medications are safe to take.
Store Breo Ellipta (fluticasone / vilanterol) at room temperature in a dry place away from heat or sunlight. Keep unused inhalers in the original foil pouch.
Breo Ellipta (fluticasone / vilanterol) expires in 6 weeks after you remove it from the foil tray. Write the expiration ("use by") date on the first blank line on the inhaler.
There's a dose counter on the front face of the Breo Ellipta (fluticasone / vilanterol) inhaler. It should say "30" for a new inhaler. Use this counter to keep track of when you need to get a refill.
You don't need to prime or shake the Breo Ellipta (fluticasone / vilanterol) inhaler before using it. Each time you open the cover of the inhaler, you're preparing 1 dose. Only open the cover of the inhaler if you're about to take a dose.
When you're ready to take your dose, slide the cover on the Breo Ellipta (fluticasone / vilanterol) inhaler until it clicks and hold in a flat position, like a hamburger. Then, breathe out as long as you can. Then, without blocking the vent, place your lips firmly around the mouthpiece and take a long, steady, and deep breath.
After you inhale from the Breo Ellipta (fluticasone / vilanterol) inhaler, try to hold your breath for 3-4 seconds, or for as long as you comfortably can. This gives the medication can reach deep into your lungs.
After you're done using Breo Ellipta (fluticasone / vilanterol), rinse your mouth with water and then spit. This helps lower the risk of thrush (fungal infection) in the mouth and throat.
Never wash the Breo Ellipta (fluticasone / vilanterol) inhaler with water or any liquid. Instead, clean the mouthpiece every once in a while by wiping it with a dry cloth. Just make sure you don't get water or moisture on or near the inhaler. Moisture can make the dry powder medication clump together and clog the inhaler.
Breo Ellipta (fluticasone / 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.
Don't use Breo Ellipta (fluticasone / vilanterol) if you're experiencing an asthma attack or COPD flare up because this medication won't provide immediate relief. Use a rescue inhaler, such as albuterol (Ventolin HFA), if you're having trouble breathing.
If you're using your rescue inhaler more often than usual, let your pulmonologist know because this could be a sign that your condition is getting worse. Don't use more doses Breo Ellipta (fluticasone / vilanterol) than recommended because this won't improve your breathing. Rather, this can raise your risk for serious side effects, such as heart problems, tremors, and dizziness.
Risk factors: Not rinsing and spitting after using Breo Ellipta (fluticasone / vilanterol) | Weakened immune system from medical conditions or medications
Breo Ellipta contains fluticasone, a steroid medication. When inhaled, it can cause a fungal infection in your mouth and throat called thrush. To lower your risk for thrush, rinse your mouth with water and spit after each inhalation of Breo Ellipta (fluticasone / vilanterol). If you develop thrush, your pulmonologist might prescribe you a medication to treat this condition and ask you to temporarily stop using Breo Ellipta (fluticasone / vilanterol). Let your pulmonologist 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.
Inhaled medications, including Breo Ellipta (fluticasone / vilanterol), can sometimes cause a muscle spasm in your lungs. This can lead to difficulty breathing, wheezing, cough, and chest discomfort. If you have a hard time breathing after inhaling Breo Ellipta (fluticasone / vilanterol), use your rescue inhaler and get medical attention right away.
Like all corticosteroid-containing medications, Breo Ellipta (fluticasone / vilanterol) can weaken your immune system and raise your risk for infections, including upper respiratory infections and pneumonia. Your risk for infections is higher if you're also taking other medications that also weaken your immune system. If you're currently being treated for a serious infection, such as tuberculosis, let your pulmonologist know. They might need to consider a different medication for your condition until you get better. Let your pulmonologist or primary care provider know right away if you have symptoms of infections, such as fever, chills, or body aches.
Risk factors: Using Breo Ellipta (fluticasone / vilanterol) for a long time | Using too much Breo Ellipta (fluticasone / vilanterol)
Use Breo Ellipta (fluticasone / vilanterol) only as directed. Don't use more than the maximum number of inhalations each day. Doing so can cause more of the steroid to be absorbed into the body and raise your risk for symptoms such as higher blood sugar or blood pressure.
On the other hand, if you're transitioning to Breo Ellipta (fluticasone / vilanterol) from oral steroids, you might experience symptoms of low steroid hormone, such as stomach pain, loss of appetite, and nausea. When you transition to Breo Ellipta (fluticasone / vilanterol), your pulmonologist will work with you to lower your dose of oral steroids slowly over time to prevent these side effects.
Children who use inhaled steroids, like Breo Ellipta (fluticasone / vilanterol), might experience a delay in growth. To lower the risk of growth problems, your child's pulmonologist will only prescribe the lowest dose needed to help their condition. Your child's care team will check your child's growth regularly while your child is using this medication. If you're concerned about how Breo Ellipta (fluticasone / vilanterol) might affect your child's growth, discuss with your child's pulmonologist to see if this medication is right for them.
Risk factors: History of glaucoma or cataracts
Although rare, people using inhaled steroids over a long period of time have reported having higher pressure in the eyes, glaucoma, and cataracts. Talk to your optometrist before using Breo Ellipta (fluticasone / vilanterol) if you have glaucoma or cataracts because they might ask you to come in more often for eye exams. Also speak with them if you notice any changes to your vision while using the medication.
Risk factors: High blood pressure | Heart failure | Heart rate or rhythm problems | Using more Breo Ellipta (fluticasone / vilanterol) than recommended
The vilanterol in Breo Ellipta might cause changes in your blood pressure, heart rate, and heart rhythm. But these side effects are typically unlikely to happen if you're taking the recommended dose of Breo Ellipta (fluticasone / vilanterol). Your pulmonologist or cardiologist might ask you to regularly check your blood pressure and heart rate at home if you have high blood pressure or other heart problems. Don't use Breo Ellipta (fluticasone / vilanterol) more often than recommended. If you find that you need to use Breo Ellipta (fluticasone / vilanterol) more often, let your providers know so they can see if you need any changes to your treatment plan. Tell your pulmonologist if you have dizziness, fatigue, tremor, rapid heartbeat, or weakness after you use Breo Ellipta (fluticasone / vilanterol).
Risk factors: Using Breo Ellipta (fluticasone / vilanterol) too much
Breo Ellipta (fluticasone / vilanterol) can cause the potassium levels in your blood to drop too low. In most cases, this happens if you use more Breo Ellipta (fluticasone / vilanterol) than recommended. Drops in blood potassium levels are typically mild and your levels should go back to usual with time. Sometimes, low potassium can cause tiredness, weakness, muscle cramps, a racing heart, and a "pins and needles" feeling in your hands and feet. Tell your provider if you experience any of these symptoms while you're using Breo Ellipta (fluticasone / vilanterol). Also let your provider know if you need to use Breo Ellipta (fluticasone / vilanterol) more often than instructed. Your treatment plan might need to be adjusted to better control your symptoms.
Risk factors: Allergy to milk proteins (lactose)
Allergic reactions to Breo Ellipta (fluticasone / vilanterol) are possible. These reactions can include life-threatening facial swelling, shock, and anaphylaxis (closing of the throat). Get medical attention right away if you notice hives, rash, red skin, swelling of the lips or tongue, or difficulty breathing after you use Breo Ellipta (fluticasone / vilanterol).
Breo Ellipta is available in 3 different strengths: 50 mcg/25 mcg (fluticasone / vilanterol), 100 mcg/25 mcg (fluticasone / vilanterol), and 200 mcg/25 mcg (fluticasone / vilanterol).
Generic fluticasone/vilanterol is available in 2 different strengths: 100 mcg/25 mcg (fluticasone / vilanterol) and 200 mcg/25 mcg (fluticasone / vilanterol).
Asthma:
Ages 18 years and older: Your prescriber will determine your dose based on how severe your asthma is and what other medications you've taken. The typical dose is 1 inhalation of Breo Ellipta 100 mcg/25 mcg (fluticasone / vilanterol) or 200 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily.
Ages 12 to under 18 years (brand name Breo Ellipta only): The typical dose is 1 inhalation of Breo Ellipta 100 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily.
Ages 5 to under 12 years (brand name Breo Ellipta only): The typical dose is 1 inhalation of Breo Ellipta 50 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily.
COPD:
The typical dose is 1 inhalation of Breo Ellipta 100 mcg/25 mcg (fluticasone / vilanterol) by mouth once daily.
Treatment of sudden, severe asthma attack
Allergy to fluticasone (inhaled corticosteroid) or vilanterol (long-acting beta agonist)
Allergy to lactose or milk proteins
Maintenance treatment of asthma in people ages 5 years and older
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