Breo Ellipta is a brand-name inhaler prescribed for asthma and chronic obstructive pulmonary disease (COPD). Breo Ellipta contains the active ingredients fluticasone furoate and vilanterol trifenatate.
Breo Ellipta is approved for maintenance (long-term) treatment of:
Drug details
You’ll find key information about Breo Ellipta below.
- Drug classes: inhaled corticosteroid and long-acting beta2-adrenergic agonist (also called long-acting beta-agonist)
- Drug form: inhaler that contains dry powder medication
- Generic available? no, but an authorized generic is available (see below)
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2013
Breo Ellipta is a brand-name medication. It’s not currently available as a generic, but an
Breo Ellipta can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Breo Ellipta. This list doesn’t include all possible side effects.
For more information on the possible side effects of Breo Ellipta or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.
More common side effects
Possible side effects depend on how your body responds to either Breo Ellipta 100/25 for COPD or Breo Ellipta for asthma.
More common side effects when used for COPD
The more common side effects of Breo Ellipta 100/25 in people with COPD can include:
- back and joint pain
- fever
More common side effects when used for asthma
The more common side effects of Breo Ellipta in people with asthma can include:
- abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular)
- voice loss
More common side effects when used for COPD or asthma
The more common side effects of Breo Ellipta in people with COPD or asthma can include:
- inflammation in lung airways
- cough
- headache
- fever
- oral thrush or esophageal thrush (fungal infection in your mouth or throat)
- respiratory infections, such as the common cold or flu
- sore throat
- pneumonia
Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Breo Ellipta aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
Serious side effects and their symptoms are similar in treatment for both COPD and asthma. They can include:
- Heart-related problems such as changes in blood pressure or heart rhythm. Symptoms can include:
- chest pain or pressure
- abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular)
- shortness of breath
- lightheadedness or dizziness
- fainting
- Oral thrush or esophageal thrush (fungal infection in your mouth or throat). Symptoms can include:
- painful white bumps in your mouth
- dry skin at the corners of your mouth
- trouble swallowing
- Pneumonia. Symptoms can include:
- chest pain
- shortness of breath
- cough (or coughing up mucus)
- fever
- Hypercorticism (high cortisol levels). Symptoms can include:
- weight gain, mainly around your upper back and midsection
- rounder face
- bruising easily
- slow healing cuts or wounds
- acne
- Adrenal suppression (low cortisol levels). Symptoms can include:
- muscle weakness
- tiredness
- skin that appears darker
- less of an appetite
- Osteopenia (decreased bone density). Symptoms can include:
- back pain
- loss of height
- slouch posture
- bone fractures
- Glaucoma and cataracts (eye problems). Symptoms can include:
- blind spots
- headache
- eye pain
- nausea and vomiting
- clouded or blurred vision
- trouble seeing at night
- seeing “halos” around light
- sensitivity to light and glare
- Hyperglycemia (high blood sugar level). Symptoms can include:
- urinating often
- fatigue
- feeling thirstier than usual
- blurry vision
- headache
- Hypokalemia (low potassium levels). Symptoms can include:
- fatigue
- weakness
- muscle cramps
- constipation
- heart palpitations (feeling of skipped or extra heartbeats)
- Slowed growth in children and teenagers. Symptoms can include not being as tall as or weighing less than most children of the same age.
Side effect details
You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on certain side effects this drug may or may not cause.
Allergic reaction
As with most drugs, some people can have an allergic reaction after taking Breo Ellipta. Symptoms of a mild allergic reaction can include:
- skin rash
- itchiness
- flushing
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
- swelling of your tongue, mouth, or throat
- trouble breathing
Note: Breo contains lactose, an ingredient in milk. If you have a severe allergy to milk protein, Breo could cause a severe allergic reaction.
Call your doctor right away if you have a severe allergic reaction to Breo Ellipta. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
Pneumonia
Taking Breo Ellipta may increase your risk for pneumonia. Symptoms of pneumonia can include coughing up phlegm, shortness of breath, fever, chills, and more.
If you think you might have pneumonia, talk with your doctor. They can prescribe treatment if needed.
Decreased bone density
An older clinical study linked long-term use of inhaled corticosteroids, such as Breo Ellipta, to lower bone density. It is unknown whether this leads to bone fractures. Major risk factors for reduced bone density include:
- not exercising enough
- family history of osteoporosis
- going through menopause before age 45
- smoking
- older age
- poor nutrition
- long-term use of drugs that can reduce bone mass, such as anticonvulsants (seizure medications) and oral corticosteroids
If you’re at risk for decreased bone density, talk with your doctor before starting Breo Ellipta.
High blood sugar levels
According to some cases that were reported after approval by the Food and Drug Administration (FDA), Breo Ellipta can increase blood sugar levels. Hyperglycemia occurs when you have high blood sugar levels.
If you have type 1 or type 2 diabetes, your doctor may recommend watching for changes in your blood sugar levels while you use Breo Ellipta. Be sure to talk with your doctor if you’re at risk for diabetes or already have it.
Low potassium levels (not a side effect)
In clinical studies, Breo Ellipta did not cause hypokalemia (low potassium levels) in people with COPD or asthma.
Breo Ellipta contains a long-acting beta2-adrenergic agonist (LABA). This type of drug may cause low potassium levels, which can lead to heart rhythm problems. But this wasn’t seen in Breo’s Ellipta studies.
Hypokalemia from the use of LABA medications may go away within a few days and doesn’t usually require treatment.
Typically, your doctor will first start you on a low dosage of the drug. They will adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.
Drug forms and strengths
Breo Ellipta comes as a disposable light gray and blue inhaler. The inhaler contains two foil blister strips of powder medication:
- One strip contains either 50 micrograms (mcg), 100 mcg, or 200 mcg of fluticasone furoate per blister.
- The other strip contains 25 mcg of vilanterol trifenatate per blister.
The strengths are written as Breo Ellipta 50/25, 100/25, and 200/25.
Each inhaler contains 30 blisters, for a total of 30 doses. Each time you fully open the inhaler cover, a new dose will be ready for you.
Dosage for COPD
For chronic obstructive pulmonary disease (COPD), the recommended dosage is one daily inhalation (puff) of Breo Ellipta 100/25. One dose contains 100 mcg of fluticasone furoate and 25 mcg of vilanterol trifenatate.
Using your inhaler, inhale Breo Ellipta through your mouth once per day. Be sure to take it at the same time each day. Don’t use it more than once every 24 hours.
Dosage for asthma
There are two possible doses of Breo Ellipta for asthma treatment in adults:
- Breo Ellipta 100/25: One dose contains 100 mcg of fluticasone furoate and 25 mcg of vilanterol trifenatate.
- Breo Ellipta 200/25: One dose contains 200 mcg of fluticasone furoate and 25 mcg of vilanterol trifenatate.
Using your inhaler, inhale the drug through your mouth once per day. Be sure to take it at the same time each day. Don’t use it more than once every 24 hours.
Your doctor will base your dosage on the severity of your asthma, your previous asthma treatment, and any other medical conditions you have.
The maximum dose of Breo Ellipta for asthma is one inhalation of Breo Ellipta 200/25 per day. If you are taking Breo Ellipta 100/25 and need a higher dose, your doctor may prescribe Breo Ellipta 200/25. If you have asthma symptoms between doses, you should use a rescue medication to give you immediate relief.
Children’s dosage
Breo Ellipta is approved for treating asthma in children ages 5 years and older. Recommended dosages in children vary depending on age, as described below.
Dosage for asthma in children ages 12 to 17 years
The recommended dosage for children ages 12 to 17 years is one puff of Breo Ellipta 100/25 mcg, once per day. (One dose contains 100 mcg of fluticasone furoate and 25 mcg of vilanterol trifenatate.)
Dosage for asthma in children ages 5 to 11 years
The recommended dosage for children 5 to 11 years old is one puff of Breo Ellipta 50/25 mcg once daily. (One dose contains 50 mcg of fluticasone furoate and 25 mcg of vilanterol trifenatate.)
What if I miss a dose?
If you miss a dose of Breo Ellipta, take it as soon as you remember. Do not take more than one inhalation per day. Take the next dose at the usual time. Do not try to catch up by taking an extra dose or increasing the next dose. This can cause dangerous side effects.
Will I need to use this drug long term?
If Breo Ellipta is effective and safe for you, you’ll probably use this drug long term. Breo Ellipta is typically used long term to manage COPD and asthma symptoms.
Note: You can also refer to this article for in-depth information about Breo Ellipta’s dosage.
As with all medications, the cost of Breo Ellipta can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use. You can refer to this article for in-depth information about Breo’s cost.
Drug coupons: You can visit Optum Perks for price estimates of Breo Ellipta. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.
Financial and insurance assistance: If you need financial support to pay for Breo Ellipta, or if you need help understanding your insurance coverage, help is available. A program called GSK For You is available. For more information and to find out if you’re eligible for support, call 888-825-5249 or visit the program website.
Generic version: Breo Ellipta is not available as a generic, but an
To learn more about saving money on prescriptions, check out this article.
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The Food and Drug Administration (FDA) approves prescription drugs such as Breo Ellipta to treat certain conditions.
Breo Ellipta for COPD
Breo Ellipta is approved to help the lungs work better in people with chronic obstructive pulmonary disease (COPD). COPD is a group of lung diseases that include chronic bronchitis and emphysema. For details about COPD, you can refer to our COPD hub.
Breo Ellipta helps you breathe by relaxing muscles in your airway and helping to keep them open. It also works to help decrease the amount of COPD flare-ups you have.
Breo is not a rescue inhaler. You should not use it for sudden flare-ups of symptoms (sometimes called exacerbations) or sudden severe trouble breathing. Be sure that you and your doctor discuss your rescue treatment options.
Breo Ellipta for asthma
Breo Ellipta is approved to treat asthma in adults and in children ages 5 years and older. Asthma symptoms can include shortness of breath, chest tightness, wheezing, and coughing.
You should not use Breo Ellipta to treat sudden trouble breathing due to an asthma attack (sometimes called an exacerbation). Breo Ellipta is not a rescue inhaler. Be sure to discuss rescue treatment options with your doctor.
For details about asthma, you can refer to our asthma and allergies hub.
Do not use Breo Ellipta as rescue therapy. It’s not meant to treat asthma attacks that have already started.
Below are some basic instructions on how to use Breo Ellipta. Be sure to take the drug as your doctor or healthcare professional instructs.
Note: Don’t open and close the Breo Ellipta inhaler unless you plan to take a dose. You’ll lose the dose if you don’t inhale at that time. (Lost doses stay in the inhaler, but you can no longer take them. It’s not possible to take a double dose or extra dose with one inhalation.)
Step 1. Prepare a dose
- Slide the inhaler cover open until you hear a click.
- If the counter doesn’t count down as the cover clicks open, the inhaler won’t prepare a dose. If this happens, contact your pharmacist or doctor.
Step 2. Inhale a dose
- Hold the inhaler, making sure your fingers are not covering the air vents.
- Breathe out fully, but not into the inhaler.
- Bring the inhaler to your mouth and close your lips tightly around the mouthpiece.
- Take a steady, deep breath through your mouth. Don’t breathe in through your nose.
- Move the inhaler away from your mouth and hold your breath for 3 to 4 seconds or as long as you’re comfortable.
- Breathe out slowly.
Step 3. Reset the inhaler and rinse your mouth
- To clean the mouthpiece, wipe it with a dry tissue before closing the cover. Then slide the cover back as far as it will go.
- Rinse your mouth with water after your dose. Be sure to spit the water out. Don’t swallow. Doing this helps prevent thrush, which is a fungal infection of the mouth and throat.
You can also refer to the drug’s instructions for use for detailed step-by-step instructions.
When to use
Use Breo Ellipta at the same time every day. Do not use Breo Ellipta more than once every 24 hours.
Other drugs are available that can treat your condition. Some may be more suitable for you than others. If you’re interested in finding an alternative to Breo, talk with your doctor. They can suggest other medications that may work well for you.
Alternatives for COPD
Examples of other drugs that may be used to treat chronic obstructive pulmonary disease (COPD) include:
- long-acting beta-agonists (LABAs), such as
- salmeterol (Serevent)
- formoterol (Perforomist)
- aformoterol (Brovana)
- indacterol
- long-acting muscarinic antagonists (LAMAs), such as
- tiotropium (Spiriva, Tiova)
- aclidinium (Tudorza Pressair)
- umeclidinium (Incruse Ellipta)
- glycopyrrolate (Lonhala Magnair)
- revefenacin (Yupelri)
- inhaled corticosteroids, such as:
- fluticasone (Flovent HFA, others)
- budesonide (Pulmicort Flexhaler, others)
- combination inhalers, such as:
- salmeterol and fluticasone (Advair Diskus)
- formoterol and budesonide (Symbicort)
- phosphodiesterase-4 inhibitors, such as:
- roflumilast (Daliresp)
- theophylline
Alternatives for asthma
Examples of other drugs that may be used for asthma treatment include:
- long-acting beta2-agonists (LABAs), such as:
- salmeterol (Serevent)
- formoterol (Perforomist)
- inhaled corticosteroids, such as:
- leukotriene modifiers, such as:
- montelukast (Singulair)
- zafirlukast (Accolate)
- zileuton (Zyflo)
- combination inhalers, such as:
- theophylline
You may wonder how Breo Ellipta compares to other medications that are prescribed for similar uses. Here we look at how Breo Ellipta and Advair Diskus are alike and different.
Uses
Breo Ellipta and Advair Diskus are both FDA-approved for long-term management of chronic obstructive pulmonary disease (COPD) and asthma in adults. The drugs help you breathe by relaxing muscles in your airways and helping them stay open. They may also help reduce the number of COPD flare-ups that people have.
Both drugs are also FDA-approved to treat asthma in children. For asthma, Breo Ellipta can treat asthma in children ages 5 years and older, and Advair Diskus can treat children ages 4 years and older.
Neither drug is approved for use as rescue therapy or to treat asthma attacks that have already started.
Breo Ellipta and Advair Diskus both contain two drugs from two different drug classes. These drugs belong to the same classes of medication. This means they work the same way within the body.
Breo Ellipta contains:
- fluticasone furoate (a inhaled corticosteroid, ICS)
- vilanterol trifenatate (a long-acting beta2-agonist, LABA)
Advair Diskus contains:
- fluticasone propionate (an ICS)
- salmeterol (a LABA)
Note: Advair is also available as Advair HFA. This version is approved to treat asthma but isn’t approved for the treatment of COPD.
Drug forms and administration
Both Breo Ellipta and Advair come as inhalers.
Breo Ellipta comes as a powder inhaler that contains two foil blister strips of medication:
- One strip contains 50 mcg, 100 mcg, or 200 mcg of fluticasone furoate per blister.
- The other strip contains 25 mcg of vilanterol trifenatate per blister.
Each inhaler contains a total of 30 doses. For both COPD and asthma, you inhale the drug once per day.
Advair Diskus also comes as a powder inhaler. The inhaler contains a foil blister strip with 100, 250, or 500 mcg of fluticasone propionate and 50 mcg of salmeterol per blister. For both COPD and asthma, you inhale the drug twice per day.
Side effects and risks
Breo Ellipta and Advair Diskus act in similar ways in the body. Because of this, they can cause very similar side effects, which can vary depending on the condition the drugs are used for. Below are examples of these side effects.
More common side effects
Side effects are possible if you take Breo Ellipta or Advair Diskus for COPD. Here are examples of more common side effects that can occur with Breo Ellipta, with Advair Diskus, or with both drugs (when taken individually).
- Can occur with Breo Ellipta:
- cough
- Can occur with Advair Diskus:
- dizziness
- tiredness or malaise (overall feeling of discomfort)
- voice loss
- Can occur with both Breo Ellipta and Advair Diskus:
Side effects are also possible if you take Breo Ellipta or Advair Diskus for asthma attacks. Here are examples of more common side effects that can occur with Breo Ellipta, with Advair Diskus, or with both drugs (when taken individually).
- Can occur with Breo Ellipta:
- few unique common side effects
- Can occur with Advair Diskus:
- Can occur with both Breo Ellipta and Advair Diskus:
- abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular)
- airway inflammation
- cough
- fever
- headache
- muscle and joint pain
- mild oral thrush and esophageal thrush (fungal infection in your mouth or throat)
- respiratory infections such as the common cold or flu
- sore throat
- voice loss
Serious side effects
If you have COPD or asthma, serious side effects can occur with Breo Ellipta, with Advair Diskus, or with both drugs (when taken individually). Here are some examples:
- Can occur with Breo Ellipta:
- few unique serious side effects
- Can occur with Advair Diskus:
- Churg-Strauss syndrome (swelling of blood vessels)
- Can occur with both Breo Ellipta and Advair Diskus:
- worsening COPD or asthma symptoms
- heart-related problems such as changes in blood pressure or heart rhythm
- severe allergic reaction
- severe oral thrush and esophageal thrush
- pneumonia
- hypercorticism (high cortisol levels) and adrenal suppression (low cortisol levels)
- decreased bone density
- glaucoma and cataracts
- hyperglycemia (high blood sugar levels)
- hypokalemia (low potassium levels)
- slowed growth in children and teenagers
Effectiveness
Clinical trials have directly compared the use of Breo Ellipta and Advair Diskus in treating COPD and asthma. In one
Three other studies found similar results in people with COPD. The combined study results showed that Breo Ellipta improved breathing slightly more than Advair Diskus. The difference was small enough that the researchers didn’t consider it meaningful.
Costs
Breo Ellipta and Advair Diskus are both brand-name drugs. Advair Diskus is available as the generic drug fluticasone/salmeterol. Breo Ellipta doesn’t have a generic form, but an
Brand-name medications usually cost more than generics. The actual price you’ll pay for any of these drugs may depend on your insurance plan, your location, and the pharmacy you use.
Visit Optum Perks to find coupons and savings for Breo Ellipta and Advair Diskus.
In addition to Advair Diskus (above), other medications are also prescribed for uses similar to those of Breo Ellipta. Below are comparisons between Breo Ellipta and other medications.
Breo vs. Symbicort
Breo Ellipta and Symbicort include medications from the same drug classes. This means that they work in similar ways within the body.
Breo Ellipta contains:
- fluticasone furoate, which is an inhaled corticosteroid (ICS)
- vilanterol trifenatate, which is a long-acting beta2-adrenergic agonist (LABA)
Symbicort contains:
- budesonide (an ICS)
- formoterol fumarate dihydrate (a LABA)
Uses
Breo Ellipta and Symbicort are FDA-approved to treat chronic obstructive pulmonary disease (COPD) and asthma in adults. Both drugs are approved to treat asthma in children ages 6 years and older.
Breo Ellipta and Symbicort relax muscles in the airways in your lungs, which helps you breathe better. They may also help decrease the number of COPD flare-ups that people have.
Neither drug is approved for use as rescue therapy or to treat asthma attacks that have already started.
Drug forms and administration
Both Breo Ellipta and Symbicort come as inhalers.
Breo Ellipta comes as a powder inhaler that contains two foil blister strips of medication:
- One strip contains either 50 mcg, 100 mcg, or 200 mcg of fluticasone furoate per blister.
- The other strip contains 25 mcg of vilanterol trifenatate per blister.
Each inhaler contains a total of 30 doses. For both COPD and asthma, you inhale the drug once per day.
Symbicort comes as a metered-dose aerosol inhaler. It’s available in two doses:
- Symbicort 80/4.5 contains 80 mcg of budesonide and 4.5 mcg of formoterol. Each inhaler contains 120 puffs.
- Symbicort 160/4.5 contains 160 mcg of budesonide and 4.5 mcg of formoterol. Each inhaler contains 120 puffs.
For both COPD and asthma, you inhale Symbicort twice per day.
Note: Symbicort is also available as Symbicort Aerosphere. This version is approved to treat COPD but not asthma.
Side effects and risks
Breo Ellipta and Symbicort both act in similar ways in the body and therefore can cause very similar side effects. Below are examples of these side effects.
More common side effects
These lists contain examples of more common side effects that can occur with Breo Ellipta, with Symbicort, or with both drugs (when taken individually) for COPD.
- Can occur with Breo Ellipta:
- back and joint pain
- fever
- headache
- Can occur with Symbicort:
- few unique common side effects
- Can occur with both Breo Ellipta and Symbicort:
- inflammation in the airways in your lungs
- back and joint pain
- cough
- oral thrush or esophageal thrush (fungal infection in your mouth or throat)
- pneumonia
- respiratory infections, such as the common cold or flu
- sore throat
These lists contain examples of more common side effects that can occur with Breo Ellipta, with Symbicort, or with both drugs (when taken individually) for asthma.
- Can occur with Breo Ellipta:
- fever
- Can occur with Symbicort:
- stuffy nose
- upset stomach
- vomiting
- Can occur with both Breo Ellipta and Symbicort:
- airway inflammation
- back and joint pain
- cough
- headache
- severe oral thrush or esophageal thrush
- respiratory infections such as the common cold or flu
- sore throat
- voice loss
Serious side effects
The following list contains examples of serious side effects that can occur with Breo Ellipta and Symbicort (when taken individually):
- serious asthma attacks
- worsening COPD or asthma symptoms
- heart-related problems, such as changes in blood pressure or heart rhythm
- severe allergic reaction
- severe oral thrush or esophageal thrush
- pneumonia
- hypercorticism (high cortisol levels) and adrenal suppression (low cortisol levels)
- decreased bone density
- glaucoma and cataracts
- hyperglycemia (high blood sugar levels)
- hypokalemia (low potassium levels)
- slowed growth in children and teenagers
Effectiveness
In separate studies, Breo Ellipta and Symbicort have both been found to be effective for long-term COPD and asthma treatment. More studies are needed to compare the drugs’ effectiveness.
Costs
Breo Ellipta and Symbicort are both brand-name drugs. They don’t have generic forms, but there is an
Brand-name medications usually cost more than generics. The actual price you would pay for either drug may depend on your insurance plan, your location, and the pharmacy you use.
Visit Optum Perks to find coupons and savings for Breo and Symbicort.
Breo Ellipta vs. Anoro Ellipta
Breo Ellipta and Anoro Ellipta both contain the drug vilanterol. This means that they work in similar ways within the body.
Breo Ellipta contains:
- fluticasone furoate, which is an inhaled corticosteroid (ICS)
- vilanterol trifenatate, which is a long-acting beta2-adrenergic agonist (LABA)
Anoro Ellipta contains:
- umeclidinium bromide, which is a long-acting muscarinic antagonist
- vilanterol trifenatate, which is a LABA
Uses
Breo Ellipta and Anoro Ellipta are both FDA-approved to treat chronic obstructive pulmonary disease (COPD) in adults.
Breo Ellipta is also approved to treat asthma in adults and children ages 6 years and older.
Anoro Ellipta is not approved to treat asthma. Neither drug is approved for use as rescue therapy or to treat asthma attacks that have already started.
Drug forms and administration
Both Breo Ellipta and Anoro Ellipta contain the word Ellipta. This refers to the type of inhaler that is used. While they are similar in design, they contain different drugs and the inhalers cannot be used interchangeably.
Breo Ellipta is a light gray and blue disposable inhaler. The inhaler contains two foil blister strips of powder medication:
- One strip contains either 50 mcg, 100 mcg, or 200 mcg of fluticasone furoate per blister.
- The other strip contains 25 mcg of vilanterol trifenatate per blister.
Each inhaler contains a total of 30 doses. For both COPD and asthma, you inhale the drug once per day.
Anoro Ellipta comes as a disposable light gray and red powder inhaler. The inhaler contains two foil blister strips of powder medication:
- One blister strip contains 62.5 mcg of umeclidinium bromide per blister.
- The other strip contains 25 mcg of vilanterol trifenatate per blister.
Each inhaler contains a total of 30 doses. For COPD treatment, you inhale Anoro Ellipta once per day.
Side effects and risks
Breo Ellipta and Anoro Ellipta both act in similar ways in the body. Because of this, they can cause very similar side effects. Below are examples of these side effects.
More common side effects
Side effects are possible if you take Breo Ellipta or Anoro Ellipta for chronic obstructive pulmonary disease (COPD). Here are examples of more common side effects that can occur with Breo Ellipta, Anoro Ellipta, or with both drugs (when taken individually).
- Can occur with Breo Ellipta:
- pneumonia
- headache
- airway inflammation
- oral thrush or esophageal thrush (fungal infection in your mouth or throat)
- Can occur with Anoro Ellipta:
- chest pain
- constipation
- diarrhea
- muscle twitches
- neck pain
- pain in arms and legs
- urinary tract infection
- Can occur with both Breo Ellipta and Anoro Ellipta:
- back and joint pain
- cough
- fever
- abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular)
- respiratory infections, such as the common cold or flu
- sore throat
Serious side effects
These lists contain examples of serious side effects that can occur with Breo Ellipta, with Anoro Ellipta, or with both drugs (when taken individually).
- Can occur with Breo Ellipta:
- hypercorticism (high cortisol levels) and adrenal suppression (low cortisol levels)
- decreased bone density
- pneumonia
- slowed growth in children and teenagers
- glaucoma
- Can occur with Anoro Ellipta:
- urinary retention (bladder doesn’t empty completely)
- Can occur with both Breo Ellipta and Anoro Ellipta:
- serious asthma attacks
- worsening COPD or asthma symptoms
- heart-related problems such as changes in blood pressure or heart rhythm
- severe allergic reaction
- severe oral thrush or esophageal thrush
- glaucoma (eye problems)
- hyperglycemia (high blood sugar levels)
- hypokalemia (low potassium levels)
Effectiveness
These drugs haven’t been directly compared in clinical studies. But in separate studies, both Breo Ellipta and Anoro Ellipta were found to be effective for COPD treatment.
Costs
Breo Ellipta and Anoro Ellipta are both brand-name drugs. They don’t have generic forms, but there is an
Brand-name medications usually cost more than generics. The actual price you would pay for either drug may depend on your insurance plan, your location, and the pharmacy you use.
Visit Optum Perks to find coupons and savings for Breo Ellipta and Anoro Ellipta.
Breo Ellipta and alcohol don’t interact. However, some alcohol may contain sulfites, which can trigger chronic obstructive pulmonary disease (COPD) flare-ups or asthma attacks. If you drink alcohol, talk with your doctor about how much alcohol is safe for you.
Breo Ellipta can interact with several other medications. It can also interact with certain supplements.
Different interactions can cause different effects. For instance, some interactions can affect how well a drug works, while others can cause increased side effects.
Breo Ellipta and other medications
Below we list some of the medications that can interact with Breo Ellipta. These lists don’t contain all drugs that may interact with Breo Ellipta.
Before taking Breo Ellipta, tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Certain antimicrobial medications
Antimicrobial medications treat infections caused by bacteria, viruses, or fungi. If you take Breo with certain antimicrobial drugs, the level of Breo Ellipta in your body may get higher. This may increase the number and strength of side effects. If you take any of these medications, talk with your doctor about the risks of using Breo Ellipta.
Examples of these medications include:
- ketoconazole
- ritonavir (Norvir)
- clarithromycin
- itraconazole (Sporanox)
- voriconazole (Vfend)
Certain antidepressants
Taking BreoEllipta with certain depression medications can cause heart rhythm problems. If you take any of these medications, talk with your doctor about the risks of using BreoEllipta.
Examples of these medications include:
- certain monoamine oxidase inhibitors (MAOIs), such as:
- isocarboxazid (Marplan)
- phenelzine (Nardil)
- tranylcypromine
- selegiline (Emsam, Zelapar)
- rasagiline (Azilect)
- certain tricyclic antidepressants (TCAs), such as:
- amitriptyline
- clomipramine (Anafranil)
- doxepin (Silenor)
- imipramine
- nortriptyline (Pamelor)
- protriptyline
Other drugs that can affect your heart rhythm
Certain drugs can increase your QT interval, which is a measurement used to check how your heart beats. Taking these drugs with Breo Ellipta can increase your risk of heart rhythm problems. If you take any of these medications, talk with your doctor about the risks of using Breo Ellipta.
Examples of these medications include:
- certain antiarrhythmics (heart rhythm) medications, such as:
- amiodarone (Nextrone, Pacerone)
- sotalol (Betapace, Betapace AF, Sorine)
- quinidine
- procainamide
- certain antimicrobials, such as:
- levofloxacin
- ciprofloxacin (Cipro, Cipro XR)
- erythromycin (Erythrocin)
- ketoconazole
- other medications, such as:
Certain blood pressure and heart medications
Beta-blockers are a type of heart and blood pressure medication. Taking certain beta-blockers can block the action of Breo Ellipta in your body. This can cause the blood vessels in your lungs to constrict (narrow). As a result, it may be harder for you to breathe. This may also put you at a higher risk for asthma attacks.
Examples of these beta-blockers include:
- carvedilol (Coreg)
- labetalol
- nadolol (Corgard)
- propranolol (Hemangeol, Inderal LA, Inderal XL, InnoPran XL)
Certain diuretics
Non-potassium-sparing diuretics are another type of heart and blood pressure medication. Taking Breo Ellipta with these drugs causes potassium to leave your body through urine. Low levels of potassium in the body can lead to heart problems. These include an abnormal heart rhythm (a heartbeat that’s too fast, too slow, or irregular).
Examples of non-potassium-sparing diuretics include:
- chlorathiazide (Diuril)
- hydrochlorothiazide (Microzide)
- bumetanide (Bumex)
- furosemide (Lasix)
- torsemide
Your doctor may prescribe Breo Ellipta by itself or with other drugs to treat chronic obstructive pulmonary disease (COPD) or asthma. It’s typical to use more than one medication for these diseases.
To manage COPD and asthma symptoms, it’s common to use rescue (short-acting) medications. These drugs work when you’re in between doses of long-term medications such as Breo Ellipta.
Most long-term medications, including Breo Ellipta, aren’t approved to treat asthma attacks that are already happening. And you usually can’t use these long-term drugs more than once or twice a day. You can use short-acting inhalers multiple times a day to treat sudden COPD flare-ups or asthma attacks.
Other types of medications your doctor might prescribe to use with Breo Ellipta include:
- Short-acting beta2-adrenergic agonists (SABAs)
- albuterol (Proventil HFA, ProAir HFA, Ventolin HFA)
- levalbuterol (Xopenex, Xopenex HFA)
- Long-acting muscarinic antagonists (LAMAs)
- aclidinium (Tudorza Pressair)
- glycopyrrolate (Longhala Magnair)
- tiotropium (Spiriva HandiHaler, Spiriva Respimat)
- umeclidinium (Incruse Ellipta)
Breo Ellipta and Incruse Ellipta
The drug combination of Breo Ellipta and Incruse Ellipta is prescribed to treat COPD only. Incruse Ellipta is a brand-name medication that contains umeclidinium bromide, a LAMA. Breo Ellipta is a combination of an ICS (fluticasone fumerate) and a LABA (vilanterol trifenatate).
Together, Breo Ellipta and Incruse Ellipta contain three types of drugs: a LABA, a LAMA, and an ICS. This combination may help people whose COPD symptoms aren’t managed with one or two drugs.
Note: The brand-name medication Trelegy Ellipta contains these three types of drugs in a single inhaler. It’s used once per day for COPD. Your doctor can recommend which combination of treatments is best for you.
Breo Ellipta and Spiriva
Doctors may prescribe the drug combination of Breo Ellipta and Spiriva to treat COPD or severe asthma. Spiriva is a brand-name medication that contains tiotropium bromide, which falls in the LAMA drug class. Breo Ellipta contains an ICS (fluticasone fumerate) and a LABA (vilanterol trifenatate).
Together, Breo Ellipta and Spiriva provide treatment with three drug classes including a LABA, a LAMA, and an ICS. This may help people whose COPD or asthma isn’t managed by one or two drugs.
Breo Ellipta and albuterol
Doctors may prescribe the drug combination of Breo Ellipta and albuterol to treat asthma and COPD. Breo Ellipta contains an ICS (fluticasone furoate) and a LABA (vilanterol trifenatate).
Albuterol, on the other hand, is a short-acting beta2-adrenergic agonist (SABA). It’s approved for treating asthma attacks and is recommended for off-label use for COPD flare-ups.
You can use albuterol as a rescue inhaler between doses of Breo Ellipta to treat any sudden attacks. This means you’ll have treatment to help prevent COPD flare-ups and asthma attacks.
Breo Ellipta can help you breathe better by relaxing muscles in your airways. When you have COPD or asthma and your symptoms flare up, your airways may narrow. This can make it harder to breathe. Narrowed airways can have many causes, including:
- muscle twitches in the airways
- fluid or sputum (mucus) buildup
- tightening of blood vessels in the lungs
Breo Ellipta contains fluticasone furoate, an inhaled corticosteroid (ICS). It’s not known how fluticasone affects COPD and asthma. But ICS drugs can reduce inflammation, so that may be how fluticasone helps manage COPD and asthma.
Breo also contains vilanterol trifenatate, a long-acting beta2-adrenergic agonist (LABA). LABAs work by causing airway muscles in the lungs to relax, so you’re able to breathe easier.
How long does it take to work?
Breo Ellipta begins working as soon as you take it. But you may not notice an improvement right away. This is because it’s used for long-term treatment. Breo should gradually improve the way your lungs work and help prevent COPD flare-ups and asthma attacks in the future.
Most people start to breathe easier about 15 minutes after taking a dose of Breo.
Keep in mind that Breo is not a rescue inhaler, and should not be used for sudden flare-ups of asthma or COPD symptoms.
There haven’t been enough studies in humans to know if Breo is safe to use during pregnancy. In one animal study, very high doses given to certain pregnant animals caused some bone problems in offspring. In other animal studies, giving pregnant animals high doses of Breo did not cause problems with the fetus or congenital anomalies (commonly known as birth defects). Animal studies don’t always predict what might happen in humans.
If you’re pregnant or planning to become pregnant, talk with your doctor. When you have asthma or COPD, it’s important that you manage your condition well during pregnancy. You and your doctor can explore the risks and benefits of taking Breo during pregnancy.
There haven’t been enough studies to show whether Breo Ellipta is safe to use while breastfeeding. Inhaled corticosteroids similar to fluticasone furoate (one of Breo Ellipta’s active drugs) have been found to pass into breast milk. So it’s best to weigh the potential benefits and risks of taking Breo Ellipta while breastfeeding. If you’re breastfeeding or planning to breastfeed, be sure to discuss this with your doctor.
Here are answers to some frequently asked questions about Breo Ellipta.
Is Breo Ellipta a steroid inhaler?
Yes. Breo Ellipta contains fluticasone furoate, which is an inhaled corticosteroid. This type of drug helps ease swelling in your airways so you can breathe easier.
Is Breo Ellipta safe for use in children?
Breo Ellipta is approved to treat asthma in adults and children 5 years and older. For COPD treatment, Breo Ellipta is only approved for use in adults.
Some similar drugs are available that are also approved for use in children. These include albuterol (ProAir HFA, Ventolin HFA, and others) and tiotropium (Spiriva Respimat). Be sure to talk with your child’s doctor about which treatment is right for them.
Can I stop using Breo Ellipta anytime?
Breo Ellipta is meant to be taken long-term. It’s important to take the drug as your doctor prescribes. Be sure to talk with your doctor before making any changes to your treatment plan.
Breo isn’t known to cause withdrawal (negative effects) if you stop taking it suddenly, and you do not need to taper (gradually decrease) your dosage. But your doctor can determine whether it’s safe for you to stop Breo treatment.
Can I use Breo Ellipta to treat sudden symptoms of asthma?
No. You should not use Breo Ellipta as a rescue therapy. This means you should not use it to treat sudden asthma attacks that have already started. Other short-term drugs, such as albuterol (ProAir HFA, Ventolin HFA, and others), can help in these situations.
Talk with your doctor about having rescue treatment options to use with Breo.
Should I be able to taste Breo Ellipta when I inhale it?
You may not be able to taste the drug, even if you’re using the inhaler correctly. So don’t be concerned if you don’t taste it. And definitely do not take another dose. That may cause you to take in too much of the drug.
If you have questions about how to correctly use Breo Ellipta, talk with a pharmacist or contact your doctor’s office.
Should I be concerned that Breo Ellipta contains a LABA drug?
No, but it’s easy to see why there may be some confusion. Breo Ellipta contains two active drugs. The first is fluticasone furoate, which belongs to a class of drugs called inhaled corticosteroids (ICSs). The second active drug is vilanterol trifenatate, which is a long-acting beta2-adrenergic agonist (LABA).
Using only LABA drugs has been shown to increase the risk of serious asthma attacks. In some clinical studies, people took only LABAs for asthma. These people had an increased risk for asthma-related problems including hospitalization and even death.
In other clinical studies, people took LABAs with ICSs. There were no additional risks for asthma-related problems when taking both LABAs and ICSs. Therefore, LABAs should be used with ICSs to the reduce risk of serious asthma attacks. Breo is a combination ICS and LABA drug.
In severe cases, COPD and asthma can cause death. If you think you’re having a serious asthma attack, call your doctor right away. If your symptoms are severe, call 911 or go to the nearest emergency room.
Have the ingredients in Breo Ellipta ever caused deaths?
All drugs have side effects. Some can lead to serious problems, including death. The combination of drugs in Breo Ellipta has not been linked to deaths.
In clinical studies, some people who took Breo Ellipta died from serious cases of pneumonia and heart problems. These are possible side effects of the drug. However, there isn’t enough information to know if Breo Ellipta was the cause of death. That’s because the number of deaths was the same in people who took a placebo (treatment with no active medication).
Breo Ellipta used to have a boxed warning for increased risk of asthma-related death. This is because one of its ingredients belongs to a group of drugs called long-acting beta2-adrenergic agonists (LABAs). When LABAs are taken alone to treat asthma, they can increase risk of asthma-related death.
Breo Ellipta no longer has this boxed warning. That’s because the Food and Drug Administration (FDA) found that when LABAs are used with inhaled corticosteroids, there is no increased risk of serious asthma problems. Breo Ellipta contains a LABA (vilanterol trifenatate) and an inhaled corticosteroid (fluticasone furoate), so it isn’t known to pose an increased risk.
If you’re concerned about serious side effects and risks with Breo treatment, be sure to discuss this with your doctor.
Before taking Breo Ellipta, talk with your doctor about your health history. Breo Ellipta may not be right for you if you have certain medical conditions. Examples of these conditions are listed below.
Worsening COPD or asthma
Sometimes, your chronic obstructive pulmonary disease (COPD) or asthma may get worse quickly, and you should not use Breo Ellipta. You should not use Breo Ellipta as rescue therapy or for asthma attacks that have already started.
Your COPD or asthma may be getting worse if:
- Breo Ellipta no longer helps your symptoms
- your short-acting beta2-adrenergic agonist (SABA) medication no longer helps your symptoms
- you’re using your SABA medication more often
Be sure to discuss your rescue treatment options with your doctor, in case you have a sudden attack of symptoms. In severe cases, COPD and asthma can cause death. If you think your disease is progressing quickly, call your doctor right away. If your symptoms are severe, call 911 or go to the nearest emergency room.
Decreased bone density
Breo can cause decreased bone density. If you already have decreased bone density, Breo Ellipta could make it worse. And if you’re at increased risk of low bone density, be sure to discuss this with your doctor. Risk factors include:
- not exercising enough
- family history of osteoporosis (weakened bones)
- going through menopause before age 45
- smoking
- older age
- poor nutrition
- long-term use of drugs that can lower bone mass, such as anticonvulsants (seizure medications) and oral corticosteroids
If you have more than one of these risk factors, talk with your doctor. You’ll need regular follow-ups to check your bone density while you take Breo Ellipta.
Abnormal heart rhythm
Breo Ellipta can cause irregular heart rhythms by lowering potassium levels. If you have a history of heart rhythm problems, talk with your doctor. Together you can determine if Breo is right for you.
Diabetes
Breo Ellipta may cause hyperglycemia (high blood sugar levels) in people who are at risk for diabetes. Breo Ellipta may also cause ketoacidosis (increased levels of ketones in the blood) in people with diabetes, which can be life-threatening. If you have a history of any of these conditions, talk with your doctor. The two of you can determine if Breo Ellipta is right for you.
Milk allergy
Breo Ellipta contains lactose, an ingredient in milk. People with severe allergies to milk protein can experience severe allergic reactions after inhaling Breo. Be sure your doctor is aware of all your allergies before they prescribe Breo.
Note: For more information about the potential negative effects of Breo Ellipta, see the “Breo Ellipta side effects” section above.
Using more than the recommended dose of Breo Ellipta can lead to serious side effects.
Overdose symptoms
Symptoms of an overdose can include:
- hypercorticism (high cortisol levels) and adrenal suppression (low cortisol levels). You may notice:
- weight gain, mostly around your midsection and upper back
- purple stretch marks on your skin
- easy bruising
- slow healing cuts or wounds
- acne
- seizures
- chest pain
- changes in blood pressure
- headache
- dry mouth
- abnormal heart rhythm (heartbeat that’s too fast, too slow, or irregular)
- nausea
- tiredness and malaise (overall feeling of discomfort)
What to do in case of overdose
If you think you’ve taken too much of this drug, call your doctor or seek guidance from America’s Poison Centers at 800-222-1222 or through its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.
When you get Breo Ellipta from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.
The expiration date helps guarantee the effectiveness of the medication during this time. The
Storage
How long a medication remains good can depend on many factors, including how and where you store it.
Store your Breo Ellipta inhaler at room temperature between 68°F and 77°F (20°C and 25°C). Pick a dry place away from sunlight and heat.
The medication is good for up to six weeks after you remove it from its packaging. You should dispose of the inhaler when the counter reaches zero.
Disposal
If you no longer need to take Breo Ellipta and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
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Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article shouldn’t be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug doesn’t indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
