Breo Ellipta (Fluticasone and Vilanterol) - Inhalation

What Is Breo Ellipta?

Breo Ellipta is a prescription inhalation powder containing a combination of two drugs, fluticasone furoate and vilanterol trifenatate. It is used in adults with asthma and chronic obstructive pulmonary disease (COPD) to improve symptoms and prevent bronchospasm and asthma attacks.

Fluticasone furoate is a corticosteroid that prevents the release of substances in the body that cause inflammation. It reduces the swelling of the airways in the lungs to make breathing easier. 

Vilanterol trifenatate is a long-acting beta-agonist (LABA) that works by relaxing the muscles around the airways to improve breathing.

The powder comes with an inhalation device to use once daily or as prescribed by a medical professional.

Drug Facts

Generic Name: Fluticasone and vilanterol

Brand Name(s): Breo Ellipta

Administration Route(s): Inhalation

Drug Availability: Prescription

Therapeutic Classification: Corticosteroid combination

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Fluticasone and vilanterol

Dosage Form(s): Powder

What Is Breo Ellipta Used For?

The Food and Drug Administration (FDA) approved Breo Ellipta (fluticasone and vilanterol) to control asthma symptoms and COPD (a group of conditions that affect the lungs and airways), including chronic bronchitis and emphysema.

The symptoms of asthma and COPD include:

  • Wheezing
  • Shortness of breath
  • Coughing
  • Chest tightness

When used alone, LABAs (like vilanterol) may sometimes increase the risk of serious asthma-related breathing problems. However, the combination of inhaled corticosteroids and LABAs, such as Breo Ellipta, does not increase the risk of severe breathing problems occurring with asthma. 

Because it only needs to be used once a day, this medication can also help improve treatment adherence.

Breo Ellipta (Fluticasone and Vilanterol) Drug Information - Illustration by Zoe Hansen

Verywell / Zoe Hansen

How to Take Breo Ellipta

Read the guidelines on the label before using this medication. Ask your doctor or pharmacist if you do not understand anything. Before using the inhaler for the first time, ask your healthcare provider to show you how to use it.

Breo Ellipta is available as a powder to inhale by mouth once a day or as directed by your healthcare provider. It comes with a particular inhaler device preloaded with blister packs containing measured doses of the medicine. Each time you use the inhaler, the device opens and loads a blister of Breo Ellipta. Follow the directions provided with the inhaler device.

Do not use more than one inhalation daily. If you open and close the inhaler cover without inhaling the medicine, you have lost the dose. If this happens, load a new dose and inhale it.

Rinse your mouth with water or gargle after each dose to prevent dry mouth, hoarseness, and oral yeast infections (thrush). Do not swallow the rinse water.

You should use this medication regularly to get the most benefit from it. Take it at the same time each day to avoid missing a dose. Do not use Breo Ellipta during a sudden attack of asthma or COPD. A short-acting inhaler is more effective during these attacks. Ask your healthcare provider to prescribe the suitable one for you.

Breo Ellipta controls the symptoms of asthma and COPD but does not cure them. Continue to use it even if you feel well. Do not stop using without talking to a medical professional, as your symptoms may return.

Storage

Keep the medicine in the foil tray it came in, tightly closed and out of reach of children. Store at room temperature, away from sunlight, excess heat, and moisture. Do not store it in the bathroom. Dispose of the inhaler six weeks after removal from the foil overwrap or after all blisters have been used and the dose indicator reads zero.

Keep all medicines out of sight and reach of children.

Properly discard unneeded or expired medications. Do not flush the medicines down the toilet or throw them in the waste bin. Instead, the best way is to return the medication through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department about take-back programs in your community.

How Long Does Breo Ellipta Take to Work?

Breo Ellipta is not a short-acting or rescue inhaler like albuterol to treat asthma and COPD. It can take several weeks before you feel the improvement in symptoms.

What Are the Side Effects of Breo Ellipta?

This is not a complete list of side effects, and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Like other medications, Breo Ellipta can cause side effects. Let your healthcare provider know about any side effects you have while using this medication.

Common Side Effects

Some of the most common side effects of Breo Ellipta are:

  • Headache
  • Nervousness
  • Shaking of body parts that you cannot control
  • Joint pain
  • Back pain
  • Runny nose or sore throat
  • Cough
  • Hoarse voice

Call your healthcare provider if any of the symptoms worsen or do not go away.

Severe Side Effects

Some side effects can be severe. Call your healthcare provider 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 can include:

  • Symptoms of severe allergy (hives; rash; swelling of the face, throat, or tongue)
  • Pounding, fast, or irregular heartbeat
  • Chest pain
  • Coughing, wheezing, or breathing problems after inhaling Breo Ellipta
  • White patches in the mouth or throat
  • Pain when swallowing
  • Fever or chills
  • Cough with green or yellow mucus (change in the color of sputum)
  • Blurred vision, tunnel vision, eye pain, or seeing halos around lights
  • High blood sugar
  • Increased thirst
  • Increased urination
  • Dry mouth
  • Low potassium level 
  • Worsening tiredness or muscle weakness
  • Feeling light-headed
  • Nausea
  • Vomiting

Long-Term Side Effects

If used for a long time, inhaled corticosteroids can increase the risk of bone loss (osteoporosis) in adults. Talk with your healthcare provider about the risk of osteoporosis and potential treatment options. People with significant risk factors for decreased bone mineral content should be monitored by their healthcare provider.

Lifestyle changes such as increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals can help. Consult your healthcare provider for specific advice and whether you may need to take calcium and vitamin D supplements.

Report Side Effects

Breo Ellipta may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Breo Ellipta Should I Use?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For inhalation dosage form (powder):
    • For treatment of asthma:
      • Adults—One inhalation once a day. Each inhalation contains 100 or 200 micrograms (mcg) of budesonide and 25 mcg of formoterol.
      • Children—Use is not recommended.
    • For treatment and prevention of worsening attacks of COPD:
      • Adults—One inhalation once a day. Each inhalation contains 100 micrograms (mcg) of budesonide and 25 mcg of formoterol.
      • Children—Use is not recommended.

Missed Dose

If you miss a regular inhalation of Breo Ellipta, take it as soon as you remember. Skip if it is almost time for the next inhalation. Do not take two inhalations in 24 hours to make up for the missed dose.

Overdose: What Happens If I Take Too Much Breo Ellipta?

Do not use Breo Ellipta more often than prescribed or at higher doses than recommended, as an overdose can occur. You may also overdose if you take Breo Ellipta with other medications containing LABA (e.g., salmeterol, formoterol fumarate).

Overdosing on fluticasone furoate itself is unlikely, but overdosing on vilanterol is possible.

Signs and symptoms of a vilanterol overdose include:

  • Seizures
  • Angina
  • Hypertension (high blood pressure) or hypotension (low blood pressure)
  • Tachycardia (rapid heartbeat)
  • Arrhythmias
  • Nervousness
  • Headache
  • Tremor
  • Muscle cramps
  • Dry mouth
  • Palpitation
  • Nausea
  • Dizziness
  • Fatigue
  • Malaise
  • Insomnia
  • Hyperglycemia
  • Hypokalemia
  • Metabolic acidosis

An overdose of vilanterol can also cause cardiac arrest and even death.

What Happens If I Overdose on Breo Ellipta?

If you think you or someone else may have overdosed on Breo Ellipta, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Breo Ellipta, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for any unwanted effects. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Tell your doctor what other medicines you are using for your asthma or COPD. Follow your doctor's instructions on how you should take these medicine.

This medicine should not be the first and only medicine you use if you are having an asthma or COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor will prescribe another medicine for you to use in case of an acute attack. If the other medicine does not work as well, tell your doctor right away.

This medicine may increase the chance of asthma-related problems. Be sure to read about these risks in the patient information leaflet and talk to your doctor or pharmacist about any questions or concerns that you have.

Talk with your doctor or get medical care right away if:

  • Your symptoms do not improve after using this medicine for 1 week or if they become worse.
  • Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).
  • You have a significant decrease in your peak flow when measured as directed by your doctor.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), indacaterol (Onbrez®), or salmeterol (Serevent®).

This medicine may weaken your immune system and increase your risk for infection. Tell your doctor about any immune system problems or infections, including herpes in your eye or tuberculosis. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

Patients with COPD may be more likely to have pneumonia when taking this medicine. Check with your doctor right away if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or increased breathing problems.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, lightheadedness, dizziness, or fainting, loss of appetite, mental depression, muscle pain or weakness, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, or shortness of breath after using this medicine.

If you develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Breo Ellipta?

Breo Ellipta is typically well tolerated, but it may not be safe to use in certain circumstances, such as:

  • An allergy to fluticasone or vilanterol, or any other allergies to the ingredients of this medication
  • Lactose intolerance or allergy to milk products: Breo Ellipta may contain milk proteins, which can cause allergic reactions or other problems.
  • Pregnancy: There is not enough resource data to prove whether Breo Ellipta will harm an unborn baby or not. Tell your healthcare provider if you are pregnant.
  • Breastfeeding: It is unknown if Breo Ellipta is safe to use while breastfeeding. Ask your provider about any risk factors.
  • Age: This medication is not approved for use by anyone younger than 18 years old.

To make sure that this medicine is safe for you, tell your healthcare provider if you have:

  • Glaucoma, increased pressure in the eye, cataracts, or change in vision
  • Weak immune system
  • Heart disease
  • QT prolongation 
  • High blood pressure
  • Thyroid disorder
  • Liver disease
  • Seizure
  • Diabetes
  • Infection (bacterial, viral, or fungal)
  • Osteoporosis
  • If you have shifted from a corticosteroid such as prednisone to an inhaler

What Other Medications Interact With Breo Ellipta?

Consult a healthcare professional if you use another LABA, such as formoterol or salmeterol.

Several medications can interact with fluticasone and vilanterol inhalation, including:

  • Certain antifungals such as itraconazol, ketoconazole, and voriconazole
  • Beta-blockers such as atenolol, labetalol, metoprolol, nadolol, and propranolol
  • Clarithromycin/telithromycin
  • Conivaptan
  • Diuretics 
  • HIV protease inhibitors such as indinavir, lopinavir, nelfinavir, ritonavir, and saquinavir 
  • Troleandomycin
  • Antidepressants such as amitriptyline, amoxapine, clomipramine desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine
  • Monoamine oxidase inhibitors, including isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine 

Tell your healthcare provider what other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking. Your provider may need to change the dose of medicines or monitor the side effects carefully.

What Medications Are Similar?

Some drugs belong to the same class of medicines as Breo Ellipta and can treat the same conditions. Some may be better suited than others. If looking for an alternative to Breo, talk with your prescriber.

Some other combination medicines in this drug class include:

Breo Ellipta is effective at preventing COPD exacerbations. Compared to others of the same class, Breo Ellipta has a long half-life, which allows patients to only have to use it once a day.

Frequently Asked Questions

  • What is Breo Ellipta used for?

    Breo Ellipta is used to prevent and reduce symptoms caused by asthma and chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. It is used once a day to control the symptoms of asthma.

  • How does Breo Ellipta work?

    Breo Ellipta is available as an inhalation powder containing a combination of two drugs, fluticasone furoate and vilanterol trifenatate. Fluticasone belongs to the class of corticosteroids commonly known as steroids. These prevent inflammation. Vilanterol is a bronchodilator that relaxes the muscles in the airway to improve breathing.

  • What drugs should not be taken with Breo Ellipta?

    The following drugs should not be taken with Breo Ellipta: certain antifungals such as itraconazole, ketoconazole, and voriconazole; beta-blockers such as atenolol, labetalol, metoprolol, nadolol, and propranolol; and clarithromycin.

  • What are the side effects of Breo Ellipta?

    Some of the common side effects are headache, cough, nervousness, joint pain, and shaking of a body part. These signs usually go away, but if the condition becomes worse, consult your healthcare provider.

  • Is Breo Ellipta a steroid?

    Breo Ellipta is a combination drug containing fluticasone and vilanterol. Fluticasone belongs to the class of corticosteroids commonly known as steroids, and vilanterol is a bronchodilator.

  • How do I safely stop taking Breo Ellipta?

    Continue to use Breo Ellipta even if you feel well. Do not stop using it without talking to your healthcare provider. If you stop using the inhaler all of a sudden, your symptoms may return.

How Can I Stay Healthy While Taking Breo Ellipta?

Breo Ellipta is an effective therapy used in patients to control the symptoms of asthma and COPD. It has limited side effects when used at appropriate doses.

Lifestyle changes can also help to minimize any long-term issues associated with Breo Ellipta use or your underlying health condition.

These changes can include:

  • Weight-bearing exercise
  • Stopping smoking
  • Limiting alcohol intake
  • Eating well-balanced meals

If using Breo Ellipta for the long-term management of severe asthma, make sure to keep to your dosing schedule. Do not stop treatment or change the dose for a sudden attack of asthma or COPD. Let your healthcare provider know if you have any problems with your treatment or condition.

Medical Disclaimer

Verywell Health's drug information is meant for education purposes only and not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your doctor before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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