Trelegy Ellipta (Fluticasone, Umeclidinium, and Vilanterol) Inhalation: Uses, Side Effects, Dosages

2022-05-28 04:16:51 By : Mr. James Wen

Karen Berger, PharmD, is a community pharmacist and medical writer/reviewer.

Trelegy Ellipta (fluticasone, umeclidinium, and vilanterol) is an inhaled prescription drug used for the maintenance treatment of adults with asthma or chronic obstructive pulmonary disease (COPD). Maintenance treatment helps to prevent and control symptoms. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

Trelegy Ellipta contains three drugs. Fluticasone is an inhaled corticosteroid. Umeclidinium is in a drug class called anticholinergics. Vilanterol is in a drug class called long-acting beta-agonists (LABAs). These three ingredients in Trelegy Ellipta work together to relax and open air passages in the lungs, making it easier to breathe.

Trelegy Ellipta is available as an inhaler. 

Generic Name: Fluticasone, umeclidinium, and vilanterol

Therapeutic Classification: Corticosteroid; anticholinergic; LABA

Active Ingredient: Fluticasone, umeclidinium, and vilanterol

Dosage Form: Powder for inhalation

The Food and Drug Administration (FDA) approved Trelegy Ellipta for adults (18 years and older) for the maintenance treatment of:

Trelegy Ellipta is not approved for children and does not treat acute bronchospasm (narrowing of the airways, which can cause wheezing and difficulty breathing).

While using this medication, read the prescription label and information leaflet that comes with it. Trelegy Ellipta is administered with an inhaler. Consult your healthcare provider if you have any questions about using the inhaler.

If you are prescribed Trelegy Ellipta, remember the following:

It is important to take this medication exactly as prescribed. Trelegy Ellipta is not a rescue inhaler. Use your rescue inhaler for asthma or bronchospasm attacks. 

Call your healthcare provider if you are sick, feeling stressed, or are planning to have surgery. Get medical help if your breathing problems worsen or if it seems like your medicines are not working as well as before. Your healthcare provider will tell you what tests you need, such as vision and bone mineral density. 

Ask your healthcare provider if you have any questions or concerns.

Store Trelegy Ellipta at room temperature (between 68 and 77 degrees Fahrenheit) and away from heat, direct light, and moisture. Keep this medication in its sealed foil package until ready to use. Throw away the inhaler device six weeks after taking it out of the foil pouch or when the dose indicator is zero, whichever comes first.

Keep this medication out of reach and out of sight of children and pets.

Trelegy Ellipta may start working after the first dose, but it is essential to take it daily to prevent and control symptoms. It may take a few weeks to feel the full effect of Trelegy Ellipta.

This is not a complete list of side effects and others may occur. A healthcare provider 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 800-FDA-1088.

The most common side effects of Trelegy Ellipta are:

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 the following:

While many people tolerate Trelegy Ellipta well, long-term or delayed side effects are possible. Some long-term side effects can be mild, such as:

Moderate long-term side effects can include:

Severe long-term side effects may include:  

Trelegy 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 FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

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.

You may need to use caution when taking Trelegy Ellipta if you are 65 years or older or have moderate to severe liver problems. Consult your healthcare provider.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult your healthcare provider.

Use Trelegy Ellipta as your provider directs, and do not skip doses. Misusing Trelegy Ellipta may cause serious heart problems or death.

If you do miss a dose, take it as soon as possible. Skip the missed dose if it is almost time for the next dose. Do not take two doses together. Do not take more than one inhalation of Trelegy Ellipta in 24 hours.

Taking too much Trelegy Ellipta can cause shakiness, chest pain, a fast heart rate, and shortness of breath.

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

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

If you will be using this medicine for a long time, it is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

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

This medicine should not be used 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 Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma. Talk to your doctor if you have concerns about this.

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

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

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

This medicine may cause a 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.

This medicine may increase your risk of having pneumonia. Call your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of this medicine or using it for a long time may cause may increase your risk of having adrenal gland problems. Talk to your doctor if you have 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.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be life-threatening. Check with your doctor right away if you have coughing, or difficulty breathing after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may increase your risk for heart and blood vessel problems, including changes in heart rhythm. Check with your doctor right away if you have dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or fast or irregular heartbeat.

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 your eyes be checked by an ophthalmologist (eye doctor).

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

This medicine may cause a slowed growth in children. Talk with your doctor if you have any concerns about this.

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.

Trelegy Ellipta is not appropriate for everyone.

There are certain reasons that you should not take this medication, such as:

Trelegy Ellipta may be prescribed with caution in some people only if the healthcare provider determines it is safe, including in people who have taken a drug called a monoamine oxidase inhibitor (MAOI) or tricyclic antidepressant within 14 days. This also includes people with:

Tell your healthcare provider about the medications you take, including prescription and over-the-counter (OTC) drugs and vitamins or supplements.

Drug interaction studies have not been explicitly done with Trelegy Ellipta, so the available information is for each component—fluticasone, umeclidinium, and vilanterol.

Monoamine oxidase inhibitors should never be taken with Trelegy Ellipta. An MAOI combined with Trelegy Ellipta can cause high blood pressure and heart problems. Examples of MAOIs are:

Tricyclic antidepressants combined with Trelegy Ellipta can also increase blood pressure and cause heart problems. Examples of TCAs include:

Beta-blockers should generally not be taken with Trelegy Ellipta (or may be used with caution in some instances) because the combination can lower the efficacy of both drugs. Examples of beta-blockers include:

Other drug interactions may occur with Trelegy Ellipta. Consult your healthcare provider for a complete list of drug interactions.

Trelegy Ellipta contains three drugs: a steroid, an anticholinergic drug, and a LABA. It can be used for the maintenance treatment of COPD or asthma.

Breztri Aerosphere is an inhaler that also contains a drug from each of these categories. It contains budesonide (a steroid), glycopyrrolate (an anticholinergic), and formoterol fumarate (a LABA). Breztri Aerosphere is approved for the maintenance treatment of COPD, but it is not approved for asthma.

There are other combination inhaled drugs that contain a steroid and a LABA. Some examples include:

Inhaled corticosteroid inhalers are available as single-ingredient products as well. Some examples include:

LABAs are also available as single-ingredient products but should never be taken alone. LABAs should always be taken with an inhaled steroid, as taking them without a steroid can increase the risk of death. This can be done as two individual products or as a combination product. Serevent (salmeterol) is an example of a LABA. 

There are also a variety of other drugs that may be prescribed for asthma or COPD maintenance, such as oral medications like Singulair (montelukast). Biologics, which are injected, are sometimes used in patients with difficult-to-control asthma.

This is a list of drugs also prescribed for asthma and COPD. It is not a list of drugs recommended to take with Trelegy Ellipta. Ask your pharmacist or a healthcare practitioner if you have questions.

Trelegy Ellipta is used in adults 18 years and older for maintenance treatment of COPD or asthma. Trelegy Ellipta does not treat an acute attack.

Trelegy Ellipta contains three drugs: fluticasone (a steroid), umeclidinium (an anticholinergic), and vilanterol (a long-acting beta-agonist). These ingredients help to relax and open the lungs, making it easier to breathe. 

Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants are some examples of drug classes that should not be mixed with Trelegy Ellipta. Beta-blockers generally should not be prescribed with Trelegy Ellipta, but in some cases, a beta-blocker may be used with caution if needed. There are other potential drug interactions as well. Tell your healthcare provider about all of the medications you take before taking Trelegy Ellipta. This includes prescription and OTC drugs as well as vitamins and supplements.

Trelegy Ellipta may start to work after the first dose. However, it is important to take Trelegy Ellipta every day to prevent and control symptoms. The full effect may take a few weeks of treatment to be seen.

The most common side effects of Trelegy Ellipta are cold and flu symptoms, headache, back pain, joint pain, altered taste, mouth sores, hoarseness, urinary tract infection, nausea, vomiting, constipation, diarrhea, and yeast infection of the mouth, throat, and/or esophagus. Other side effects can occur.

Your healthcare provider will advise you on how long to take Trelegy Ellipta. Do not stop taking the medication without guidance from your provider. Trelegy Ellipta should not be stopped abruptly.

Before taking Trelegy Ellipta, discuss your medical history and all medication you take with your healthcare provider. When taking Trelegy, follow your healthcare provider’s instructions for use. Read the patient information leaflet that comes with your prescription and ask your provider if you have any questions about the drug or how to use the inhaler.

Trelegy Ellipta must be taken once daily, every day, to help prevent and control symptoms. Each time you use Trelegy Ellipta, rinse your mouth with water and spit it out. This will help prevent a fungal infection of the mouth. 

Trelegy Ellipta cannot be used to treat an acute attack. Your rescue inhaler is fast-acting and should be used to treat symptoms of an acute asthma attack or bronchospasm. Common rescue inhalers include ProAir HFA (albuterol), Proventil HFA (albuterol), Ventolin HFA (albuterol), and Xopenex HFA (levalbuterol). If you notice you are using your rescue inhaler more frequently than usual, or feel like it is not working as well as it used to, contact your healthcare provider. 

Always carry your rescue inhaler with you. It can be helpful to have an extra rescue inhaler for work or school. Check the dose counter frequently to make sure your inhaler has enough remaining doses, and always call in your refills a few days early. This will allow extra time in case the pharmacy staff needs to contact your provider for refills, or if the inhaler has to be ordered. Check expiration dates periodically, to make sure your rescue inhaler is not expired.

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

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DailyMed. Label: Trelegy Ellipta - fluticasone furoate, umeclidinium bromide and vilanterol trifenatate powder.

U.S. National Library of Medicine. MedlinePlus. Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation.

Prescribers’ Digital Reference. Fluticasone furoate/umeclidinium/vilanterol - Drug Summary.

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