Pronunciation:

floo-TIK-a-sone FURE-oh-ate, ue-mek-li-DIN-ee-um, vye-LAN-ter-ol

Brand Names:

• Trelegy Ellipta

Dosage Forms:

• Powder

Classifications:

Therapeutic—

Corticosteroid Combination

Pharmacologic—

Fluticasone

Uses of This Medicine:

Fluticasone, umeclidinium, and vilanterol combination is used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

Fluticasone, umeclidinium, and vilanterol combination is used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is used long term to improve breathing problems and to reduce the number of COPD flare-ups (worsening of your COPD symptoms for several days). This medicine will not relieve a COPD attack that has already started.

Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma and COPD symptoms.

Inhaled umeclidinium and vilanterol are long-acting bronchodilators. These are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of fluticasone, umeclidinium, and vilanterol combination is not recommended in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone, umeclidinium, and vilanterol combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Desmopressin
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Potassium Citrate
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Adagrasib
• Alfuzosin
• Amantadine
• Amifampridine
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arotinolol
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Bedaquiline
• Befunolol
• Bemiparin
• Betaxolol
• Bevantolol
• Bisoprolol
• Boceprevir
• Bopindolol
• Bucindolol
• Bupranolol
• Buprenorphine
• Bupropion
• Buserelin
• Carbamazepine
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Cosyntropin
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dibenzepin
• Dilevalol
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Duvelisib
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Josamycin
• Ketoconazole
• Labetalol
• Landiolol
• Lapatinib
• Larotrectinib
• Lefamulin
• Lenacapavir
• Lenvatinib
• LetibotulinumtoxinA-wlbg
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lofepramine
• Lofexidine
• Lonafarnib
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lumefantrine
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Mefloquine
• Melitracen
• Mepindolol
• Methacholine
• Methadone
• Methotrimeprazine
• Methylene Blue
• Metipranolol
• Metoprolol
• Metronidazole
• Mibefradil
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nadolol
• Nadroparin
• Nafarelin
• Nebivolol
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nirmatrelvir
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Oliceridine
• Olutasidenib
• Omaveloxolone
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxprenolol
• Oxycodone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pindolol
• Pipamperone
• Pirtobrutinib
• Pitolisant
• Ponesimod
• Posaconazole
• Practolol
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Propranolol
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Revefenacin
• Ribociclib
• Risperidone
• Ritlecitinib
• Ritonavir
• Safinamide
• Saquinavir
• Sargramostim
• Scopolamine
• Secretin Human
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Somatrogon-ghla
• Sorafenib
• Sotalol
• Sufentanil
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Talinolol
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tertatolol
• Tetrabenazine
• Tianeptine
• Timolol
• Tiotropium
• Tipranavir
• Tolterodine
• Toremifene
• Tramadol
• Tranylcypromine
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Trofinetide
• Troleandomycin
• Tucatinib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to milk proteins, severe or
• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute—Should not be used in patients with these conditions.

• Bladder blockage or
• Cataracts, history of or
• Diabetes or
• Enlarged prostate or
• Glaucoma, history of or
• Heart or blood vessel disease (eg, coronary insufficiency) or
• Heart rhythm problems (eg, arrhythmia, prolonged QT interval) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Osteoporosis, family history of or
• Problems passing urine or
• Seizures or
• Thyrotoxicosis (excess thyroid hormone in the body)—Use with caution. May make these conditions worse.

• Infection or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Inhaled fluticasone, umeclidinium, and vilanterol combination is used to prevent asthma attacks and treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Inhaled fluticasone, umeclidinium, and vilanterol combination is used with a special inhaler that comes with a Medication Guide and patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

Use this medicine at the same time each day.

Do not stop using this medicine or other breathing medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

To use the inhaler:

• This medicine comes in a foil tray. Peel back the lid to open the tray.
• Slide the inhaler cover down until you hear a clicking sound. The inhaler is now ready to use. Do not open the cover of the inhaler until you are ready to use it. Do not close the cover until you have taken the medicine. If you open and close the inhaler without inhaling the dose, you will lose the medicine.
• Turn your head away from the inhaler, and breathe out fully. Do not breathe into the inhaler.
• Put the mouthpiece between your lips, and close your lips around the mouthpiece. Do not block the air vent with your fingers.
• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath for 3 or 4 seconds or for as long as you can before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• When you are finished, you may clean the mouthpiece with a dry tissue, if needed, before closing the inhaler cover.
• The inhaler has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the inhaler has less than 10 doses left, the left half of the counter will show up in red to remind you to refill your prescription.

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

Dosing—

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 fluticasone, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
    • 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 fluticasone, 62.5 mcg of umeclidinium, and 25 mcg of vilanterol.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not take more than 1 inhalation per day.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away this medicine 6 weeks after it was opened or when the counter reads "0."

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bladder pain

bloody or cloudy urine

chest pain or tightness

chills

cough

diarrhea

difficult, burning, or painful urination

fever

frequent urge to urinate

headache

loss of appetite

lower back or side pain

nausea

pain in the nose and mouth

pain or tenderness around the eyes and cheekbones

sneezing

sore throat

stuffy or runny nose

stomach pain

trouble breathing

weakness

Incidence not known

Difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

redness of the skin

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

change in taste

headache

loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.