Trelegy Ellipta is an inhalation powder containing a combination of fluticasone, umeclidinium, and vilanterol.

Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Umeclidinium is an anticholinergic. Vilanterol is a bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.

Trelegy Ellipta is used to improve symptoms and prevent bronchospasm in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Trelegy Ellipta is also used in adults to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing.

Trelegy Elliptae is not for use in treating an asthma or bronchospasm attack.

Vilanterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when vilanterol is used in a combination product with fluticasone and umeclidinium.

Trelegy Ellipta is not a rescue medicine for asthma or bronchospasm attacks. It will not work fast enough to treat a bronchospasm attack. Use only fast-acting inhalation medicine for an attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Use Trelegy Ellipta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Using this medicine improperly can cause death or serious side effects on the heart.

Use Trelegy Ellipta at the same time each day, and not more than once in a 24-hour period.

Read and follow all patient instructions provided with the inhaler device. Ask your doctor or pharmacist if you do not understand these instructions.

To prevent yeast infection in your mouth, rinse with water (but do not swallow) after using Trelegy Ellipta.

Trelegy Ellipta is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Your dose needs may change due to surgery, illness, stress, or worsened COPD. Do not change your dose or dosing schedule without your doctor's advice.

You may need frequent medical tests. Your vision and your bone mineral density may also need to be checked.

Store Trelegy Ellipta at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

Usual Adult Dose of Trelegy Ellipta for Chronic Obstructive Pulmonary Disease -- Maintenance:

1 inhalation (fluticasone/umeclidinium/vilanterol 100 mcg-62.5 mcg-25 mcg) orally once a day
Maximum dose: 1 inhalation every 24 hours

Comments:
-More frequent administration or a greater number of inhalations than the recommended dose should not be used, as adverse effects are more likely to occur with higher doses.
-Use with caution when transferring from systemically active corticosteroid therapy.
-Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to this drug.

Uses:
-Long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
-Reduce exacerbations of COPD in patients with a history of exacerbations.

You should not use Trelegy Ellipta if you are allergic to fluticasone, umeclidinium, vilanterol, or milk proteins.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a seizure;

• a weak immune system;

• any type of bacterial, fungal, or viral infection, or an infection caused by parasites;

• liver disease;

• glaucoma, cataracts, or other vision problems;

• diabetes (or ketoacidosis);

• osteoporosis;

• a thyroid disorder; or

• an enlarged prostate, bladder obstruction, or urination problems.

If you have been using an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

It is not known whether Trelegy Ellipta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using Trelegy Ellipta. Ask your doctor about any risk.

Trelegy Ellipta is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Do not use more than 1 inhalation in a single day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Do not use a second inhaled bronchodilator that contains vilanterol or a similar medicine, such as salmeterol, indacaterol, formoterol, or arformoterol.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a medicine that contains fluticasone (a steroid).

Get emergency medical help if you have signs of an allergic reaction to Trelegy Ellipta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• tremors, nervousness, chest pain, fast or pounding heartbeats;

• sores or white patches in your mouth and throat, pain when swallowing;

• wheezing, choking, or other breathing problems after using this medicine;

• painful or difficult urination;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• a lung infection - fever, chills, cough with mucus, feeling short of breath;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or

• signs of a hormonal disorder - worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Common Trelegy Ellipta side effects may include:

• cold or flu symptoms such as runny or stuffy nose, sore throat, cough, chest tightness;

• a lung infection;

• nausea, vomiting, constipation, diarrhea;

• joint pain;

• mouth sores, hoarse voice;

• headache, back pain; or

• mouth pain, changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• atropine;

• antifungal or antiviral medicine;

• medicine to treat depression, anxiety, mood disorders, or mental illness;

• cold or allergy medicine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• other bronchodilator asthma medication.

This list is not complete. Other drugs may interact with fluticasone, umeclidinium, and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.