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Trelegy Ellipta

Generic Name: fluticasone, umeclidinium, and vilanterol (floo TIK a sone, ue ME kli DIN ee um, and vye LAN ter ol)
Brand Names: Trelegy Ellipta

What is Trelegy Ellipta?

See also: Stiolto

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 may also be used for purposes not listed in this medication guide.

Important Information

Trelegy Ellipta is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

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

Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

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

Before taking this medicine

You should not use Trelegy Ellipta if you are allergic to fluticasone, umeclidinium, vilanterol, or milk proteins. This medicine is for use only in people with COPD and should not be used to treat asthma.

Tell your doctor if you have ever had:

  • heart disease, high blood pressure;

  • a seizure;

  • a weak immune system;

  • any type of infection, including tuberculosis, herpes infection of the eyes, or an infection caused by parasites;

  • liver disease;

  • glaucoma or cataracts;

  • diabetes (or ketoacidosis);

  • osteoporosis;

  • a thyroid disorder; or

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

If you also use 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 breast-feed while using Trelegy Ellipta. Ask your doctor about any risk.

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

How should I use Trelegy Ellipta?

Use Trelegy Ellipta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. 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 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.

Trelegy Ellipta dosing information

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.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

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.

What happens if I overdose?

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.

What should I avoid while using Trelegy Ellipta?

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 medicine that contains a steroid.

Trelegy Ellipta side effects

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;

  • fever, chills, cough with mucus, feeling short of breath;

  • nausea, vomiting, feeling weak or light-headed;

  • 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;

  • increased thirst or increased urination; or

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

Common Trelegy Ellipta side effects may include:

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

  • nausea, vomiting, stomach pain;

  • constipation, diarrhea;

  • joint pain;

  • 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.

See also: Side effects (in more detail)

What other drugs will affect Trelegy Ellipta?

Tell your doctor about all your other medicines, especially:

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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Trelegy Ellipta only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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