Combination fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, a long-acting muscarinic antagonist (LAMA); and vilanterol, a long-acting beta2-adrenergic agonist (LABA).
Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Also, indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
Trelegy Ellipta is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. TRELEGY ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
Important Limitations Of Use
- Trelegy Ellipta is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
Dosage & administration
- TRELEGY ELLIPTA should be administered as 1 inhalation once daily by the orally inhaled route only.
- After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
- TRELEGY ELLIPTA should be used at the same time every day.
- Do not use TRELEGY ELLIPTA more than 1 time every 24 hours.
Common side effects of Trelegy Ellipta include:
- back pain,
- changes in taste,
- mouth pain,
- sore throat,
- and gastroenteritis (nausea, vomiting, cramps, and fever).
The dose of Trelegy Ellipta for maintenance treatment of COPD is 1 inhalation once daily. Trelegy Ellipta may interact with ketoconazole and other azole antifungals, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, diuretics, antocholinergics, antiviral medications, conivaptan, nefazodone, and macrolide antibiotics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Trelegy Ellipta; it is unknown how it would affect a fetus. It is unknown if Trelegy Ellipta passes into breast milk. Consult your doctor before breastfeeding.
Do not use TRELEGY ELLIPTA if you:
- have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
- are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the ingredients in TRELEGY ELLIPTA.\
How to use your inhaler
- TRELEGY ELLIPTA comes in a tray.
- Peel back the lid to open the tray.
- The tray contains a desiccant to reduce moisture. Do not eat or inhale. Throw it away in the household trash out of reach of children and pets.
Your inhaler contains 30 doses.
- Each time you fully open the cover of the inhaler (you will hear a clicking sound), a dose is ready to be inhaled. This is shown by a decrease in the number on the counter.
- If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in 1 inhalation.
- Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine.
- Write the “Tray opened” and “Discard” dates on the inhaler label. The “Discard” date is 6 weeks from the date you open the tray.
Before the inhaler is used for the first time, the counter should show the number 30. This is the number of doses in the inhaler.
- Each time you open the cover, you prepare 1 dose of medicine.
- The counter counts down by 1 each time you open the cover.
Step 1. Open the cover of the inhaler.
- Slide the cover down to expose the mouthpiece. You should hear a “click.” The counter will count down by 1 number. You do not need to shake this kind of inhaler. Your inhaler is now ready to use.
- If the counter does not count down as you hear the click, the inhaler will not deliver the medicine. Call your healthcare provider or pharmacist if this happens.
Step 2. Breathe out.
- While holding the inhaler away from your mouth, breathe out (exhale) fully. Do not breathe out into the mouthpiece.
Step 3. Inhale your medicine.
- Put the mouthpiece between your lips, and close your lips firmly around it. Your lips should fit over the curved shape of the mouthpiece.
- Take one long, steady, deep breath in through your mouth. Do not breathe in through your nose.
- Do not block the air vent with your fingers.
- Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds (or as long as comfortable for you).
Step 4. Breathe out slowly and gently.
- You may not taste or feel the medicine, even when you are using the inhaler correctly.
- Do not take another dose from the inhaler even if you do not feel or taste the medicine.
Step 5. Close the inhaler.
- You can clean the mouthpiece if needed, using a dry tissue, before you close the cover. Routine cleaning is not required.
- Slide the cover up and over the mouthpiece as far as it will go.
Step 6. Rinse your mouth.
- Rinse your mouth with water after you have used the inhaler and spit the water out. Do not swallow the water.
When you have fewer than 10 doses remaining in your inhaler, the left half of the counter shows red as a reminder to get a refill.
- After you have inhaled the last dose, the counter will show “0” and will be empty.
- Throw the empty inhaler away in your household trash out of reach of children and pets.