HOW TO USE

TRELEGY ELLIPTA

Once-daily dosing, one step at a time

TRELEGY offers the simplicity of once-daily dosing, with 3 separate long-acting medicines in 1 easy-to-use inhaler. TRELEGY does not replace a rescue inhaler.

The demonstration video below is intended to complement the Instructions for Use at the end of the Patient Information for TRELEGY ELLIPTA. For full instructions on how to use TRELEGY, as well as other important information, please see the complete Prescribing Information, including Patient Information, for TRELEGY. You can also ask your healthcare provider or pharmacist for more information. You can also use the instructions for the TRELEGY ELLIPTA inhaler below.

Using your TRELEGY ELLIPTA inhaler

View transcript

TEXT ONSCREEN:
How to use your TRELEGY ELLIPTA inhaler

ANNOUNCER:
This presentation will show you how to take a dose of your prescribed medicine. For full information on how to use your inhaler, and other important facts about your medicine, please see the complete Prescribing Information for your prescribed product.

TEXT ONSCREEN:
Throw away the desiccant, out of reach of children and pets.

Wait to open the cover until you are ready to take your dose.

[Arrow points to “Cover” of inhaler.]

ANNOUNCER:
To avoid wasting doses, do not open and close the cover without inhaling the medicine.

[Arrow points to “Cover” of inhaler.]

TEXT ONSCREEN:
If you open and close the cover without inhaling the medicine, you will lose the dose.

ANNOUNCER:
Lost doses are held in the inhaler, and it is not possible to accidentally take a double dose, or an extra dose, in 1 inhalation.

TEXT ONSCREEN:
Lost doses are held in the inhaler but will no longer be available to be inhaled.

[Arrow points to “Cover” of inhaler.]

It is not possible to accidentally take a double dose or an extra dose in 1 inhalation.

ANNOUNCER:
Slide down until you hear a click.

TEXT ONSCREEN:
Slide the cover down until you hear a “click.”

[Arrow points to “Mouthpiece”, “Air vent”, and “Dose counter” of inhaler.]

ANNOUNCER:
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.

TEXT ONSCREEN:
If the counter does not count down as you hear the click, the inhaler will not deliver the medicine.

[Arrow points to “Dose counter” of inhaler.]

ANNOUNCER:
Your inhaler is now ready to use.

TEXT ONSCREEN:
You do not need to shake this kind of inhaler.

ANNOUNCER:
While holding the inhaler away from your mouth, breathe out fully.

TEXT ONSCREEN:
Breathe out.

ANNOUNCER:
Do not breathe out into the mouthpiece.

TEXT ONSCREEN:
Do not breathe out into the mouthpiece.

ANNOUNCER:
Do not block the air vent with your fingers.

TEXT ONSCREEN:
Do not block the air vent with your fingers.

ANNOUNCER:
Take a long, steady, deep breath in through your mouth.

TEXT ONSCREEN:
Close your lips firmly around the mouthpiece. Take a long, steady, deep breath.

ANNOUNCER:
Do not breathe in through your nose.

TEXT ONSCREEN:
Do not breathe in through your nose.

ANNOUNCER:
Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds or as long as is comfortable for you.

TEXT ONSCREEN:
Hold your breath for about 3 to 4 seconds.

ANNOUNCER:
Breathe out slowly and gently.

TEXT ONSCREEN:
Breathe out.

ANNOUNCER:
You may not taste or feel the medicine even when you’re using the inhaler correctly. Do not take another dose from the inhaler.

TEXT ONSCREEN:
Do not take another dose from the inhaler, even if you do not feel or taste the medicine.

ANNOUNCER:
If you need to clean the mouthpiece, use a dry tissue before closing the cover.

TEXT ONSCREEN:
Routine cleaning is not required.

ANNOUNCER:
To close, slide the cover up and over the mouthpiece as far as it will go.

TEXT ONSCREEN:
Slide the cover up and over the mouthpiece as far as it will go.

ANNOUNCER:
Rinse your mouth with water after you’ve taken a dose of your medicine and spit the water out. Do not swallow the water.

TEXT ONSCREEN:
Rinse your mouth with water.

ANNOUNCER:
For full information on how to use your inhaler, see the complete prescribing information for your prescribed product. If you still have questions about how to use your inhaler, call GlaxoSmithKline at 1-888-825-5249.

TEXT ONSCREEN:
[GSK logo]

For full instructions on how to use TRELEGY ELLIPTA and other important information, please see the complete Prescribing Information, including Patient Information and Instructions for Use, for TRELEGY ELLIPTA.

If you still have questions about how to use your inhaler, call GSK at 1-888-825-5249.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Trademarks are owned by or licensed to the GSK group of companies.
©2023 GSK or licensor.
FVUVID230005 April 2023
Produced in USA.

[GSK logo]

Step-by-step instructions for how to use the TRELEGY ELLIPTA inhaler:

Wait to open the cover until you are ready to take a dose. Before the inhaler is used for the first time, the counter should show the number 30 (14 if you have a sample from your doctor or the hospital). This is the number of doses in the inhaler.

If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be securely held inside 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.

Make sure to ask your doctor or pharmacist for more information.

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 is 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.

Important Note:

When should you get a refill?

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.

QUICK POLL

With your COPD, which of the following is most important to you right now?

QUICK POLL

Has your doctor suggested TRELEGY?

QUICK POLL

Do you have a doctor’s appointment scheduled in the next 2 months?

QUICK POLL

3 medicines. 1 inhaler. Once a day.

TRELEGY combines 3 long-acting medicines in 1 inhaler. That means 1 single inhalation once a day gives you a full 24 hours of better breathing. Your results may vary.

Do not stop taking TRELEGY unless told to do so by your healthcare provider because your symptoms might get worse.

TRELEGY is not a rescue medication and will not replace your rescue inhaler for sudden breathing problems. If you don’t have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Why does the dose counter start at 30 instead of 60?

Each inhaler of TRELEGY contains 30 doses, which equals a 30-day supply. That’s why your dose counter starts at 30, and counts down with each dose.

TRELEGY contains 3 medicines. Inside the inhaler, the 3 medicines are packaged into 2 separate strips that each contain 30 blisters. When you open the inhaler (and hear the click), the contents of 1 blister from each of the 2 strips combine to form 1 dose of TRELEGY.

You may see the quantity “60” mentioned in printouts about your prescription, but your inhaler provides 30 doses. The “60” refers to the number of blisters inside the inhaler, and not the number of doses.

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Approved Uses & Safety Info

Approved Uses

Once-daily TRELEGY is a prescription medicine used long term to treat COPD, including chronic bronchitis, emphysema, or both and to treat asthma in adults. TRELEGY 100/62.5/25 mcg is the only strength approved for COPD. TRELEGY is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

Limitations of Use
TRELEGY is not used to relieve sudden breathing problems and will not replace a rescue inhaler. TRELEGY should not be used in children younger than 18 years of age. It is not known if TRELEGY is safe and effective in children younger than 18 years of age.

Important Safety Information

TRELEGY contains vilanterol. Long-acting beta₂-adrenergic agonist (LABA) medicines such as vilanterol,

TRELEGY contains vilanterol. Long-acting beta₂-adrenergic agonist (LABA) medicines such as vilanterol, when used alone, increase the risk of hospitalizations and death from asthma problems. TRELEGY contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a

TRELEGY contains vilanterol. Long-acting beta₂-adrenergic agonist (LABA) medicines such as vilanterol, when used alone, increase the risk of hospitalizations and death from asthma problems. TRELEGY contains an ICS, an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
Do not use TRELEGY to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
TRELEGY should not be used in children younger than 18 years of age. It is not known if TRELEGY is safe and effective in children.
Do not use TRELEGY if you have a severe allergy to milk proteins or are allergic to any of the ingredients in TRELEGY. Ask your healthcare provider if you are not sure.
Do not use TRELEGY more often than prescribed.
Do not take TRELEGY with other medicines that contain a LABA or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take.
Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need your rescue inhaler more often than usual or it does not work as well to relieve your symptoms.
TRELEGY can cause serious side effects, including:
- fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY to help reduce your chance of getting thrush.
- pneumonia. People with COPD have a higher chance of getting pneumonia. TRELEGY may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms: change in amount or color of mucus; fever; chills; increased cough; increased breathing problems.
- weakened immune system and increased chance of getting infections.
- reduced adrenal function. This can happen when you stop taking oral corticosteroids and start taking inhaled corticosteroids.
- sudden breathing problems immediately after inhaling TRELEGY. If this happens, stop taking TRELEGY and call your healthcare provider right away.
- serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms: rash; hives; swelling of your face, mouth, and tongue; breathing problems.
- effects on heart: increased blood pressure; a fast or irregular heartbeat, awareness of heartbeat; chest pain.
- effects on nervous system: tremor; nervousness.
- bone thinning or weakness (osteoporosis).
- eye problems including glaucoma, increased pressure in your eye, cataracts, blurred vision, worsening of narrow-angle glaucoma, or other changes in vision. You should have regular eye exams while using TRELEGY. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include: eye pain or discomfort; nausea or vomiting; blurred vision; seeing halos or bright colors around lights; red eyes. If you have these symptoms, call your healthcare provider right away before taking another dose.
- new or worse urinary retention. Symptoms may include: difficult, painful, or frequent urination; urination in a weak stream or drips. If you have these symptoms, stop taking TRELEGY and call your healthcare provider right away.
- changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
- slowed growth in children.
Common side effects of TRELEGY 100/62.5/25 mcg for COPD include: upper respiratory tract infection; pneumonia; bronchitis; thrush in your mouth and throat (rinse your mouth with water without swallowing after use to help prevent this); headache; back pain; joint pain; flu; inflammation of the sinuses; runny nose and sore throat; taste disturbance; constipation; painful and frequent urination (signs of a urinary tract infection); nausea, vomiting, and diarrhea; mouth and throat pain; cough; and hoarseness.
Common side effects of TRELEGY for asthma include: runny nose and sore throat; upper respiratory tract infection; bronchitis; respiratory tract infection; inflammation of the sinuses; painful and frequent urination (signs of a urinary tract infection); flu; headache; back pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

GSK For You — If you don’t have prescription coverage, need cost information, or need help paying for your medicine, visit GSKforyou.com or call 1-866-GSK-FOR-U

The shape of the ELLIPTA inhaler is a trademark of the GSK group of companies.

Trademarks are property of their respective owners.

HOW TO USE

TRELEGY ELLIPTA

Once-daily dosing, one step at a time

Using your TRELEGY ELLIPTA inhaler

Step-by-step instructions for how to use the TRELEGY ELLIPTA inhaler: