Trelegy Ellipta (Page 10 of 10)

16 HOW SUPPLIED/STORAGE AND HANDLING

TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack).

One strip contains fluticasone furoate (100 or 200 mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5 and 25 mcg per blister, respectively).

A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:

NDC 0173-0887-10 TRELEGY ELLIPTA 100/62.5/25 mcg 30 inhalations (60 blisters)

NDC 0173-0887-14 TRELEGY ELLIPTA 100/62.5/25 mcg 14 inhalations (28 blisters), institutional pack

NDC 0173-0893-10 TRELEGY ELLIPTA 200/62.5/25 mcg 30 inhalations (60 blisters)

NDC 0173-0893-14 TRELEGY ELLIPTA 200/62.5/25 mcg 14 inhalations (28 blisters), institutional pack

Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.

TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard TRELEGY ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Serious Asthma-Related Events

Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization or asthma-related death. Available data show that when ICS and LABA are used together, such as with TRELEGY ELLIPTA, there is not a significant increase in the risk of these events. [See Warnings and Precautions (5.1).]

Not for Acute Symptoms

Inform patients that TRELEGY ELLIPTA is not meant to relieve acute symptoms of COPD or asthma and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta₂ -agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.

Instruct patients to seek medical attention immediately if they experience any of the following:

•

Decreasing effectiveness of inhaled, short-acting beta₂ -agonists

•

Need for more inhalations than usual of inhaled, short-acting beta₂ -agonists

•

Significant decrease in lung function as outlined by the physician

Tell patients they should not stop therapy with TRELEGY ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation. [See Warnings and Precautions (5.2).]

Do Not Use Additional Long-acting Beta₂ -agonists

Instruct patients not to use other LABA for COPD and asthma. [See Warnings and Precautions (5.3).]

Oropharyngeal Candidiasis

Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with TRELEGY ELLIPTA, but at times therapy with TRELEGY ELLIPTA may need to be temporarily interrupted under close medical supervision. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush. [See Warnings and Precautions (5.4).]

Pneumonia

Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare providers if they develop symptoms of pneumonia. [See Warnings and Precautions (5.5).]

Immunosuppression and Risk of Infections

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. [See Warnings and Precautions (5.6).]

Hypercorticism and Adrenal Suppression

Advise patients that TRELEGY ELLIPTA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to TRELEGY ELLIPTA. [See Warnings and Precautions (5.8).]

Paradoxical Bronchospasm

As with other inhaled medicines, TRELEGY ELLIPTA can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue TRELEGY ELLIPTA and contact their healthcare provider right away. [See Warnings and Precautions (5.10).]

Hypersensitivity Reactions, including Anaphylaxis

Advise patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur after administration of TRELEGY ELLIPTA. Instruct patients to discontinue TRELEGY ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use TRELEGY ELLIPTA. [See Warnings and Precautions (5.11).]

Reduction in Bone Mineral Density

Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk. [See Warnings and Precautions (5.13).]

Glaucoma and Cataracts

Advise patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations.

Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develop. [See Warnings and Precautions (5.14).]

Worsening of Urinary Retention

Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately if any of these signs or symptoms develop. [See Warnings and Precautions (5.15).]

Risks Associated with Beta-agonist Therapy

Inform patients of adverse effects associated with beta₂ -agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness. Instruct patients to consult a health care practitioner immediately should any of these signs and symptoms develop. [See Warnings and Precautions (5.12).]

Trademarks are owned by or licensed to the GSK group of companies.

GlaxoSmithKline

Durham, NC 27701

©2022 GSK group of companies or its licensor.

TRL:8PI

PATIENT INFORMATION TRELEGY ELLIPTA (TREL-e-ge e-LIP-ta) (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) for oral inhalation use
What is TRELEGY ELLIPTA? • TRELEGY ELLIPTA combines 3 medicines in 1 inhaler, an inhaled corticosteroid (ICS) medicine (fluticasone furoate), an anticholinergic medicine (umeclidinium), and a long-acting beta2 -adrenergic agonist (LABA) medicine (vilanterol). • ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. • Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. • TRELEGY ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler. • TRELEGY ELLIPTA is a prescription medicine used long term (chronic) to treat people with: Chronic Obstructive Pulmonary Disease (COPD): • TRELEGY ELLIPTA is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. • TRELEGY ELLIPTA is used to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days). Asthma: • TRELEGY ELLIPTA is a prescription medicine used to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing. • TRELEGY ELLIPTA contains vilanterol. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. TRELEGY ELLIPTA 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. TRELEGY ELLIPTA should not be used in children younger than 18 years of age. It is not known if TRELEGY ELLIPTA is safe and effective in children younger than 18 years of age.
Do not use TRELEGY ELLIPTA: • to treat sudden, severe symptoms of COPD or asthma. • if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure. • if you are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the ingredients in TRELEGY ELLIPTA. See the end of this Patient Information for a complete list of ingredients in TRELEGY ELLIPTA.
Before using TRELEGY ELLIPTA, tell your healthcare provider about all of your medical conditions, including if you: • have heart problems. • have high blood pressure. • have seizures. • have thyroid problems. • have diabetes. • have liver problems. • have weak bones (osteoporosis). • have an immune system problem. • have eye problems such as glaucoma, increased pressure in your eye, cataracts, blurred vision, or other changes in vision. TRELEGY ELLIPTA may make your glaucoma worse. • are allergic to milk proteins. • have prostate or bladder problems, or problems passing urine. TRELEGY ELLIPTA may make these problems worse. • have any type of viral, bacterial, parasitic, or fungal infection. • are exposed to chickenpox or measles. • are pregnant or plan to become pregnant. It is not known if TRELEGY ELLIPTA may harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if the medicines in TRELEGY ELLIPTA pass into your breast milk and if they can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRELEGY ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take: • anticholinergics (including tiotropium, ipratropium, aclidinium) • atropine • other LABA (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol) • antifungal or anti-HIV medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use TRELEGY ELLIPTA? Read the step-by-step instructions for using TRELEGY ELLIPTA at the end of this Patient Information. • Do not use TRELEGY ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. • TRELEGY ELLIPTA comes in 2 different strengths. Your healthcare provider prescribed the strength that is best for you. • Use TRELEGY ELLIPTA exactly as your healthcare provider tells you to use it. Do not use TRELEGY ELLIPTA more often than prescribed. • Use 1 inhalation of TRELEGY ELLIPTA 1 time each day. Use TRELEGY ELLIPTA at the same time each day. • If you miss a dose of TRELEGY ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time. • If you take too much TRELEGY ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness. • Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines. • Do not stop using TRELEGY ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed. • TRELEGY ELLIPTA does not relieve sudden symptoms of COPD or asthma and you should not take extra doses of TRELEGY ELLIPTA to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you. • Call your healthcare provider or get medical care right away if: o your breathing problems get worse. o you need to use your rescue inhaler more often than usual. o your rescue inhaler does not work as well to relieve your symptoms.
What are the possible side effects of TRELEGY ELLIPTA? TRELEGY ELLIPTA can cause serious side effects, including: • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRELEGY ELLIPTA to help reduce your chance of getting thrush. • pneumonia. People with COPD have a higher chance of getting pneumonia. TRELEGY ELLIPTA may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:
	o increase in mucus (sputum) production o change in mucus color o fever	o chills o increased cough o increased breathing problems
• weakened immune system and increased chance of getting infections (immunosuppression). • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as TRELEGY ELLIPTA). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse COPD or asthma symptoms, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
	o feeling tired o lack of energy o weakness	o nausea and vomiting o low blood pressure (hypotension)
• sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using TRELEGY ELLIPTA 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 of a serious allergic reaction:
	o rash o hives	o swelling of your face, mouth, and tongue o breathing problems
• effects on heart.
	o increased blood pressure o a fast or irregular heartbeat, awareness of heartbeat	o chest pain
• effects on nervous system.
	o tremor	o 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 ELLIPTA. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
	o eye pain or discomfort o nausea or vomiting o blurred vision	o seeing halos or bright colors around lights o red eyes
If you have these symptoms, call your healthcare provider right away before taking another dose. • urinary retention. People who take TRELEGY ELLIPTA may develop new or worse urinary retention. Symptoms of urinary retention may include:
	o difficulty urinating o painful urination	o urinating frequently o urination in a weak stream or drips
If you have these symptoms of urinary retention, stop taking TRELEGY ELLIPTA, and call your healthcare provider right away before taking another dose. • 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 ELLIPTA include: COPD:
• 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 • hoarseness
Asthma:
• runny nose and sore throat • upper respiratory tract infection • bronchitis • respiratory tract infection • inflammation of the sinuses		• respiratory tract infection (signs of a urinary tract infection) • flu • headache • back pain
These are not all the possible side effects of TRELEGY ELLIPTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store TRELEGY ELLIPTA? • Store TRELEGY ELLIPTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight. • Store TRELEGY ELLIPTA in the unopened tray and only open when ready for use. • Safely throw away TRELEGY ELLIPTA in the trash 6 weeks after you open the tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler. Keep TRELEGY ELLIPTA and all medicines out of the reach of children.
General information about the safe and effective use of TRELEGY ELLIPTA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TRELEGY ELLIPTA for a condition for which it was not prescribed. Do not give TRELEGY ELLIPTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TRELEGY ELLIPTA that is written for health professionals.
What are the ingredients in TRELEGY ELLIPTA? Active ingredients: fluticasone furoate, umeclidinium, vilanterol Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate For more information about TRELEGY ELLIPTA, call 1-888-825-5249 or visit our website at www.trelegy.com. Trademarks are owned by or licensed to the GSK group of companies. GlaxoSmithKline, Durham, NC 27701 ©2022 GSK group of companies or its licensor. TRL:7PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: December 2022

INSTRUCTIONS FOR USE TRELEGY ELLIPTA (TREL-e-ge e-LIP-ta) (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) for oral inhalation use
Read this before you start: • 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. Your TRELEGY ELLIPTA inhaler (click image for full-size original) How to use your inhaler • TRELEGY ELLIPTA comes in a tray. • Peel back the lid to open the tray. See Figure A. • 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. See Figure B.
Figure A	Figure B
Important Notes: • Your inhaler contains 30 doses (14 doses if you have a sample or institutional pack). • 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. Check the counter. See Figure C.
Figure C	• Before the inhaler is used for the first time, the counter should show the number 30 (14 if you have a sample or institutional pack). 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.
Prepare your dose: Wait to open the cover until you are ready to take your dose.
Figure D	Step 1. Open the cover of the inhaler. See Figure D. • 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.
Figure E	Step 2. Breathe out. See Figure E. • While holding the inhaler away from your mouth, breathe out (exhale) fully. Do not breathe out into the mouthpiece.
Figure F	Step 3. Inhale your medicine. See Figure F. • 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.
Figure G	• Do not block the air vent with your fingers. See Figure G.
Figure H	• Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds (or as long as comfortable for you). See Figure H.
Figure I	Step 4. Breathe out slowly and gently. See Figure I. • 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.
(click image for full-size original) Figure J	Step 5. Close the inhaler. See Figure J. • 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.
(click image for full-size original) Figure K	Step 6. Rinse your mouth. See Figure K. • 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?
Figure L	• 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. See Figure L. • 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.
For more information about TRELEGY ELLIPTA or how to use your inhaler, call 1-888-825-5249 or visit our website at www.trelegy.com. Trademarks are owned by or licensed to the GSK group of companies. GlaxoSmithKline, Durham, NC 27701 ©2020 GSK group of companies or its licensor. TRL:4IFU

This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: December 2022

PRINCIPAL DISPLAY PANEL

NDC 0173-0887-10

Trelegy ELLIPTA

(fluticasone furoate, umeclidinium, and vilanterol inhalation powder)

100 mcg/62.5 mcg/25 mcg

Rx Only

FOR ORAL INHALATION ONLY

TRELEGY ELLIPTA contains 2 foils strips of 30 blisters each. Each blister on one strip contains 100 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 62.5 mcg of umeclidinium, 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.

1 ELLIPTA Inhaler containing 30 doses (60 blisters total)

Made in UK

©2018 GSK group of companies or its licensor.

10000000149452 Rev. 7/18

PRINCIPAL DISPLAY PANEL

NDC 0173-0893-10

TRELEGY ELLIPTA

(fluticasone furoate, umeclidinium, and vilanterol inhalation powder)

200 mcg/62.5 mcg/25 mcg

Rx Only

FOR ORAL INHALATION ONLY

TRELEGY ELLIPTA contains 2 foils strips of 30 blisters each. Each blister on one strip contains 200 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 62.5 mcg of umeclidinium, 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.

1 ELLIPTA Inhaler containing 30 doses (60 blisters total)

Made in UK

©2020 GSK group of companies or its licensor.

62000000055048 Rev. 9/20

TRELEGY ELLIPTA fluticasone furoate, umeclidinium bromide and vilanterol trifenatate powder

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0887 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUTICASONE FUROATE (FLUTICASONE) FLUTICASONE FUROATE 100 ug UMECLIDINIUM BROMIDE (UMECLIDINIUM) UMECLIDINIUM 62.5 ug VILANTEROL TRIFENATATE (VILANTEROL) VILANTEROL 25 ug

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE LACTOSE MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0887-10 1 TRAY in 1 CARTON contains a TRAY 1 1 INHALER in 1 TRAY This package is contained within the CARTON (0173-0887-10) and contains a INHALER 1 30 POWDER in 1 INHALER This package is contained within a TRAY and a CARTON (0173-0887-10) 2 NDC:0173-0887-14 1 TRAY in 1 CARTON contains a TRAY 2 1 INHALER in 1 TRAY This package is contained within the CARTON (0173-0887-14) and contains a INHALER 2 14 POWDER in 1 INHALER This package is contained within a TRAY and a CARTON (0173-0887-14) 3 NDC:0173-0887-61 1 TRAY in 1 CARTON contains a TRAY 3 1 INHALER in 1 TRAY This package is contained within the CARTON (0173-0887-61) and contains a INHALER 3 14 POWDER in 1 INHALER This package is contained within a TRAY and a CARTON (0173-0887-61)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA209482 09/18/2017

TRELEGY ELLIPTA fluticasone furoate, umeclidinium bromide and vilanterol trifenatate powder

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0893 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUTICASONE FUROATE (FLUTICASONE) FLUTICASONE FUROATE 200 ug UMECLIDINIUM BROMIDE (UMECLIDINIUM) UMECLIDINIUM 62.5 ug VILANTEROL TRIFENATATE (VILANTEROL) VILANTEROL 25 ug

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE LACTOSE MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0893-10 1 TRAY in 1 CARTON contains a TRAY 1 1 INHALER in 1 TRAY This package is contained within the CARTON (0173-0893-10) and contains a INHALER 1 30 POWDER in 1 INHALER This package is contained within a TRAY and a CARTON (0173-0893-10) 2 NDC:0173-0893-14 1 TRAY in 1 CARTON contains a TRAY 2 1 INHALER in 1 TRAY This package is contained within the CARTON (0173-0893-14) and contains a INHALER 2 14 POWDER in 1 INHALER This package is contained within a TRAY and a CARTON (0173-0893-14) 3 NDC:0173-0893-61 1 TRAY in 1 CARTON contains a TRAY 3 1 INHALER in 1 TRAY This package is contained within the CARTON (0173-0893-61) and contains a INHALER 3 14 POWDER in 1 INHALER This package is contained within a TRAY and a CARTON (0173-0893-61)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA209482 09/09/2020

Labeler — GlaxoSmithKline LLC (167380711)

Revised: 12/2022 GlaxoSmithKline LLC