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Trelegy Ellipta fluticasone furoate, umeclidinium bromide and vilanterol trifenatate 200 ug; 62.5 ug; 25 ug Powder — NDC 00173-0893-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Trelegy Ellipta fluticasone furoate, umeclidinium bromide and vilanterol trifenatate 200 ug; 62.5 ug; 25 ug Powder — NDC 0173-0893-10 (Billing 00173-0893-10)

by GlaxoSmithKline LLC · 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER

This is a package of Trelegy Ellipta fluticasone furoate, umeclidinium bromide and vilanterol trifenatate 200 ug; 62.5 ug; 25 ug Powder from GlaxoSmithKline LLC, marketed since Sep 2020 and currently FDA-listed; retail pharmacies pay about $11.15 per unit (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 00173-0893-10
🏷️ FDA NDC (as labeled) 0173-0893-10 billing pads the labeler segment with a zero
This package
Contains30 powder in 1 inhaler Cost per ea$11.15 NADAC Per package$334.58 / 30 powders Pack sizes3 compare ↓
Also priced by: Medicaid pays $10.92/unit · Part D plans $11.17/unit — full pricing hub ↓
Main listing for product 0173-0893 · Also comes in: 1 inhaler 0173-0893-14 1 inhaler 0173-0893-61
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0173-0893-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0173 labeler · 0893 product · 10 package
Package marketed since
Sep 9, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0173089310 9
Medicaid fills, this package
369,671 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0173-0893-10
Product NDC 0173-0893
11-digit billing NDC 00173089310
NCPDP billing unit EA — each (per item)
RxCUI 1945039, 1945044, 1945047, 1945048, 2395769, 2395771, 2395774, 2395775
UNII 7AN603V4JV, 40AHO2C6DG, JS86977WNV
Application # NDA209482
SPL Set ID b5a81d5a-4648-4c7a-951d-33c014a63c7e
Established class (EPC) Anticholinergic; Corticosteroid; beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists; Cholinergic Antagonists; Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-09
Route RESPIRATORY (INHALATION)
Dosage form POWDER
Substance FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 081555
GCN 48708
HICL code 044508
Ingredient (HICL) Fluticasone/Umeclidin/Vilanter
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B64
Therapeutic class — specific (HIC3) Beta-Adrenergic-Anticholinergic-Glucocort, Inhaled
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name TRELEGY ELLIPTA 200-62.5-25
FDB brand name Trelegy Ellipta
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081555
  • GCN: 48708
  • HICL (First Databank): 044508
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1945039
Why two NDCs? The FDA registers this code as 0173-0893-10 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00173-0893-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
How it works Adrenergic beta2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TRELEGY ELLIPTA 200-62.5-25 Ingredient Fluticasone/Umeclidin/Vilanter
📗 Our plain-language guide HelloPharmacist
  • It is for the daily, long-term treatment of COPD, and of asthma in adults 18 and older. It helps control symptoms over time. It will not stop a sudden attack.
  • Take one inhalation once a day, at the same time each day. Never use it more than once in 24 hours. Rinse your mouth with water afterward and spit it out without swallowing.
  • No. It is not a rescue inhaler. Use your short-acting rescue inhaler such as albuterol. Call your doctor if you need it more than usual or it works less well.
  • Can I use it when I suddenly can't breathe?
📖 Read our full Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $11.153 $334.58 / 30 powders
Medicaid paysCMS SDUD · 12 mo $10.92 $327.62 / 30 powders
Medicare drug plans payPart D · Q2 2026 $11.17 $334.99 / 30 powders
NADAC price history (per ea) — tap or hover for the price & month
Nov 2021 Jan 2024 Jun 2026 Sep 2026 $11.163 $9.657
▲ Up 15% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00173-0893-10 You're viewing this Main listing 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER $11.15 / ea $334.58 2020-09-09 — Active
00173-0893-14 0173-0893-14 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER $11.20 / ea $156.80 2020-09-09 — Active
00173-0893-61 0173-0893-61 1 TRAY in 1 CARTON / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER Sample — — 2020-09-09 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($11.15 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tray in 1 carton / 1 inhaler in 1 tray / 30 powder in 1 inhaler.
What NDC number is used to bill for this package of Trelegy Ellipta fluticasone furoate, umeclidinium bromide and vilanterol trifenatate 200 ug; 62.5 ug; 25 ug Powder?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Trelegy Ellipta 200 ug/1; 62.5 ug/1; 25 ugthis 00173-0893-10 GlaxoSmithKline 1 inhaler $11.153 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
First FDA approval
Sep 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 18, 2017 RLD RS ⏳ ~4.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11090294 — method of use (U-3202)
US 8746242 — drug product
US 8534281 — drug product
US 7488827 — drug substance
US 8534281 — drug product
US 9750726 — drug product
US 8746242 — drug product
US 9750726 — drug product
US 12396986 — drug product
US 12396986 — drug product
US 7488827 — drug substance
US 8534281*PED — drug product
US 8746242*PED — drug product
US 8534281*PED — drug product
US 8746242*PED — drug product
2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (15)
PatentTypeUse codeExpires
US 11090294 ↗ Method of use U-3202 Nov 29, 2030
US 8746242 ↗ Drug product — Oct 11, 2030
US 8534281 ↗ Drug product — Mar 8, 2030
US 7488827 ↗ Drug substance — Dec 18, 2027
US 8534281 ↗ Drug product — Mar 8, 2030
US 9750726 ↗ Drug product — Nov 29, 2030
US 8746242 ↗ Drug product — Oct 11, 2030
US 9750726 ↗ Drug product — Nov 29, 2030
US 12396986 ↗ Drug product — Nov 29, 2030
US 12396986 ↗ Drug product — Nov 29, 2030
US 7488827 ↗ Drug substance — Dec 18, 2027
US 8534281*PED ↗ Drug product — Sep 8, 2030
US 8746242*PED ↗ Drug product — Apr 11, 2031
US 8534281*PED ↗ Drug product — Sep 8, 2030
US 8746242*PED ↗ Drug product — Apr 11, 2031
Common questions
Is there a generic version of TRELEGY ELLIPTA 200-62.5-25?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TRELEGY ELLIPTA 200-62.5-25. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Fluticasone, Umeclidinium, and Vilanterol Oral Inhalation inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGlaxoSmithKline LLC
Application holderGLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
FDA applicationNDA209482 (NDA)
Labeler code00173
First marketedSep 2020
Product typeHuman Prescription Drug
Portfolio98 products on file

More NDCs from GlaxoSmithKline LLC labeler code 00173

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 137 words ▾

1 INDICATIONS AND USAGE TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) • the maintenance treatment of asthma in patients aged 18 years and older. ( 1.2 ) Limitations of Use: Not indicated for relief of acute bronchospasm.

( 1.3 , 5.2 )

1.1Maintenance Treatment of Chronic Obstructive Pulmonary Disease TRELEGY ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

1.2Maintenance Treatment of Asthma TRELEGY ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 18 years and older.

1.3Limitations of Use TRELEGY ELLIPTA is NOT indicated for the relief of acute bronchospasm.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.1 ) • Maintenance treatment of COPD: 1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg once daily administered by oral inhalation. ( 2.2 ) • Maintenance treatment of asthma: 1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg or TRELEGY ELLIPTA 200/62.5/25 mcg once daily administered by oral inhalation. ( 2.3 )

2.1Dosage and Administration Overview • Administer 1 actuation of TRELEGY ELLIPTA once daily by oral inhalation. • After inhalation, rinse the 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. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] .

2.2Recommended Dosage for Maintenance Treatment of Chronic Obstructive Pulmonary Disease The recommended dosage of TRELEGY ELLIPTA for maintenance treatment of COPD is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg) once daily by oral inhalation. • TRELEGY ELLIPTA 100/62.5/25 mcg is the only strength indicated for the treatment of COPD. • If shortness of breath occurs in the period between doses, an inhaled, short-acting beta 2 -agonist (rescue medicine, e.g., albuterol) should be used for immediate relief.

2.3Recommended Dosage for Maintenance Treatment of Asthma The recommended starting dosage of TRELEGY ELLIPTA for maintenance treatment of asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg) or fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of TRELEGY ELLIPTA 200/62.5/25 mcg) once daily, by oral inhalation. • When choosing the starting dosage strength of TRELEGY ELLIPTA, consider the patients’ disease severity; their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage; as well as the patients’ current control of asthma symptoms and risk of future exacerbation. • The maximum recommended dosage is 1 inhalation of TRELEGY ELLIPTA 200/62.5/25 mcg once daily. • For patients who do not respond adequately to TRELEGY ELLIPTA 100/62.5/25 mcg once daily, increasing the dose to TRELEGY ELLIPTA 200/62.5/25 mcg once daily may provide additional improvement in asthma control.

For patients who do not respond adequately to TRELEGY ELLIPTA 200/62.5/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options. • If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be used for immediate relief.

💊 Dosage Forms and Strengths 79 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation powder: • 100 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol (100/62.5/25 mcg) per actuation. • 200 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol (200/62.5/25 mcg) per actuation. Inhalation powder: • 100 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol (100/62.5/25 mcg) per actuation. ( 3 ) • 200 mcg fluticasone furoate, 62.5 mcg umeclidinium, and 25 mcg vilanterol (200/62.5/25 mcg) per actuation.

( 3 )

⛔ Contraindications 99 words ▾

4 CONTRAINDICATIONS TRELEGY ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, umeclidinium, vilanterol, or any of the excipients [see Warnings and Precautions ( 5.11 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures.

( 4 ) • Severe hypersensitivity to milk proteins or any ingredients. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • LABA monotherapy increases the risk of serious asthma-related events. ( 5.1 ) • Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms.

( 5.2 ) • Do not use in combination with additional therapy containing a LABA because of risk of overdose. ( 5.3 ) • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically.

Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.4 ) • Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.

( 5.5 ) • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

( 5.6 ) • Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to TRELEGY ELLIPTA. ( 5.7 ) • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.

If such changes occur, discontinue TRELEGY ELLIPTA slowly. ( 5.8 ) • If paradoxical bronchospasm occurs, discontinue TRELEGY ELLIPTA and institute alternative therapy. ( 5.10 ) • Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.

( 5.12 ) • Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.13 ) • Glaucoma and cataracts may occur with long-term use of ICS. Worsening of narrow-angle glaucoma may occur.

Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY ELLIPTA long term. ( 5.14 ) • Worsening of urinary retention may occur.

Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur. ( 5.15 ) • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. ( 5.16 ) • Be alert to hypokalemia and hyperglycemia.

( 5.17 )

5.1Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of long-acting beta 2 -adrenergic agonists (LABA) as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy.

When LABA are used in fixed‑dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone (see Serious Asthma-Related Events with Inhaled Corticosteroid/Long ‑ acting Beta 2 -adrenergic Agonists) . Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta 2 -adrenergic Agonists Four (4) large, 26-week, randomized, double-blind, active-controlled clinical safety trials were conducted to evaluate the risk of serious asthma-related events when LABA were used in fixed-dose combination with ICS compared with ICS alone in subjects with asthma.

Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared budesonide/formoterol with budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol with mometasone furoate. The fourth trial included pediatric subjects aged 4 to 11 years and compared fluticasone… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Serious Asthma-Related Events – Hospitalizations, Intubations, Death [see Warnings and Precautions ( 5.1 )] • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.4 )] • Increased Risk of Pneumonia in COPD [see Warnings and Precautions ( 5.5 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.6 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.8 )] • Paradoxical Bronchospasm [see Warnings and Precautions ( 5.10 )] • Cardiovascular Effects [see Warnings and Precautions ( 5.12 )] • Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.13 )] • Worsening of Narrow-Angle Glaucoma [see Warnings and Precautions ( 5.14 )] • Worsening of Urinary Retention [see Warnings and Precautions ( 5.15 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. • COPD: Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.

( 6.1 ) • Asthma: Most common adverse reactions (incidence ≥2%) are pharyngitis/nasopharyngitis, upper respiratory tract infection/viral upper respiratory tract infection, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience in Chronic Obstructive Pulmonary Disease The safety of TRELEGY ELLIPTA in COPD is based on the safety data from two 12-week treatment trials with coadministration of umeclidinium and the fixed-dose combination of fluticasone furoate/vilanterol and a 52-week long-term trial of TRELEGY ELLIPTA 100/62.5/25 mcg compared with the fixed-dose combinations of fluticasone furoate/vilanterol and umeclidinium/vilanterol [see Clinical Studies ( 14.1 )] . Trials 1 and 2 Two 12-week treatment trials (Trial 1 and Trial 2) evaluated the coadministration of umeclidinium + fluticasone furoate/vilanterol, the components of TRELEGY ELLIPTA, compared with placebo + fluticasone furoate/vilanterol.

A total of 824 subjects with COPD across two 12-week, randomized, double-blind clinical trials received at least 1 dose of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg or placebo + fluticasone furoate/vilanterol 100/25 mcg administered once daily (mean age: 64 years, 92% White, 66% male across all treatments) [see Clinical Studies ( 14.1 )] . The incidence of adverse reactions associated with the use of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg presented in Table 2 is based on the two 12-week trials.

Table 2. Adverse Reactions with Umeclidinium + Fluticasone Furoate/Vilanterol with ≥1% Incidence and More Common than Placebo + Fluticasone Furoate/Vilanterol in Subjects with COPD (Trials 1 and 2) Umec = Umeclidinium, FF/VI = Fluticasone Furoate/Vilanterol. Adverse Reaction Umec + FF/VI (n = 412) % Placebo + FF/VI (n = 412) % Nervous system disorders Headache 4 3 Dysgeusia 2 <1 Musculoskeletal and connective tissue disorders Back pain 4 2 Respiratory, thoracic, and mediastinal disorders Cough 1 <1 Oropharyngeal pain 1 0 Gastrointestinal disorders Diarrhea 2 <1 Infections and infestations Gastroenteritis 1 0 Trial 3 – Long-term Safety Data A 52-week trial (Trial 3) evaluated the long-term safety of TRELEGY ELLIPTA 100/62.5/25 mcg compared with the fixed-d… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects. ( 7.1 ) • Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution.

May potentiate effect of vilanterol on cardiovascular system. ( 7.2 ) • Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm.

( 7.3 ) • Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists. ( 7.4 ) • Anticholinergics: May interact additively with concomitantly used anticholinergic medications.

Avoid administration of TRELEGY ELLIPTA with other anticholinergic-containing drugs. ( 7.5 )

7.1Inhibitors of Cytochrome P450 3A4 Fluticasone furoate and vilanterol are substrates of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol. Caution should be exercised when considering the coadministration of TRELEGY ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.9 ), Clinical Pharmacology ( 12.3 )] .

7.2Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and QTc Prolonging Drugs Vilanterol, like other beta 2 -agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents, because the effect of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

7.3Beta-adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as vilanterol, but may also produce severe bronchospasm in patients with COPD or asthma. Therefore, patients with COPD or asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.

7.4Non–Potassium-Sparing Diuretics The electrocardiographic changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non–potassium-sparing diuretics.

7.5Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of TRELEGY ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.14 , 5.15 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects. ( 8.6 , 12.3 )

8.1Pregnancy Risk Summary There are insufficient data on the use of TRELEGY ELLIPTA or its individual components, fluticasone furoate, umeclidinium, and vilanterol, in pregnant women to inform a drug‑associated risk. (See Clinical Considerations.) In an animal reproduction study, fluticasone furoate and vilanterol administered by inhalation alone or in combination to pregnant rats during the period of organogenesis produced no fetal structural abnormalities. The highest fluticasone furoate and vilanterol doses in this study were approximately 4.5 and 40 times the maximum recommended human daily inhalation doses (MRHDID) of 200 and 25 mcg, respectively in adults.

(See Data.) Umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 40 and 150 times, respectively, the human exposure at the MRHDID of 62.5 mcg. (See Data.) The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. Labor or Delivery: TRELEGY ELLIPTA should be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility.

Data Animal Data: The combination of fluticasone furoate, umeclidinium, and vilanterol has not been studied in pregnant animals. Studies in pregnant animals have been conducted with fluticasone furoate and vilanterol in combination and individually with fluticasone furoate, umeclidinium, or vilanterol. Fluticasone Furoate and Vilanterol: In an embryofetal developmental study, pregnant rats received fluticasone furoate and vilanterol during the period of organogenesis at doses up to approximately 4.5 and 40 times the MRHDID of 200 and 25 mcg, respectively, alone or in combination (on a mcg/m 2 basis at inhalation doses up to approximately 95 mcg/kg/day).

No evidence of structural abnormalities was observed. Fluticasone Furoate: In 2 separate embryofetal developmental studies, pregnant rats and rabbits received fluticasone furoate during the period of organogenesis at doses up to approximately 4.5 times and equal to, respectively, the MRHDID of 200 mcg (on a mcg/m 2 basis at maternal inhalation doses up to 91 and 8 mcg/kg/day, respectively). No evidence of structural abnormalities in fetuses was observed in either species.

In a perinatal and postnatal developmental study in rats, dams received fluticasone furoate during late gestation and lactation periods at doses up to approximately 1.5 times the MRHDID of 200 mcg (on a mcg/m 2 basis at maternal inhalation doses up to 27 mcg/kg/day). No evidence of effects on offspring development was observed. Umeclidinium: In 2 separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 40 and 150 times, respectively the MRHDID of 62.5 mcg (on an AUC basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits).

No evidence of teratogenic effects was observed in either species. In a perinatal and post… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are insufficient data on the use of TRELEGY ELLIPTA or its individual components, fluticasone furoate, umeclidinium, and vilanterol, in pregnant women to inform a drug‑associated risk. (See Clinical Considerations.) In an animal reproduction study, fluticasone furoate and vilanterol administered by inhalation alone or in combination to pregnant rats during the period of organogenesis produced no fetal structural abnormalities. The highest fluticasone furoate and vilanterol doses in this study were approximately 4.5 and 40 times the maximum recommended human daily inhalation doses (MRHDID) of 200 and 25 mcg, respectively in adults.

(See Data.) Umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 40 and 150 times, respectively, the human exposure at the MRHDID of 62.5 mcg. (See Data.) The estimated risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal outcomes such as pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. Labor or Delivery: TRELEGY ELLIPTA should be used during late gestation and labor only if the potential benefit justifies the potential for risks related to beta-agonists interfering with uterine contractility.

Data Animal Data: The combination of fluticasone furoate, umeclidinium, and vilanterol has not been studied in pregnant animals. Studies in pregnant animals have been conducted with fluticasone furoate and vilanterol in combination and individually with fluticasone furoate, umeclidinium, or vilanterol. Fluticasone Furoate and Vilanterol: In an embryofetal developmental study, pregnant rats received fluticasone furoate and vilanterol during the period of organogenesis at doses up to approximately 4.5 and 40 times the MRHDID of 200 and 25 mcg, respectively, alone or in combination (on a mcg/m 2 basis at inhalation doses up to approximately 95 mcg/kg/day).

No evidence of structural abnormalities was observed. Fluticasone Furoate: In 2 separate embryofetal developmental studies, pregnant rats and rabbits received fluticasone furoate during the period of organogenesis at doses up to approximately 4.5 times and equal to, respectively, the MRHDID of 200 mcg (on a mcg/m 2 basis at maternal inhalation doses up to 91 and 8 mcg/kg/day, respectively). No evidence of structural abnormalities in fetuses was observed in either species.

In a perinatal and postnatal developmental study in rats, dams received fluticasone furoate during late gestation and lactation periods at doses up to approximately 1.5 times the MRHDID of 200 mcg (on a mcg/m 2 basis at maternal inhalation doses up to 27 mcg/kg/day). No evidence of effects on offspring development was observed. Umeclidinium: In 2 separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 40 and 150 times, respectively the MRHDID of 62.5 mcg (on an AUC basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits).

No evidence of teratogenic effects was observed in either species. In a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods at doses up to approximately 20 times the MRHDID (on an AUC basis at maternal subcutaneous doses up to… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of TRELEGY ELLIPTA have not been established in pediatric patients (aged 17 years and younger). TRELEGY ELLIPTA is not indicated for use in pediatric patients. Effects on Growth Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents.

Controlled clinical trials have shown that ICS may cause a reduction in growth in children. In these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appears to be related to dose and duration of exposure. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of HPA axis function.

The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. A randomized, double-blind, parallel-group, multicenter, 1-year, placebo-controlled trial evaluated the effect of once-daily treatment with 110 mcg of fluticasone furoate in the nasal spray formulation on growth velocity assessed by stadiometry. The subjects were 474 prepubescent children (girls aged 5 to 7.5 years and boys aged 5 to 8.5 years).

Mean growth velocity over the 52-week treatment period was lower in the subjects receiving fluticasone furoate nasal spray (5.19 cm/year) compared with placebo (5.46 cm/year). The mean reduction in growth velocity was 0.27 cm/year (95% CI: 0.06, 0.48) [see Warnings and Precautions ( 5.18 )] .

🧓 Geriatric Use 158 words ▾

8.5Geriatric Use Based on available data, no adjustment of the dosage of TRELEGY ELLIPTA in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. In COPD Trials 1 and 2 (coadministration trials), 189 subjects aged 65 years and older, of which 39 subjects were aged 75 years and older, were administered umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg. In COPD Trial 3, 2,265 subjects aged 65 years and older, of which 565 subjects were aged 75 years and older, were administered TRELEGY ELLIPTA.

In an asthma clinical trial (Trial 4), 159 subjects aged 65 years and older, of which 27 subjects were aged 75 years and older, were administered TRELEGY ELLIPTA 100/62.5/25 mcg or TRELEGY ELLIPTA 200/62.5/25 mcg. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects.

🆘 Overdosage 217 words ▾

10 OVERDOSAGE TRELEGY ELLIPTA contains fluticasone furoate, umeclidinium, and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to TRELEGY ELLIPTA. Treatment of overdosage consists of discontinuation of TRELEGY ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm.

Cardiac monitoring is recommended in cases of overdosage. Fluticasone Furoate Because of low systemic bioavailability (15.2%) and an absence of acute drug-related systemic findings in clinical trials, overdosage of fluticasone furoate is unlikely to require any treatment other than observation. If used at excessive doses for prolonged periods, systemic effects such as hypercorticism may occur [see Warnings and Precautions (5.8)] .

Umeclidinium High doses of umeclidinium may lead to anticholinergic signs and symptoms. Vilanterol The expected signs and symptoms with overdosage of vilanterol are those of excessive beta‑adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms of beta-adrenergic stimulation (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis).

As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of vilanterol.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action TRELEGY ELLIPTA TRELEGY ELLIPTA contains fluticasone furoate, umeclidinium, and vilanterol. The mechanisms of action described below for the individual components apply to TRELEGY ELLIPTA. These drugs represent 3 different classes of medications (an ICS, an anticholinergic, and a LABA), each having different effects on clinical and physiological indices.

Fluticasone Furoate Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown.

The precise mechanism through which fluticasone furoate affects COPD and asthma symptoms is not known. Inflammation is an important component in the pathogenesis of COPD and asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats. These anti-inflammatory actions of corticosteroids may contribute to their efficacy. Umeclidinium Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic.

It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations.

In preclinical in vitro as well as in vivo studies, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.

Vilanterol Vilanterol is a LABA. In vitro tests have shown the functional selectivity of vilanterol was similar to salmeterol. The clinical relevance of this in vitro finding is unknown.

Although beta 2 -receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -receptors are the predominant receptors in the heart, there are also beta 2 -receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta 2 -agonists may have cardiac effects. The pharmacologic effects of beta 2 -adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3ʹ,5ʹ-adenosine monophosphate (cyclic AMP).

Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of umeclidinium/vilanterol on cardiac rhythm in subjects diagnosed with COPD was assessed using 24-hour Holter monitoring in 6- and 12-month trials: 53 subjects received umeclidinium/vilanterol 62.5/25 mcg, 281 subjects received umeclidinium/vilanterol 125/25 mcg, and 182 subjects received placebo. No clinically meaningful effects on cardiac rhythm were observed. The cardiovascular effects from dual combinations of fluticasone furoate/vilante… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~2 min read ▾

12.1Mechanism of Action TRELEGY ELLIPTA TRELEGY ELLIPTA contains fluticasone furoate, umeclidinium, and vilanterol. The mechanisms of action described below for the individual components apply to TRELEGY ELLIPTA. These drugs represent 3 different classes of medications (an ICS, an anticholinergic, and a LABA), each having different effects on clinical and physiological indices.

Fluticasone Furoate Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown.

The precise mechanism through which fluticasone furoate affects COPD and asthma symptoms is not known. Inflammation is an important component in the pathogenesis of COPD and asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats. These anti-inflammatory actions of corticosteroids may contribute to their efficacy. Umeclidinium Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic.

It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations.

In preclinical in vitro as well as in vivo studies, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.

Vilanterol Vilanterol is a LABA. In vitro tests have shown the functional selectivity of vilanterol was similar to salmeterol. The clinical relevance of this in vitro finding is unknown.

Although beta 2 -receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -receptors are the predominant receptors in the heart, there are also beta 2 -receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta 2 -agonists may have cardiac effects. The pharmacologic effects of beta 2 -adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3ʹ,5ʹ-adenosine monophosphate (cyclic AMP).

Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

📦 How Supplied / Storage and Handling ~1 min read ▾

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.

📋 Description ~2 min read ▾

11 DESCRIPTION TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure: Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C 27 H 29 F 3 O 6 S.

It is practically insoluble in water. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure: Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C 29 H 34 NO 2 •Br (as a quaternary ammonium bromide compound). It is slightly soluble in water.

Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1 R )-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure: Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C 24 H 33 Cl 2 NO 5 •C 20 H 16 O 2 . It is practically insoluble in water. TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips.

Each blister on one strip contains a white powder blend of micronized fluticasone furoate (100 or 200 mcg) and lactose monohydrate (12.4 or 12.3 mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (75 mcg), and lactose monohydrate (12.3 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.

Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92 or 184 mcg of fluticasone furoate, 55 mcg of umeclidinium, and 22 mcg of vilanterol per dose when tested at a flow rate of 60 L/min for 4 seconds. At flow rates of 30, 60, and 90 L/min for 4 seconds under in vitro test conditions, TRELEGY ELLIPTA delivers ≥90% of the target dose for each component. In adult subjects with very severe COPD (FEV 1 /FVC [forced vital capacity] <70% and FEV 1 <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was

65.8L/min (range: 43.5 to

94.1L/min). In adult subjects with severe asthma, mean peak inspiratory flow through the ELLIPTA inhaler was

96.6L/min (range: 72.4 to 124.6 L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Fluticasone furoate chemical structure Umeclidinium chemical structure Vilanterol chemical structure

💬 Information for Patients ~3 min read ▾

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 beta 2 -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 beta 2 -agonists • Need for more inhalations than usual of inhaled, short-acting beta 2 -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 Beta 2 -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 A… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Linear pharmacokinetics was observed for fluticasone furoate (200 to 800 mcg), umeclidinium (62.5 to 500 mcg), and vilanterol (25 to 100 mcg). The pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol from TRELEGY ELLIPTA are comparable to the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol when administered as fluticasone furoate/vilanterol or umeclidinium/vilanterol. Systemic drug levels [steady-state C max and AUC (0-24) ] of fluticasone furoate, umeclidinium, and vilanterol following administration of TRELEGY ELLIPTA 100/62.5/25 mcg based on a combined pharmacokinetic dataset from 3 studies in subjects with COPD (N = 821) were within the range of those observed following administration of fluticasone furoate/vilanterol plus umeclidinium administered via 2 inhalers, fluticasone furoate/vilanterol and umeclidinium/vilanterol as the dual combinations, and after administration of fluticasone furoate, umeclidinium, and vilanterol as monotherapy.

Systemic drug levels [steady-state C max and AUC (0-24) ] of fluticasone furoate, umeclidinium, and vilanterol following administration of TRELEGY ELLIPTA (100/62.5/25 or 200/62.5/25 mcg) based on a population pharmacokinetic analysis from subjects with asthma (1,265 subjects for fluticasone furoate; 634 subjects for umeclidinium; 1,263 subjects for vilanterol) were within the range of those observed following administration of fluticasone furoate/vilanterol as the dual combination when compared with fluticasone furoate 100 and 200 mcg, respectively; the systemic exposure of umeclidinium 62.5 mcg following TRELEGY ELLIPTA (100/62.5/25 or 200/62.5/25 mcg) was within the range of those observed following administration of umeclidinium 62.5 mcg as monotherapy.

The pharmacokinetics of the individual components of TRELEGY ELLIPTA are presented as follows. Plasma levels of fluticasone furoate, umeclidinium, and vilanterol may not predict therapeutic effect. Absorption Fluticasone Furoate: Following inhaled administration of fluticasone furoate, C max occurred within 0.5 to 1 hour.

Absolute bioavailability of fluticasone furoate when administered by inhalation was 15.2%, primarily due to absorption of the inhaled portion of the dose delivered to the lung. Oral bioavailability from the swallowed portion of the dose is low (approximately 1.3%) due to extensive first-pass metabolism. Following repeat dosing of inhaled fluticasone furoate, steady state was achieved within 6 days with up to 2.6-fold accumulation.

Umeclidinium: Following inhaled administration of umeclidinium in healthy subjects, C max occurred at 5 to 15 minutes. Umeclidinium is mostly absorbed from the lung after inhaled doses with minimum contribution from oral absorption. Following repeat dosing of inhaled umeclidinium, steady state was achieved within 14 days with up to 1.8-fold accumulation.

Vilanterol: Following inhaled administration of vilanterol in healthy subjects, C max occurred at 5 to 15 minutes. Vilanterol is mostly absorbed from the lung after inhaled doses with negligible contribution from oral absorption. Following repeat dosing of inhaled vilanterol, steady state was achieved within 14 days with up to 1.7-fold accumulation.

Distribution Fluticasone Furoate: Following intravenous administration to healthy subjects, the mean volume of distribution at steady state was 661 L. Binding of fluticasone furoate to human plasma proteins was high (>99%). Umeclidinium: Following intravenous administration to healthy subjects, the mean volume of distribution was 86 L.

In vitro plasma protein binding in human plasma was on average 89%. Vilanterol: Following intravenous administration to healthy subjects, the mean volume of distribution at steady state was 165 L. In vitro plasma protein binding in human plasma was on average 94%.

Elimination Metabolism: Fluticasone Furoate: Fluticasone furoate is cleared from systemic circulation principally by hepatic metabolism via CY… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Cardiac Electrophysiology The effect of umeclidinium/vilanterol on cardiac rhythm in subjects diagnosed with COPD was assessed using 24-hour Holter monitoring in 6- and 12-month trials: 53 subjects received umeclidinium/vilanterol 62.5/25 mcg, 281 subjects received umeclidinium/vilanterol 125/25 mcg, and 182 subjects received placebo. No clinically meaningful effects on cardiac rhythm were observed. The cardiovascular effects from dual combinations of fluticasone furoate/vilanterol and umeclidinium/vilanterol in healthy subjects are presented below.

Fluticasone Furoate/Vilanterol Combination: Healthy Subjects: QTc interval prolongation was studied in a double-blind, multiple-dose, placebo- and positive-controlled crossover study in 85 healthy volunteers. The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 4.9 (7.5) milliseconds and 9.6 (12.2) milliseconds seen 30 minutes after dosing for fluticasone furoate/vilanterol 200/25 mcg and fluticasone furoate/vilanterol 800/100 mcg, respectively. A dose-dependent increase in heart rate was also observed.

The maximum mean (95% upper confidence bound) difference in heart rate from placebo after baseline correction was 7.8 (9.4) beats/min and 17.1 (18.7) beats/min seen 10 minutes after dosing for fluticasone furoate/vilanterol 200/25 mcg and fluticasone furoate/vilanterol 800/100 mcg (8/4 times the recommended dosage), respectively. Umeclidinium/Vilanterol Combination: Healthy Subjects: QTc interval prolongation was studied in a double-blind, multiple-dose, placebo- and positive-controlled crossover trial in 86 healthy subjects.

The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 4.6 (7.1) milliseconds and 8.2 (10.7) milliseconds for umeclidinium/vilanterol 125/25 mcg and umeclidinium/vilanterol 500/100 mcg (8/4 times the recommended dosage), respectively. A dose-dependent increase in heart rate was also observed. The maximum mean (95% upper confidence bound) difference in heart rate from placebo after baseline correction was 8.8 (10.5) beats/min and 20.5 (22.3) beats/min seen 10 minutes after dosing for umeclidinium/vilanterol 125/25 mcg and umeclidinium/vilanterol 500/100 mcg, respectively.

HPA Axis Effects Healthy Subjects: Inhaled fluticasone furoate at repeat doses up to 400 mcg was not associated with statistically significant decreases in serum or urinary cortisol in healthy subjects. Decreases in serum and urine cortisol levels were observed at fluticasone furoate exposures several-fold higher than exposures observed at the therapeutic dose. Subjects with Chronic Obstructive Pulmonary Disease: In a trial with subjects with COPD, treatment with fluticasone furoate (50, 100, or 200 mcg)/vilanterol 25 mcg, vilanterol 25 mcg, or fluticasone furoate (100 or 200 mcg) for 6 months did not affect 24-hour urinary cortisol excretion.

A separate trial with subjects with COPD demonstrated no effects on serum cortisol after 28 days of treatment with fluticasone furoate (50, 100, or 200 mcg)/vilanterol 25 mcg. Subjects with Asthma: A randomized, double-blind, parallel-group trial in 185 subjects with asthma showed no difference between once-daily treatment with fluticasone furoate/vilanterol 100/25 mcg or fluticasone furoate/vilanterol 200/25 mcg compared with placebo on serum cortisol weighted mean (0 to 24 hours), serum cortisol AUC (0-24) , and 24-hour urinary cortisol after 6 weeks of treatment, whereas prednisolone 10 mg given once daily for 7 days resulted in significant cortisol suppression.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Chronic Obstructive Pulmonary Disease The clinical efficacy of TRELEGY ELLIPTA has been evaluated in 3 clinical trials in subjects with COPD, including chronic bronchitis and/or emphysema: Trial 1 (NCT01957163), Trial 2 (NCT02119286), and Trial 3 (NCT02164513). Trials 1 and 2 were multicenter, randomized, double-blind, parallel-group, 12-week treatment trials in subjects with COPD. Across both trials, a total of 412 subjects received coadministration of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg, the components of TRELEGY ELLIPTA.

Comparative in vitro data (drug delivery and aerodynamic particle size distribution) provide support for reliance on coadministration studies with umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg. These data demonstrated no pharmaceutical interactions and that each drug component (fluticasone furoate, umeclidinium, and vilanterol) was delivered in a comparable manner whether administered via a single ELLIPTA inhaler or from separate inhalers. The population demographics for Trials 1 and 2 were: mean age of 64 years, 92% White, 66% male, and an average smoking history of 48 pack-years, with 50% identified as current smokers.

At screening, the mean postbronchodilator percent predicted FEV 1 was 46% (range: 14% to 76%), the mean postbronchodilator FEV 1 /FVC ratio was 0.48 (range: 0.21 to 0.70), and the mean percent reversibility was 13% (range: -24% to 86%). Trial 3 was a randomized, multicenter, double-blind, parallel-group, 52-week treatment trial comparing the clinical efficacy of TRELEGY ELLIPTA 100/62.5/25 mcg with the fixed-dose combinations of fluticasone furoate/vilanterol 100/25 mcg and umeclidinium/vilanterol 62.5/25 mcg. A total of 10,355 subjects with COPD with a history of 1 or more moderate or severe exacerbations in the prior 12 months were randomized (2:2:1) to receive TRELEGY ELLIPTA, fluticasone furoate/vilanterol, or umeclidinium/vilanterol administered once daily.

The population demographics across all treatments were: mean age of 65 years, 77% White, 66% male, and an average smoking history of 46.6 pack-years, with 35% identified as current smokers. At study entry, the most common COPD medications were ICS + anticholinergic + LABA (34%), ICS + LABA (26%), anticholinergic + LABA (8%), and anticholinergic (7%); the mean postbronchodilator percent predicted FEV 1 was 46% (SD: 15%), the mean postbronchodilator FEV 1 /FVC ratio was 0.47 (SD: 0.12), and the mean percent reversibility was 10% (range: -59% to 125%).

Lung Function: In Trials 1 and 2, the primary endpoint was change from baseline in trough (predose) FEV 1 at Day 85 (defined as the mean of the FEV 1 values obtained at 23 and 24 hours after the previous dose on Day 84). For both COPD trials, umeclidinium + fluticasone furoate/vilanterol demonstrated a statistically significant increase relative to placebo + fluticasone furoate/vilanterol (Table 4); similar results were demonstrated for the secondary endpoint of the weighted mean FEV 1 (0 to 6 hours postdose) on Day 84 ( Table 4 ).

Table 4. Least Squares Mean Change from Baseline in Trough FEV 1 and Weighted Mean FEV 1 (0-6 h) at Week 12 (Days 84/85) FEV 1 = Forced Expiratory Volume in 1 Second, FF/VI = Fluticasone Furoate/Vilanterol 100/25 mcg, UMEC = Umeclidinium 62.5 mcg. a At Day 85. b At Day 84. c For Placebo + FF/VI: Trial 1, n = 206; Trial 2, n = 206. Treatment n Trough FEV 1 (mL) a Weighted Mean FEV 1 (0-6 h) (mL) b Difference from Placebo + FF/VI (95% CI) Difference from Placebo + FF/VI (95% CI) Trial 1 UMEC + FF/VI 206 124 153 (93, 154) (118, 187) Trial 2 UMEC + FF/VI 206 122 147 (91, 152) (114, 179) Greater least squares (LS) mean changes from baseline in FEV 1 over time were demonstrated for the umeclidinium + fluticasone furoate/vilanterol treatment group compared with the placebo + fluticasone furoate/vilanterol treatment group starting at 15 minutes postdose on Day 1.

For Trial 1, LS mean changes in… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility TRELEGY ELLIPTA No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with TRELEGY ELLIPTA; however, studies are available for the individual components, fluticasone furoate, umeclidinium, and vilanterol, as described below. Fluticasone Furoate Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 9 and 19 mcg/kg/day, respectively (both approximately 0.5 times the MRHDID of 200 mcg for adults on a mcg/m 2 basis).

Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells in vitro. There was also no evidence of genotoxicity in the in vivo micronucleus test in rats. No evidence of impairment of fertility was observed in male and female rats at inhaled fluticasone furoate doses up to 29 and 91 mcg/kg/day, respectively (approximately 3 and 8 times, respectively, the MRHDID of 200 mcg for adults on an AUC basis).

Umeclidinium Umeclidinium produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 137 and 295/200 mcg/kg/day (male/female), respectively (approximately 17 and 20/20 times, respectively, the MRHDID for adults on an AUC basis). Umeclidinium tested negative in the following genotoxicity assays: the in vitro Ames assay, in vitro mouse lymphoma assay, and in vivo rat bone marrow micronucleus assay. No evidence of impairment of fertility was observed in male and female rats at subcutaneous doses up to 180 mcg/kg/day and at inhaled doses up to 294 mcg/kg/day, respectively (approximately 60 and 40 times, respectively, the MRHDID for adults on an AUC basis).

Vilanterol In a 2-year carcinogenicity study in mice, vilanterol caused a statistically significant increase in ovarian tubulostromal adenomas in females at an inhaled dose of 29,500 mcg/kg/day (approximately 9,920 times the MRHDID for adults on an AUC basis). No increase in tumors was seen at an inhaled dose of 615 mcg/kg/day (approximately 370 times the MRHDID for adults on an AUC basis). In a 2-year carcinogenicity study in rats, vilanterol caused statistically significant increases in mesovarian leiomyomas in females and shortening of the latency of pituitary tumors at inhaled doses greater than or equal to 84.4 mcg/kg/day (greater than or equal to approximately 25 times the MRHDID for adults on an AUC basis).

No tumors were seen at an inhalation dose of 10.5 mcg/kg/day (approximately equal to the MRHDID for adults on an AUC basis). These tumor findings in rodents are similar to those reported previously for other beta-adrenergic agonist drugs. The relevance of these findings to human use is unknown.

Vilanterol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vivo rat bone marrow micronucleus assay, in vivo rat unscheduled DNA synthesis (UDS) assay, and in vitro Syrian hamster embryo (SHE) cell assay. Vilanterol tested equivocal in the in vitro mouse lymphoma assay. No evidence of impairment of fertility was observed in male and female rats at inhaled vilanterol doses up to 31,500 and 37,100 mcg/kg/day, respectively (both approximately 4,090 times the MRHDID based on AUC).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility TRELEGY ELLIPTA No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with TRELEGY ELLIPTA; however, studies are available for the individual components, fluticasone furoate, umeclidinium, and vilanterol, as described below. Fluticasone Furoate Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 9 and 19 mcg/kg/day, respectively (both approximately 0.5 times the MRHDID of 200 mcg for adults on a mcg/m 2 basis).

Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells in vitro. There was also no evidence of genotoxicity in the in vivo micronucleus test in rats. No evidence of impairment of fertility was observed in male and female rats at inhaled fluticasone furoate doses up to 29 and 91 mcg/kg/day, respectively (approximately 3 and 8 times, respectively, the MRHDID of 200 mcg for adults on an AUC basis).

Umeclidinium Umeclidinium produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 137 and 295/200 mcg/kg/day (male/female), respectively (approximately 17 and 20/20 times, respectively, the MRHDID for adults on an AUC basis). Umeclidinium tested negative in the following genotoxicity assays: the in vitro Ames assay, in vitro mouse lymphoma assay, and in vivo rat bone marrow micronucleus assay. No evidence of impairment of fertility was observed in male and female rats at subcutaneous doses up to 180 mcg/kg/day and at inhaled doses up to 294 mcg/kg/day, respectively (approximately 60 and 40 times, respectively, the MRHDID for adults on an AUC basis).

Vilanterol In a 2-year carcinogenicity study in mice, vilanterol caused a statistically significant increase in ovarian tubulostromal adenomas in females at an inhaled dose of 29,500 mcg/kg/day (approximately 9,920 times the MRHDID for adults on an AUC basis). No increase in tumors was seen at an inhaled dose of 615 mcg/kg/day (approximately 370 times the MRHDID for adults on an AUC basis). In a 2-year carcinogenicity study in rats, vilanterol caused statistically significant increases in mesovarian leiomyomas in females and shortening of the latency of pituitary tumors at inhaled doses greater than or equal to 84.4 mcg/kg/day (greater than or equal to approximately 25 times the MRHDID for adults on an AUC basis).

No tumors were seen at an inhalation dose of 10.5 mcg/kg/day (approximately equal to the MRHDID for adults on an AUC basis). These tumor findings in rodents are similar to those reported previously for other beta-adrenergic agonist drugs. The relevance of these findings to human use is unknown.

Vilanterol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vivo rat bone marrow micronucleus assay, in vivo rat unscheduled DNA synthesis (UDS) assay, and in vitro Syrian hamster embryo (SHE) cell assay. Vilanterol tested equivocal in the in vitro mouse lymphoma assay. No evidence of impairment of fertility was observed in male and female rats at inhaled vilanterol doses up to 31,500 and 37,100 mcg/kg/day, respectively (both approximately 4,090 times the MRHDID based on AUC).

📄 Patient Package Insert ~3 min read ▾

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 beta 2 -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, arform… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~4 min read ▾

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 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. 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.

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… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 196 words ▾

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) GSK Made in UK ©2025 GSK group of companies or its licensor. 62000000099742 Rev. 4/25 Trelegy Ellipta 100mcg-62.5mcg-25mcg 30 dose carton

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) GSK Made in UK ©2025 GSK group of companies or its licensor. 62000000099735 Rev. 4/25 Trelegy Ellipta 200mcg-62.5mcg-25mcg 30 dose carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
369.7K
Units reimbursed last 4 qtrs
24.4M
Gross reimbursed last 4 qtrs
$266.38M
Avg / prescription
$720.59
Avg / unit
$10.9208
Latest quarter Q1 2026
85.8KRx
Medicaid pays / ea
$10.9208
gross reimbursed
vs
NADAC / ea
$11.1525
acquisition cost
=
Spread
−$0.2317
-2% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
39% FFS 61% MCO
Fee-for-service · 142,846 Rx Managed care · 226,825 Rx
State Medicaid map
Alaska: 102,660 units · 14,005 per 100k residents AK Maine: 47,040 units · 3,372 per 100k residents ME Washington: 192,808 units · 2,468 per 100k residents WA Idaho: 196,920 units · 10,026 per 100k residents ID Montana: 33,570 units · 2,966 per 100k residents MT North Dakota: no data reported ND Minnesota: 137,280 units · 2,393 per 100k residents MN Wisconsin: 348,780 units · 5,902 per 100k residents WI Michigan: 2,820,256 units · 28,099 per 100k residents MI New York: 4,137,601 units · 21,141 per 100k residents NY Vermont: 9,420 units · 1,456 per 100k residents VT New Hampshire: 45,780 units · 3,265 per 100k residents NH Oregon: 408,176 units · 9,643 per 100k residents OR Nevada: 150,362 units · 4,708 per 100k residents NV Wyoming: 12,420 units · 2,127 per 100k residents WY South Dakota: 77,191 units · 8,399 per 100k residents SD Iowa: 304,440 units · 9,493 per 100k residents IA Illinois: 321,930 units · 2,565 per 100k residents IL Indiana: 817,350 units · 11,911 per 100k residents IN Ohio: 586,406 units · 4,976 per 100k residents OH Pennsylvania: 2,362,099 units · 18,225 per 100k residents PA New Jersey: 147,380 units · 1,586 per 100k residents NJ Massachusetts: 216,660 units · 3,095 per 100k residents MA California: 1,716,240 units · 4,405 per 100k residents CA Utah: 124,290 units · 3,637 per 100k residents UT Colorado: 390,960 units · 6,651 per 100k residents CO Nebraska: 226,800 units · 11,466 per 100k residents NE Missouri: 222,900 units · 3,597 per 100k residents MO Kentucky: 995,760 units · 22,001 per 100k residents KY West Virginia: 76,500 units · 4,322 per 100k residents WV Virginia: 1,144,680 units · 13,133 per 100k residents VA Maryland: 555,091 units · 8,982 per 100k residents MD Connecticut: 1,149,540 units · 31,782 per 100k residents CT Rhode Island: 174,960 units · 15,978 per 100k residents RI Arizona: 135,120 units · 1,818 per 100k residents AZ New Mexico: 69,480 units · 3,287 per 100k residents NM Kansas: 148,140 units · 5,039 per 100k residents KS Arkansas: 14,220 units · 464 per 100k residents AR Tennessee: 418,284 units · 5,870 per 100k residents TN North Carolina: 686,790 units · 6,339 per 100k residents NC South Carolina: 85,440 units · 1,590 per 100k residents SC Delaware: 66,180 units · 6,419 per 100k residents DE Oklahoma: 143,460 units · 3,540 per 100k residents OK Louisiana: 918,836 units · 20,088 per 100k residents LA Mississippi: 44,700 units · 1,520 per 100k residents MS Alabama: 119,550 units · 2,340 per 100k residents AL Georgia: 191,220 units · 1,734 per 100k residents GA D.C.: 32,880 units · 4,842 per 100k residents DC Hawaii: 102,480 units · 7,141 per 100k residents HI Texas: 552,780 units · 1,812 per 100k residents TX Florida: 240,780 units · 1,065 per 100k residents FL
Units reimbursed · per 100k residents
46431,782
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 31,782 /100k
2 Michigan 28,099 /100k
3 Kentucky 22,001 /100k
4 New York 21,141 /100k
5 Louisiana 20,088 /100k
6 Pennsylvania 18,225 /100k
7 Rhode Island 15,978 /100k
8 Alaska 14,005 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 inhaler this page00173-0893-10 369,671 Rx · $266,379,407
1 inhaler00173-0893-14 675 Rx · $236,253
1 inhaler00173-0893-61 No Medicaid data
Drug total (last 4 qtrs): 370,346 Rx · 24,412,485 units · $266,615,660 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Trelegy Ellipta — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Trelegy Ellipta. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.54B
Claims incl. refills
1.7M
Beneficiaries
905.8K
Spend / beneficiary
$1,704.53
Spend / claim
$932.09
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate — the ingredient across all brands.

Top reported reactions

Dyspnoea5,784
Wrong Technique In Device Usage Process3,230
Product Complaint2,906
Cough2,834
Death2,348
Pneumonia2,088
Asthma1,777

Age at onset

Infant3
Child3
Adolescent15
Adult3,337
Elderly3,196

Reporter sex

0 reports
Male · 40%
Female · 60%

Serious outcomes

Death3,276
Life-threatening569
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 7,109 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 00173-0892-01 · GlaxoSmithKline 00173-0897-13 · GlaxoSmithKline →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.