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Arnuity Ellipta fluticasone furoate 100 ug Powder — NDC 00173-0874-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Arnuity Ellipta fluticasone furoate 100 ug Powder — NDC 0173-0874-10 (Billing 00173-0874-10)

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

This is a package of Arnuity Ellipta fluticasone furoate 100 ug Powder from GlaxoSmithKline LLC, marketed since Aug 2014 and currently FDA-listed; retail pharmacies pay about $6.65 per unit (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 00173-0874-10
🏷️ FDA NDC (as labeled) 0173-0874-10 billing pads the labeler segment with a zero
This package
Contains30 powder in 1 inhaler Cost per ea$6.65 NADAC Per package$199.40 / 30 powders Pack sizes2 compare ↓
Also priced by: Medicaid pays $6.82/unit · Part D plans $6.68/unit — full pricing hub ↓
Main listing for product 0173-0874 · Also comes in: 1 inhaler 0173-0874-14
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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 0173-0874-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0173 labeler · 0874 product · 10 package
Package marketed since
Aug 20, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0173087410 8
Medicaid fills, this package
67,886 prescriptions in the last four reported quarters
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0173-0874-10
Product NDC 0173-0874
11-digit billing NDC 00173087410
NCPDP billing unit EA — each (per item)
RxCUI 1547658, 1547660, 1547663, 1547664, 1547666, 1547668, 1547671, 1547672,
UNII JS86977WNV
Application # NDA205625
SPL Set ID 50f193ee-1691-486d-9370-a664df63695c
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-08-20
Route RESPIRATORY (INHALATION)
Dosage form POWDER
Substance FLUTICASONE FUROATE

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

GCN Seq No 072722
GCN 37007
HICL code 034756
Ingredient (HICL) Fluticasone Furoate
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 B6M
Therapeutic class — specific (HIC3) Glucocorticoids, Orally Inhaled
AHFS code 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name ARNUITY ELLIPTA 100 MCG INH
FDB brand name Arnuity Ellipta
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 072722
  • GCN: 37007
  • HICL (First Databank): 034756
  • AHFS class code: 48:10.08.00
  • RxCUI (RxNorm): 1547658
Why two NDCs? The FDA registers this code as 0173-0874-10 — 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 → 00173-0874-10. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, Glucocorticoids
How it works Corticosteroid Hormone Receptor 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 ARNUITY ELLIPTA 100 MCG INH Ingredient Fluticasone Furoate
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Inhalers and powders are for long-term asthma control, nasal sprays are for allergy or nasal symptoms, and skin products calm inflamed, itchy skin. Check...
  • No. It does not relieve sudden breathing trouble. Use your rescue medicine as directed and call your doctor if episodes do not respond to it.
  • Can I use my fluticasone inhaler for an asthma attack?
  • Inhaled steroids can cause thrush, a yeast infection in the mouth and throat. Rinsing with water and spitting it out after each dose helps lower that risk.
📖 Read our full Fluticasone guide →
8
Nutrient depletion considerations

Fluticasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Fluticasone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $6.647 $199.40 / 30 powders
Medicaid paysCMS SDUD · 12 mo $6.82 $204.65 / 30 powders
Medicare drug plans payPart D · Q2 2026 $6.68 $200.50 / 30 powders
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Dec 2025 Apr 2026 Sep 2026 $6.662 $5.897
▲ Up 13% over the last 14 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
00173-0874-10 You're viewing this Main listing 1 INHALER in 1 CARTON / 30 POWDER in 1 INHALER $6.65 / ea $199.40 2014-08-20 — Active
00173-0874-14 0173-0874-14 1 INHALER in 1 CARTON / 14 POWDER in 1 INHALER $6.65 / ea $93.09 2014-08-20 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($6.65 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 inhaler in 1 carton / 30 powder in 1 inhaler.
What NDC number is used to bill for this package of Arnuity Ellipta fluticasone furoate 100 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
Fluticasone Furoate Ellipta 100 ug 66993-0167-97 Prasco 1 inhaler $4.284 — Availability likely save 36%
Arnuity Ellipta 100 ugthis 00173-0874-10 GlaxoSmithKline 1 inhaler $6.647 — 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

🏛️
2018
First FDA approval
May 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Listed protection lapsed
listed protections lapsed 2026
🔒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: The latest listed FDA patent/protection lapsed Mar 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.
📅 FDA approved May 17, 2018 RLD RS

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
Exclusivity M-290
2018 2020 2022 2024 2026
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.

FDA exclusivity
CodeWhat it grantsExpires
M-290New indication / labeling change (3-year)Mar 1, 2026
Common questions
Is there a generic version of ARNUITY ELLIPTA 100 MCG INH?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for ARNUITY ELLIPTA 100 MCG INH. The latest listed protection lapsed in Mar 2026, so a generic is no longer blocked by listed patents/exclusivity — though one still needs FDA approval and a manufacturer willing to market it.
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 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.

1 inactive ingredient 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 applicationNDA205625 (NDA)
Labeler code00173
First marketedAug 2014
Product typeHuman Prescription Drug
Portfolio97 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 79 words ▾

1 INDICATIONS AND USAGE ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm. ARNUITY ELLIPTA is an inhaled corticosteroid indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older.

( 1 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1 , 5.2 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • For oral inhalation only. ( 2.1 ) • Maintenance treatment of asthma in adult and pediatric patients aged 12 years and older: The starting dosage, 1 actuation of ARNUITY ELLIPTA 100 mcg or ARNUITY ELLIPTA 200 mcg once daily, is based on prior asthma therapy and disease severity. ( 2.2 ) • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of ARNUITY ELLIPTA 50 mcg once daily. ( 2.2 )

2.1Administration • Administer 1 actuation of ARNUITY ELLIPTA once daily by oral inhalation. • After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. • ARNUITY ELLIPTA should be used at the same time every day. Do not use ARNUITY ELLIPTA more than 1 time every 24 hours. • The maximum benefit may not be achieved for up to 2 weeks or longer after starting treatment. Individual patients may experience a variable time to onset and degree of symptom relief.

No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with mild hepatic impairment [see Clinical Pharmacology ( 12.3 )] .

2.2Recommended Dosage Adult and Pediatric Patients Aged 12 Years and Older The recommended starting dosage for adult and pediatric patients aged 12 years and older not on an inhaled corticosteroid (ICS) is fluticasone furoate 100 mcg (1 actuation of ARNUITY ELLIPTA 100 mcg) once daily by oral inhalation. • For other adult and pediatric patients aged 12 years and older, the recommended starting dosage should be based on previous asthma drug therapy and disease severity. • For adult and pediatric patients aged 12 years and older who do not respond to ARNUITY ELLIPTA 100 mcg after 2 weeks of therapy, replacement with ARNUITY ELLIPTA 200 mcg may provide additional asthma control. • The maximum recommended dosage in adult and pediatric patients aged 12 years and older is ARNUITY ELLIPTA 200 mcg once daily. • If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist (rescue medicine, e.g., albuterol) should be used for immediate relief. • If a previously effective dosage regimen of ARNUITY ELLIPTA fails to provide adequate improvement in asthma control, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g., replacing the current strength of ARNUITY ELLIPTA with a higher strength, initiating an ICS and long-acting beta 2 -agonist [LABA] combination product, initiating oral corticosteroids) should be considered. • After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of adverse reactions.

Pediatric Patients Aged 5 to 11 Years The recommended dosage for pediatric patients aged 5 to 11 years is fluticasone furoate 50 mcg (1 actuation of ARNUITY ELLIPTA 50 mcg) once daily by oral inhalation [see Warnings and Precautions ( 5.10 )] .

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation powder: Plastic inhaler containing a foil blister strip of powder. Each blister contains fluticasone furoate 50 mcg, 100 mcg, or 200 mcg. Inhalation powder: A foil blister strip of powder formulation for oral inhalation. Each blister contains 50 mcg, 100 mcg, or 200 mcg of fluticasone furoate. ( 3 )

⛔ Contraindications 99 words ▾

4 CONTRAINDICATIONS ARNUITY ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions ( 5.8 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures.

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

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • 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.

( 5.1 ) • Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) • 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. ( 5.3 ) • Risk of impaired adrenal function when transferring from systemic corticosteroids.

Wean patients slowly from systemic corticosteroids if transferring to ARNUITY ELLIPTA. ( 5.4 ) • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ARNUITY ELLIPTA slowly.

( 5.5 ) • If paradoxical bronchospasm occurs, discontinue ARNUITY ELLIPTA and institute alternative therapy. ( 5.7 ) • Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.9 ) • Monitor growth of pediatric patients.

( 5.10 ) • Glaucoma and cataracts may occur with long-term use of inhaled corticosteroids. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ARNUITY ELLIPTA long term. ( 5.11 )

5.1Oropharyngeal Candidiasis ARNUITY ELLIPTA contains fluticasone furoate, an ICS. Localized infections of the mouth and pharynx with Candida albicans have occurred in subjects treated with orally inhaled drug products containing fluticasone furoate. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with ARNUITY ELLIPTA continues.

In some cases, therapy with ARNUITY ELLIPTA may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following administration of ARNUITY ELLIPTA to help reduce the risk of oropharyngeal candidiasis.

5.2Acute Asthma Episodes ARNUITY ELLIPTA is not indicated for the relief of acute symptoms, i.e., as rescue therapy for treatment of acute episodes of bronchospasm. ARNUITY ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta 2 -agonist.

Instruct patients to contact their healthcare providers immediately if episodes of asthma not responsive to bronchodilators occur during the course of treatment with ARNUITY ELLIPTA. During such episodes, patients may require therapy with oral corticosteroids.

5.3Immunosuppression and Risk of Infections Persons who are using drugs that suppress the immune system, such as corticosteroids, including ARNUITY ELLIPTA, are more susceptible to infections than healthy individuals. Chickenpox and measles can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure.

How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The safety and effectiveness of ARNUITY ELLIPTA have not been established in pediatric patients less than 5 years of age and ARNUITY ELLIPTA is not indicated for use in this population. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.

If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the Prescribing In… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.1 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.3 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] • Reduction in BMD [see Warnings and Precautions ( 5.9 )] • Growth Effects in Pediatrics [see Warnings and Precautions ( 5.10 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.11 )] Most common adverse reactions reported in ≥5% of adult and pediatric subjects aged 12 years and older are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache.

( 6.1 ) Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection. ( 6.1 ) 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 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. Adult and Pediatric Subjects Aged 12 Years and Older The safety of ARNUITY ELLIPTA was evaluated in 10 double-blind, parallel-group, controlled trials (7 with placebo) of 8 to 76 weeks’ duration that enrolled 6,219 subjects with asthma.

Doses of fluticasone furoate studied ranged from 25 to 800 mcg. ARNUITY ELLIPTA 100 mcg was studied in 1,663 subjects, and ARNUITY ELLIPTA 200 mcg was studied in 608 subjects. Subject ages ranged from 12 to 84 years, 65% were female, and 75% were Caucasian.

In these trials, the proportion of subjects who discontinued study treatment early due to adverse reactions was 2% for subjects treated with both ARNUITY ELLIPTA 100 mcg and ARNUITY ELLIPTA 200 mcg and ≤1% for placebo-treated subjects. Serious adverse events, whether considered drug-related or not by the investigators, that occurred in more than 1 subject and in a greater percentage of subjects treated with ARNUITY ELLIPTA than placebo included hypertension, abscess, breast cancer, traumatic limb amputation, subarachnoid hemorrhage, and intervertebral disc protrusion; all events occurred at rates ≤1%.

The incidence of adverse reactions associated with ARNUITY ELLIPTA 100 mcg is shown in Table 1 and is based on one 24-week trial (Trial 1) in adult and pediatric subjects aged 12 years and older with asthma. Table 1. Adverse Reactions with ARNUITY ELLIPTA 100 mcg with ≥3% Incidence and More Common than Placebo (Trial 1, Intent-to-Treat Population) Adverse Reaction ARNUITY ELLIPTA 100 mcg (n = 114) % Placebo (n = 115) % Nasopharyngitis 8 5 Bronchitis 7 6 Upper respiratory tract infection 6 5 Headache 6 4 Pharyngitis 4 3 Sinusitis 4 <1 Toothache 3 <1 Gastroenteritis viral 3 0 Oral candidiasis 3 0 Oropharyngeal candidiasis 3 0 Oropharyngeal pain 3 0 The incidence of adverse reactions associated with ARNUITY ELLIPTA 200 mcg is shown in Table 2 and is based on one 24-week trial (Trial 3) in adult and pediatric subjects aged 12 years and older with asthma.

This trial did not have a placebo arm. Table 2. Adverse Reactions with ARNUITY ELLIPTA 200 mcg with ≥3% Incidence (Trial 3, Safety Population) Adverse Reaction ARNUITY ELLIPTA 200 mcg (n = 119) % ARNUITY ELLIPTA 100 mcg (n = 119) % Nasopharyngitis 13 12 Headache 13 10 Bronchitis 7 12 Influenza 7 4 Upper respiratory tract infection 6 2 Sinusitis 4 7 Oropharyngeal pain 4 3 Pharyngitis 3 6 Back pain 3 3 Dysphonia 3 2 Oral candidiasis 3 <1 Procedural pain 3 <1 Rhinitis 3 <1 Throat irritation 3 <1 Abdominal pain 3 0 Cough 3 0 Adverse reactions observed in the other trials were consistent with those described in Tables 1 and 2.

Long-term Safety Long-term safety data are based on 2 trials in adult and pediatric subjects aged 12 years and older with asthm… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 81 words ▾

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. ( 7.1 )

7.1Inhibitors of Cytochrome P450 3A4 Fluticasone furoate is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate. Caution should be exercised when considering the coadministration of ARNUITY ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.6 ), Clinical Pharmacology ( 12.3 )] .

👥 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 ARNUITY ELLIPTA in pregnant women to inform a drug-associated risk (see Clinical Considerations ). In animal reproduction studies, fluticasone furoate administered by inhalation to rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. The highest fluticasone furoate doses in the rat and rabbit studies were 4 times and 1 time, respectively, the maximum recommended human daily inhalation dose (MRHDID) (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. Data Animal Data: 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 and 1 times, respectively, the MRHDID (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 time the MRHDID (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.

8.2Lactation Risk Summary There is no information available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production. Low concentrations of other ICS have been detected in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ARNUITY ELLIPTA and any potential adverse effects on the breastfed child from fluticasone furoate or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ARNUITY ELLIPTA for maintenance treatment of asthma have been established in pediatric patients aged 5 years and older. Use of ARNUITY ELLIPTA for this indication in patients 12 years of age and older is supported by evidence from 4 adequate and well-controlled trials in adult and pediatric patients 12 years of age and older. Use of ARNUITY ELLIPTA for this indication in patients 5 to 11 years of age is supported by evidence from an adequate and well-controlled trial in patients 5 to 11 years of age [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 )] .

The safety and effectiveness of ARNUITY ELLIPTA have not been established in pediatric patients less than 5 years of age. Effects on Growth Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. A reduction of growth velocity in these patients may occur as a result of poorly controlled asthma or from use of corticosteroids, including ICS.

The effects of long-term treatment of pediatric patients with ICS, including fluticasone furoate, on final adult height are not known. Controlled clinical trials have shown that ICS may cause a reduction in growth in children. In these trials, the mean reduction in g… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are insufficient data on the use of ARNUITY ELLIPTA in pregnant women to inform a drug-associated risk (see Clinical Considerations ). In animal reproduction studies, fluticasone furoate administered by inhalation to rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. The highest fluticasone furoate doses in the rat and rabbit studies were 4 times and 1 time, respectively, the maximum recommended human daily inhalation dose (MRHDID) (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. Data Animal Data: 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 and 1 times, respectively, the MRHDID (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 time the MRHDID (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.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of ARNUITY ELLIPTA for maintenance treatment of asthma have been established in pediatric patients aged 5 years and older. Use of ARNUITY ELLIPTA for this indication in patients 12 years of age and older is supported by evidence from 4 adequate and well-controlled trials in adult and pediatric patients 12 years of age and older. Use of ARNUITY ELLIPTA for this indication in patients 5 to 11 years of age is supported by evidence from an adequate and well-controlled trial in patients 5 to 11 years of age [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 ), and Clinical Studies ( 14.2 )] .

The safety and effectiveness of ARNUITY ELLIPTA have not been established in pediatric patients less than 5 years of age. Effects on Growth Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. A reduction of growth velocity in these patients may occur as a result of poorly controlled asthma or from use of corticosteroids, including ICS.

The effects of long-term treatment of pediatric patients with ICS, including fluticasone furoate, on final adult height are not known. 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. The potential for “catch-up” growth following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied.

The growth of pediatric patients receiving orally inhaled corticosteroids, including ARNUITY ELLIPTA, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including ARNUITY ELLIPTA, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

A randomized, double-blind, parallel-group, multicenter, 1-year, placebo-controlled trial evaluated the effect of once-daily treatment with ARNUITY ELLIPTA 50 mcg on growth velocity assessed by stadiometry. The subjects were 457 prepubertal children (girls aged 5 to younger than 8 years and boys aged 5 to younger than 9 years). Mean growth velocity over the 52-week treatment period was lower in the subjects receiving ARNUITY ELLIPTA (5.90 cm/year) compared with placebo (6.06 cm/year).

The mean difference in growth velocity was -0.16 cm/year (95% CI: -0.46, 0.14) [see Warnings and Precautions ( 5.10 )] .

🧓 Geriatric Use 157 words ▾

8.5Geriatric Use For the 4 confirmatory trials, 71 subjects were aged 65 years and older (56 of which were treated with ARNUITY ELLIPTA) and 5 were aged 75 years and older (1 of which was treated with ARNUITY ELLIPTA) [see Clinical Studies ( 14.2 )] . Based on available data, no adjustment of the dosage of ARNUITY ELLIPTA in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. Clinical trials of ARNUITY ELLIPTA did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 119 words ▾

10 OVERDOSAGE No human overdosage data have been reported for ARNUITY ELLIPTA. The potential for acute toxic corticosteroid effects following overdosage with ARNUITY ELLIPTA is low. Because of low systemic bioavailability (13.9%) 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 ( 5.5 )] . Single- and repeat-dose trials of fluticasone furoate at doses of 50 to 4,000 mcg have been studied in human subjects. Decreases in mean serum cortisol were observed at dosages of 500 mcg or higher given once daily for 14 days.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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 asthma symptoms is not known. Inflammation is an important component in the pathogenesis of 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. Though effective for the treatment of asthma, corticosteroids may not affect symptoms immediately.

Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone furoate. This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic bioavailability (approximately 1.3%), and the minimal pharmacological activity of the metabolites detected in man.

12.2Pharmacodynamics The pharmacodynamics of fluticasone furoate was characterized in trials of fluticasone furoate given as a single component and also in trials of fluticasone furoate given in combination with vilanterol. Cardiac Electrophysiology A QT/QTc trial did not demonstrate an effect of fluticasone furoate administration on the QTc interval. The effect of a single dose of 4,000 mcg of orally inhaled fluticasone furoate on the QTc interval was evaluated over 24 hours in 40 healthy male and female subjects in a placebo- and positive-controlled (a single dose of 400 mg oral moxifloxacin) cross-over trial.

The QTcF maximal mean change from baseline following fluticasone furoate was similar to that observed with placebo with a treatment difference of 0.788 msec (90% CI: -1.802, 3.378). In contrast, moxifloxacin given as a 400-mg tablet resulted in prolongation of the QTcF maximal mean change from baseline compared with placebo with a treatment difference of 9.929 msec (90% CI: 7.339, 12.520). Hypothalamic-Pituitary-Adrenal 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 Asthma: A randomized, double-blind, parallel-group trial in 104 pediatric subjects with asthma (aged 5 to 11 years) showed no difference between once-daily treatment with ARNUITY ELLIPTA 50 mcg compared with placebo on serum cortisol weighted mean (0 to 24 hours) and serum cortisol AUC (0-24) following 6 weeks of treatment. A randomized, double-blind, parallel-group trial in 185 subjects with asthma aged 12 to 65 years showed no difference between once-daily treatment with fluticasone furoate/vilanterol 100/25 mcg or fluticasone furoate/vilanterol 200/25 mcg compared wit… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action 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 asthma symptoms is not known. Inflammation is an important component in the pathogenesis of 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. Though effective for the treatment of asthma, corticosteroids may not affect symptoms immediately.

Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone furoate. This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic bioavailability (approximately 1.3%), and the minimal pharmacological activity of the metabolites detected in man.

📦 How Supplied / Storage and Handling 208 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ARNUITY ELLIPTA 50 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0888-10). ARNUITY ELLIPTA 100 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0874-10) or 14 blisters (institutional pack) (NDC 0173-0874-14). ARNUITY ELLIPTA 200 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 0173-0876-10) or 14 blisters (institutional pack) (NDC 0173-0876-14).

The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid. 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. ARNUITY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard ARNUITY 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 ~1 min read ▾

11 DESCRIPTION ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) 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. ARNUITY ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister.

The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, ARNUITY ELLIPTA 50 mcg, ARNUITY ELLIPTA 100 mcg, and ARNUITY ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds.

In adult subjects with asthma and a mean FEV 1 of

2.55L/sec (range: 1.63 to

3.97L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was

51.8L/min (range: 26.8 to

89.9L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. fluticasone furoate 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). Not for Acute Symptoms Inform patients that ARNUITY ELLIPTA is not meant to relieve acute symptoms of 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 Advise patients not to increase the dose or frequency of ARNUITY ELLIPTA. The daily dosage of ARNUITY ELLIPTA should not exceed 1 inhalation.

If they miss a dose, instruct patients to take it as soon as they remember, not to exceed 1 inhalation per day. Advise patients to take their next dose at the same time they normally do and to not take 2 doses at 1 time. Tell patients they should not stop therapy with ARNUITY ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation. [See Warnings and Precautions ( 5.2 ).] 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 ARNUITY ELLIPTA, but at times therapy with ARNUITY 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 ( 5.1 ).] 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 ( 5.3 ).] Hypercorticism and Adrenal Suppression Advise patients that ARNUITY 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 ARNUITY ELLIPTA. [See Warnings and Precautions ( 5.5 ).] Hypersensitivity Reactions, including Anaphylaxis Advise patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, flushing, allergic dermatitis, bronchospasm) may occur after administration of ARNUITY ELLIPTA.

Instruct patients to discontinue ARNUITY 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 ARNUITY ELLIPTA. [See Warnings and Precautions ( 5.8 ).] Reduction in Bone Mineral Density Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk. [See Warnings and Precautions ( 5.9 )] Reduced Growth Velocity Inform patients that orally inhaled corticosteroids, including ARNUITY ELLIPTA, may cause a reduction in growth velocity when administered to pediatric patients.

Physicians should closely follow the growth of pediatric patients taking corticosteroids by any route. [See Warnings and Precautions ( 5.10 ).] Glaucoma and Cataracts Advise patients that long-term use of ICS may increase the risk of some eye problem… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of fluticasone furoate was characterized in trials of fluticasone furoate given as a single component and in trials of fluticasone furoate given in combination with vilanterol. Linear pharmacokinetics was observed for fluticasone furoate (200 to 800 mcg). On repeated once-daily inhalation administration, steady state of fluticasone furoate plasma concentration was achieved after 6 days, and the accumulation was up to 2.6-fold as compared with single dose.

Absorption Fluticasone furoate plasma levels may not predict therapeutic effect. Peak plasma concentrations are reached within 0.5 to 1 hour. Absolute bioavailability of fluticasone furoate when administrated by inhalation was 13.9%, 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. Systemic exposure (AUC) in subjects with asthma was 26% lower than observed in healthy subjects. Distribution 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 (99.6%). Elimination Metabolism: Fluticasone furoate is cleared from systemic circulation principally by hepatic metabolism via CYP3A4 to metabolites with significantly reduced corticosteroid activity. There was no in vivo evidence for cleavage of the furoate moiety resulting in the formation of fluticasone.

Excretion: Fluticasone furoate and its metabolites are eliminated primarily in the feces, accounting for approximately 101% and 90% of the orally and intravenously administered doses, respectively. Urinary excretion accounted for approximately 1% and 2% of the orally and intravenously administered doses, respectively. Following repeat-dose inhaled administration, the plasma elimination phase half-life averaged 24 hours.

Specific Populations The effects of renal and hepatic impairment and other intrinsic factors on the pharmacokinetics of fluticasone furoate are shown in Figure 1 . Figure 1. Impact of Intrinsic Factors on the Pharmacokinetics (PK) of Fluticasone Furoate (FF) a Age, gender, and ethnicity comparison for ARNUITY ELLIPTA in adult and pediatric subjects aged 12 years and older with asthma. b Renal groups (fluticasone furoate/vilanterol 200 mcg/25 mcg) and hepatic groups (fluticasone furoate/vilanterol 200 mcg/25 mcg or fluticasone furoate/vilanterol 100 mcg/12.5 mcg) compared with healthy control group.

Pediatric Patients: A population pharmacokinetics analysis to assess impact of age on fluticasone furoate systemic exposure was conducted using combined data from clinical trials in pediatric subjects aged 5 to 11 years (n = 306). There was no relevant effect of age on the apparent clearance of fluticasone furoate. The rate and extent of fluticasone furoate systemic exposure at steady state in children aged 5 to 11 years were comparable to that observed in adult and pediatric subjects aged 12 years and older following dosing with fluticasone furoate 100 mcg monotherapy.

Racial or Ethnic Groups: Systemic exposure [AUC (0-24) ] to inhaled fluticasone furoate 200 mcg was 27% to 49% higher in healthy subjects of Japanese, Korean, and Chinese heritage compared with White subjects. Similar differences were observed for subjects with asthma ( Figure 1 ). However, there is no evidence that this higher exposure to fluticasone furoate results in clinically relevant effects on urinary cortisol excretion or on efficacy in these racial groups.

Patients with Hepatic Impairment: Following repeat dosing of fluticasone furoate/vilanterol 200/25 mcg (100/12.5 mcg in the severe impairment group) for 7 days, there was an increase of 34%, 83%, and 75% in fluticasone furoate systemic exposure (AUC) in subjects with mild, moderate, and severe hepatic impairment, respectively, compared with healthy subjects ( Figure 1… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics The pharmacodynamics of fluticasone furoate was characterized in trials of fluticasone furoate given as a single component and also in trials of fluticasone furoate given in combination with vilanterol. Cardiac Electrophysiology A QT/QTc trial did not demonstrate an effect of fluticasone furoate administration on the QTc interval. The effect of a single dose of 4,000 mcg of orally inhaled fluticasone furoate on the QTc interval was evaluated over 24 hours in 40 healthy male and female subjects in a placebo- and positive-controlled (a single dose of 400 mg oral moxifloxacin) cross-over trial.

The QTcF maximal mean change from baseline following fluticasone furoate was similar to that observed with placebo with a treatment difference of 0.788 msec (90% CI: -1.802, 3.378). In contrast, moxifloxacin given as a 400-mg tablet resulted in prolongation of the QTcF maximal mean change from baseline compared with placebo with a treatment difference of 9.929 msec (90% CI: 7.339, 12.520). Hypothalamic-Pituitary-Adrenal 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 Asthma: A randomized, double-blind, parallel-group trial in 104 pediatric subjects with asthma (aged 5 to 11 years) showed no difference between once-daily treatment with ARNUITY ELLIPTA 50 mcg compared with placebo on serum cortisol weighted mean (0 to 24 hours) and serum cortisol AUC (0-24) following 6 weeks of treatment. A randomized, double-blind, parallel-group trial in 185 subjects with asthma aged 12 to 65 years 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 The safety and efficacy of ARNUITY ELLIPTA were evaluated in 3,611 adult and pediatric subjects aged 12 years and older with asthma. The development program included 4 confirmatory trials of 3 and 6 months’ duration and 3 dose-ranging trials of 8 weeks’ duration. The efficacy of ARNUITY ELLIPTA is based primarily on the dose-ranging trials and the confirmatory trials described below.

One additional trial evaluated the safety and efficacy of ARNUITY ELLIPTA in 593 subjects aged 5 to 11 years.

14.1Dose-Ranging Trials Eight doses of fluticasone furoate ranging from 25 to 800 mcg once daily were evaluated in 3 randomized, double-blind, placebo-controlled, 8-week trials in adult and pediatric subjects aged 12 years and older with asthma. Across the 3 trials, subjects were uncontrolled at baseline on treatments of short-acting beta 2 -agonist and/or non-corticosteroid controller medications (Trial 687 NCT00603382), low-dose ICS (Trial 685 NCT00603278), or medium doses of ICS (Trial 684 NCT00603746). The trials in Figure 3 were dose-ranging trials of ARNUITY ELLIPTA not designed to provide comparative effectiveness data and should not be interpreted as evidence of superiority/inferiority to fluticasone propionate.

A dose-related increase in trough FEV1 at Week 8 was seen for doses from 25 to 200 mcg with no consistent additional benefit for doses above 200 mcg as seen in Figure 3 . To evaluate dosing frequency, a separate trial compared fluticasone furoate 200 mcg once daily, fluticasone furoate 100 mcg twice daily, fluticasone propionate 100 mcg twice daily, and fluticasone propionate 200 mcg once daily. The results supported the selection of the once-daily dosing frequency.

Figure 3. Dose-Ranging Trials FF = Fluticasone furoate, FP = Fluticasone propionate, OD = Once daily, BD = Twice daily. Figure 3

14.2Confirmatory Trials Adult and Pediatric Subjects Aged 12 Years and Older The clinical development program for ARNUITY ELLIPTA included 4 confirmatory trials in adult and pediatric subjects with asthma aged 12 years and older. The trials were designed to evaluate the safety and efficacy of ARNUITY ELLIPTA given once daily in the evening on lung function in subjects who were not controlled on their current treatments of ICS, or combination therapy consisting of an ICS plus a LABA. Study treatments were delivered as inhalation powders.

The primary endpoint in all trials was change from baseline in evening trough FEV 1 measured approximately 24 hours after the final dose of study medication. Trough FEV 1 (assessed at approximately 24 hours after the previous dose) was also assessed at clinic visits throughout the trials. Trials 2 and 4 had a co-primary endpoint of change from baseline in weighted mean serial FEV 1 measured after the final dose of study medication at 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours post-dose.

Clinical Trials with ARNUITY ELLIPTA 100 mcg: Trial 1 (NCT01159912) was a 24-week trial that evaluated the efficacy of ARNUITY ELLIPTA 100 mcg compared with placebo on lung function in subjects with asthma. Inhaled fluticasone propionate 250 mcg twice daily was included as an active control. Of the 343 subjects, 59% were female and 79% were Caucasian.

The mean age was 41 years. The trial included a 4-week run-in period during which the subjects were symptomatic while taking their usual low- to mid-dose ICS therapy (i.e., fluticasone propionate 100 to 500 mcg daily or equivalent). Mean baseline percent predicted FEV 1 was approximately 73% overall and was similar across the 3 treatment groups.

Thirty-five percent of subjects on placebo and 19% of subjects on ARNUITY ELLIPTA 100 mcg failed to complete the 24-week trial. The change in trough FEV 1 from baseline to Week 24, or the last available on-treatment visit prior to Week 24, was assessed to evaluate the efficacy of ARNUITY ELLIPTA 100 mcg. The mean change from baseline in trough FEV 1 was greater among subjects receivin… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 128 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 (less than the MRHDID 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 1 and 4 times, respectively, the MRHDID for adults on a mcg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 125 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 (less than the MRHDID 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 1 and 4 times, respectively, the MRHDID for adults on a mcg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

Patient Information ARNUITY ELLIPTA (ar-NEW-i-te e-LIP-ta) (fluticasone furoate inhalation powder) for oral inhalation use What is ARNUITY ELLIPTA? • ARNUITY ELLIPTA is an inhaled corticosteroid (ICS) medicine (fluticasone furoate). o ICS medicines such as fluticasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. • ARNUITY ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler. • ARNUITY ELLIPTA is a prescription medicine used to prevent and control symptoms of asthma for better breathing.

It is not known if ARNUITY ELLIPTA is safe and effective in children younger than 5 years of age. Do not use ARNUITY ELLIPTA: • to treat sudden symptoms of 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 or any of the ingredients in ARNUITY ELLIPTA.

See the end of this Patient Information for a complete list of ingredients in ARNUITY ELLIPTA. Before using ARNUITY ELLIPTA, tell your healthcare provider about all of your medical conditions, including if you: • have liver problems. • have weak bones (osteoporosis). • have an immune system problem. • have eye problems such as glaucoma, increased pressure in your eye, cataracts, or other changes in vision. • are allergic to milk proteins. • have any type of viral, bacterial, fungal, or parasitic infection. • are exposed to chickenpox or measles. • are pregnant or plan to become pregnant.

It is not known if ARNUITY ELLIPTA may harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if the medicine in ARNUITY ELLIPTA passes into your breast milk and if it 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.

ARNUITY ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal, anti-HIV, or any other corticosteroid medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use ARNUITY ELLIPTA?

Read the step-by-step instructions for using ARNUITY ELLIPTA at the end of this Patient Information. • Do not use ARNUITY ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly. • ARNUITY ELLIPTA comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you. • Use ARNUITY ELLIPTA exactly as your healthcare provider tells you to use it. Do not use ARNUITY ELLIPTA more often than prescribed. • Children and adolescents may need help to use ARNUITY ELLIPTA. • Use 1 inhalation of ARNUITY ELLIPTA 1 time each day.

Use ARNUITY ELLIPTA at the same time each day. • If you miss a dose of ARNUITY ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time.

Do not take 2 doses at 1 time. • Do not stop using ARNUITY ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed. • ARNUITY ELLIPTA does not relieve sudden symptoms of asthma and you should not take extra doses of ARNUITY ELLIPTA to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms.

If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you. • Call your healthcare provider or get medical care right away if: o your breathing problems get worse. o you need to use your rescue inhaler more often than usual. o your rescue inhaler does not work as well to relieve your symptoms. o your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~4 min read ▾

INSTRUCTIONS FOR USE ARNUITY ELLIPTA (ar-NEW-i-te e-LIP-ta) (fluticasone furoate 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 ARNUITY ELLIPTA inhaler How to use your inhaler • ARNUITY 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 100-mcg or 200-mcg strength 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 100-mcg or 200-mcg strength 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 1 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 a… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 185 words ▾

PRINCIPAL DISPLAY PANEL NDC 0173-0888-10 ARNUITY ELLIPTA \ (fluticasone furoate inhalation powder) 50 mcg Rx Only FOR ORAL INHALATION ONLY Each blister contains 50 mcg of fluticasone furoate and lactose monohydrate. 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters GSK Made in Singapore ©2023 GSK group of companies or its licensor. 62000000087776 Rev. 4/23 Arnuity Ellipta 50 mcg 30 count carton

PRINCIPAL DISPLAY PANEL NDC 0173-0874-10 ARNUITY ELLIPTA (fluticasone furoate inhalation powder) 100 mcg Rx Only FOR ORAL INHALATION ONLY Each blister contains 100 mcg of fluticasone furoate and lactose monohydrate. 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters GSK Made in Singapore ©2023 the GSK group of companies or its licensor. 62000000087842 Rev. 4/23 Arnuity Ellipta 100 mcg 30 count carton

PRINCIPAL DISPLAY PANEL NDC 0173-0876-10 ARNUITYELLIPTA (fluticasone furoate inhalation powder) 200 mcg Rx Only FOR ORAL INHALATION ONLY Each blister contains 200 mcg of fluticasone furoate and lactose monohydrate. 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters GSK Made in Singapore ©2023 the GSK group of companies 62000000087779 Rev. 4/23 Arnuity Ellipta 200 mcg 30 count 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
67.9K
Units reimbursed last 4 qtrs
2.2M
Gross reimbursed last 4 qtrs
$15.01M
Avg / prescription
$221.10
Avg / unit
$6.8216
Latest quarter Q1 2026
14.8KRx
Medicaid pays / ea
$6.8216
gross reimbursed
vs
NADAC / ea
$6.6468
acquisition cost
=
Spread
+$0.1748
+3% 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 ⓘ
52% FFS 48% MCO
Fee-for-service · 35,233 Rx Managed care · 32,653 Rx
State Medicaid map
Alaska: 2,040 units · 278 per 100k residents AK Maine: 57,630 units · 4,131 per 100k residents ME Washington: 1,950 units · 25.0 per 100k residents WA Idaho: 9,810 units · 499 per 100k residents ID Montana: 12,180 units · 1,076 per 100k residents MT North Dakota: 16,080 units · 2,054 per 100k residents ND Minnesota: 25,080 units · 437 per 100k residents MN Wisconsin: 47,670 units · 807 per 100k residents WI Michigan: 28,890 units · 288 per 100k residents MI New York: 327,660 units · 1,674 per 100k residents NY Vermont: 25,380 units · 3,923 per 100k residents VT New Hampshire: 3,090 units · 220 per 100k residents NH Oregon: 4,950 units · 117 per 100k residents OR Nevada: 21,720 units · 680 per 100k residents NV Wyoming: 8,100 units · 1,387 per 100k residents WY South Dakota: 510 units · 55.5 per 100k residents SD Iowa: 25,408 units · 792 per 100k residents IA Illinois: 42,090 units · 335 per 100k residents IL Indiana: 97,651 units · 1,423 per 100k residents IN Ohio: 93,511 units · 793 per 100k residents OH Pennsylvania: 171,032 units · 1,320 per 100k residents PA New Jersey: 11,070 units · 119 per 100k residents NJ Massachusetts: 196,256 units · 2,803 per 100k residents MA California: 162,300 units · 417 per 100k residents CA Utah: 6,120 units · 179 per 100k residents UT Colorado: 86,220 units · 1,467 per 100k residents CO Nebraska: 16,050 units · 811 per 100k residents NE Missouri: 60,210 units · 972 per 100k residents MO Kentucky: 7,470 units · 165 per 100k residents KY West Virginia: 87,722 units · 4,956 per 100k residents WV Virginia: 40,410 units · 464 per 100k residents VA Maryland: 33,840 units · 548 per 100k residents MD Connecticut: 10,920 units · 302 per 100k residents CT Rhode Island: 10,080 units · 921 per 100k residents RI Arizona: 30,328 units · 408 per 100k residents AZ New Mexico: 97,771 units · 4,625 per 100k residents NM Kansas: 3,990 units · 136 per 100k residents KS Arkansas: 63,360 units · 2,066 per 100k residents AR Tennessee: 17,370 units · 244 per 100k residents TN North Carolina: 31,980 units · 295 per 100k residents NC South Carolina: 20,400 units · 380 per 100k residents SC Delaware: 13,410 units · 1,301 per 100k residents DE Oklahoma: 14,970 units · 369 per 100k residents OK Louisiana: 8,370 units · 183 per 100k residents LA Mississippi: no data reported MS Alabama: 6,630 units · 130 per 100k residents AL Georgia: 72,030 units · 653 per 100k residents GA D.C.: 4,710 units · 694 per 100k residents DC Hawaii: 1,710 units · 119 per 100k residents HI Texas: 30,390 units · 99.6 per 100k residents TX Florida: 31,770 units · 141 per 100k residents FL
Units reimbursed · per 100k residents
25.04,956
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 West Virginia 4,956 /100k
2 New Mexico 4,625 /100k
3 Maine 4,131 /100k
4 Vermont 3,923 /100k
5 Massachusetts 2,803 /100k
6 Arkansas 2,066 /100k
7 North Dakota 2,054 /100k
8 New York 1,674 /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 page00173-0874-10 67,886 Rx · $15,009,474
1 inhaler00173-0874-14 40 Rx · $4,122
Drug total (last 4 qtrs): 67,926 Rx · 2,200,849 units · $15,013,595 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 Arnuity 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 Arnuity 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
$42.96M
Claims incl. refills
138K
Beneficiaries
83K
Spend / beneficiary
$517.79
Spend / claim
$311.31
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 Arnuity Ellipta (this brand).

Top reported reactions

Dyspnoea1,536
Asthma1,297
Wheezing895
Cough888
Therapeutic Product Effect Incomplete761
Nausea670
Pain650

Age at onset

Neonate22
Infant2
Child47
Adolescent27
Adult1,003
Elderly666

Reporter sex

9,646 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Life-threatening464
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,101 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.
← 00173-0873-06 · GlaxoSmithKline 00173-0876-10 · 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.