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Trimbow beclomethasone dipropionate/formoterol fumarate/glycopyrrolate 172 ug; 4.9 ug; 10.6 ug Aerosol, Metered

by Chiesi USA, Inc. · 1 CANISTER in 1 CARTON (10122-590-02) / 120 AEROSOL, METERED in 1 CANISTER

NDC 10122-0590-02

🏷️ FDA NDC (as labeled) 10122-590-02 billing pads the product segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Sep 17, 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 10122-590-02

Product NDC 10122-590

11-digit billing NDC 10122059002

RxCUI 2747295, 2747302, 2747312, 2747315

UNII 5B307S63B2, W34SHF8J2K, V92SO9WP2I

Application # NDA219622

SPL Set ID 4e13e70f-f550-4603-bbfb-346f80df3c4f

Established class (EPC) Anticholinergic; Cholinergic Muscarinic Antagonist; Corticosteroid; beta2-Adrenergi

Mechanism of action Adrenergic beta2-Agonists; Cholinergic Antagonists; Cholinergic Muscarinic Antagonists; Corticosteroid Hormone Receptor Agonists

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-05-14

Route RESPIRATORY (INHALATION)

Dosage form AEROSOL, METERED

Substance BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Why two NDCs? The FDA registers this code as 10122-590-02 — a 5-3-2 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 product segment → 10122-0590-02. 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 acting locally, Corticosteroids, potent (group III), Corticosteroids

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.

🏭 Manufacturer & labeler

LabelerChiesi USA, Inc.

Application holderCHIESI FARMACEUTICI SPA

FDA applicationNDA219622 (NDA)

Labeler code10122

First marketedMay 2026

Product typeHuman Prescription Drug

Portfolio25 products on file

🔎 All NDCs from Chiesi USA, Inc.

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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist

No — Trimbow is a maintenance inhaler, meaning it's designed to prevent asthma symptoms over time, not to stop an attack in progress. It won't work fast enough in an emergency. You...
Can I use Trimbow when I'm having an asthma attack?
The steroid in Trimbow (beclomethasone) can settle on the lining of your mouth and throat, creating the right conditions for a fungal infection called oral thrush — white patches t...
Why do I need to rinse my mouth after every dose?

📖 Read our full Beclomethasone / Formoterol / Glycopyrrolate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

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

UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.

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.

💲 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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Trimbow 172 ug/1; 4.9 ug/1; 10.6 ug 10122-0121-02	Chiesi	1 canister	—	—	FDA listed	—
Trimbow 172 ug/1; 4.9 ug/1; 10.6 ugthis 10122-0590-02	Chiesi	1 canister	—	—	FDA listed	—

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

🏛️

2026

First FDA approval

May 2026

📍

2026

Currently FDA-listed

listed with the FDA

🛡️

2034

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 Dec 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved May 14, 2026 RLD RS ⏳ ~8.3 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 12357568 — method of use (U-4538)

US 11590074 — method of use (U-4538)

US 10617638 — method of use (U-4538)

US 10159645 — method of use (U-4538)

US 10806701 — drug product

US 11389401 — drug product

US 10806701 — drug product

Exclusivity NP

2026 2028 2030 2032 2034

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 (12)

Patent	Type	Use code	Expires
US 12357568 ↗	Method of use	U-4538	Dec 23, 2030
US 12357568 ↗	Method of use	U-4538	Dec 23, 2030
US 11590074 ↗	Method of use	U-4538	Dec 23, 2030
US 11590074 ↗	Method of use	U-4538	Dec 23, 2030
US 10617638 ↗	Method of use	U-4538	Dec 23, 2034
US 10617638 ↗	Method of use	U-4538	Dec 23, 2034
US 10159645 ↗	Method of use	U-4538	Dec 23, 2030
US 10159645 ↗	Method of use	U-4538	Dec 23, 2030
US 10806701 ↗	Drug product	—	Dec 23, 2030
US 11389401 ↗	Drug product	—	Dec 23, 2030
US 11389401 ↗	Drug product	—	Dec 23, 2030
US 10806701 ↗	Drug product	—	Dec 23, 2030

FDA exclusivity

Code	What it grants	Expires
NP	New Product	May 14, 2029
NP	New Product	May 14, 2029

Common questions

Is there a generic version of this drug?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2034 — 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.

🔬 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 Beclomethasone dipropionate/formoterol fumarate/glycopyrrolate — the ingredient across all brands.

Top reported reactions

Dyspnoea162

Diarrhoea87

Pneumonia83

Acute Kidney Injury72

Chronic Obstructive Pulmonary Disease72

Vomiting70

Headache66

Reporter sex

Serious outcomes

Hospitalization767

Life-threatening140

Disabling132

Death118

Reports over time (by year) — tap or hover for the count & year

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
10122-0590-02 You're viewing this	1 CANISTER in 1 CARTON (10122-590-02) / 120 AEROSOL, METERED in 1 CANISTER	2026-05-14	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 10122-590-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 10122-0590-02, written without dashes as 10122059002. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 10122-0590-02, the first segment (10122) is the labeler code FDA assigned to Chiesi USA, Inc.; the middle segment (0590) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Chiesi USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Chiesi USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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

🎯 Indications and Usage 102 words ▾

1 INDICATIONS AND USAGE TRIMBOW is indicated for the maintenance treatment of asthma in adult patients aged 18 years and older. Limitati ons of Use TRIMBOW is NOT indicated for relief of acute bronchospasm [see Warnings and Precautions ( 5.2 ) ] . TRIMBOW is a combination of beclomethasone dipropionate (BDP) (an inhaled corticosteroid [ICS]), formoterol fumarate (FF) (a long-acting beta 2 -adrenergic agonist [LABA]), and glycopyrrolate (G) (an anticholinergic) indicated for the maintenance treatment of asthma in adult patients aged 18 years and older.

( 1 ) Limitation s of Use Not indicated for relief of acute bronchospasm. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION For oral inhalation only. ( 2.1 ) Prime TRIMBOW before first time use and re-prime if not used for 30 days or longer. ( 2.1 ) Recommended Dosage : TRIMBOW 172 mcg/9.8 mcg/21.2 mcg (administered as 2 actuations of beclomethasone dipropionate 86 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) twice daily by oral inhalation or TRIMBOW 344 mcg/9.8 mcg/21.2 mcg (administered as 2 actuations of beclomethasone dipropionate 172 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) twice daily by oral inhalation.

( 2.2 )

2.1Preparation and Admini stration Information Administer TRIMBOW by oral inhalation. After inhalation, rinse the mouth with water without swallowing it to help reduce the risk of oropharyngeal candidiasis [see Warnings and Precautions ( 5.4 )] . Priming Before Use Prime TRIMBOW by actuating 2 times prior to using the first dose from a new canister.

Re-prime if the inhaler has not been used for 30 days or longer . Dose Counter TRIMBOW has a dose counter attached to the canister. The counter starts at 122 and counts down each time a spray is released.

The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000 or if 2 months have passed since first use date, whichever comes first.

2.2Recommen d ed Dosage The recommended dosage of: TRIMBOW is beclomethasone dipropionate 172 mcg, formoterol fumarate 9.8 mcg, and glycopyrrolate 21.2 mcg (administered as 2 actuations of TRIMBOW 86 mcg/4.9 mcg/10.6 mcg [beclomethasone dipropionate 86 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg]) twice daily (in the morning and evening) by oral inhalation. or TRIMBOW is beclomethasone dipropionate 344 mcg, formoterol fumarate 9.8 mcg, and glycopyrrolate 21.2 mcg (administered as 2 actuations of TRIMBOW 172 mcg/4.9 mcg/10.6 mcg [beclomethasone dipropionate 172 mcg, formoterol fumarate 4.9 mcg, glycopyrrolate 10.6 mcg]) twice daily (in the morning and evening) by oral inhalation The recommended starting dosage for TRIMBOW is based upon patients' asthma severity or level of control of asthma symptoms on current inhaled corticosteroids.

For patients who do not respond adequately to a starting dose of TRIMBOW 172 mcg/9.8 mcg/21.2 mcg (2 actuations of TRIMBOW 86 mcg/4.9 mcg/10.6 mcg [beclomethasone dipropionate 86 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg]) twice daily, additional asthma control may be provided by replacement with a dose of TRIMBOW 344 mcg/9.8 mcg/21.2 mcg (2 actuations of TRIMBOW 172 mcg/4.9 mcg/10.6 mcg [beclomethasone dipropionate 344 mcg, formoterol fumarate 9.8 mcg, and glycopyrrolate 21.2 mcg]) twice daily. For patients who do not respond adequately to a dose of TRIMBOW 344 mcg/9.8 mcg/21.2 mcg twice daily, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.

The maximum recommended dosage is TRIMBOW 344 mcg/9.8 mcg/21.2 mcg (2 actuations of TRIMBOW 172 mcg/4.9 mcg/10.6 mcg [beclomethasone dipropionate 344 mcg, formoterol fumarate 9.8 mcg, and glycopyrrolate 21.2 mcg]) twice daily by oral inhalation. Do not take more than two oral inhalations twice daily.

💊 Dosage Forms and Strengths 124 words ▾

3 DOSAGE FORMS AND STRENGTHS Inhalation aerosol: a pressurized metered dose inhaler that delivers a combination of 86 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 86 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) per actuation. Inhaler supplied with a grey plastic actuator, dose counter, grey mouthpiece and red cap. 172 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 172 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) per actuation.

Inhaler supplied with grey plastic actuator, dose counter, grey mouthpiece and green cap. Inhalation aerosol: 86 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 86 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) per actuation. ( 3 ) 172 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 172 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) per actuation.

( 3 )

⛔ Contraindications 85 words ▾

4 CONTRAINDICATIONS TRIMBOW is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [ see Wa rnings and Precautions ( 5.2 ) ] . Hypersensitivity to beclomethasone dipropionate, formoterol fumarate, glycopyrrolate or to any of the excipients [see Warnings and Precautions ( 5.9 ) and Description ( 11 )] . Primary treatment of status asthmaticus or asthma requiring intensive measures.

( 4 ) Severe hypersensitivity to any of the 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 asthma. Do not use to treat acute symptoms.

( 5.2 ) Avoid 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 ) 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. ( 5.5 ) Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to TRIMBOW.

( 5.6 ) Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue TRIMBOW slowly. ( 5.7 ) If paradoxical bronchospasm occurs, discontinue TRIMBOW and institute alternative therapy.

( 5.8 ) Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. ( 5.10 ) Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.11 ) 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 TRIMBOW long term.

( 5.12 ) 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. ( 5.13 ) Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

( 5.14 ) Be alert to hypokalemia and hyperglycemia. ( 5.15 )

5.1Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of long-acting beta 2 -adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroid (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 (TRIMBOW is not indicated for pediatric 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 Beta2-adrenergic Agonists ) . Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta 2 -adrenergic Agonists Four 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 patients with asthma.

Three trials included adult and adolescent patients aged 12 years and older: 1 trial compared budesonide/formoterol fumarate with budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol fumarate with mometasone furoate. The fourth trial included pediatric subjects aged 4 to 11 years and compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder. The primary saf…

🤒 Adverse Reactions ~2 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 ) ] Immunosuppression and Risk of Infections [ see Warnings and Precautions ( 5.5 )] Hypercorticism and Adrenal Suppression [ see Warnings and Precautions ( 5.7 ) ] Paradoxical Bronchospasm [ see Warnings and Precautions ( 5.8 )] Cardiovascular Effects [ see Warnings and Precautions ( 5.10 )] Reduction in Bone Mineral Density [ see Warnings and Precautions ( 5.11 )] Worsening of Narrow-Angle Glaucoma [ see Warnings and Precautions ( 5.12 )] Worsening of Urinary Retention [ see Warnings and Precautions ( 5.13 ) ] 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.

Most common adverse reactions (incidence ≥ 1%) are bronchitis, hypertension, back pain, blood pressure increased, dysphonia, upper respiratory tract infection, influenza, anemia, muscle spasms, laryngitis, oropharyngeal pain, and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience The safety of TRIMBOW in asthma is based on the safety data from two randomized, double-blind, parallel-group, active-controlled trials of 52 weeks’ duration (TRIMARAN and TRIGGER) that included 2,294 adult patients with asthma who received TRIMBOW or BDP/FF comparator [ see Clinical Studies ( 14 ) ] . The incidence of adverse reactions occurring in ≥1% of the patients treated with a dose of TRIMBOW 172 mcg/9.8 mcg/21.2 mcg or a dose of TRIMBOW 344 mcg/9.8 mcg/21.2 mcg, both doses at twice daily by oral inhalation, is shown in Table 2.

Table 2. Adverse Reactions with TRIMBOW with ≥1% Incidence and Greater than Active Control in Adult Patients with Asthma in the TRIMARAN and TRIGGER 52-week Trials Adverse Reactions in TRIMARAN ( n , %) TRIMBOW 172 mcg / 9.8 mcg /2 1. 2 mcg twice daily (N = 576) BDP/FF 172 mcg / 9.8 mcg twice daily (N = 574) Hypertension 16 (3) 9 (2) Blood pressure increased 12 (2) 7 (1) Dysphonia 11 (2) 3 (<1) Upper respiratory tract infection 11 (2) 10 (2) Influenza 9 (2) 7 (1) Anemia 8 (1) 5 (1) Adverse Reactions in TRIGGER ( n , %) TRIMBOW 344 mcg / 9.8 mcg /2 1.

2 mcg twice daily (N = 571) BDP/FF 344 mcg / 9.8 mcg twice daily (N = 57 3 ) Bronchitis 18 (3) 18 (3) Back pain 12 (2) 5 (1) Dysphonia 11 (2) 9 (2) Hypertension 10 (2) 7 (1) Influenza 7 (1) 6 (1) Muscle spasms 6 (1) 6 (1) Laryngitis 6 (1) 3 (<1) Oropharyngeal pain 6 (1) 3 (<1) Sinusitis 6 (1) 3 (<1) Abbreviations: BDP, beclomethasone dipropionate; FF, formoterol fumarate; N, number of patients

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Other adrenergic drugs may potentiate effect: Use with caution. ( 7.1 ) Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes. Use with caution.

( 7.2 ) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system. ( 7.3 ) Beta-blockers: Use with caution.

May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. ( 7.4 ) Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of TRIMBOW with other anticholinergic-containing drugs.

( 7.6 ) 7. 1 Adrenergic Drugs If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of formoterol fumarate, a component of TRIMBOW, may be potentiated [see Warnings and Precautions ( 5.3 )] . 7.

2 Xanthine Derivatives, Steroids, or Diuretics Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate the hypokalemic effect of beta 2 -adrenergic agonists such as formoterol fumarate, a component of TRIMBOW. 7. 3 Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, and QTc Prolonging Drugs Formoterol, as with other beta 2 -agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, macrolides or drugs known to prolong the QTc interval because the action 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. 4 Beta-adre ner gic Receptor Blocking Agents Beta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently.

Beta-blockers not only block the therapeutic effects of beta2-agonists, such as formoterol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with asthma.

In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution. 7. 5 Non-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.

7. 6 Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of TRIMBOW with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.12 , 5.13 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment: formoterol fumarate systemic exposure may increase in patients with severe hepatic impairment. Monitor for systemic beta-agonists effects. ( 8.6 , 12.3 ) Renal impairment: In patients with severe renal impairment, use should be considered only if the potential benefit of the treatment outweighs the risk ( 8.7 ).

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with TRIMBOW or its individual components, beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes (See Clinical Considerations ) . In animal reproduction studies, beclomethasone dipropionate (BDP) resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or greater than approximately 0.6 times the maximum recommended human daily inhalation dose (MRHDID) in adults (800 mcg/day) [see Data ] .

In rats exposed to beclomethasone dipropionate by inhalation, dose-related gross injury to the fetal adrenal glands was observed at doses greater than 140 times the MRHDID, but there was no evidence of external or skeletal malformations or embryolethality at inhalation doses of up to 350 times the MRHDID. In animal reproduction studies, formoterol fumarate (FF) produced malformations that included umbilical hernia and brachygnathia (a skeletal malformation) in rats at oral doses 1,200 and 6,100 times the MRHDID in adults, respectively.

In rabbits, formoterol fumarate produced subcapsular cysts on the liver at oral doses 49,000 times the MRHDID in adults. In rats exposed to formoterol fumarate by inhalation, no teratogenic effects were observed at 500 times the MRHDID in adults. Glycopyrrolate (G) administered by the oral route in rats and rabbits did not cause structural abnormalities or affect fetal survival at exposures approximately 179 and 50 times MRHDID, respectively.

TRIMBOW administered by the oral route in rats caused reduction in fetal weights and increased incidence of visceral variations at doses 83 and 0.8 times the MRHDID and higher for BDP (metabolite- B17MP) and FF, respectively. TRIMBOW also caused decreased pup survival, increase in post-implantation loss and reduced mean litter size in rats at 1.9, 3.7, and 7.7 times the MRHDID (based on a mg/m 2 ) for BDP, FF, and G, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have background risk of birth defect, loss, or other adverse outcomes. 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 : There are no well-controlled human trials that have investigated the effects of TRIMBOW on preterm labor or labor at term. TRIMBOW 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.

Infants and neonates born to mothers receiving substantial doses should be observed for adrenal suppression. If treatment during pregnancy is necessary, the lowest effective dose should be used. Data Animal Data Beclomethasone dipropionate (BDP) In an embryofetal development study in pregnant rats, beclomethasone dipropionate administration during organogenesis from gestation days 6 to 15 at inhaled doses 140 times the MRHDID in a…

🤰 Pregnancy ~3 min read ▾

There were no findings in the adrenal glands of rat fetuses at an inhaled dose that was 30 times the MRHDID in adults (on a mg/m 2 basis at a maternal dose of 2,400 mcg/kg/day).…

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of TRIMBOW have not been established in pediatric patients.

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use Of the total number of TRIMBOW-treated patients in clinical studies for asthma, 204 (18%) were 65 years of age and older [see Clinical Studies ( 14 )] . No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between elderly and younger patients.

🆘 Overdosage 215 words ▾

10 OVERDOSAGE TRIMBOW contains beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate; therefore, the risks associated with overdosage for the individual components described below apply to TRIMBOW. Treatment of overdosage consists of discontinuation of TRIMBOW 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. Beclomethasone Dipropionate If used at excessive doses for prolonged periods, systemic corticosteroid effects, such as hypercorticism may occur [ see Warnings and Precautions ( 5.7 ) ] . Formoterol Fumarate The signs and symptoms with overdosage of formoterol fumarate are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms: angina, hypertension or hypotension, tachycardia, with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, and insomnia.

Metabolic acidosis may also occur. Cardiac arrest and even death may be associated with an overdose of formoterol fumarate. Glycopyrrolate High doses of glycopyrrolate, a component of TRIMBOW, may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation, or difficulties in voiding.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action TRIMBOW contains beclomethasone dipropionate, formoterol fumarate and glycopyrrolate. The mechanism of action described below for the individual components applies to TRIMBOW. These drugs represent three different classes of medications (an inhaled corticosteroid, a long-acting beta 2 -adrenergic agonist and an anticholinergic) that have different effects on clinical physiology.

Beclomethasone Dipropionate Beclomethasone dipropionate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism through which beclomethasone dipropionate effects asthma symptoms is not known. Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines).

These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma. Beclomethasone dipropionate is a prodrug that is rapidly activated by hydrolysis to the active monoester, 17-monopropionate (17-BMP). Beclomethasone 17-monopropionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor, which is approximately 13 times that of dexamethasone, 6 times that of triamcinolone acetonide, 1.5 times that of budesonide and 25 times that of beclomethasone dipropionate.

The clinical relevance of these findings is unknown. Formoterol Fumarate Formoterol fumarate is a long-acting selective beta 2 -adrenergic agonist (beta 2 -agonist) with a rapid onset of action. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.

In vitro studies have shown that formoterol fumarate has more than 200-fold greater agonist activity at beta 2 -receptors than at beta 1 -receptors. 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 -adrenoceptor agonist drugs, including formoterol fumarate, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-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. Glycopyrrolate Glycopyrrolate is a long-acting antimuscarinic agent 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 the M3 receptor at the smooth muscle leading to bronchodilation. In preclinical in vitro as well as in vivo studies, prevention of acetylcholine, ovalbumin, acetaldehyde and histamine-induced bronchoconstrictive effects was dose-dependent.

The clinical relevance of these findings is unknown. The bronchodilation following inhalation of glycopyrrolate is predominantly a site-specific effect.

12.2Pharmacodynamics Cardiac Electrophysiology A randomized, double-blind, placebo controlled, single dose study in 95 healthy volunteers assessed the effect of beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate (BDP/FF/G) on the heart rate corrected QT interval based on the Fridericia's correction (QTcF) using electrocardiographic monitoring. The maximum mean (90% two-sided upper confidence bound) difference in QTcF from placebo after baseline correction was 4.4 (5.9) milliseconds and 11.8…

🧬 Mechanism of Action ~2 min read ▾

The clinical relevance of these findings is unknown. The bronchodilation following inhalation of glycopyrrolate is predominantly a site-specific effect.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TRIMBOW (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) Inhalation Aerosol: TRIMBOW 86 mcg/4.9 mcg/10.6 mcg: is supplied as a pressurized aluminum container, a grey plastic actuator with the dose counter on the back, a grey mouthpiece and a red cap. TRIMBOW 172 mcg/4.9 mcg/10.6 mcg: is supplied as a pressurized aluminum container, a grey plastic actuator with the dose counter on the back, a grey mouthpiece and a green cap. Each pressurized container of TRIMBOW is packaged in a carton containing one canister, one actuator, a Patient Information leaflet, and the Instructions for Use.

TRIMBOW is available as presented in Table 4. Table 4 Package Information for TRIMBOW Strength ( beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) Number of Actuations per Canister Net Fill Weight NDC 86 mcg/4.9 mcg/10.6 mcg 120 11.8 grams NDC 10122-120-02 172 mcg/4.9 mcg/10.6 mcg 120 11.8 grams NDC 10122-121-02 The TRIMBOW container should only be used with the TRIMBOW actuator, and the TRIMBOW actuator should not be used with any other inhalation drug product. Prime the inhaler according to Instructions for Use .

If the inhaler has not been used for 30 days or longer, re-prime the inhaler by releasing 2 actuations (puffs) into the air, away from the face and eyes, before use. Dose Counter TRIMBOW has a dose counter attached to the canister. The counter starts at 122 and counts down each time a spray is released.

Do not use or store near heat or open flame. Exposure to temperatures above 122°F may cause bursting. Never throw container into fire or incinerator.

Keep out of reach of children. Do not spray into eyes. Storage: Prior to first use: Store refrigerated at 36°F to 46°F (2°C to 8°C).

After first use: Store the inhaler below 77°F (25°C) for a maximum of two months. Do not freeze. Do not expose to temperatures higher than 122°F (50°C) as this may cause bursting.

📋 Description ~3 min read ▾

11 DESCRIPTION TRIMBOW (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of beclomethasone dipropionate [an inhaled corticosteroid (ICS)], formoterol fumarate [an inhaled long-acting beta 2 -adrenergic agonist (a LABA)] and glycopyrrolate (an anticholinergic) for oral inhalation. Beclomethasone dipropionate, an inhaled corticosteroid [ICS], has the chemical name [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate.

Beclomethasone dipropionate is a white to creamy white, odorless powder, insoluble in water, freely soluble in acetone, and sparingly soluble in alcohol, with a molecular weight of 521.04218 g/mol, and the molecular formula is C 28 H 37 ClO 7 . The structural formula is as follows: Formoterol fumarate, a long-acting β2 agonist has the chemical name (E)-but-2-enedioic acid; N -[2-hydroxy-5-[(1 R )-1-hydroxy-2-[[(1 R )-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-formamide dihydrate. Formoterol fumarate is a powder that is slightly soluble in water.

Formoterol fumarate has a molecular weight of 840.91 g/mol, and the molecular formula is C 42 H 52 N 4 O 12 . The structural formula is as follows: Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S) . Glycopyrrolate is a quarternary ammonium bromide salt with the following chemical name: [ RS- ]-3-[( SR )-(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-Pyrrolidinium bromide.

Two asymmetric atoms of carbon are present in the molecule: Glycopyrronium bromide is represented by the (R,S)-(S,R) racemic pair of enantiomers, corresponding to the threo diastereoisomeric structure. Glycopyrrolate is a powder that is freely soluble in water. Glycopyrrolate has a molecular weight of 398.33 g/mol, and the molecular formula is C 19 H 28 BrNO 3 .

The structural formula is as follows: Glycopyrrolate contains two chiral centers and is a racemate of a 1;1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. TRIMBOW 86 mcg/4.9 mcg/10.6 mcg and TRIMBOW 172 mcg/4.9 mcg/10.6 mcg are formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized, metered-dose inhalers, each containing 120 actuations.

The canister is supplied with a grey plastic actuator with an integrated dose counter mechanism and mouthpiece, and a red cap (TRIMBOW 86 mcg/4.9 mcg/10.6 mcg) or a green cap (TRIMBOW 172 mcg/4.9 mcg/10.6 mcg). As a solution, TRIMBOW does not need to be shaken before use. TRIMBOW should be “primed” by actuating 2 times prior to using the first dose from a new canister.

If the inhaler has not been used for 30 days or longer, re-prime the inhaler [ see How Supplied/Storage and Handling ( 16 ) ] . After priming, each actuation meters 100 or 200 mcg of beclomethasone dipropionate, 6.0 mcg of formoterol fumarate (equivalent to 5.7 mcg of formoterol fumarate anhydrous), and 12.5 mcg of glycopyrrolate (equivalent to 10 mcg of glycopyrronium) in 73.8 mg of solution from the valve and delivers 86 or 172 mcg of beclomethasone dipropionate, 4.9 mcg of formoterol fumarate (equivalent to 4.2 mcg of formoterol fumarate anhydrous), and 10.6 mcg of glycopyrrolate (equivalent to 8.5 mcg of glycopyrronium) from the actuator.

The actual amount of drug delivered to the lung may depend on patient factors, such as coordination of the device (metered dose inhaler [MDI]) actuation with the inhalation maneuver, inspiratory flow and peak inspiratory flow through the delivery system, which may vary in patients with asthma and other pulmonary diseases and conditions. Avoid spraying in the eyes or face while using TRIMBOW. TRIMBOW contains dehydrated alcohol (18% v/v), HFA 134a, and hydrochloric acid as excipients in the formulation.

The struct…

💬 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 TRIMBOW, 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 TRIMBOW is not meant to relieve acute symptoms of asthma and extra doses should not be used for that purpose [see Warnings and Precautions ( 5.2 )] . Advise patients to treat acute symptoms with an inhaled, short-acting beta 2 -agonist/corticosteroid or short-acting beta 2 -agonist. Provide patients with such medication and instruct them how it should be used.

Instruct patients to seek medical attention immediately if they experience any of the following: Decreasing effectiveness of inhaled, short-acting beta2-agonist/corticosteroid combination, or inhaled, short-acting beta 2 -agonists Need for more inhalations than usual of inhaled, short acting beta 2 -agonists/corticosteroid combination, or inhaled short acting beta 2 -agonists Significant decrease in lung function as outlined by the healthcare provider Tell the patient they should not stop therapy with TRIMBOW without physician/provider guidance since symptoms may recur after discontinuation [See Warnings and Precautions ( 5.2 )] .

Avoid Use of Additional Long-acting Beta 2 -agonists Instruct patients not to use other LABA drugs for asthma [See Warnings and Precautions ( 5.3 )] . Oropharyngeal Candidiasis Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx (i.e., thrush) in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with TRIMBOW, but at times therapy with TRIMBOW 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 )] . 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 ( 5.5 ) ] .

Hypercorticism and Adrenal Suppression Advise patients that TRIMBOW 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 TRIMBOW [See Warnings and Precautions ( 5.7 )] .

Paradoxical Bronchospasm As with other inhaled medicines, TRIMBOW can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue TRIMBOW and contact their healthcare provider right away [See Warnings and Precautions ( 5.8 )] . Hypersensitivity Reactions, including Anaphylaxis Advise patients that hypersensitivity reactions have been reported after administration.

If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, instruct patients to discontinue TRIMBOW immediately [See Warnings and Precautions ( 5.9 )] . 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 ( 5.11 ) ] . Ocular Effects suc…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressant: A medicine that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adrenal insufficiency: A condition where the adrenal glands do not make enough of certain needed hormones, such as cortisol, a stress hormone.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

BMD: A measurement of the amount of mineral, such as calcium, in your bones, used to estimate how strong they are.

bone mineral density: A measurement of the amount of mineral, such as calcium, in your bones, used to estimate how strong they are.

bronchodilation: A widening of the airways in the lungs, which makes breathing easier.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

immunosuppression: A weakening of the body's defense system, which makes it harder to fight off infections.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhalation: Breathed in through the mouth or nose so the medicine reaches the lungs or airways.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intraocular pressure: The fluid pressure inside the eye.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

metabolite: A new substance formed when the body breaks a medicine down.

monotherapy: Treatment using a single medicine by itself.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

prodrug: A medicine that is inactive when taken and must be changed by the body into its working form.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

tuberculosis: A serious infection, usually of the lungs, caused by tuberculosis bacteria and spread through the air.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

urinary retention: Being unable to empty the bladder fully or at all.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 10122-0550-28 · Chiesi 10122-0610-10 · Chiesi →

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.

Trimbow beclomethasone dipropionate/formoterol fumarate/glycopyrrolate 172 ug; 4.9 ug; 10.6 ug Aerosol, Metered

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