Umeclidinium Ellipta 62.5 ug Aerosol, Powder
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Anticholinergic class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Umeclidinium oral inhalation is used in adults to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Umeclidinium inhalation is in a class of medications called anticholinergics. It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Read the full MedlinePlus article ↗- No, this is not a rescue inhaler. Umeclidinium Ellipta is a maintenance inhaler, which means you take it once every day on a regular schedule to help keep your airways open and pre...
- What exactly is this inhaler for — is it the one I use when I can't breathe?
- Take one inhalation through the Ellipta device by mouth, once a day, at the same time each day — morning works well for most people. Never use it more than once in 24 hours. The de...
- Most people tolerate this inhaler well. The most common side effects are things like a stuffy or runny nose, a sore throat, upper respiratory infections, cough, and joint pain. Mor...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Umeclidinium Bromide — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
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💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.412 | $222.35 / 30 aerosols |
| 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Umeclidinium Ellipta 62.5 ugthis 66993-0189-97 | Prasco | 1 inhaler | $7.412 | — | Availability likely | — |
| Incruse Ellipta 62.5 ug 00173-0873-06 | GlaxoSmithKline | 1 inhaler | $10.277 | — | Availability likely | +39% |
Where does this data come from?
⏳ Availability & generic status
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.
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.
🛈 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.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7488827 ↗ | Drug substance | — | Dec 18, 2027 |
Is there a generic version of UMECLIDINIUM ELLIPTA 62.5 MCG?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 66993-0189-97 You're viewing this | 1 TRAY in 1 CARTON (66993-189-97) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER | 2026-04-06 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dosage of Umeclidinium ELLIPTA for maintenance treatment of COPD is 1 actuation (umeclidinium 62.5 mcg) once daily by oral inhalation. • Umeclidinium ELLIPTA should be used at the same time every day. Do not use Umeclidinium ELLIPTA more than 1 time every 24 hours. • No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] . • For oral inhalation only. ( 2 ) • Maintenance treatment of COPD: 1 actuation of Umeclidinium ELLIPTA once daily administered by oral inhalation.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Inhalation powder: 62.5 mcg umeclidinium per actuation. Inhalation powder: 62.5 mcg of umeclidinium per actuation. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Umeclidinium ELLIPTA is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions ( 5.3 )] • Hypersensitivity to umeclidinium or any of the excipients [see Warnings and Precautions ( 5.3 ), Description ( 11 )] • Severe hypersensitivity to milk proteins. ( 4 ) • Hypersensitivity to any ingredient. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Do not initiate in acutely deteriorating COPD. Do not use to treat acute symptoms. ( 5.1 ) • If paradoxical bronchospasm occurs, discontinue Umeclidinium ELLIPTA and institute alternative therapy.
( 5.2 ) • 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. ( 5.4 ) • 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. ( 5.5 )
5.1Deterioration of Disease and Acute Episodes Umeclidinium ELLIPTA should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD. Umeclidinium ELLIPTA has not been studied in subjects with acutely deteriorating COPD. The initiation of Umeclidinium ELLIPTA in this setting is not appropriate.
Umeclidinium ELLIPTA should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Umeclidinium 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.
If Umeclidinium ELLIPTA no longer controls symptoms of bronchoconstriction; the patient’s inhaled, short-acting beta 2 -agonist becomes less effective; or the patient needs more short-acting beta 2 -agonist than usual, these may be markers of deterioration of disease. In this setting re-evaluate the patient and the COPD treatment regimen at once. Increasing the daily dose of Umeclidinium ELLIPTA beyond the recommended dose is not appropriate in this situation.
5.2Paradoxical Bronchospasm As with other inhaled therapies, Umeclidinium ELLIPTA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Umeclidinium ELLIPTA, it should be treated immediately with an inhaled, short-acting bronchodilator; Umeclidinium ELLIPTA should be discontinued immediately; and alternative therapy should be instituted.
5.3Hypersensitivity Reactions, including Anaphylaxis Hypersensitivity reactions such as anaphylaxis, angioedema, pruritus, rash, and urticaria may occur after administration of Umeclidinium ELLIPTA. Discontinue Umeclidinium 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 Umeclidinium ELLIPTA [see Contraindications (4), Adverse Reactions ( 6.2 )] .
5.4Worsening of Narrow-Angle Glaucoma Umeclidinium ELLIPTA should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should also be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develop.
5.5Worsening of Urinary Retention Umeclidinium ELLIPTA, like all therapies containing an anticholinergic, should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develop.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions ( 5.2 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.4 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 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. In the 8 clinical trials conducted to support initial approval of Umeclidinium ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg.
In the 4 randomized, double-blind, placebo- or active-controlled, efficacy clinical trials, 1,185 subjects received umeclidinium for up to 24 weeks, of which 487 subjects received the recommended dose of umeclidinium 62.5 mcg. In a 12-month, randomized, double-blind, placebo-controlled, long-term safety trial, 227 subjects received umeclidinium 125 mcg for up to 52 weeks [see Clinical Studies ( 14 )] . The incidence of adverse reactions associated with umeclidinium ELLIPTA in Table 1 is based upon 2 placebo-controlled trials: one 24-week trial (Trial 1) and one 12-week trial (Trial 2) [see Clinical Studies ( 14.2 )].
Table 1. Adverse Reactions with Umeclidinium ELLIPTA with ≥1% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease Adverse Reaction Umeclidinium ELLIPTA (n = 487) % Placebo (n = 348) % Infections and infestations Nasopharyngitis 8% 7% Upper respiratory tract infection 5% 4% Pharyngitis 1% <1% Viral upper respiratory tract infection 1% <1% Respiratory, thoracic, and mediastinal disorders Cough 3% 2% Musculoskeletal and connective tissue disorders Arthralgia 2% 1% Myalgia 1% <1% Gastrointestinal disorders Abdominal pain upper 1% <1% Toothache 1% <1% Injury, poisoning, and procedural complications Contusion 1% <1% Cardiac disorders Tachycardia 1% <1% Other adverse reactions with umeclidinium ELLIPTA observed with an incidence <1% but more common than placebo included atrial fibrillation.
In a long-term safety trial (Trial 3), 336 subjects (n = 227 umeclidinium 125 mcg, n = 109 placebo) were treated for up to 52 weeks with umeclidinium 125 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the efficacy trials described above. Adverse reactions that occurred with a frequency ≥1% in subjects receiving umeclidinium 125 mcg that exceeded that in placebo in this trial were: nasopharyngitis, upper respiratory tract infection, urinary tract infection, pharyngitis, pneumonia, lower respiratory tract infection, rhinitis, supraventricular tachycardia, supraventricular extrasystoles, sinus tachycardia, idioventricular rhythm, headache, dizziness, sinus headache, cough, back pain, arthralgia, pain in extremity, neck pain, myalgia, nausea, dyspepsia, diarrhea, rash, depression, and vertigo.
The safety and efficacy of umeclidinium ELLIPTA in combination with an inhaled corticosteroid/long-acting beta 2 -adrenergic agonist (ICS/LABA) were also evaluated in four 12‑week clinical trials (Trial 4, Trial 5, Trial 6, and Trial 7). A total of 1,637 subjects with COPD across four 12‑week, randomized, double-blind clinical trials received at least 1 dose of umeclidinium ELLIPTA (62.5 mcg) or placebo administered once daily in addition to background ICS/LABA…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of Umeclidinium ELLIPTA with other anticholinergic-containing drugs. ( 7.1 )
7.1Anticholinergics There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid coadministration of Umeclidinium ELLIPTA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [see Warnings and Precautions ( 5.4 , 5.5 )] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are insufficient data on the use of umeclidinium in pregnant women to inform a drug‑associated risk. Umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled 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. Data Animal Data: In separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the MRHDID, respectively (on an AUC basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits).
No evidence of teratogenic effects was observed in either species. In a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods with no evidence of effects on offspring development at doses up to approximately 26 times the MRHDID (on an AUC basis at maternal subcutaneous doses up to 60 mcg/kg/day).
8.2Lactation Risk Summary There is no information available on the presence of umeclidinium in human milk, the effects on the breastfed child, or the effects on milk production. Umeclidinium was detected in the plasma of offspring of lactating rats treated with umeclidinium suggesting its presence in maternal milk. (See Data.) The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Umeclidinium ELLIPTA and any potential adverse effects on the breastfed child from umeclidinium or from the underlying maternal condition.
Data Subcutaneous administration of umeclidinium to lactating rats at greater than or equal to 60 mcg/kg/day resulted in a quantifiable level of umeclidinium in 2 of 54 pups, which may indicate transfer of umeclidinium in milk.
8.4Pediatric Use The safety and effectiveness of Umeclidinium ELLIPTA have not been established in pediatric patients. Umeclidinium ELLIPTA is not indicated for use in pediatric patients.
8.5Geriatric Use Based on available data, no adjustment of the dosage of Umeclidinium ELLIPTA in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. Clinical trials of umeclidinium ELLIPTA included 810 subjects aged 65 years and older, and, of those, 183 subjects were aged 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects.
8.6Hepatic Impairment Patients with moderate hepatic impairment (Child-Pugh score of 7-9) showed no relevant increases in C max or AUC, nor did protein binding differ between subjects with moderate hepatic impairment and their healthy controls. Studies in subjects with severe hepatic impairment have not been performed [see Clinical Pharmacology ( 12.3 )] .
8.7Renal Impairment Patients with severe renal impairment (CrCl <30 mL/min) showed no relevant increases in C max or AUC, nor did protein binding differ between subjects with severe renal impairment and their healthy controls. No dosage adjustment is required in patients with renal impairment [see Clinical Pharmacology ( 12.3 )] .
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are insufficient data on the use of umeclidinium in pregnant women to inform a drug‑associated risk. Umeclidinium administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended human daily inhaled 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. Data Animal Data: In separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 50 and 200 times the MRHDID, respectively (on an AUC basis at maternal inhalation doses up to 278 mcg/kg/day in rats and at maternal subcutaneous doses up to 180 mcg/kg/day in rabbits).
No evidence of teratogenic effects was observed in either species. In a perinatal and postnatal developmental study in rats, dams received umeclidinium during late gestation and lactation periods with no evidence of effects on offspring development at doses up to approximately 26 times the MRHDID (on an AUC basis at maternal subcutaneous doses up to 60 mcg/kg/day).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Umeclidinium ELLIPTA have not been established in pediatric patients. Umeclidinium ELLIPTA is not indicated for use in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Based on available data, no adjustment of the dosage of Umeclidinium ELLIPTA in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. Clinical trials of umeclidinium ELLIPTA included 810 subjects aged 65 years and older, and, of those, 183 subjects were aged 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE High doses of umeclidinium may lead to anticholinergic signs and symptoms. Treatment of overdosage consists of discontinuation of Umeclidinium ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation.
The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown.
The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.
12.2Pharmacodynamics Cardiac Electrophysiology QTc interval prolongation was studied in a double-blind, multiple-dose, placebo- and positive‑controlled, crossover study in 86 healthy subjects. Following repeat doses of umeclidinium 500 mcg once daily (8 times the recommended dosage) for 10 days, umeclidinium does not prolong QTc to any clinically relevant extent.
12.3Pharmacokinetics Linear pharmacokinetics was observed for umeclidinium (62.5 to 500 mcg). Absorption Umeclidinium plasma levels may not predict therapeutic effect. Following inhaled administration of umeclidinium in healthy subjects, C max occurred at 5 to 15 minutes.
Umeclidinium is mostly absorbed from the lung after inhaled doses with minimum contribution from oral absorption. Following repeat dosing of inhaled Umeclidinium ELLIPTA, steady state was achieved within 14 days with up to 1.8-fold accumulation. Distribution Following intravenous administration to healthy subjects, the mean volume of distribution was 86 L.
In vitro plasma protein binding in human plasma was on average 89%. Elimination Metabolism : In vitro data showed that umeclidinium is primarily metabolized by the enzyme cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter. The primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (e.g., glucuronidation), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Systemic exposure to the metabolites is low. Excretion : The effective half-life after once-daily orally inhaled dosing is 11 hours. Following intravenous dosing with radiolabeled umeclidinium, mass balance showed 58% of the radiolabel in the feces and 22% in the urine.
The excretion of the drug-related material in the feces following intravenous dosing indicated elimination in the bile. Following oral dosing to healthy male subjects, radiolabel recovered in feces was 92% of the total dose and that in urine was <1% of the total dose, suggesting negligible oral absorption. Specific Populations Population pharmacokinetic analysis showed no evidence of a clinically significant effect of age (40 to 93 years) ( Figure 1 ), gender (69% male) ( Figure 1 ), inhaled corticosteroid use (48%), or weight (34 to 161 kg) on systemic exposure of umeclidinium.
In addition, there was no evidence of a clinically significant effect of race. Patients with Hepatic Impairment: The impact of hepatic impairment on the pharmacokinetics of Umeclidinium ELLIPTA has been evaluated in subjects with moderate hepatic impairment (Child‑Pugh score of 7-9). There was no evidence of an increase in systemic exposure to umeclidinium (C max and AUC) ( Figure 1 ).
There was no evidence of altered protein binding in subjects with moderate hepatic impairment compared with healthy subjects. Umeclidinium ELLIPTA has not been evaluated in subjects with severe hepatic impairment. Patients with Renal Impairment: The pharmacokinetics of Umeclidinium ELLIPTA has been evaluated in subjects with severe renal impairment (CrCl <30 mL/min)…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Umeclidinium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation.
The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown.
The bronchodilation following inhalation of umeclidinium is predominantly a site-specific effect.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Umeclidinium ELLIPTA is supplied as a disposable light grey and light green plastic inhaler containing a foil strip with 30 blisters (NDC 66993-189-97). 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. Umeclidinium ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use.
Discard Umeclidinium 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 ▾
11 DESCRIPTION Umeclidinium ELLIPTA is an inhalation powder drug product for delivery of umeclidinium (an anticholinergic) to patients by oral inhalation. Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure: Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is C 29 H 34 NO 2 •Br (as a quaternary ammonium bromide compound). It is slightly soluble in water.
Umeclidinium ELLIPTA is a light grey and light green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), magnesium stearate (75 mcg), and lactose monohydrate (to 12.5 mg). 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, Umeclidinium ELLIPTA delivers 55 mcg of umeclidinium per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (COPD with forced expiratory volume in 1 second/forced vital capacity [FEV 1 /FVC] <70% and FEV 1 <30% predicted or FEV 1 <50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was
67.5L/min (range: 41.6 to
83.3L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Umeclidinium bromide chemical structure
💬 Information for Patients ▾
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 Umeclidinium ELLIPTA is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta 2 -agonist such as albuterol.
Provide patients with such medication and instruct them in how it should be used. Instruct patients to seek medical attention immediately if they experience any of the following: • Decreasing effectiveness of inhaled, short-acting beta 2 -agonists • Need for more inhalations than usual of inhaled, short-acting beta 2 -agonists • Significant decrease in lung function as outlined by the physician Tell patients they should not stop therapy with Umeclidinium ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation. [See Warnings and Precautions ( 5.1 ).] Paradoxical Bronchospasm As with other inhaled medicines, Umeclidinium ELLIPTA can cause paradoxical bronchospasm.
If paradoxical bronchospasm occurs, instruct patients to discontinue Umeclidinium ELLIPTA and contact their healthcare provider right away. [See Warnings and Precautions ( 5.2 ).] Worsening of Narrow-Angle Glaucoma Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develop. [See Warnings and Precautions ( 5.4 ).] Worsening of Urinary Retention Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination).
Instruct patients to consult a physician immediately if any of these signs or symptoms develop. [See Warnings and Precautions ( 5.5 ).] ELLIPTA is a trademark owned by or licensed to the GSK group of companies. Manufactured for: Prasco Laboratories Mason, OH 45040 USA Manufactured by: GlaxoSmithKline Durham, NC 27701 UMC-PS:1PI