Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate (Trelegy Ellipta)

Trade Name : Trelegy Ellipta

GlaxoSmithKline LLC

POWDER

Strength 10062.525 ug/1ug/1ug/1

FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate (Trelegy Ellipta) which is also known as Trelegy Ellipta and Manufactured by GlaxoSmithKline LLC. It is available in strength of 100; 62.5; 25 ug/1; ug/1; ug/1 per ml. Read more

Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate (Trelegy Ellipta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

TRELEGY ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Important Limitations of Use
TRELEGY ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a longu2011acting beta-adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ()
Important limitations of use: Not indicated for relief of acute bronchospasm or the treatment of asthma. (, )

TRELEGY ELLIPTA should be administered as 1 inhalation once daily by the orally inhaled route only.
After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis.
TRELEGY ELLIPTA should be used at the same time every day.
Do not use TRELEGY ELLIPTA more than 1 time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment .

Inhalation powder: Disposable light grey and beige plastic inhaler containing 2 foil blister strips of powder intended for oral inhalation only. One strip contains fluticasone furoate (100u00a0mcg per blister) and the other strip contains a blend of umeclidinium and vilanterol (62.5u00a0mcg and 25u00a0mcg per blister, respectively).
Inhalation powder: Inhaler containing 2 foil blister strips of powder formulation for oral inhalation. One strip contains fluticasone furoate 100u00a0mcg per blister and the other contains umeclidinium/vilanterol 62.5u00a0mcg/25u00a0mcg per blister. ()

The use of TRELEGY ELLIPTA is contraindicated in patients:
Severe hypersensitivity to milk proteins or any ingredients. ()

No data

Candida albicans

The following adverse reactions are described in greater detail in other sections:
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.
The safety of TRELEGY ELLIPTA is based on the safety data from two 12-week treatment trials with coadministration of umeclidinium and the fixed-dose combination of fluticasone furoate/vilanterol and a 52-week long-term trial of TRELEGY ELLIPTA compared with the fixed-dose combinations of fluticasone furoate/vilanterol and umeclidinium/vilanterol .
Trials 1 and 2
Two 12-week treatment trials (Trial 1 and Trial 2) evaluated the coadministration of umeclidinium + fluticasone furoate/vilanterol, the components of TRELEGY ELLIPTA, compared with placebo + fluticasone furoate/vilanterol. A total of 824 subjects with COPD across two 12-week, randomized, double-blind clinical trials received at least 1 dose of umeclidinium 62.5u00a0mcg + fluticasone furoate/vilanterol 100 mcg/25 mcg or placebo + fluticasone furoate/vilanterol 100 mcg/25 mcg administered once daily (mean age: 64u00a0years, 92% white, 66% male across all treatments) . The incidence of adverse reactions associated with the use of umeclidinium 62.5u00a0mcg + fluticasone furoate/vilanterol 100u00a0mcg/25 mcg presented in is based on the two 12-week trials.
Trial 3 - Long-term Safety Data
A 52-week trial (Trialu00a03) evaluated the long-term safety of TRELEGY ELLIPTA compared with the fixed-dose combinations of fluticasone furoate/vilanterol 100u00a0mcg/25u00a0mcg and umeclidinium/vilanterol 62.5u00a0mcg/25u00a0mcg. A total of 10,355 subjects with COPD with a history of moderate or severe exacerbations within the prior 12 months were randomized (2:2:1) to receive TRELEGY ELLIPTA, fluticasone furoate/vilanterol, or umeclidinium/vilanterol administered once daily in a double-blind clinical trial (mean age: 65u00a0years, 77% white, 66% male across all treatments) .
The incidence of adverse reactions in the long-term trial were consistent with those in Trialsu00a01 and 2. However, in addition to the adverse reactions shown in , adverse reactions occurring in u22651% of the subjects treated with TRELEGY ELLIPTA (nu00a0=u00a04,151) for up to 52u00a0weeks also included upper respiratory tract infection, pneumonia , bronchitis, oral candidiasis , arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.
Most common adverse reactions (incidence u22651%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia. ()
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .

No data

Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects. (, )

No human overdosage data has been reported for TRELEGY ELLIPTA.
TRELEGY ELLIPTA contains fluticasone furoate, umeclidinium, and vilanterol; therefore, the risks associated with overdosage for the individual components described below apply to TRELEGY ELLIPTA. Treatment of overdosage consists of discontinuation of TRELEGY ELLIPTA together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. Cardiac monitoring is recommended in cases of overdosage.

TRELEGY ELLIPTA is an inhalation powder drug product for delivery of a combination of fluticasone furoate (an ICS), umeclidinium (an anticholinergic), and vilanterol (a LABA) to patients by oral inhalation.
Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6u03b1,11u03b2,16u03b1,17u03b1)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:
Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is CHFOS. It is practically insoluble in water.
Umeclidinium bromide has the chemical name 1-[2-(benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide and the following chemical structure:
Umeclidinium bromide is a white powder with a molecular weight of 508.5, and the empirical formula is CHNOu2022Br (as a quaternary ammonium bromide compound). It is slightly soluble in water.
Vilanterol trifenatate has the chemical name triphenylacetic acid-4-{(1)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure:
Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is CHClNOu2022CHO. It is practically insoluble in water.
TRELEGY ELLIPTA is a light grey and beige plastic inhaler containing 2 foil blister strips. Each blister on one strip contains a white powder mix of micronized fluticasone furoate (100u00a0mcg) and lactose monohydrate (12.3u00a0mg) and each blister on the other strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5u00a0mcg of umeclidinium), micronized vilanterol trifenatate (40u00a0mcg equivalent to 25u00a0mcg of vilanterol), magnesium stearate (75u00a0mcg), and lactose monohydrate (12.3u00a0mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.
Comparative in vitro data for drug delivery and aerodynamic particle size distribution of the delivered drugs fluticasone furoate, umeclidinium, and vilanterol demonstrated that there were no pharmaceutical interactions and each drug was delivered in a comparable manner whether administered via a single ELLIPTA inhaler or from separate inhalers.
Under standardized in vitro test conditions, TRELEGY ELLIPTA delivers 92, 55, and 22 mcg of fluticasone furoate, umeclidinium, and vilanterol, respectively, per dose when tested at a flow rate of 60 L/min for 4 seconds.
In adult subjects with very severe COPD (FEV/FVC [forced vital capacity] <70% and FEV <30% predicted), mean peak inspiratory flow through the ELLIPTA inhaler was 65.8u00a0L/min (range: 43.5 to 94.1u00a0L/min). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

No data

TRELEGY ELLIPTA
No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with TRELEGY ELLIPTA; however, studies are available for the individual components, fluticasone furoate, umeclidinium, and vilanterol, as described below.
Fluticasone Furoate
Fluticasone furoate produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 9 and 19u00a0mcg/kg/day, respectively (both approximately equal to the MRHDID for adults on a mcg/m basis).
Fluticasone furoate did not induce gene mutation in bacteria or chromosomal damage in a mammalian cell mutation test in mouse lymphoma L5178Y cells inu00a0vitro. There was also no evidence of genotoxicity in the inu00a0vivo micronucleus test in rats.
No evidence of impairment of fertility was observed in male and female rats at inhaled fluticasone furoate doses up to 29 and 91u00a0mcg/kg/day, respectively (approximately 7 and 17 times, respectively, the MRHDID for adults on an AUC basis).
Umeclidinium
Umeclidinium produced no treatment-related increases in the incidence of tumors in 2-year inhalation studies in rats and mice at inhaled doses up to 137 and 295/200 mcg/kg/day (male/female), respectively (approximately 17 and 20/20 times the MRHDID for adults on an AUC basis, respectively).
Umeclidinium tested negative in the following genotoxicity assays: the in vitro Ames assay, in vitro mouse lymphoma assay, and in vivo rat bone marrow micronucleus assay.
No evidence of impairment of fertility was observed in male and female rats at subcutaneous doses up to 180u00a0mcg/kg/day and at inhaled doses up to 294 mcg/kg/day, respectively (approximately 60 and 40 times, respectively, the MRHDID for adults on an AUC basis).
Vilanterol
In a 2-year carcinogenicity study in mice, vilanterol caused a statistically significant increase in ovarian tubulostromal adenomas in females at an inhaled dose of 29,500 mcg/kg/day (approximately 9,920 times the MRHDID for adults on an AUC basis). No increase in tumors was seen at an inhaled dose of 615 mcg/kg/day (approximately 370 times the MRHDID for adults on an AUC basis).
In a 2-year carcinogenicity study in rats, vilanterol caused statistically significant increases in mesovarian leiomyomas in females and shortening of the latency of pituitary tumors at inhaled doses greater than or equal to 84.4 mcg/kg/day (greater than or equal to approximately 25 times the MRHDID for adults on an AUC basis). No tumors were seen at an inhalation dose of 10.5u00a0mcg/kg/day (approximately equal to the MRHDID for adults on an AUC basis).
These tumor findings in rodents are similar to those reported previously for other beta-adrenergic agonist drugs. The relevance of these findings to human use is unknown.
Vilanterol tested negative in the following genotoxicity assays: the in vitro Ames assay, in vivo rat bone marrow micronucleus assay, in vivo rat unscheduled DNA synthesis (UDS) assay, and in vitro Syrian hamster embryo (SHE) cell assay. Vilanterol tested equivocal in the in vitro mouse lymphoma assay.
No evidence of impairment of fertility was observed in male and female rats at inhaled vilanterol doses up to 31,500 and 37,100 mcg/kg/day, respectively (both approximately 4,090 times the MRHDID based on AUC).

The clinical efficacy of TRELEGY ELLIPTA has been evaluated in 3 clinical trials in subjects with COPD, including chronic bronchitis and/or emphysema: Trial 1 (NCT #01957163), Trial 2 (NCT #02119286), and Trial 3 (NCT #02164513).
Trials 1 and 2 were multicenter, randomized, double-blind, parallel-group, 12-week treatment trials. Across both trials, a total of 412 subjects received coadministration of umeclidinium 62.5u00a0mcg + fluticasone furoate/vilanterol 100u00a0mcg/25u00a0mcg, the components of TRELEGY ELLIPTA. Comparative in vitro data provide support for reliance on coadministration studies with umeclidinium 62.5u00a0mcg + fluticasone furoate/vilanterol 100u00a0mcg/25u00a0mcg n
The population demographics for Trialsu00a01 and 2 were: mean age of 64 years, 92% white, 66% male, and an average smoking history of 48 pack-years, with 50% identified as current smokers. At screening, the mean postbronchodilator percent predicted FEV was 46% (range: 14% to 76%), the mean postbronchodilator FEV/FVC ratio was 0.48 (range: 0.21 to 0.70), and the mean percent reversibility was 13% (range: -24% to 86%).
Trial 3 was a randomized, multicenter, double-blind, parallel-group, 52-week treatment trial comparing the clinical efficacy of TRELEGY ELLIPTA with the fixed-dose combinations of fluticasone furoate/vilanterol 100u00a0mcg/25u00a0mcg and umeclidinium/vilanterol 62.5u00a0mcg/25u00a0mcg. A total of 10,355 subjects with COPD with a history of 1 or more moderate or severe exacerbations in the prior 12 months were randomized (2:2:1) to receive TRELEGY ELLIPTA, fluticasone furoate/vilanterol, or umeclidinium/vilanterol administered once daily.
The population demographics across all treatments were: mean age of 65 years, 77% white, 66% male, and an average smoking history of 46.6 pack-years, with 35% identified as current smokers. At study entry, the most common COPD medications were ICS + anticholinergic + LABA (34%), ICS + LABA (26%), anticholinergic + LABA (8%), and anticholinergic (7%); the mean postbronchodilator percent predicted FEV was 46% (SD: 15%), the mean postbronchodilator FEV/FVC ratio was 0.47 (SD: 0.12), and the mean percent reversibility was 10% (range: -59% to 125%).
Lung Function:
Greater LS mean changes from baseline in FEV over time were demonstrated for the umeclidinium + fluticasone furoate/vilanterol treatment group compared with the placebo + fluticasone furoate/vilanterol treatment group starting at 15 minutes postdose on Day 1. For Trial 1, LS mean changes in FEV over time relative to baseline are displayed for Day 1 and Day 84 in Figures 4 and 5, respectively. Similar results were seen in Trial 2.
Figure 4. Least Squares (LS) Mean Change from Baseline in Postdose Serial FEV (mL) on Day 1
Figure 5. Least Squares (LS) Mean Change from Baseline in Postdose Serial FEV (mL) on Day 84
In Trial 3, treatment with TRELEGY ELLIPTA demonstrated a statistically significant improvement in lung function (mean change from baseline trough FEV at Weeku00a052) compared with fluticasone furoate/vilanterol and umeclidinium/vilanterol. The mean change from baseline in trough (predose) FEV at Weeku00a052 was 97u00a0mL for TRELEGY ELLIPTA compared with fluticasone furoate/vilanterol (95%u00a0CI: 85, 109; <0.001) and 54u00a0mL for TRELEGY ELLIPTA compared with umeclidinium/vilanterol (95%u00a0CI: 39, 69; <0.001). The effects on lung function (mean change from baseline trough FEV) of TRELEGY ELLIPTA compared with fluticasone furoate/vilanterol and umeclidinium/vilanterol were observed at all timepoints over the course of the 52-week study (Figureu00a06).
Figureu00a06. Least Squares (LS) Mean Change from Baseline in Trough FEV (mL)
Exacerbations:
Treatment with TRELEGY ELLIPTA statistically significantly reduced the on-treatment annual rate of moderate/severe exacerbations by 15% compared with fluticasone furoate/vilanterol and by 25% compared with umeclidinium/vilanterol ().
Treatment with TRELEGY ELLIPTA statistically significantly decreased the risk of a moderate/severe exacerbation as measured by time to first exacerbation when compared with fluticasone furoate/vilanterol (14.8%; 95%u00a0CI: 9.3, 19.9; <0.001) and umeclidinium/vilanterol (16.0%; 95%u00a0CI: 9.4, 22.1; <0.001).
Treatment with TRELEGY ELLIPTA reduced the on-treatment annual rate of severe exacerbations (i.e., requiring hospitalization or resulting in death) by 13% compared with fluticasone furoate/vilanterol (95%u00a0CI: -1, 24; u00a0=u00a00.064) which was not statistically significant. Treatment with TRELEGY ELLIPTA statistically significantly reduced the on-treatment annual rate of severe exacerbations by 34% compared with umeclidinium/vilanterol (95%u00a0CI: 22, 44; <0.001).
Health-Related Quality of Life:n- Pn- P
Other Endpoints:

TRELEGY ELLIPTA is supplied as a disposable light grey and beige plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters for the institutional pack). One strip contains fluticasone furoate (100u00a0mcg per blister), and the other strip contains a blend of umeclidinium and vilanterol (62.5u00a0mcg and 25u00a0mcg per blister, respectively). A blister from each strip is used to create 1 dose. The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:
NDC 0173-0887-10u00a0u00a0u00a0u00a0u00a0 TRELEGY ELLIPTAu00a0u00a0u00a0u00a0u00a0 30 inhalations (60 blisters)
NDC 0173-0887-14 u00a0u00a0u00a0u00a0u00a0TRELEGY ELLIPTAu00a0u00a0u00a0u00a0u00a0 14 inhalations (28 blisters), institutional pack
Store at room temperature between 68u00b0F and 77u00b0F (20u00b0C and 25u00b0C); excursions permitted from 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
TRELEGY ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard TRELEGY ELLIPTA 6 weeks after opening the foil tray or when the counter reads u201c0u201d (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Not for Acute Symptoms
Inform patients that TRELEGY 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-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:
Tell patients they should not stop therapy with TRELEGY ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation.
Do Not Use Additional Long-acting Beta-agonists
Instruct patients not to use other LABA.
Local Effects
Inform patients that localized infections with occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with TRELEGY ELLIPTA, but at times therapy with TRELEGY ELLIPTA may need to be temporarily interrupted under close medical supervision. Advise patients to rinse the mouth with water without swallowing after inhalation to help reduce the risk of thrush.
Pneumonia
Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare providers if they develop symptoms of pneumonia.
Immunosuppression
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.
Hypercorticism and Adrenal Suppression
Advise patients that TRELEGY ELLIPTA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to TRELEGY ELLIPTA.
Paradoxical Bronchospasm
As with other inhaled medicines, TRELEGY ELLIPTA can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue TRELEGY ELLIPTA and contact their healthcare provider right away.
Hypersensitivity Reactions, including Anaphylaxis
Advise patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur after administration of TRELEGY ELLIPTA. Instruct patients to discontinue TRELEGY ELLIPTA if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use TRELEGY ELLIPTA.
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.
Glaucoma and Cataracts
Advise patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations.
Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develop.
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.
Risks Associated with Beta-agonist Therapy
Inform patients of adverse effects associated with beta-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.
Trademarks are owned by or licensed to the GSK group of companies.
TRELEGY ELLIPTA was developed in collaboration with Innoviva.
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92019 GSK group of companies or its licensor.
TRL:5PI

This Instructions for Use has been approved by the U.S. Food and Drug Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: April 2018

PRINCIPAL DISPLAY PANEL
NDC 0173-0887-10
Trelegy
(fluticasone furoate, umeclidinium, and vilanterol inhalation powder)
100 mcg/62.5 mcg/25 mcg
Rx Only
FOR ORAL INHALATION ONLY
TRELEGY ELLIPTA contains 2 foils strips of 30 blisters each. Each blister on one strip contains 100 mcg of fluticasone furoate and lactose monohydrate. Each blister on the other strip contains 62.5 mcg of umeclidinium, 25 mcg of vilanterol, magnesium stearate, and lactose monohydrate.
1 ELLIPTA Inhaler containing 30 doses (60 blisters total)
Made in UK
u00a92018 GSK group of companies or its licensor.
10000000149452
Rev. 7/18

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Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate (Trelegy Ellipta)

Trade Name : Trelegy Ellipta

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