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TRELEGY is for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and for reducing exacerbations in patients with a history of exacerbations. TRELEGY is NOT indicated for relief of acute bronchospasm or asthma.

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Contact GSK 1-XXX-XXX-XXXX
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For appropriate patients with COPD

Less to take. More to take in.

TRELEGY–the only once-daily triple therapy (//) for COPD delivered in a single inhaler

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TRELEGY is now approved for reducing exacerbations in patients

with a history of COPD exacerbations.

Informing the Pathway of COPD Treatment

10,000+ Patients

Symptomatic patients with at least 1 COPD exacerbation in the last year while on maintenance medication1,2*

52-WEEK Study

A randomized, double-blind, 3-arm, parallel group; primary endpoint measured was the annual rate of moderate to severe exacerbations

1ST AND Only

First and only trial to study the efficacy and safety of triple therapy vs an ICS/LABA and vs a LAMA/LABA in an exacerbating COPD population
Exacerbation severity criteria:
Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.
*
Eligible patients were symptomatic with a postbronchodilator percent predicted FEV1 <50% and a history of 1 or more moderate or severe exacerbations within the previous year, or with a postbronchodilator percent predicted FEV1 of 50% to 80% and a history of 2 or more moderate exacerbations or 1 severe exacerbation in the previous year. At screening, patients (mean age: 65 years) had a mean postbronchodilator percent predicted FEV1 of 45.5% and a mean postbronchodilator FEV1/FVC ratio: 0.47.
FEV1=forced expiratory volume in 1 second; FVC=forced vital capacity.

IMPACT TRIAL: DESIGNED TO REFLECT CLINICAL PRACTICE

Swipe right and scroll up & down to see the full table below.

Current maintenance medications included ICS + LABA + LAMA (34%), ICS + LABA (26%), LAMA + LABA (8%), LAMA (7%), and other (25%).
Each delivered once daily via the ELLIPTA inhaler.
FF=fluticasone furoate; UMEC=umeclidinium; VI=vilanterol.

There's more information to take in with the landmark IMPACT Trial

Discover the latest clinical data from the IMPACT Trial on exacerbations, lung function, and health-related quality of life for your patients with a history of COPD exacerbations
See the Impact Data
  • One inhaler.
  • Once daily.
  • One co-pay.*
*One co-pay is not a guarantee of coverage or lower out-of-pocket costs for patients than alternative treatments. Formulary status and patient out-of-pocket costs may vary, may be up to the prescription’s retail cost, and are subject to change.

Simplify the delivery of an ICS, LABA,andLAMA

with once-daily TRELEGY

For patients with COPD, once-daily dosing with one ELLIPTA may help to simplify triple therapy treatment. According to 2018, use of multiple inhalers is one factor that may lead to poor inhaler technique.3

TRELEGY does not replace a rescue inhaler. Patients should be provided a short-acting beta2-agonist, such as albuterol, to treat acute symptoms and instructed on how it should be used. TRELEGY combines three medications in a single inhaler.

  • An ICS to reduce inflammation
  • A LABA to increase bronchodilation
  • A LAMA to reduce bronchoconstriction

Chat with GSK Medical Information to learn more about once-daily TRELEGY

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Simplified dosing for triple therapy –

only with Trelegy!

Once-daily triple therapy for patients with COPD delivered in an easy-to-use ELLIPTA inhaler4

  • Breath actuated so there’s no hand-breath coordination required
  • Preloaded with 30 doses of an ICS/LABA/LAMA
  • Single-step dose activation means a dose is ready when the cover is opened fully
See Dosing Info

Discover TRELEGY ELLIPTAthe only once-daily triple therapy for COPD delivered in a single inhaler

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Less to take.

More to take in.

Important Safety Information for TRELEGY ELLIPTA

Contraindications

  • TRELEGY is contraindicated in patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, umeclidinium, vilanterol, or any of the excipients.

Important Safety Information for TRELEGY ELLIPTA

Contraindications

  • TRELEGY is contraindicated in patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate, umeclidinium, vilanterol, or any of the excipients.

Warnings and Precautions

  • TRELEGY is not for the treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with inhaled corticosteroids (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.
  • TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
  • TRELEGY is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
  • Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate. Advise patients to rinse their mouths with water without swallowing after inhalation.
  • Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported following use of inhaled corticosteroids, like fluticasone furoate.
  • Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
  • Particular care is needed for patients transferred from systemic corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY.
  • Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of inhaled corticosteroids in susceptible individuals. If such changes occur, appropriate therapy should be considered.
  • Caution should be exercised when considering the coadministration of TRELEGY with long‐term ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue TRELEGY and institute alternative therapy.
  • Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY if such reactions occur.
  • Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, TRELEGY may need to be discontinued. TRELEGY should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  • Decreases in bone mineral density have been observed with long‐term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating TRELEGY and periodically thereafter.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long‐term administration of inhaled corticosteroids or inhaled anticholinergics; therefore, monitoring is warranted.
  • Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
  • Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
  • Be alert to hypokalemia and hyperglycemia.

Adverse Reactions

  • The most common adverse reactions (≥1% and more common than placebo + FF/VI) reported in two 12-week clinical trials with umeclidinium + FF/VI, the components of TRELEGY, (and placebo + FF/VI) were: headache, 4% (3%); back pain, 4% (2%); dysgeusia, 2% (<1%); diarrhea, 2% (<1%); cough, 1% (<1%); oropharyngeal pain, 1% (0%); and gastroenteritis, 1% (0%).
  • Additional adverse reactions (≥1% incidence) reported in subjects taking TRELEGY in a 52-week trial included upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

DRUG INTERACTIONS

  • TRELEGY should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
  • Use beta‐blockers with caution, as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.
  • Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.
  • Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects.

USE IN SPECIFIC POPULATIONS

  • Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.

1004828R0 May 2018

Please see full Prescribing Information, including Patient Information, for TRELEGY.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1‑888‑825‑5249 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

TRELEGY ELLIPTA was developed in collaboration with INNOVIVA logo

Trademarks are owned by or licensed to the GSK group of companies.

This website is funded and developed by GSK. This site is intended for US healthcare professionals only.

©2018 GSK group of companies or its licensor.

Produced in USA. 1003901R0 May 2018

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Study Description1,2

Design: 12-month, randomized, double-blind, parallel-group, global, multicenter study comparing the rate of moderate/severe exacerbations between TRELEGY and FF/VI 100/25 and between TRELEGY and UMEC/VI 62.5/25. Patients were eligible if they were symptomatic with a postbronchodilator percent predicted FEV1 <50% and a history of 1 or more moderate or severe exacerbations within the previous year, or with a postbronchodilator percent predicted FEV1 of 50% to 80% and a history of 2 or more moderate or 1 severe exacerbation in the previous year. After screening, patients were randomized to treatment following a 2-week run-in period on their current COPD treatment. The most frequently reported combinations of current medications included ICS + LABA + LAMA (34%), ICS + LABA (26%), LAMA + LABA (8%), LAMA (7%), and other (25%).

Patients: Patients with COPD (mean age: 65 years). At screening, patients had a mean postbronchodilator percent predicted FEV1 of 45.5% and a mean postbronchodilator FEV1/FVC ratio: 0.47.

Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

FEV1=forced expiratory volume in 1 second; FF=fluticasone furoate; FVC=forced vital capacity; ICS=inhaled corticosteroid; LABA=long-acting beta2-adrenergic agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; UMEC=umeclidinium; VI=vilanterol.

Study Description1,2

Design: 12-month, randomized, double-blind, parallel-group, global, multicenter study comparing the rate of moderate/severe exacerbations between TRELEGY and FF/VI 100/25 and between TRELEGY and UMEC/VI 62.5/25. Patients were eligible if they were symptomatic with a postbronchodilator percent predicted FEV1 <50% and a history of 1 or more moderate or severe exacerbations within the previous year, or with a postbronchodilator percent predicted FEV1 of 50% to 80% and a history of 2 or more moderate exacerbations or 1 severe exacerbation in the previous year. After screening, patients were randomized to treatment following a 2-week run-in period on their current COPD treatment. The most frequently reported combinations of current medications included ICS + LABA + LAMA (34%), ICS + LABA (26%), LAMA + LABA (8%), LAMA (7%), and other (25%).

Patients: Patients with COPD (mean age: 65 years). At screening, patients had a mean postbronchodilator percent predicted FEV1 of 45.5% and a mean postbronchodilator FEV1/FVC ratio: 0.47.

Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

FEV1=forced expiratory volume in 1 second; FF=fluticasone furoate; FVC=forced vital capacity; ICS=inhaled corticosteroid; LABA=long-acting beta2-adrenergic agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; UMEC=umeclidinium; VI=vilanterol.

Eligibility requirements and restrictions

Who is eligible to receive the Savings Program Offer for TRELEGY?

Eligibility

Patients may be eligible for this offer if they have commercial insurance and insurance does not cover the full cost of the prescription or if they are not insured and are responsible for the cost of their prescriptions. Government beneficiaries; patients who are enrolled in any federal healthcare program, including patients enrolled in Medicare (Part D or otherwise), Medicaid, Medigap, Veterans Affairs (VA) or Department of Defense (DOD) programs, or TRICARE; patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government prescription drug benefit program for retirees; or patients enrolled in any similar federal or state programs, including state pharmaceutical assistance programs, are NOT eligible for this offer. Further, patients CANNOT use this coupon if they are Medicare eligible. For coupon eligibility purposes, all those 65 or older will be considered Medicare eligible. If patients are government beneficiaries or Medicare eligible, they may not use this savings card even if they elect to be processed as an uninsured (cash-paying) patient. This offer is not health insurance and is restricted to residents of the United States, Puerto Rico, and US territories. Void where prohibited by law, taxed, or restricted. Not valid in Massachusetts or California if an AB-rated generic drug is available for the product.

Terms of Use

Eligible commercially insured patients with a valid prescription for TRELEGY who present this savings card at participating pharmacies will pay $10 per 30-day supply. Eligible patients without insurance will receive up to $100 in savings on each 30-day supply. This offer is valid for up to 12 uses, and each 30-day supply counts as one use. Patient is responsible for applicable taxes, if any. This offer is limited to one per person and is nontransferable and cannot be combined with any other coupon, free trial, or similar offer. No substitutions are permitted. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the amount received by the patient through this offer. Offer must be presented along with a valid prescription for TRELEGY at the time of purchase. Your acceptance of this offer must be consistent with the terms of any drug benefit plan provided to you by your health insurer. You agree to report your use of this coupon to your health insurer if required.

GSK or McKesson (on GSK's behalf) reserves the right to rescind, revoke, or amend this offer at any time without notice. This offer may not be sold, purchased, traded, or counterfeited. Duplicates of this uniquely coded offer are invalid and not redeemable at the pharmacy. This offer is not conditioned on any past, present, or future purchase, including refills. This offer expires on 12/31/2019.

Request Savings OffersRequest a Rep
The St George’s Respiratory Questionnaire (SGRQ) is a validated, respiratory-disease–specific, patient-reported instrument that measures symptoms, activities, and impact on daily life domains. Total scores on the SGRQ range from 0 to 100, with lower scores indicating better health-related quality of life. A clinically meaningful response was defined as a decrease in total score of at least 4 units, as compared with baseline value.
COPD=chronic obstructive pulmonary disease
FEV1=forced expiratory volume in 1 second
FF=fluticasone furoate
FF=fluticasone furoate; VI=vilanterol
FVC=forced vital capacity
GOLD=Global Initiative for Chronic Obstructive Lung Disease
ICS=inhaled corticosteroid
LABA=long-acting beta2-adrenergic agonist
LAMA=long-acting muscarinic antagonist
LS=least squares
SGRQ=St George's Respiratory Questionnaire
UMEC=umeclidinium
VI=vilanterol