Procedure No. Dose is ready when cover is opened fully; counter shows how many doses remain. This site is intended for US healthcare professionals only. 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. Do not block the air vent with fingers. TRELEGY ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Special populations . Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. When choosing the starting dosage strength of TRELEGY ELLIPTA, consider the patients’ disease severity; their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage; as well as the patients’ current control of asthma symptoms and risk of future exacerbation. Trelegy Ellipta(Per inhalation Fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, vilanterol 25 mcg): Maintenance treatment to prevent & relieve sympt By clicking this link, you will be taken to a website that is independent from GSK. Design: One study was conducted in patients with COPD (N=266) and one study was conducted in patients with ASTHMA (N=250). Orally inhaled corticosteroids may reduce growth velocity in children and adolescents. Use TRELEGY ELLIPTA at the same time each day. Trelegy Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. Keep inhaler away from extreme heat, cold or humidity. • If you miss a dose of TRELEGY ELLIPTA, take it as soon as you remember. Breathe out, inhale medicine. To use your inhaler: Firstly, check the dose counter to make sure the inhaler isn’t empty. Have your doctor or pharmacist explain how to use the inhaler and read the instructions carefully before using the inhaler. At the conclusion of two 4-week clinical studies, 1 in ASTHMA and 1 in COPD: Inhalers did not contain active treatment. Trelegy Ellipta 92micrograms/dose / 55micrograms/dose / 22micrograms/dose dry powder inhaler (GlaxoSmithKline UK Ltd) The other contained an anticholinergic. TRELEGY 200/62.5/25 mcg (or FF/VI 200/25 mcg) were: pharyngitis/nasopharyngitis, 15% (16%); upper respiratory tract infection/viral upper respiratory tract infection, 7% (6%); headache, 5% (6%); bronchitis, 5% (5%); sinusitis/acute sinusitis, 3% (2%); respiratory tract infection/viral respiratory tract infection, 3% (2%); back pain, 2% (1%); urinary tract infection, 2% (<1%). For patients who do not respond adequately to Trelegy Ellipta 100/62.5/25 mcg once daily, increasing the dose to Trelegy Ellipta 200/62.5/25 mcg once daily may … COPD is a long-term condition that slowly gets worse. In subjects with asthma, the most common adverse reactions (≥2% incidence with TRELEGY) reported in a 24-week to 52-week clinical trial with: TRELEGY 100/62.5/25 mcg (or FF/VI 100/25 mcg) were: pharyngitis/nasopharyngitis, 17% (16%); headache, 9% (7%); upper respiratory tract infection/viral upper respiratory tract infection, 5% (7%); respiratory tract infection/viral respiratory tract infection, 4% (4%); bronchitis, 4% (3%); influenza, 4% (3%); back pain, 3% (4%); sinusitis/acute sinusitis, 2% (3%); rhinitis, 2% (3%). 3 Centers for Medicare & Medicaid Services (CMS). Glaucoma, increased intraocular pressure, and cataracts have been reported following the long‐term administration of ICS or inhaled anticholinergics. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY long term. See Dosage and Administration in the full Prescribing Information. For patients who do not respond adequately to TRELEGY ELLIPTA 100/62.5/25 mcg once daily, increasing the dose to TRELEGY ELLIPTA 200/62.5/25 mcg once daily may provide additional improvement in asthma control. It should be … Ellipta inhaler has an 18x lower carbon footprint than a pMDI⁷⁻⁸. TRELEGY is a prescription medicine used long term to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing. Discontinue TRELEGY if such reactions occur. Administer 1 actuation of TRELEGY ELLIPTA once daily by oral inhalation. FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US GSK press release, Sep 10, 2020 6. 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. Maximum recommended dosage is 1 inhalation of TRELEGY 200/62.5/25 mcg once daily. Patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol; Asthma in patients aged 18 years and older. For patients who do not respond adequately to TRELEGY 200/62.5/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options. INDICATIONS & IMPORTANT SAFETY INFORMATION, TRELEGY delivers an ICS, a LABA, and a LAMA in an easy-to-use. TRELEGY ELLIPTA 100/62.5/25 mcg is the only strength indicated for the treatment of COPD. The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day. Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day. In the ASTHMA study, 98% of patients demonstrated correct use. Don't use more than your doctor tells you to use. The counter counts down by 1 each time the patient opens the cover. Don’t inhale a double dose to make up for a forgotten dose. Show your patients how to use the inhaler. Prices start at $600.63 Do not take more than 1 inhalation per day. Do not use TRELEGY ELLIPTA more than 1 time every 24 hours. Take your next dose at your usual time. COPD: TRELEGY 100/62.5/25 mcg is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). My consultant recently recommended this 3 in 1. Review Instructions for Use in Patient Information. The counter counts down by 1 each time the patient opens the cover. The recommended starting dosage of TRELEGY ELLIPTA for maintenance treatment of asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg) or fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of TRELEGY ELLIPTA 200/62.5/25 mcg) once daily, by oral inhalation. You should try to take your dose of Trelegy Ellipta at the same time each day. Asthma: initially 1 inh of 100/62.5/25mcg or 200/62.5/25mcg once daily, based on disease severity and previous asthma therapy. Together the blister strips also contain inactive ingredients: TRELEGY does not replace a rescue inhaler. Oral Inhalation Administration. TRELEGY ELLIPTA (UMECLIDINIUM BROMIDE/FLUTICASONE FUROATE/ / VILANTEROL TRIFENATATE) Overview Trelegy Ellipta(UMECLIDINIUM BROMIDE/FLUTICASONE FUROATE/ / VILANTEROL TRIFENATATE) is an inhalation powder medicine. Throw away the inhaler 6 weeks after first removing it from the tray or when the dose counter reads zero, whichever comes first. Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of ICS in susceptible individuals. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief. If such changes occur, reduce the dose of TRELEGY slowly and consider other treatments for management of COPD or asthma symptoms. ​When choosing the starting dosage strength of TRELEGY ELLIPTA, consider the patients’ disease severity; their previous asthma therapy, including the inhaled corticosteroid (ICS) dosage; as well as the patients’ current control of asthma symptoms and risk of future exacerbation. When choosing the starting dose, consider: Maximum recommended dosage is 1 inhalation of TRELEGY 200/62.5/25 mcg once daily. This equates to a maximum daily dose containing fluticasone furoate 100 micrograms, umeclidinium (as bromide) 62.5 micrograms, and vilanterol (as trifenatate) 25 micrograms. Special populations . FLUTICASONE; UMECLIDINIUM; VILANTEROL (floo TIK a sone; ue MEK li DIN ee um; vye LAN ter ol) inhalation is a combination of 3 medicines that decrease inflammation and help to open up the airways of your lungs. Special populations Try to use the inhaler at the same time every day to get the most benefit from it and to help you remember to use it. • Use 1 inhalation of TRELEGY ELLIPTA 1 time each day. Medicaid and CHIP Overview for Assisters. Not indicated for the relief of acute bronchospasm. Could once-daily triple therapy in a single inhaler make a difference for your patients? Each inhaler of TRELEGY contains 30 doses, which equals a 30-day supply. 4.2 Posology and method of administration . Adult Dosage: COPD: 1 inh of 100/62.5/25mcg once daily (max). The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day. Asthma: TRELEGY is indicated for the maintenance treatment of asthma in patients aged 18 years and older. Global Initiative for Chronic Obstructive Lung Disease (GOLD). The trial’s more than 10,000 patients were from 1,035 study centers globally. Do not take 2 doses at 1 time. Updated August 2018. 2020 report. Please see full Prescribing Information, including Patient Information, for TRELEGY. Do not stop using Trelegy Ellipta unless told to do so by your healthcare provider because your … There are 2 doses the 200 and 100 which is the dose of the fluticasone furoate. Inhaler contains 30 doses (14 doses if you have a sample or institutional pack) Do not open the cover of inhaler until ready to use it. Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate. Trelegy Ellipta is supplied as a disposable plastic inhaler containing 2 foil strips, each with 30 blisters or 14 blisters for the institutional pack. Elderly patients . These drugs represent 3 different classes of medications (an ICS, a LABA, and a LAMA), each having different effects on clinical and physiological indices. If a dose is missed the next dose should be inhaled at the usual time the next day.¹. Ellipta is a propellant-free dry powder inhaler (DPI). Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap. TRELEGY is not indicated for use in children and adolescents. Dosing | The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients using corticosteroids. Monitor for corticosteroid-related side effects. It may take a few tries to feel comfortable using your inhaler, but it does get easier with practice. TRELEGY ELLIPTA is a dry powder inhaler. ​The recommended starting dosage of TRELEGY ELLIPTA for maintenance treatment of asthma is fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg) or fluticasone furoate 200 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg (1 actuation of TRELEGY ELLIPTA 200/62.5/25 mcg) once daily, by oral inhalation. ... Update September 16, 2020: Trelegy is now approved for asthma. If you get this sort of attack, you must use a quick-acting reliever inhaler (such as salbutamol). Throw away the inhaler 6 weeks after first removing it from the tray or when the dose counter reads zero, whichever comes first. The dose of Trelegy Ellipta for maintenance treatment of COPD is 1 inhalation once daily. For patients who do not respond adequately to TRELEGY 200/62.5/25 mcg once daily, re-evaluate and consider other therapeutic regimens and additional therapeutic options. Maximum Allowable Copayments Determined by Eligible Population's Household Income. See helpful resources for your practice and your patients. Inhaler contains 30 doses (14 doses if you have a sample or institutional pack) Do not open the cover of inhaler until ready to use it. Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first. EMEA/H/C/004363/0000 . COPD=chronic obstructive pulmonary disease; GINA=Global Initiative for Asthma; GOLD=Global Initiative for Chronic Obstructive Lung Disease; ICS=inhaled corticosteroid; LABA=long-acting beta2-adrenergic agonist; LAMA=long-acting muscarinic antagonist; SABA=short-acting beta2-agonist. Additional adverse reactions (≥1% incidence) reported in subjects with COPD 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. After inhalation, rinse the mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. The full instructions for using TRELEGY ELLIPTA are given on a leaflet inside the pack. How's everyone doing on Trelegy? Correct use was evaluated using instructions derived from the prescribing information for products delivered in the ELLIPTA inhaler. Oral Inhalation dosage (powder for inhalation; i.e., Trelegy Ellipta): Adults: 100 mcg fluticasone/ 62.5 mcg umeclidinium/ 25 mcg vilanterol per inhalation (1 oral inhalation) once daily, at the same time each day, is the recommended and maximum dosage. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Keep all medications away from children and pets. Oral powder for inhalation (Trelegy Ellipta inhaler): Administer via oral inhalation. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. 2020. The site you are linking to is not controlled or endorsed by GSK, and GSK is not responsible for the content provided on that site. Both studies were 28-day, open-label, placebo studies designed to assess ease of use of the ELLIPTA inhaler among adult patients who used the inhaler correctly on Day 28. The shape of the ELLIPTA inhaler is a trademark of the GSK group of companies. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop. Trelegy Ellipta is a prescription medication used to treat chronic obstructive pulmonary disease (COPD), a group of diseases that includes chronic bronchitis and emphysema.. Do not take more than 1 inhalation per day. TRELEGY ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. 1 easy-to-use, TRELEGY contains 2 foil blister strips with 30 daily doses of ICS, LABA, and LAMA. You take Trelegy Ellipta once a day by breathing in the powdered medication through the inhaler. FLUTICASONE; UMECLIDINIUM; VILANTEROL (floo TIK a sone; ue MEK li DIN ee um; vye LAN ter ol) inhalation is a combination of 3 medicines that decrease inflammation and … If such effects occur, TRELEGY may need to be discontinued. Use TRELEGY ELLIPTA at the same time each day. The recommended dose of fluticasone - umeclidinium - vilanterol is one inhalation taken once daily. Patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients. If you stop using Trelegy Ellipta Use this … In the COPD study, 97% of patients demonstrated correct use. Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects. ELLIPTA inhaler rated “easy-to-use” by >90% of patients with, Description of COPD and ASTHMA easy-to-use studies. Dosing ConsiderationsSimplified DeliveryEasy-to-use1,2 InhalerTriple Mechanism of Action, Dosing Considerations Simplified Delivery Easy-to-use1,2 Inhaler Triple Mechanism of Action. The tray is … Again, like the others, it is important to rinse the mouth after use. 1 daily inhalation. 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. Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the US. No dose adjustment is required in patients over 65 years (see section 5.2) . Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Asthma: initially 1 inh of 100/62.5/25mcg or 200/62.5/25mcg once daily, based on disease severity and previous asthma therapy. It is the same price as the fluticasone, vilanterol and umeclidinium triple-therapy inhaler (Trelegy). Do not take more than 1 inhalation per day. Store at room temperature away from moisture, heat, and light. Be alert to hypokalemia and hyperglycemia. This equates to a maximum daily dose containing fluticasone furoate 100 micrograms, umeclidinium (as bromide) 62.5 micrograms, and vilanterol (as trifenatate) 25 micrograms. Last updated on Sep 9, 2020. Trelegy Ellipta . Do not breathe in through the nose. Just with back up of ventolin if/as required. Just inhale your next dose at the usual time. The analysis consisted of fill data for TRELEGY ELLIPTA (fluticasone furoate, umeclidinium, and vilanterol inhalation powder). Dose Adults The recommended and maximum dose is one inhalation of TRELEGY ELLIPTA 100/62.5/25 once daily either morning or evening but at the same time every day. Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first. Moreover, it is used to make breathing easier and reduce flare-ups in patients with Chronic Obstructive Pulmonary … If a dose is missed the next dose should be inhaled … This equates to a maximum daily dose containing fluticasone furoate 100 micrograms, umeclidinium (as bromide) 62.5 micrograms, and vilanterol (as trifenatate) 25 micrograms. Lower respiratory tract infections, including pneumonia, have been reported following use of ICS, like fluticasone furoate. Keep the inhaler device in the sealed foil tray until ready to start using it. 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. Adults . How to use the Trelegy Ellipta inhaler See “Step-by-step instructions” after section 6 in this leaflet for full information. It is a prescription drug. Medically reviewed by Drugs.com. Throw away 6 weeks after removing it from the foil pouch, when the dose counter reads "0" or after the expiration date, whichever is first. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. • Use 1 inhalation of TRELEGY ELLIPTA 1 time each day. So it means just taking one inhaler dose a day. Patients enrolled in the trial had moderate to very severe COPD and a history of exacerbations in the previous 12 months. TRELEGY ELLIPTA was developed in collaboration with. This compares with £56.82 (excluding VAT) when beclometasone and formoterol are prescribed in a dual-therapy inhaler (Fostair or Fostair NEXThaler) together with glycopyrronium in a single therapy inhaler (Seebri Breezhaler). The recommended and maximum dose is one inhalation of TRELEGY ELLIPTA 100/62.5/25 once daily either morning or evening but at the same time every day. Trelegy Ellipta may interact with ketoconazole and other azole antifungals, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants , beta-blockers, diuretics , antocholinergics, antiviral medications, conivaptan, nefazodone, and macrolide antibiotics. A history of exacerbations in the following: ADVERSE REACTIONS: TRELEGY is available in inhaler form containing 2 strips... Not flush medications down the toilet or pour them into a drain unless instructed to do so in. From GSK each time the patient opens the cover use was evaluated using instructions from! Advise patients to contact a healthcare provider immediately if signs or symptoms 30 doses which! Ellipta blister, with inhalation device worsen with concomitant beta-agonists see helpful resources for your patients contact at... Than once in 24 hours on a leaflet inside the pack umeclidinium and a beta-agonist! Is used to relieve a sudden attack of breathlessness or wheezing development of pneumonia patients! 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( TRELEGY ELLIPTA 100/62.5/25 mcg is for maintenance treatment of COPD is 1 inhalation of ELLIPTA... This is a steroid that reduces swelling in the previous 12 months and additional options. Mouth with water without swallowing to help reduce the dose counter reads trelegy inhaler dose, whichever comes.! 5.2 ) fatal course of chickenpox or measles may occur in susceptible patients using corticosteroids such changes,..., dosing Considerations for 2 indications: Simplified Delivery of triple therapy: 3 medications the information on... A more serious or even fatal course of chickenpox or measles may occur in susceptible individuals swallowing. Asthma, the recommended and maximum dose is missed the next dose should be at! Respond adequately to TRELEGY name: fluticasone furoate / umeclidinium / vilanterol anaphylaxis, angioedema,,. ( aged 17 years and older ocular symptoms or use TRELEGY ELLIPTA dose in Adults: TRELEGY not. Applies to your personal circumstances to report SUSPECTED ADVERSE REACTIONS, contact at.

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