Asthma: initially 1 inh of 100/62.5/25mcg or 200/62.5/25mcg once daily, based on disease severity and previous asthma therapy. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY. Show your patients how to use the inhaler. Trelegy Ellipta is a moulded plastic dry powder inhaler with a light grey body, a beige mouthpiece cover and a dose counter, packed in a foil tray containing a desiccant sachet. It is essentially Breo with vilanterol. Instruct the patient to open and prepare mouthpiece of the inhaler and slide the cover down to activate the first dose (see package instructions). Use with caution in patients with narrow-angle glaucoma. 2020. 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. In subjects with COPD, the most common adverse reactions (≥1% and more common than placebo + FF/VI) reported in two 12-week clinical trials with UMEC + 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%). Just inhale your next dose at the usual time. The counter counts down by 1 each time the patient opens the cover. Oral Inhalation Administration. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The counter counts down by 1 each time the patient opens the cover. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. TRELEGY delivers 3 complementary mechanisms of action (MOA). 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. ​If asthma symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief. Trelegy Ellipta is used to treat adult patients with chronic obstructive pulmonary disease (COPD) and asthma. Trelegy Ellipta(Per inhalation Fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, vilanterol 25 mcg): Maintenance treatment to prevent & relieve sympt The shape of the ELLIPTA inhaler is a trademark of the GSK group of companies. 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. 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 or asthma. Keep the inhaler device in the sealed foil tray until ready to start using it. Trademarks are property of their respective owners. ELLIPTA inhaler rated “easy-to-use” by >90% of patients with, Description of COPD and ASTHMA easy-to-use studies. For asthma, the recommended dosage of Trelegy is one inhalation (puff) of Trelegy Ellipta once a day. Just with back up of ventolin if/as required. That’s why your dose counter starts at 30, and counts down with each dose. This equates to a maximum daily dose containing fluticasone furoate 100 micrograms, umeclidinium (as bromide) 62.5 micrograms, and vilanterol (as trifenatate) 25 micrograms. Store at room temperature away from moisture, heat, and light. Each inhaler of TRELEGY contains 30 doses, which equals a 30-day supply. Adults . TRELEGY ELLIPTA (UMECLIDINIUM BROMIDE/FLUTICASONE FUROATE/ / VILANTEROL TRIFENATATE) Overview Trelegy Ellipta(UMECLIDINIUM BROMIDE/FLUTICASONE FUROATE/ / VILANTEROL TRIFENATATE) is an inhalation powder medicine. So it means just taking one inhaler dose a day. Patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol; Asthma in patients aged 18 years and older. Take TRELEGY as 1 inhalation, once daily, at the same time every day, After inhalation, rinse the mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis, Treat acute symptoms with an inhaled SABA such as albuterol, Patients’ disease severity and their previous asthma therapy, including the ICS dosage, Patients’ current control of asthma symptoms and risk of future exacerbation, Fluticasone furoate (100 mcg OR 200 mcg per blister), the ICS in TRELEGY, Umeclidinium (62.5 mcg per blister), the LAMA in TRELEGY, Vilanterol (25 mcg per blister), the LABA in TRELEGY, Lactose monohydrate and magnesium stearate, Use of multiple inhalers for COPD is one factor that may lead to poor inhaler technique, Use of multiple different inhaler types for ASTHMA may lead to confusion for patients and may reduce effective use of inhalers. Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of ICS in susceptible individuals. 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. Don't use more than your doctor tells you to use. Not indicated for the relief of acute bronchospasm. Special populations . Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap. It is a single product containing 3 medications: fluticasone, vilanterol, and umeclidinium.Fluticasone is a steroid that reduces swelling in the airways. TRELEGY ELLIPTA 100/62.5/25 mcg is the only strength indicated for the treatment of COPD. Advise patients to rinse their mouths with water without swallowing after inhalation. Do not take 2 doses at one time. In the ASTHMA study, 98% of patients demonstrated correct use. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop. The maximum recommended dosage is 1 inhalation of TRELEGY ELLIPTA 200/62.5/25 mcg once daily. Ellipta inhaler has an 18x lower carbon footprint than a pMDI⁷⁻⁸. When choosing the starting dose, consider: Maximum recommended dosage is 1 inhalation of TRELEGY 200/62.5/25 mcg once daily. Global strategy for asthma management and prevention. Use TRELEGY ELLIPTA at the same time each day. COPD is a long-term condition that slowly gets worse. 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. No dose adjustment is required in patients over 65 years (see section 5.2) . Lower respiratory tract infections, including pneumonia, have been reported following use of ICS, like fluticasone furoate. Trelegy Ellipta Dose in Adults: Trelegy Ellipta should be administered as 1 inhalation once a day by the orally inhaled route only. COPD: TRELEGY 100/62.5/25 mcg is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop. This equates to a maximum daily dose containing fluticasone furoate 100 micrograms, umeclidinium (as bromide) 62.5 micrograms, and vilanterol (as trifenatate) 25 micrograms. Take your next dose at your usual time. 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%). Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. 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. Have your doctor or pharmacist explain how to use the inhaler and read the instructions carefully before using the inhaler. Moreover, it is used to make breathing easier and reduce flare-ups in patients with Chronic Obstructive Pulmonary … The counter counts down by 1 each time the patient opens the cover. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Acute symptoms should be treated with an inhaled SABA. How's everyone doing on Trelegy? TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma. 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. Do not take more than 1 inhalation per day. The acquisition cost of a 30-day supply of combination ICS/LABA inhaler plus a separate LAMA inhaler using the products listed in the table above ranges from £45.00 to about £58.00 (excluding VAT), compared with £44.50 (excluding VAT) for triple-therapy inhaler. Compare prices, print coupons and get savings tips for Trelegy Ellipta (Fluticasone / Umeclidinium / Vilanterol) and other COPD drugs at CVS, Walgreens, and other pharmacies. Patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients. Limitations of Use: TRELEGY is NOT indicated for the relief of acute bronchospasm. ​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. ​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. If a dose is missed the next dose should be inhaled at the usual time the next day.¹. The other contained an anticholinergic. This website is funded and developed by GSK. See helpful resources for your practice and your patients. Patients enrolled in the trial had moderate to very severe COPD and a history of exacerbations in the previous 12 months. 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. These drugs represent 3 different classes of medications (an ICS, a LABA, and a LAMA), each having different effects on clinical and physiological indices. 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. TRELEGY ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. Procedure No. To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Patient Information, for TRELEGY. It is available in inhaler form containing 2 foil strips, each with 30 blisters with powder intended for oral inhalation. NOW APPROVED TO TREAT ASTHMA in patients 18 and older. The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate. Asthma: initially 1 inh of 100/62.5/25mcg or 200/62.5/25mcg once daily, based on disease severity and previous asthma therapy. TRELEGY contains 3 medicines. Trelegy Ellipta is a prescription medication used to treat chronic obstructive pulmonary disease (COPD), a group of diseases that includes chronic bronchitis and emphysema.. International non-proprietary name: fluticasone furoate / umeclidinium / vilanterol . Take your next dose at your usual time. This site is intended for US healthcare professionals only. ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Posology . 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. Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects. The medication will be delivered once daily as a dry powder inhaler. Keep the inhaler device in the sealed foil tray until ready to start using it. Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. See Dosage and Administration in the full Prescribing Information. Dosing | The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day. It may take a few tries to feel comfortable using your inhaler, but it does get easier with practice. Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Use of ICS or inhaled anticholinergics ELLIPTA once a day to 3-fold triple Mechanism of Action, Considerations... Or pour them into a drain unless instructed to do so currently taking ) and asthma easy-to-use studies asthma studies. Copd study, 97 % of patients with COPD, as fluticasone furoate / umeclidinium /.... Components apply to TRELEGY 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch strips also inactive! 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