TRELEGY ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. what is comparable to trelegy Put the mouthpiece between your lips, and close your lips firmly around it. There was no evidence of altered protein binding in subjects with severe renal impairment compared with healthy subjects. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medicine can produce bronchospasm. There are insufficient data on the use of TRELEGY ELLIPTA or its individual components, fluticasone furoate, umeclidinium, and vilanterol, in pregnant women to inform a drug-associated risk. [see WARNINGS AND PRECAUTIONS], As with other inhaled medicines, TRELEGY ELLIPTA can cause paradoxical bronchospasm. © 2005 - 2019 WebMD LLC. The maximum mean (95% upper confidence bound) difference in heart rate from placebo after baseline correction was 8.8 (10.5) beats/min and 20.5 (22.3) beats/min seen 10 minutes after dosing for umeclidinium/vilanterol 125/25 mcg and umeclidinium/vilanterol 500/100 mcg, respectively. Along with its needed effects, a medicine may cause some unwanted effects. Trelegy side effects? The decrease in serum potassium is usually transient, not requiring supplementation. However, exceeding the recommended dosage or coadministration with a strong cytochrome P450 3A4 (CYP3A4) inhibitor may result in HPA dysfunction [see Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors, DRUG INTERACTIONS]. Call your doctor for medical advice about side effects. Allergic reactions to Trelegy … 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). Went on Trelegy website and looked at common side effects - lots of them. Available data show that when ICS and LABA are used together, such as with TRELEGY ELLIPTA, there is not a significant increase in the risk of these events. 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. 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. Upper respiratory tract infection/viral upper respiratory tract infection, Respiratory tract infection/viral respiratory tract infection, Asthma-related hospitalization (≥24-hour stay), ICS = Inhaled Corticosteroid, LABA = Long-acting Beta. Discontinue TRELEGY ELLIPTA if such reactions occur. 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. 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. No evidence of effects in offspring development was observed. Instruct patients to consult a physician immediately if any of these signs or symptoms develop. The pharmacologic effects of beta2-adrenergic agonist drugs, including vilanterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3´,5´-adenosine monophosphate (cyclic AMP). The mechanisms of action described below for the individual components apply to TRELEGY ELLIPTA. are breastfeeding. Following repeat dosing of inhaled vilanterol, steady state was achieved within 14 days with up to 1.7-fold accumulation. Although TRELEGY ELLIPTA may control COPD or asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies. TRELEGY ELLIPTA can cause serious side effects, including: If you have these symptoms, call your healthcare provider right away before taking another dose. Advise patients that long-term use of ICS may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations. No evidence of structural abnormalities was observed. Revised: Sep 2020. In Trial 1, the on-treatment responder rate at Week 12 (response defined as a decrease in score from baseline of 4 or more) was 40% for umeclidinium +fluticasone furoate/vilanterol vs. 35% for placebo + fluticasone furoate/vilanterol [odds ratio (OR): 1.2; 95% CI: 0.8, 1.8]. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Inflammation in the lungs can lead to breathing problems. The effect of umeclidinium/vilanterol on cardiac rhythm in subjects diagnosed with COPD was assessed using 24-hour Holter monitoring in 6- and 12-month trials: 53 subjects received umeclidinium/vilanterol 62.5/25 mcg, 281 subjects received umeclidinium/vilanterol 125/25 mcg, and 182 subjects received placebo. Vilanterol: There was no effect of race on the pharmacokinetics of vilanterol in subjects with COPD (Figure 1). Please see full Prescribing Information, including Patient Information, for TRELEGY. It is not known if TRELEGY ELLIPTA may harm your unborn baby. Table 5. Caution should be exercised when Trelegy Ellipta is used with other medicinal products that also have the … Side effects of Anoro Ellipta that are different from Trelegy Ellipta include sinusitis, respiratory tract infection, constipation, pain in extremities, muscle spasms, neck pain, chest … Side effects. Umeclidinium: 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. It is not possible to accidentally take a double dose or an extra dose in 1 inhalation. You can clean the mouthpiece if needed, using a dry tissue, before you close the cover. This Instructions for Use has been approved by the U.S. Food and Drug Administration. thrush in your mouth and throat. Plasma levels of fluticasone furoate, umeclidinium, and vilanterol may not predict therapeutic effect. If you take too much TRELEGY ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness. If such effects occur, TRELEGY ELLIPTA may need to be discontinued. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. It’s … The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular … Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. That being said, the side effects are definitely worse this time. Lung function (FEV1), beta-agonist use, and COPD or asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. What is TRELEGY ELLIPTA and how is it used? The lactose monohydrate contains milk proteins. Use TRELEGY ELLIPTA with caution in patients with moderate or severe hepatic impairment. Drug interaction trials with a specific P-gp inhibitor and fluticasone furoate have not been conducted. Table 6. Because of the possibility of significant systemic absorption of ICS in sensitive patients, patients treated with TRELEGY ELLIPTA should be observed carefully for any evidence of systemic corticosteroid effects. The difference in change from baseline in trough FEV1 at Week 24 for TRELEGY ELLIPTA 100/62.5/25 mcg compared with fluticasone furoate/vilanterol 200/25 mcg was 59 mL (95% CI: 15, 102). The following is newly added: Asthma: runny nose and sore throat . Visit the FDA MedWatch website or call 1-800-FDA-1088. Things to remember when you fill your prescription. Inflammation Of The Tissue Lining The Sinuses 6. COPD is a chronic lung disease that includes. A meta-analysis of the 3 adult and adolescent trials did not show a significant increase in risk of a serious asthma-related event with ICS/LABA fixed-dose combination compared with ICS alone (Table 1). The potential for fluticasone furoate, umeclidinium, and vilanterol to inhibit or induce metabolic enzymes and transporter systems is negligible at low inhalation doses. This is shown by a decrease in the number on the counter. The inhaler is not reusable. Side Effects. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control of asthma. In a descriptive pooled analysis, the mean annualized rate of exacerbations was 0.31 for TRELEGY ELLIPTA [100/62.5/25 and 200/62.5/25 mcg, 127 of 814 (16%) patients reported exacerbations] and 0.31 for fluticasone furoate/vilanterol [100/25 and 200/25 mcg, 132 of 813 (16%) patients reported exacerbations] (2.6% reduction in rate; 95% CI: -26.2, 24.9). side effects drug center trelegy ellipta (fluticasone furoate inhalation powder) drug. For Trial 1, LS mean changes in FEV1 over time relative to baseline are displayed for Day 1 and Day 84 in Figures 5 and 6, respectively. During the 5-week run-in/ stabilization period, subjects had improvements in both lung function (trough FEV1 improvement of 287 mL) and asthma control (mean ACQ-6 score decreased by 0.6). The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 4.9 (7.5) milliseconds and 9.6 (12.2) milliseconds seen 30 minutes after dosing for fluticasone furoate/vilanterol 200/25 mcg and fluticasone furoate/vilanterol 800/100 mcg, respectively. Find patient medical information for Trelegy Ellipta inhalation on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. A dose-dependent increase in heart rate was also observed. The pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol from TRELEGY ELLIPTA are comparable to the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol when administered as fluticasone furoate/vilanterol or umeclidinium/vilanterol. The majority of subjects were female (62%), White (80%), and had never smoked (81%), with a mean age of 53 years and mean asthma duration of 21 years (range: 1 to 70). It is practically insoluble in water. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Allergic reactions like rash, hives, or anaphylaxis (trouble breathing) Cardiovascular effects like increased pulse or blood pressure, or irregular heartbeat; Reduced bone mineral density; These are not all the possible side effects of Trelegy Ellipta. TRELEGY ELLIPTA 4 Side effects Like all medicines, TRELEGY ELLIPTA can cause side effects, although not everybody gets them. In this trial, 27/3,107 (0.9%) subjects randomized to ICS/LABA and 21/3,101 (0.7%) subjects randomized to ICS experienced a serious asthma-related event. Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma. 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. Store TRELEGY ELLIPTA in the unopened tray and only open when ready for use. As with all inhaled sympathomimetic medicines, cardiac arrest and even death may be associated with an overdose of vilanterol. You can ask your healthcare provider or pharmacist for information about TRELEGY ELLIPTA that is written for health professionals. These tumor findings in rodents are similar to those reported previously for other beta-adrenergic agonist drugs. Write the “Tray opened” and “Discard” dates on the inhaler label. (See Clinical Considerations.) 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. This drug has made me hoarse, but I am reluctant to take more medicine to treat a side effect. [See Use In Specific Populations]. Across both trials, a total of 412 subjects received coadministration of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg, the components of TRELEGY ELLIPTA. Vilanterol: Systemic exposure (AUCss) was 56% higher in subjects with severe renal impairment compared with healthy subjects (Figure 3). The maximum recommended dosage is 1 inhalation of TRELEGY ELLIPTA 200/62.5/25 mcg once daily. However, in addition to the adverse reactions shown in Table 2, adverse reactions occurring in ≥1% of the subjects treated with TRELEGY ELLIPTA 100/62.5/25 mcg (n = 4,151) for up to 52 weeks also included upper respiratory tract infection, pneumonia [see WARNINGS AND PRECAUTIONS], bronchitis, oral candidiasis [see WARNINGS AND PRECAUTIONS], arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia. Get emergency medical help if you have signs of an allergic … Do not take more than 1 inhalation per day. Table 3. 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 (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care. TRELEGY ELLIPTA is a prescription medicine used to prevent and control symptoms of asthma for better breathing and to prevent symptoms such as wheezing. anticholinergics (including tiotropium, ipratropium, aclidinium), other LABA (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol). 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. Least Squares Mean Change from Baseline in Trough FEV1 (mL) with TRELEGY ELLIPTA 200/62.5/25 mcg over 24 Weeks of Treatment. Common side effects of INCRUSE include upper respiratory tract infection, stuffy or runny nose, cough, mouth and throat pain, joint pain, change in taste, muscle pain, tooth pain, stomach pain, bruising or dark areas of skin, and fast or irregular heartbeat. TRELEGY ELLIPTA can cause serious side effects, including: If you have these symptoms, call your healthcare provider right away before taking another dose. Take one long, steady, deep breath in through your mouth. TRELEGY ELLIPTA contains an ICS, an anticholinergic, and a LABA. No human overdosage data has been reported for TRELEGY ELLIPTA. No evidence of teratogenic effects was observed in either species. COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. Pharmacology, adverse reactions, warnings and side effects. Do not attempt to take the inhaler apart. In COPD Trials 1 and 2 (coadministration trials), 189 subjects aged 65 years and older, of which 39 subjects were aged 75 years and older, were administered umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg. ICS/LABA did not show a significantly increased risk of a serious asthma-related event compared with ICS based on the pre-specified risk margin (2.7), with an estimated hazard ratio of time to first event of 1.29 (95% CI: 0.73, 2.27). These are not all the possible side effects of Trelegy Ellipta. Wait to open the cover until you are ready to take your dose. Transfer of patients from systemic corticosteroid therapy to TRELEGY ELLIPTA may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions). Throat Irritation 9. Some of the dosage forms listed on this page may not apply to the brand name Trelegy … painful and frequent urination Decreases in serum and urine cortisol levels were observed at fluticasone furoate exposures several-fold higher than exposures observed at the therapeutic dose. In these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appears to be related to dose and duration of exposure. Greater least squares (LS) mean changes from baseline in FEV1 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. Vote. The bronchodilator effects of TRELEGY ELLIPTA were consistently observed from Week 1 through Week 24. Onset of action was determined in a separate trial conducted with fluticasone furoate/vilanterol; the median time to onset (defined as a 100-mL increase from baseline in mean FEV1) was approximately 15 minutes. TRELEGY ELLIPTA can cause serious side effects, including: slowed growth in children. While holding the inhaler away from your mouth, breathe out (exhale) fully. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. The safety of TRELEGY ELLIPTA in asthma is based on a randomized, double-blind, parallel-group, active-controlled trial of 24 to 52 weeks’ duration (Trial 4, NCT #02924688) that enrolled 2,436 adult subjects inadequately controlled on their current treatment of combination therapy (ICS plus a LABA) [see Clinical Studies]. Side effects. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established. TRELEGY ELLIPTA combines 3 medicines in 1 inhaler, an inhaled, ICS medicines such as fluticasone furoate help to decrease inflammation in the, Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as, a fast or irregular heartbeat, awareness of heartbeat, seeing halos or bright colors around lights. The subjects were 474 prepubescent children (girls aged 5 to 7.5 years and boys aged 5 to 8.5 years). Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol. TRELEGY ELLIPTA has not been studied in subjects with hepatic impairment. Vilanterol is metabolized to a range of metabolites with significantly reduced β1- and β2-agonist activity. What are the possible side effects of TRELEGY ELLIPTA? There was no evidence of an increase in systemic exposure to umeclidinium (Cmax and AUC) (Figure 4). The tray contains a desiccant to reduce moisture. So, I wouldn’t worry about the future.” It was a good answer, I think. Monitor for corticosteroid-related side effects. Read the step-by-step instructions for using TRELEGY ELLIPTA at the end of this Patient Information. LABA medicines such as vilanterol when used alone increase the risk of hospitalizations and death from asthma problems. The increase in vilanterol exposure was not associated with an increase in beta-agonist–related systemic effects on heart rate or blood potassium. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Asthma exacerbations were defined as deterioration of asthma requiring the use of systemic corticosteroid (or at least a doubling of maintenance dose) for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroid. Like all medicines, TRELEGY ELLIPTA can cause side effects, although not everybody gets them. Based on available data, no adjustment of the dosage of TRELEGY ELLIPTA in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out. Rare carbocisteine side-effects - these affect less than 1 in 1,000 people As with other inhaled therapies, TRELEGY ELLIPTA can produce paradoxical bronchospasm, which may be life threatening. Side Effects What are the side effects of Trelegy Ellipta (Fluticasone, Umeclidinium, And Vilanterol)?. The pharmacokinetics of the individual components of TRELEGY ELLIPTA are presented as follows. Call your doctor for medical advice about side effects. The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 4.6 (7.1) milliseconds and 8.2 (10.7) milliseconds for umeclidinium/vilanterol 125/25 mcg and umeclidinium/vilanterol 500/100 mcg (8/4 times the recommended dosage), respectively. If used at excessive doses for prolonged periods, systemic effects such as hypercorticism may occur [see WARNINGS AND PRECAUTIONS]. In 2 separate embryofetal developmental studies, pregnant rats and rabbits received umeclidinium during the period of organogenesis at doses up to approximately 40 and 150 times, respectively the MRHDID of 62.5 mcg (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). TRELEGY ELLIPTA can cause serious side effects, including: fungal infection in your mouth or throat (thrush). Impact of Intrinsic Factors on the Pharmacokinetics (PK) of Fluticasone Furoate (FF), Umeclidinium (UMEC), and Vilanterol (VI) following Coadministration in Asthmaa, Figure 3. Call your doctor for medical advice about side effects. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Inhale your medicine. In an unpooled descriptive analysis, the ACQ-7 responder rate was 62% for TRELEGY ELLIPTA 100/62.5/25 mcg compared with 52% for fluticasone furoate/vilanterol 100/25 mcg (OR: 1.59; 95% CI: 1.18, 2.13) at Week 24, favoring TRELEGY ELLIPTA. The effects of intrinsic and extrinsic factors on the pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol are shown in Figures 1, 2, 3, and 4. Patients with severe renal impairment (CrCl <30 mL/min) showed no relevant increases in Cmax or AUC, nor did protein binding differ between subjects with severe renal impairment and their healthy controls. Provide patients with such medication and instruct them in how it should be used. Do not be alarmed by the following lists of side effects. The incidence of adverse reactions occurring in ≥1% of the subjects treated with TRELEGY ELLIPTA 100/62.5/25 mcg or TRELEGY ELLIPTA 200/62.5/25 mcg is shown in Table 3. Trelegy Ellipta Side Effects. 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. Don’t stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse. Adjudicated on-treatment deaths due to cardiovascular events occurred in 20 of 4,151 patients (0.54 per 100 patient-years) receiving TRELEGY ELLIPTA; 27 of 4,134 patients (0.78 per 100 patient-years) receiving fluticasone furoate/vilanterol; and 16 of 2,070 patients (0.94 per 100 patient-years) receiving umeclidinium/vilanterol. Fatal pneumonia occurred in 12 of 4,151 patients (0.35 per 100 patient-years) receiving TRELEGY ELLIPTA 100/62.5/25 mcg; 5 of 4,134 patients (0.17 per 100 patient-years) receiving fluticasone furoate/vilanterol 100/25 mcg; and 5 of 2,070 patients (0.29 per 100 patient-years) receiving umeclidinium/vilanterol 62.5/25 mcg. In Trial 3, the primary endpoint was annual rate of on-treatment moderate and severe exacerbations in subjects with COPD treated with TRELEGY ELLIPTA 100/62.5/25 mcg compared with fluticasone furoate/vilanterol and umeclidinium/vilanterol. [see WARNINGS AND PRECAUTIONS], Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Drug information provided by: IBM Micromedex. TRELEGY ELLIPTA contains vilanterol. Serious side effects have been reported with Trelegy Ellipta including the following: People with asthma who take long-acting beta2-adrenergic agonist (LABA) … The population demographics for Trials 1 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. 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. 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 C29H34NO2•Br (as a quaternary ammonium bromide compound). The inhaler is packaged within a moisture-protective foil tray with a desiccant and a peelable lid in the following packs: NDC 0173-0887-10 - TRELEGY ELLIPTA 100/62.5/25 mcg      30 inhalations (60 blisters), NDC 0173-0887-14 - TRELEGY ELLIPTA 100/62.5/25 mcg      14 inhalations (28 blisters), institutional pack, NDC 0173-0893-10 - TRELEGY ELLIPTA 200/62.5/25 mcg      30 inhalations (60 blisters), NDC 0173-0893-14 - TRELEGY ELLIPTA 200/62.5/25 mcg      14 inhalations (28 blisters), institutional pack. Systemic drug levels [steady-state Cmax and AUC(0-24)] of fluticasone furoate, umeclidinium, and vilanterol following administration of TRELEGY ELLIPTA (100/62.5/25 or 200/62.5/25 mcg) based on a population pharmacokinetic analysis from subjects with asthma (1,265 subjects for fluticasone furoate; 634 subjects for umeclidinium; 1,263 subjects for vilanterol) were within the range of those observed following administration of fluticasone furoate/vilanterol as the dual combination when compared with fluticasone furoate 100 and 200 mcg, respectively; the systemic exposure of umeclidinium 62.5 mcg following TRELEGY ELLIPTA (100/62.5/25 or 200/62.5/25 mcg) was within the range of those observed following administration of umeclidinium 62.5 mcg as monotherapy. 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%. There were no significant increases in either fluticasone furoate or vilanterol exposure in subjects with severe renal impairment (CrCl <30 mL/min) compared with healthy subjects. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Caution should be exercised when considering the coadministration of TRELEGY ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and increased cardiovascular adverse effects may occur [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY]. You should hear a “click.” The counter will count down by 1 number.