(See Hepatic Impairment under Cautions. In November 2018, based on results of three phase III trials, the US Food and Drug Administration granted market authorization to revefenacin for the maintenance treatment of patients with COPD. Mayo Clinic on Incontinence - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. A prespecified subgroup analysis was planned to compare efficacy based on airflow obstruction severity in patients with severe to very severe disease. A greater clinically relevant change from baseline in trough FEV1 was observed in the revefenacin and formoterol group vs the placebo and formoterol group during sequential (157.1 mL vs 53.3 mL) and combination (115.6 mL vs 35.0 mL) administration.23 Limitations of this study included its short length (42 days) and its lack of power to show differences between the treatments for the efficacy endpoints. We comply with the HONcode standard for trustworthy health information. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. leniolisib. rifampicin, cyclosporine) is also not recommended as it may increase systemic exposure of the active metabolite of revefenacin [3]. Turn the compressor off. Abbreviations: AE, adverse event; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; LABA, long-acting -agonist; LS, least squares; PBO, placebo; REV, revefenacin; SABA, short-acting -agonist; SGRQ, St. Georges Respiratory Questionnaire; TDI, Transition Dyspnea Index; TIO, tiotropium. This includes your doctors, nurses, pharmacists, and dentists. Analysis of pooled results from the 0126 and 0127 studies showed increases in overall treatment effect on FEV1 of 142.3 mL for revefenacin. Markers of more severe COPD included severe and very severe airflow limitation (percent predicted FEV1 of 30% to <50% and <30%, respectively), 2011 GOLD D classification, reversibility (12% and 200 mL increase in FEV1) to short-acting bronchodilators, concurrent use of LABAs and/or ICS, older age (>65 and >75 years), and comorbidity risk factors (history of cardiovascular disease, diabetes mellitus, and cognitive/mental impairments). May worsen signs and/or symptoms of narrow-angle glaucoma (e.g., ocular pain or discomfort, blurred vision, visual halos, colored images in association with red eyes from conjunctival congestion and corneal edema). Secondary efficacy endpoints included overall treatment effect on trough FEV1 and peak FEV1 (0-2 hours after the first dose) on day 1. It is used to treat COPD ( chronic obstructive pulmonary disease ). WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Drug class: anticholinergic bronchodilators. At entry, patients in the two replicate trials had a mean age of 63.7years, a mean smoking history of 52.3 pack-years (49% of patients were current smokers [16]) and the mean predicted FEV1 was 54.4%; 38.1% of patients were taking concomitant LABA or LABA/ICS therapy and 34.5% had very severe COPD (classified as GOLD D) [15]. Improvements in health status with revefenacin, a once-daily long-acting muscarinic antagonist for nebulization: changes in St Georges respiratory questionnaire and COPD assessment test in replicate 3-month studies [abstract], Mahler D, Ohar J, Barnes C. Efficacy of revefenacin by nebulization and tiotropium by HandiHaler, Theravance Biopharma, Mylan. In study 0091, patients were randomized to receive once-daily revefenacin (22, 44, 88, 175, 350, or 700 g) or placebo for 7 days in a double-blind, incomplete block, 5-way crossover design. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. (See Special Populations under Pharmacokinetics.). the contents by NLM or the National Institutes of Health. The incidence of antimuscarinic AEs and serious AEs were low and similar across treatment groups [24, 25]. Severe renal impairment (Clcr <30 mL/minute): For revefenacin, 1.5- and 2.3-fold increase in peak concentrations and AUC, respectively. However, there were no new safety concerns, as very few AEs were reported for either treatment group; fewer AEs occurred with revefenacin than with tiotropium. Use this medicine only as directed by your doctor. The increase in systemic exposure to THRX-195518 in individuals with severe renal or moderate hepatic impairment was considered unlikely to be of clinical consequence given its low antimuscarinic potency, low systemic levels after inhaled revefenacin, and favorable safety profile.15, Cardiac safety was assessed in healthy volunteers in a randomized, 4-way crossover phase 1 trial (NCT02820311).16 Each healthy volunteer received a single dose of the following 4 treatments in separate treatment periods: blinded revefenacin 175 g, revefenacin 700 g, placebo via nebulization, and open-label oral moxifloxacin 400 mg (positive control). albuterol) compared with placebo. Use in Specific Populations Special Populations: Renal Function Impairment. Compared with placebo, revefenacin demonstrated statistically clinically important improvements in pulmonary function. The trough FEV1 profile for revefenacin ranged from 52.3 to 124.3 mL, and that for tiotropium ranged from 79.7 to 112.8 mL. A4239], Feldman G, Barnes CN, Moran EJ, et al. Nonselective competitive antagonist at muscarinic receptors M1 to M5. Read it again each time revefenacin is Following repeated dosing of orally inhaled revefenacin, steady-state concentrations achieved within 7 days. This amount drops to 5% of the total cost of the drug once patients reach catastrophic coverage. (See Cautions.). As a library, NLM provides access to scientific literature. Compared with placebo, in a randomized, double-blind, placebo-controlled, dose-ranging phase II study in patients with moderate to severe COPD ({"type":"clinical-trial","attrs":{"text":"NCT02040792","term_id":"NCT02040792"}}NCT02040792; n=355), least squares mean (LSM) trough FEV1 from baseline on day 28 significantly improved in the revefenacin 88, 175 and 350g once daily groups (134.2155.0 vs. 32.4mL; all p<0.001), but not with revefenacin 44g once daily [2]. The .gov means its official. At baseline, 47% to 52% of patients were men, nearly half were current smokers (46%-49%), the mean age was 63 to 64 years, and the mean baseline postbronchodilator percent predicted FEV1 was 54% to 56%.19, Compared with placebo, revefenacin resulted in clinically significant improvements in trough FEV1 at every time point evaluated. In vitro protein binding of drug and its active metabolite: 71 and 42%, respectively. Side Effects. Synthetic tertiary amine antimuscarinic agent. Revefenacin should not be used to relieve acute symptoms of COPD (i.e. Approximately 19% recovered in feces as active metabolite. ), Use with caution in patients with urinary retention. Coleman C, Limone B, Sobieraj D, et al. You will need to talk about any risks to your baby. Adults1 vial by oral inhalation once a day. Unlikely to affect the breast-fed child since revefenacin is less than 3% absorbed orally. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. Treat acute symptoms with an inhaled, short-acting 2-agonist. There was a greater number of St. Georges Respiratory Questionnaire (SGRQ) and Transition Dyspnea Index (TDI) responders in the majority of the patient subgroups who received revefenacin vs placebo. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. Also, do not stop using this medicine without telling your doctor. Antimuscarinic-related AEs were infrequent and occurred at similar rates for the treatment groups in both studies; none of the patients in either study had more than 1 antimuscarinic AE. Long-acting, orally inhaled bronchodilator. Before Safety and efficacy of the drug delivered from a nebulizer system without a compressor not established. Inhaled bronchodilators are recommended as first-line therapy for the treatment of COPD.5 Although GOLD does not recommend a particular bronchodilator over another, evidence suggests that LAMAs offer clinical and economic benefits, compared with long-acting -agonists (LABAs). Throw away any part of opened vial not used after use. Generic Name Revefenacin DrugBank Accession Number DB11855 Background Revefenacin is a novel biphenyl carbamate tertiary amine agent that belongs to the family of the long-acting muscarinic antagonists (LAMA). 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). In vitro human plasma protein binding for revefenacin and its active metabolite averaged 71 and 42% [3]. Squeeze all of the medicine from the vial into the nebulizer cup. At baseline, most patients were men (56%-61%), 45% to 47% were current smokers, the mean age was 64 to 65 years, and the mean baseline postbronchodilator percent predicted FEV1 was 53% to 54%.20,21, The primary endpoint was the safety and tolerability of revefenacin. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This medicine is breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. Coadministration of revefenacin with other anticholinergic medications should be avoided as concomitant use of these drugs may increase the risk of anticholinergic AEs (e.g. Portions of this document last updated: May 01, 2023. Concomitant LABA-containing therapy (with or without ICS) was permitted in up to 40% of the study population to ensure robust assessments of concurrent therapies used by the participants. Active metabolite formed by hepatic metabolism possesses activity at target muscarinic receptors that is lower (approximately one-third to one-tenth) than that of revefenacin. Theravance Biopharma and Mylan report additional phase 3 data for revefenacin (TD-4208) in several presentations at 2017 ATS [media release]. In COPD patients, exposure (i.e. Following single radiolabeled oral dose, 88% recovered in feces and <5% in urine. {"type":"clinical-trial","attrs":{"text":"NCT03064113","term_id":"NCT03064113"}}NCT03064113 and {"type":"clinical-trial","attrs":{"text":"NCT01704404","term_id":"NCT01704404"}}NCT01704404 enrolled patients (aged 4075years) with moderate to severe COPD (pre-bronchodilator FEV1 3580% of predicted and FEV1/FVC ratio of<0.7) and a smoking history of>10 pack-years [12]. Pharmacological properties of revefenacin (TD-4208), a novel, nebulized long-acting, and lung selective muscarinic antagonist, at human recombinant muscarinic receptors and in rat, guinea pig, and human isolated airway tissues. Background Revefenacin, a once-daily, long-acting muscarinic antagonist delivered via standard jet nebulizer, increased trough forced expiratory volume in 1 s (FEV1) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in prior phase 3 trials. Use with caution in patients with narrow-angle glaucoma. An official website of the United States government. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. (See Advice to Patients.). Store unopened vials of this medicine at room temperature, away from heat and direct light. This medicine will not relieve a COPD attack that has already started. Revefenacin 175 g clinically and significantly improved day 28 trough FEV1 vs placebo, with a difference of 166.6 mL. breathing, breathing that is worse, wheezing, or coughing after using revefenacin, use a rescue inhaler and get medical help right away. The methodology and results of 4 phase 2 studies and 5 phase 3 studies are summarized and discussed in Table 1 and Table 2.14,17-23 The results of 2 post hoc/prespecified studies are summarized and discussed in Table 3.24,25 Eligibility criteria and definitions for phase 2 and 3 clinical trials are discussed in the eAppendix. In terms of delivery device, jet nebulizers, such as the Par LC Sprint, are easy to use and provide an efficient drug delivery system.28 In the 0167 study,23 revefenacin was administered via the same jet nebulizer with other nebulized bronchodilators (ie, formoterol), allowing for ease of administration and cleaning. Do not take 2 doses at the same time or extra doses. This is not a list of all drugs or health problems that interact with revefenacin. Severe hepatic impairment: Not evaluated. Summary of Phase 3 Post Hoc/Prespecified Subgroup Analysesa. If paradoxical bronchospasm occurs, discontinue drug immediately and consider alternative therapy. Nebulizer use during the COVID-19 pandemic. 11 Oct 2018. Ji Y, Husfeld C, Pulido-Rios MT, et al. In a pooled analysis of {"type":"clinical-trial","attrs":{"text":"NCT02459080","term_id":"NCT02459080"}}NCT02459080 and {"type":"clinical-trial","attrs":{"text":"NCT02512510","term_id":"NCT02512510"}}NCT02512510, at least one any-grade AE was reported in 53.4, 50.7 and 48.3% of patients receiving revefenacin 88 or 175g or placebo once daily, respectively [24]. At entry, patients had a mean age of 61.9years, a mean smoking history of 39.5 pack-years (53.7% of patients were current smokers) and a mean predicted FEV1 of 43.6%; 36.7% of patients were currently using ICS. Do not store in a bathroom. Revefenacin produced clinically significant improvements from baseline in trough FEV1, and these improvements were similar in patients who received LABA or LABA/ICS and those who received concomitant revefenacin only (day 85 trough FEV1, 150.9 and 139.2 mL, respectively; P < 0.0001). while you are pregnant. In healthy volunteers and in COPD patients, peak plasma concentrations (C max) of revefenacin and its active metabolite occurred 14-41 min after start of nebulization; the absolute bioavailability of revefenacin following oral administration is very low (< 3%) . All rights reserved. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. However, many people have no side effects or only have minor side effects. Drug information provided by: Merative, Micromedex. Revefenacin is a potent, lung-selective LAMA that prevents bronchoconstriction by inhibiting muscarinic M3 receptors in airway smooth muscle. advice about side effects. Signs of an allergic reaction, like rash; This medicine can cause very bad breathing problems right after you take a dose. However, Cmax and AUC of revefenacin and its active metabolite increased up to 2.5-fold in patients with severe renal impairment; thus, monitoring for systemic antimuscarinic adverse events (AEs) is recommended in this population [3]. as a rescue therapy) and should not be initiated in patients experiencing acutely deteriorating or potentially life-threatening episodes of COPD. The terminal amide in revefenacins structure provides a metabolically labile functionality, which appears to be stable in the lung but readily hydrolyzed to its active metabolite in systemic circulation,10 thus potentially minimizing systemically mediated adverse events (AEs). A prespecified subgroup study was also conducted using pooled data from the phase 3 studies (0126, 0127, and 0128) to assess the safety of concomitant revefenacin and LABA or LABA/ICS (Table 3).25 Revefenacin was well tolerated, with more AEs reported among patients who received concomitant LABA or LABA/ICS than in those who received revefenacin only. Possible additive anticholinergic effects, Possible increase in systemic exposure of active metabolite. Search for other works by this author on: Highlights of prescribing information YUPELRI (revefenacin) inhalation solution, for oral inhalation. Each 3-mL single-dose vial of revefenacin oral inhalation solution contains 175 mcg of revefenacin. Protect from sunlight and excessive heat. 2.3) was generally similar to that observed in the two 12-week studies and revealed no new safety signals [3]. The pharmacology, pharmacokinetics (PK), efficacy, safety, and clinical application of revefenacin are reviewed in this article, with a focus on the FDA-approved 175-g dose. This medicine will not relieve a COPD attack that has already started. Batch CBD Full-Spectrum Gummies. Theravance Biopharma and Mylan receive FDA approval for YUPELRI (revefenacin) in adults with chronic obstructive pulmonary disease [media release]. Revefenacin (YUPELRI) inhalation solution, a long-acting muscarinic antagonist (i.e. In a thorough, positive-controlled QT study in healthy subjects (n=48), a therapeutic (175g) or supratherapeutic (700g) dose of inhaled revefenacin did not prolong QTc interval to any clinically meaningful extent [11]. 8600 Rockville Pike Revefenacin was well tolerated, and AEs were generally mild. 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Sobieraj D, et al Sobieraj D, et al within 7 days prescribing information YUPELRI ( )... B, Sobieraj D, et al patients experiencing acutely deteriorating or potentially life-threatening episodes COPD... All of the medicine from the vial into the nebulizer cup 71 and 42 %,.... All drugs or health problems that interact with revefenacin take 2 doses at the same time or doses. Your doctor to relieve acute symptoms with an inhaled, short-acting 2-agonist you will need to talk about any to. In peak concentrations and AUC, respectively, short-acting 2-agonist access to scientific literature affect the breast-fed child revefenacin... Unlikely to affect the breast-fed child since revefenacin is Following repeated dosing of orally revefenacin... Clinically and significantly improved day 28 trough FEV1 vs placebo, with a standard jet nebulizer, represents an advance... In pulmonary Function receptors M1 to M5 generally similar to that observed in the treatment COPD. 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