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<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
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yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK548918_"><span class="title" itemprop="name">Revefenacin</span></h1><p class="fm-aai"><a href="#_NBK548918_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Revefenacin.OVERVIEW"><h2 id="_Revefenacin_OVERVIEW_">OVERVIEW</h2><div id="Revefenacin.Introduction"><h3>Introduction</h3><p>Revefenacin is a synthetic anticholinergic agent that is used as a once daily, nebulized inhalant for maintenance treatment of patients with chronic obstructive pulmonary disease. Revefenacin has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.</p></div><div id="Revefenacin.Background"><h3>Background</h3><p>Revefenacin (rev" e fen' a sin) is a synthetic anticholinergic which inhibits the muscarinic actions of acetylcholine on autonomic nerve endings, which decreases bronchial smooth muscle contractions and can alleviate bronchospasm in patients with chronic obstructive pulmonary disease (COPD). Revefenacin has potent activity against muscarinic acetylcholine receptors found in bronchial smooth muscle (M3). Its quaternary ammonium structure decreases its ability to cross lipid membranes such as the blood brain barrier. Revefenacin was approved for use in the United States in 2018 for use as a once daily respiratory inhalant for maintenance treatment of bronchospasm associated with COPD. Revefenacin is available under the brand name Yupelri as an inhalation solution in multiuse vials of 175 mcg in 3 mL. The recommended dose in adults is 175 mcg by inhalation once daily. When given by inhaler, revefenacin has minimal systemic absorption and few anticholinergic side effects. Side effects are mild but can include the headache, cough, symptoms of upper respiratory infections and back pain. Revefenacin is not recommended for patients with hepatic impairment, and concurrent use of other anticholinergic agents should be avoided. Potential severe adverse events include paradoxical bronchospasm, narrow-angle glaucoma, urinary retention and immediate hypersensitivity reactions.</p></div><div id="Revefenacin.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Like other anticholinergic agents, revefenacin has not been linked to episodes of liver enzyme elevations or clinically apparent liver injury. Another reason for its hepatic safety may relate to its low systemic absorption when administered by inhaler.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p><p>Drug Class: <a href="/books/n/livertox/Anticholinergics/?report=reader">Anticholinergic Agents</a></p></div></div><div id="Revefenacin.PRODUCT_INFORMATION"><h2 id="_Revefenacin_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div id="Revefenacin.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Revefenacin – Yupelri®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Anticholinergic Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Revefenacin" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></div><div id="Revefenacin.CHEMICAL_FORMULA_AND_STRUCTU"><h2 id="_Revefenacin_CHEMICAL_FORMULA_AND_STRUCTU_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figRevefenacinT1"><a href="/books/NBK548918/table/Revefenacin.T1/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figRevefenacinT1" rid-ob="figobRevefenacinT1"><img class="small-thumb" src="/books/NBK548918/table/Revefenacin.T1/?report=thumb" src-large="/books/NBK548918/table/Revefenacin.T1/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Revefenacin.T1"><a href="/books/NBK548918/table/Revefenacin.T1/?report=objectonly" target="object" rid-ob="figobRevefenacinT1">Table</a></h4></div></div></div><div id="Revefenacin.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Revefenacin_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 12 April 2019</p><p>Abbreviations: COPD, chronic obstructive pulmonary disease.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Revefenacin.R1">Barnes PJ. Pulmonary pharmacology. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 727-49.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Revefenacin.R2">Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized,double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res 2017; 18: 182. [<a href="/pmc/articles/PMC5667509/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5667509</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29096627" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29096627</span></a>]<div><i>(Among 355 patients with chronic obstructive pulmonary disease [COPD] treated with nebulized revefenacin [44, 88, 175, or 350 mcg] or placebo once daily for 28 days, forced expiratory volume improved more with the higher doses than with placebo, and adverse event rates were similar in all groups, systemic anticholinergic effects being uncommon).</i></div></div></li><li><div class="bk_ref" id="Revefenacin.R3">Quinn D, Barnes CN, Yates W, Bourdet DL, Moran EJ, Potgieter P, Nicholls A, et al. Pharmacodynamics, pharmacokinetics and safety of revefenacin (TD-4208), a long-acting muscarinic antagonist, in patients with chronic obstructive pulmonary disease (COPD): Results of two randomized, double-blind, phase 2 studies. Pulm Pharmacol Ther 2018; 48: 71-9. [<a href="https://pubmed.ncbi.nlm.nih.gov/28987804" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28987804</span></a>]<div><i>(Among 59 patients with COPD treated with once daily nebulized revefenacin or placebo for 7 days, forced expiratory volume improved with all doses of revefenacin compared to placebo, and adverse events were mild and similar in rates in all groups).</i></div></div></li><li><div class="bk_ref" id="Revefenacin.R4">Heo YA. Revefenacin: first global approval. Drugs 2019; 79: 85-91. [<a href="/pmc/articles/PMC6445810/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6445810</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30560478" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30560478</span></a>]<div><i>(Review of the development, clinical efficacy and safety of revefenacin, an inhaled, long acting muscarinic antagonist approved for use in patients with COPD; mentions that the frequency and severity of adverse events were “generally similar across treatment groups”; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Revefenacin.R5">Revefenacin (Yupelri) for COPD. Med Lett Drugs Ther 2019; 61: 14-5. [<a href="https://pubmed.ncbi.nlm.nih.gov/30856160" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30856160</span></a>]<div><i>(Concise review of the maintenance therapy of COPD and the clinical efficacy, safety and costs of revefenacin shortly after its approval in the US as a once daily nebulized inhalant for the management treatment of patients with COPD; does not mention ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Revefenacin.R6">
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<a href="https://www.accessdata.fda.gov/scripts/cder/daf/" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.accessdata<wbr style="display:inline-block"></wbr>​.fda.gov/scripts/cder/daf/</a>
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<div>
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<i>(FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA scientific review of the new drug application for safety and efficacy; mentions that there were no differences in laboratory test results between revefenacin and comparator arms of pre-licensure clinical trials and the one patient who developed clinically apparent liver injury during revefenacin treatment was found to have pancreatic cancer as a cause of jaundice).</i>
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</div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548918_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">April 12, 2019</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Revefenacin. [Updated 2019 Apr 12].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Retinoids/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/livertox/Ribavirin/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="boxed-text" id="figobRevefenacinBPI"><div id="Revefenacin.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Revefenacin – Yupelri®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Anticholinergic Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Revefenacin" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></article><article data-type="table-wrap" id="figobRevefenacinT1"><div id="Revefenacin.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548918/table/Revefenacin.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Revefenacin.T1_lrgtbl__"><table><thead><tr><th id="hd_h_Revefenacin.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_Revefenacin.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Revefenacin.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Revefenacin.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Revefenacin.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Revefenacin</td><td headers="hd_h_Revefenacin.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/313371011" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">864750-70-9</a>
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</td><td headers="hd_h_Revefenacin.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">C35-H43-N5-O4</td><td headers="hd_h_Revefenacin.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">
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<div class="graphic"><img src="/books/NBK548918/bin/Revefenacin_Structure.jpg" alt="Revefenacin Chemical Structure" /></div>
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</td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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