nih-gov/www.ncbi.nlm.nih.gov/books/NBK597221/index.html?report=reader

184 lines
40 KiB
Text

<!DOCTYPE html>
<html xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" class="no-js no-jr">
<head>
<!-- For pinger, set start time and add meta elements. -->
<script type="text/javascript">var ncbi_startTime = new Date();</script>
<!-- Logger begin -->
<meta name="ncbi_db" content="books">
<meta name="ncbi_pdid" content="book-part">
<meta name="ncbi_acc" content="NBK597221">
<meta name="ncbi_domain" content="livertox">
<meta name="ncbi_report" content="reader">
<meta name="ncbi_type" content="fulltext">
<meta name="ncbi_objectid" content="">
<meta name="ncbi_pcid" content="/NBK597221/?report=reader">
<meta name="ncbi_pagename" content="Finerenone - LiverTox - NCBI Bookshelf">
<meta name="ncbi_bookparttype" content="chapter">
<meta name="ncbi_app" content="bookshelf">
<!-- Logger end -->
<!--component id="Page" label="meta"/-->
<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Finerenone - LiverTox - NCBI Bookshelf</title>
<meta charset="utf-8">
<meta name="apple-mobile-web-app-capable" content="no">
<meta name="viewport" content="initial-scale=1,minimum-scale=1,maximum-scale=1,user-scalable=no">
<meta name="jr-col-layout" content="auto">
<meta name="jr-prev-unit" content="/books/n/livertox/Finasteride/?report=reader">
<meta name="jr-next-unit" content="/books/n/livertox/Fingolimod/?report=reader">
<meta name="bk-toc-url" content="/books/n/livertox/?report=toc">
<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE">
<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
<meta name="citation_title" content="Finerenone">
<meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
<meta name="citation_date" content="2023/10/13">
<meta name="citation_pmid" content="37956233">
<meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK597221/">
<link rel="schema.DC" href="http://purl.org/DC/elements/1.0/">
<meta name="DC.Title" content="Finerenone">
<meta name="DC.Type" content="Text">
<meta name="DC.Publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
<meta name="DC.Date" content="2023/10/13">
<meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK597221/">
<meta name="description" content="Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist that is used in the therapy of chronic renal disease in patients with type 2 diabetes to slow progression of renal dysfunction and reduce the risk of cardiovascular disease morbidity and mortality. Finerenone has not been linked to serum enzyme elevations during therapy or with instances of clinically apparent liver injury.">
<meta name="og:title" content="Finerenone">
<meta name="og:type" content="book">
<meta name="og:description" content="Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist that is used in the therapy of chronic renal disease in patients with type 2 diabetes to slow progression of renal dysfunction and reduce the risk of cardiovascular disease morbidity and mortality. Finerenone has not been linked to serum enzyme elevations during therapy or with instances of clinically apparent liver injury.">
<meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK597221/">
<meta name="og:site_name" content="NCBI Bookshelf">
<meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png">
<meta name="twitter:card" content="summary">
<meta name="twitter:site" content="@ncbibooks">
<meta name="bk-non-canon-loc" content="/books/n/livertox/Finerenone/?report=reader">
<link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK597221/">
<link href="https://fonts.googleapis.com/css?family=Archivo+Narrow:400,700,400italic,700italic&amp;subset=latin" rel="stylesheet" type="text/css">
<link rel="stylesheet" href="/corehtml/pmc/jatsreader/ptpmc_3.22/css/libs.min.css">
<link rel="stylesheet" href="/corehtml/pmc/jatsreader/ptpmc_3.22/css/jr.min.css">
<meta name="format-detection" content="telephone=no">
<link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css">
<link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css//books_print.min.css" type="text/css" media="print">
<link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_reader.min.css" type="text/css">
<style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} .body-content h2, .body-content .h2 {border-bottom: 1px solid #97B0C8} .body-content h2.inline {border-bottom: none} a.page-toc-label , .jig-ncbismoothscroll a {text-decoration:none;border:0 !important} .temp-labeled-list .graphic {display:inline-block !important} .temp-labeled-list img{width:100%}</style>
<link rel="shortcut icon" href="//www.ncbi.nlm.nih.gov/favicon.ico">
<meta name="ncbi_phid" content="CE8B0B2C7D7D3B410000000000290023.m_5">
<meta name='referrer' content='origin-when-cross-origin'/><link type="text/css" rel="stylesheet" href="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/css/3852956/3849091.css"></head>
<body>
<!-- Book content! -->
<div id="jr" data-jr-path="/corehtml/pmc/jatsreader/ptpmc_3.22/"><div class="jr-unsupported"><table class="modal"><tr><td><span class="attn inline-block"></span><br />Your browser does not support the NLM PubReader view.<br />Go to <a href="/pmc/about/pr-browsers/">this page</a> to see a list of supported browsers<br />or return to the <br /><a href="/books/NBK597221/?report=classic">regular view</a>.</td></tr></table></div><div id="jr-ui" class="hidden"><nav id="jr-head"><div class="flexh tb"><div id="jr-tb1"><a id="jr-links-sw" class="hidden" title="Links"><svg xmlns="http://www.w3.org/2000/svg" version="1.1" x="0px" y="0px" viewBox="0 0 70.6 85.3" style="enable-background:new 0 0 70.6 85.3;vertical-align:middle" xml:space="preserve" width="24" height="24">
<style type="text/css">.st0{fill:#939598;}</style>
<g>
<path class="st0" d="M36,0C12.8,2.2-22.4,14.6,19.6,32.5C40.7,41.4-30.6,14,35.9,9.8"></path>
<path class="st0" d="M34.5,85.3c23.2-2.2,58.4-14.6,16.4-32.5c-21.1-8.9,50.2,18.5-16.3,22.7"></path>
<path class="st0" d="M34.7,37.1c66.5-4.2-4.8-31.6,16.3-22.7c42.1,17.9,6.9,30.3-16.4,32.5h1.7c-66.2,4.4,4.8,31.6-16.3,22.7 c-42.1-17.9-6.9-30.3,16.4-32.5"></path>
</g>
</svg> Books</a></div><div class="jr-rhead f1 flexh"><div class="head"><a href="/books/n/livertox/Finasteride/?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="body"><div class="t">Finerenone</div><div class="j">LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]</div></div><div class="tail"><a href="/books/n/livertox/Fingolimod/?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></div><div id="jr-tb2"><a id="jr-bkhelp-sw" class="btn wsprkl hidden" title="Help with NLM PubReader">?</a><a id="jr-help-sw" class="btn wsprkl hidden" title="Settings and typography in NLM PubReader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 512 512" preserveAspectRatio="none"><path d="M462,283.742v-55.485l-29.981-10.662c-11.431-4.065-20.628-12.794-25.274-24.001 c-0.002-0.004-0.004-0.009-0.006-0.013c-4.659-11.235-4.333-23.918,0.889-34.903l13.653-28.724l-39.234-39.234l-28.72,13.652 c-10.979,5.219-23.68,5.546-34.908,0.889c-0.005-0.002-0.01-0.003-0.014-0.005c-11.215-4.65-19.933-13.834-24-25.273L283.741,50 h-55.484l-10.662,29.981c-4.065,11.431-12.794,20.627-24.001,25.274c-0.005,0.002-0.009,0.004-0.014,0.005 c-11.235,4.66-23.919,4.333-34.905-0.889l-28.723-13.653l-39.234,39.234l13.653,28.721c5.219,10.979,5.545,23.681,0.889,34.91 c-0.002,0.004-0.004,0.009-0.006,0.013c-4.649,11.214-13.834,19.931-25.271,23.998L50,228.257v55.485l29.98,10.661 c11.431,4.065,20.627,12.794,25.274,24c0.002,0.005,0.003,0.01,0.005,0.014c4.66,11.236,4.334,23.921-0.888,34.906l-13.654,28.723 l39.234,39.234l28.721-13.652c10.979-5.219,23.681-5.546,34.909-0.889c0.005,0.002,0.01,0.004,0.014,0.006 c11.214,4.649,19.93,13.833,23.998,25.271L228.257,462h55.484l10.595-29.79c4.103-11.538,12.908-20.824,24.216-25.525 c0.005-0.002,0.009-0.004,0.014-0.006c11.127-4.628,23.694-4.311,34.578,0.863l28.902,13.738l39.234-39.234l-13.66-28.737 c-5.214-10.969-5.539-23.659-0.886-34.877c0.002-0.005,0.004-0.009,0.006-0.014c4.654-11.225,13.848-19.949,25.297-24.021 L462,283.742z M256,331.546c-41.724,0-75.548-33.823-75.548-75.546s33.824-75.547,75.548-75.547 c41.723,0,75.546,33.824,75.546,75.547S297.723,331.546,256,331.546z"></path></svg></a><a id="jr-fip-sw" class="btn wsprkl hidden" title="Find"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 550 600" preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-rtoc-sw" class="btn wsprkl hidden" title="Table of Contents"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M20,20h10v8H20V20zM36,20h44v8H36V20zM20,37.33h10v8H20V37.33zM36,37.33h44v8H36V37.33zM20,54.66h10v8H20V54.66zM36,54.66h44v8H36V54.66zM20,72h10v8 H20V72zM36,72h44v8H36V72z"></path></svg></a></div></div></nav><nav id="jr-dash" class="noselect"><nav id="jr-dash" class="noselect"><div id="jr-pi" class="hidden"><a id="jr-pi-prev" class="hidden" title="Previous page"><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 class="pginfo">Page <i class="jr-pg-pn">0</i> of <i class="jr-pg-lp">0</i></div><a id="jr-pi-next" class="hidden" title="Next page"><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><div id="jr-is-tb"><a id="jr-is-sw" class="btn wsprkl hidden" title="Switch between Figures/Tables strip and Progress bar"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><rect x="10" y="40" width="20" height="20"></rect><rect x="40" y="40" width="20" height="20"></rect><rect x="70" y="40" width="20" height="20"></rect></svg></a></div><nav id="jr-istrip" class="istrip hidden"><a id="jr-is-prev" href="#" class="hidden" title="Previous"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M80,40 60,65 80,90 70,90 50,65 70,40z M50,40 30,65 50,90 40,90 20,65 40,40z"></path><text x="35" y="25" textLength="60" style="font-size:25px">Prev</text></svg></a><a id="jr-is-next" href="#" class="hidden" title="Next"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M20,40 40,65 20,90 30,90 50,65 30,40z M50,40 70,65 50,90 60,90 80,65 60,40z"></path><text x="15" y="25" textLength="60" style="font-size:25px">Next</text></svg></a></nav><nav id="jr-progress"></nav></nav></nav><aside id="jr-links-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">NCBI Bookshelf</div></div><div class="cnt lol f1"><a href="/books/">Home</a><a href="/books/browse/">Browse All Titles</a><a class="btn share" target="_blank" rel="noopener noreferrer" href="https://www.facebook.com/sharer/sharer.php?u=https://www.ncbi.nlm.nih.gov/books/NBK597221/"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 33 33" style="vertical-align:middle" width="24" height="24" preserveAspectRatio="none"><g><path d="M 17.996,32L 12,32 L 12,16 l-4,0 l0-5.514 l 4-0.002l-0.006-3.248C 11.993,2.737, 13.213,0, 18.512,0l 4.412,0 l0,5.515 l-2.757,0 c-2.063,0-2.163,0.77-2.163,2.209l-0.008,2.76l 4.959,0 l-0.585,5.514L 18,16L 17.996,32z"></path></g></svg> Share on Facebook</a><a class="btn share" target="_blank" rel="noopener noreferrer" href="https://twitter.com/intent/tweet?url=https://www.ncbi.nlm.nih.gov/books/NBK597221/&amp;text=Finerenone"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 33 33" style="vertical-align:middle" width="24" height="24"><g><path d="M 32,6.076c-1.177,0.522-2.443,0.875-3.771,1.034c 1.355-0.813, 2.396-2.099, 2.887-3.632 c-1.269,0.752-2.674,1.299-4.169,1.593c-1.198-1.276-2.904-2.073-4.792-2.073c-3.626,0-6.565,2.939-6.565,6.565 c0,0.515, 0.058,1.016, 0.17,1.496c-5.456-0.274-10.294-2.888-13.532-6.86c-0.565,0.97-0.889,2.097-0.889,3.301 c0,2.278, 1.159,4.287, 2.921,5.465c-1.076-0.034-2.088-0.329-2.974-0.821c-0.001,0.027-0.001,0.055-0.001,0.083 c0,3.181, 2.263,5.834, 5.266,6.438c-0.551,0.15-1.131,0.23-1.73,0.23c-0.423,0-0.834-0.041-1.235-0.118 c 0.836,2.608, 3.26,4.506, 6.133,4.559c-2.247,1.761-5.078,2.81-8.154,2.81c-0.53,0-1.052-0.031-1.566-0.092 c 2.905,1.863, 6.356,2.95, 10.064,2.95c 12.076,0, 18.679-10.004, 18.679-18.68c0-0.285-0.006-0.568-0.019-0.849 C 30.007,8.548, 31.12,7.392, 32,6.076z"></path></g></svg> Share on Twitter</a></div></aside><aside id="jr-rtoc-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">Table of Content</div></div><div class="cnt lol f1"><a href="/books/n/livertox/?report=reader">Title Information</a><a href="/books/n/livertox/toc/?report=reader">Table of Contents Page</a></div></aside><aside id="jr-help-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">Settings</div></div><div class="cnt f1"><div id="jr-typo-p" class="typo"><div><a class="sf btn wsprkl">A-</a><a class="lf btn wsprkl">A+</a></div><div><a class="bcol-auto btn wsprkl"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 200 100" preserveAspectRatio="none"><text x="10" y="70" style="font-size:60px;font-family: Trebuchet MS, ArialMT, Arial, sans-serif" textLength="180">AUTO</text></svg></a><a class="bcol-1 btn wsprkl"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M15,25 85,25zM15,40 85,40zM15,55 85,55zM15,70 85,70z"></path></svg></a><a class="bcol-2 btn wsprkl"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M5,25 45,25z M55,25 95,25zM5,40 45,40z M55,40 95,40zM5,55 45,55z M55,55 95,55zM5,70 45,70z M55,70 95,70z"></path></svg></a></div></div><div class="lol"><a class="" href="/books/NBK597221/?report=classic">Switch to classic view</a><a href="/books/NBK597221/pdf/Bookshelf_NBK597221.pdf">PDF (101K)</a><a href="/books/NBK597221/?report=printable">Print View</a></div></div></aside><aside id="jr-bkhelp-p" class="hidden flexv"><div class="tb sk-htbar flexh"><div><a class="jr-p-close btn wsprkl">Done</a></div><div class="title-text f1">Help</div></div><div class="cnt f1 lol"><a id="jr-helpobj-sw" data-path="/corehtml/pmc/jatsreader/ptpmc_3.22/" data-href="/corehtml/pmc/jatsreader/ptpmc_3.22/img/bookshelf/help.xml" href="">Help</a><a href="mailto:info@ncbi.nlm.nih.gov?subject=PubReader%20feedback%20%2F%20NBK597221%20%2F%20sid%3ACE8B5AF87C7FFCB1_0191SID%20%2F%20phid%3ACE8B0B2C7D7D3B410000000000290023.4">Send us feedback</a><a id="jr-about-sw" data-path="/corehtml/pmc/jatsreader/ptpmc_3.22/" data-href="/corehtml/pmc/jatsreader/ptpmc_3.22/img/bookshelf/about.xml" href="">About PubReader</a></div></aside><aside id="jr-objectbox" class="thidden hidden"><div class="jr-objectbox-close wsprkl">&#10008;</div><div class="jr-objectbox-inner cnt"><div class="jr-objectbox-drawer"></div></div></aside><nav id="jr-pm-left" class="hidden"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 40 800" preserveAspectRatio="none"><text font-stretch="ultra-condensed" x="800" y="-15" text-anchor="end" transform="rotate(90)" font-size="18" letter-spacing=".1em">Previous Page</text></svg></nav><nav id="jr-pm-right" class="hidden"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 40 800" preserveAspectRatio="none"><text font-stretch="ultra-condensed" x="800" y="-15" text-anchor="end" transform="rotate(90)" font-size="18" letter-spacing=".1em">Next Page</text></svg></nav><nav id="jr-fip" class="hidden"><nav id="jr-fip-term-p"><input type="search" placeholder="search this page" id="jr-fip-term" autocorrect="off" autocomplete="off" /><a id="jr-fip-mg" class="wsprkl btn" title="Find"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 550 600" preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-fip-done" class="wsprkl btn" title="Dismiss find">&#10008;</a></nav><nav id="jr-fip-info-p"><a id="jr-fip-prev" class="wsprkl btn" title="Jump to previuos match">&#9664;</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">&#9654;</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="_NBK597221_"><span class="title" itemprop="name">Finerenone</span></h1><p class="fm-aai"><a href="#_NBK597221_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Finerenone.OVERVIEW"><h2 id="_Finerenone_OVERVIEW_">OVERVIEW</h2><div id="Finerenone.Introduction"><h3>Introduction</h3><p>Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist that is used in the therapy of chronic renal disease in patients with type 2 diabetes to slow progression of renal dysfunction and reduce the risk of cardiovascular disease morbidity and mortality. Finerenone has not been linked to serum enzyme elevations during therapy or with instances of clinically apparent liver injury.</p></div><div id="Finerenone.Background"><h3>Background</h3><p>Finerenone (fin er&#x02019; e none) is a selective, nonsteroidal mineralocorticoid receptor antagonist that is used to treat chronic renal disease in patients with type 2 diabetes. Patients with chronic renal disease have high levels of serum aldosterone, a mineralocorticoid hormone that, upon engagement of its cellular receptors in the kidney, leads to sodium retention and loss of potassium. Aldosterone activation also appears to increase proinflammatory cytokines and mediators of fibrosis in kidneys and elsewhere. The finding of elevation in aldosterone levels in patients with renal disease led to strategies to reduce mineralocorticoid receptor activation in patients with chronic kidney disease. In several randomized, placebo controlled trials, chronic therapy with finerenone, a specific inhibitor of the mineralocorticoid receptor, was shown to decrease albuminuria, prevent decline in estimated glomerular filtration rate (eGFR), and decrease renal as well as cardiovascular death in patients with chronic kidney disease and type 2 diabetes. Finerenone was approved for this indication in the United States in 2021. Finerenone is available as tablets of 10 and 20 mg under the brand name Kerendia. The recommended maintenance dose is 20 mg daily after a 4 week titration phase. Finerenone is contraindicated in patients with renal failure (eGFR less than 20 mL/min) and in patients with hyperkalemia. It is typically used in combination with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). Side effects of finerenone can include hyperkalemia, hyponatremia and hypotension. Severe hyperkalemia can occur with finerenone therapy in patients with renal failure, with preexisting hyperkalemia, and in those taking potent inducers of CYP 3A4.</p></div><div id="Finerenone.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In placebo-controlled trials of finerenone in several thousand patients, there was usually no mention of serum enzyme elevations or hepatotoxicity. In the largest placebo controlled trial, the rate of &#x0201c;hepatobiliary&#x0201d; adverse events was similar in patients on finerenone compared to placebo (4.4% vs 4.8%), and there were no reported hepatic serious adverse events. Since its approval and more widespread use, finerenone has not been implicated in instances of acute hepatic injury and the product label does not mention aminotransferase elevations or clinically apparent liver injury in lists of potential adverse events.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p></div><div id="Finerenone.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The mechanism by which finerenone might cause liver injury is not known. Finerenone is metabolized in the liver largely via the cytochrome P450 system. It is a substrate of CYP 3A4 and it should be avoided in patients taking inhibitors or inducers of CYP 3A4. In particular, potent inhibitors of CYP 3A4 can cause increases in plasma levels of finerenone which can trigger its dose-dependent side effects such as hyperkalemia and hyponatremia.</p><p>Drug Class: Cardiovascular Agents</p><p>Other Drugs for Renal Disease: <a href="/books/n/livertox/Eplerenone/?report=reader">Eplerenone</a>, <a href="/books/n/livertox/Spironolactone/?report=reader">Spironolactone</a>, <a href="/books/n/livertox/SGLT-2_Inhibitors/?report=reader">SGLT2 Inhibitors</a></p></div></div><div id="Finerenone.PRODUCT_INFORMATION"><h2 id="_Finerenone_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figFinerenoneTc"><a href="/books/NBK597221/table/Finerenone.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figFinerenoneTc" rid-ob="figobFinerenoneTc"><img class="small-thumb" src="/books/NBK597221/table/Finerenone.Tc/?report=thumb" src-large="/books/NBK597221/table/Finerenone.Tc/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Finerenone.Tc"><a href="/books/NBK597221/table/Finerenone.Tc/?report=objectonly" target="object" rid-ob="figobFinerenoneTc">Table</a></h4><p class="float-caption no_bottom_margin"><i>REPRESENTATIVE TRADE NAMES</i> Finerenone &#x02013; Kerendia&#x000ae;</p></div></div></div><div id="Finerenone.CHEMICAL_FORMULA_AND_STRUCTUR"><h2 id="_Finerenone_CHEMICAL_FORMULA_AND_STRUCTUR_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figFinerenoneTd"><a href="/books/NBK597221/table/Finerenone.Td/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figFinerenoneTd" rid-ob="figobFinerenoneTd"><img class="small-thumb" src="/books/NBK597221/table/Finerenone.Td/?report=thumb" src-large="/books/NBK597221/table/Finerenone.Td/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Finerenone.Td"><a href="/books/NBK597221/table/Finerenone.Td/?report=objectonly" target="object" rid-ob="figobFinerenoneTd">Table</a></h4></div></div></div><div id="Finerenone.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Finerenone_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 13 October 2023</p><p>Abbreviations: ACE, angiotensin converting enzyme; ARB, angiotensin receptor blocker; eGFR, estimated glomerular filtration rate; SGLT2, sodium-glucose cotransporter 2.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Finerenone.REF.zimmerman.1999">Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.<div><i>(Review of hepatotoxicity published in 1999 before the availability of finerenone mentions that thiazide diuretics have been implicated in rare instances of hepatotoxicity but does not discuss spironolactone or finerenone).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.fda">FDA. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000IntegratedR.pdf" ref="pagearea=cite-ref&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">https://www<wbr style="display:inline-block"></wbr>&#8203;.accessdata<wbr style="display:inline-block"></wbr>&#8203;.fda.gov/drugsatfda_docs<wbr style="display:inline-block"></wbr>&#8203;/nda/2021/215341Orig1s000IntegratedR.pdf</a><div><i>(FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA integrated review of the finerenone application for safety and efficacy which mentions [page 54] that laboratory findings other than those of electrolytes and creatinine &#x0201c;did not reveal any other findings of interest or concern&#x0201d;).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.pitt.2013.2453">Pitt
B, Kober
L, Ponikowski
P, Gheorghiade
M, Filippatos
G, Krum
H, Nowack
C, et al.
Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial.
Eur Heart J.
2013; 34: 2453-63. [<a href="/pmc/articles/PMC3743070/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC3743070</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/23713082" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 23713082</span></a>]<div><i>(Among 457 patients with chronic renal disease treated with different doses of finerenone [2.5, 5 or 10 mg daily], spironolactone or placebo for 4 weeks, there was less hyperkalemia with finerenone than spironolactone and adverse events were generally mild; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.bakris.2015.884">Bakris
GL, Agarwal
R, Chan
JC, Cooper
ME, Gansevoort
RT, Haller
H, Remuzzi
G, et al.; Mineralocorticoid Receptor Antagonist Tolerability Study&#x02013;Diabetic Nephropathy (ARTS-DN) Study Group. Effect of finerenone on albuminuria in patients with diabetic nephropathy: A randomized clinical trial.
JAMA. 2015; 314: 884-94. [<a href="https://pubmed.ncbi.nlm.nih.gov/26325557" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 26325557</span></a>]<div><i>(Among 821 patients with diabetes and albuminuria treated with 7 different doses of finerenone [1.25 to 25 mg daily] or spironolactone or placebo for 4 weeks, there was a dose-dependent decrease in urinary albumin while hyperkalemia arose with higher doses of finerenone; no mention of ALT levels or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.filippatos.2016.2105">Filippatos
G, Anker
SD, B&#x000f6;hm
M, Gheorghiade
M, K&#x000f8;ber
L, Krum
H, Maggioni
AP, et al.
A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease.
Eur Heart J.
2016; 37: 2105-14. [<a href="/pmc/articles/PMC4946749/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC4946749</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27130705" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 27130705</span></a>]<div><i>(Among 821 adults with diabetes and albuminuria treated with one of 7 different doses of finerenone [1.25 to 25 mg] or placebo once daily for 90 days, there was a dose-dependent reduction in urinary albumin levels in finerenone treated patients and an increased rate of hyperkalemia with the higher doses; no mention of ALT levels or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.bakris.2020.2219">Bakris
GL, Agarwal
R, Anker
SD, Pitt
B, Ruilope
LM, Rossing
P, Kolkhof
P, et al.; FIDELIO-DKD Investigators. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.
N Engl J Med.
2020; 383: 2219-2229. [<a href="https://pubmed.ncbi.nlm.nih.gov/33264825" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 33264825</span></a>]<div><i>(Among 5674 patients with chronic kidney disease and type 2 diabetes treated with finerenone [20 mg daily] or placebo for a median of 2.6 years, finerenone was associated with lower rates of a combined endpoint of renal failure, a decrease in eGFR [40%] and lower rates of renal death [18% vs 21%], but no difference in overall mortality or hospitalization, while adverse event rates were similar in the two groups including those classified as &#x0201c;hepatobiliary&#x0201d; [4.4% vs 4.8%], while discontinuations because of hyperkalemia occurred in 2.3% vs 0.9%).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.ingelfinger.2020.2285">Ingelfinger
JR, Rosen
CJ. Finerenone&#x02013;halting relative hyperaldosteronism in chronic kidney disease.
N Engl J Med.
2020; 383: 2285-2286. [<a href="https://pubmed.ncbi.nlm.nih.gov/33095527" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 33095527</span></a>]<div><i>(Editorial in response to Bakris [2020] discusses the role of aldosterone activation in causing sodium retention but also release of mediators of inflammation and fibrosis, which has led to strategies to decrease aldosterone activation as therapy of chronic renal disease).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.allison.2021.13">Allison
SJ. Finerenone in chronic kidney disease.
Nat Rev Nephrol.
2021; 17: 13. [<a href="https://pubmed.ncbi.nlm.nih.gov/33110253" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 33110253</span></a>]<div><i>(Commentary on the results of treating patients with chronic kidney disease with long term finerenone [Bakris 2020] and role of aldosterone activation in causing inflammation and fibrosis leading to progression of renal and heart disease, mentions that an ongoing trial will assess the effects of finerenone on patients with less advanced chronic renal disease).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.heinig.2018.715">Heinig
R, Gerisch
M, Engelen
A, Nagelschmitz
J, Loewen
S. Pharmacokinetics of the novel, selective, non-steroidal mineralocorticoid receptor antagonist finerenone in healthy volunteers: results from an absolute bioavailability study and drug-drug interaction studies in vitro and in vivo.
Eur J Drug Metab Pharmacokinet.
2018;43:715-727. [<a href="https://pubmed.ncbi.nlm.nih.gov/29779093" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 29779093</span></a>]<div><i>(Evaluation of pharmacokinetics of finerenone in health volunteers found that it was metabolized mostly by CYP 3A4 and to a lesser extent by CYP 2C8, but only CYP 3A4 inducers and inhibitors had an effect on finerenone levels).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.agarwal.2022.474">Agarwal
R, Filippatos
G, Pitt
B, Anker
SD, Rossing
P, Joseph
A, Kolkhof
P, et al.; FIDELIO-DKD and FIGARO-DKD investigators. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.
Eur Heart J.
2022;43:474-484. [<a href="/pmc/articles/PMC8830527/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC8830527</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/35023547" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 35023547</span></a>]<div><i>(Pooled analysis of two randomized controlled trials of finerenone [10 or 20 mg] versus placebo in patients with type 2 diabetes and chronic renal disease in 13,026 adults with median follow up of 3 years found lower rates of composite endpoints of cardiovascular events and worsening renal function with finerenone therapy [12.7% vs 14.4%], with similar adverse event rates [86.1% vs 86.4%] but higher rates of hyperkalemia [12% vs 6%]; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF11">Finerenone (Kerendia) for chronic kidney disease.
Med Lett Drugs Ther.
2021;63:131-132. [<a href="https://pubmed.ncbi.nlm.nih.gov/34544101" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 34544101</span></a>]<div><i>(Concise summary of the mechanism of action, clinical efficacy, safety, and costs of finerenone shortly after its approval in the US, mentions adverse events of hyperkalemia, hyponatremia, and hypotension; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.rossing.2022.2991">Rossing
P, Anker
SD, Filippatos
G, Pitt
B, Ruilope
LM, Birkenfeld
AL, McGill
JB, et al.; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone in patients with chronic kidney disease and type 2 diabetes by sodium-glucose cotransporter 2 inhibitor treatment: The FIDELITY Analysis.
Diabetes Care.
2022;45:2991-2998. [<a href="/pmc/articles/PMC9862372/" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pmc">PMC free article<span class="bk_prnt">: PMC9862372</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/35972218" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 35972218</span></a>]<div><i>(Re-analysis of trials of finerenone in patients with chronic renal disease and diabetes showed that it was effective in the subgroup of patients receiving SGLT2 inhibitors with no difference in tolerance).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF13">In brief: Finerenone (Kerendia) for diabetic kidney disease.
Med Lett Drugs Ther.
2023;65:15-16. [<a href="https://pubmed.ncbi.nlm.nih.gov/36651794" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 36651794</span></a>]<div><i>(Brief summary of the mechanism of action, clinical efficacy and safety of finerenone shortly after published guidelines on its use were published, mentions that finerenone has been shown to modestly improve renal and cardiovascular outcomes, but it is expensive and can cause hyperkalemia).</i></div></div></li><li><div class="bk_ref" id="Finerenone.REF.perakakis.2023">Perakakis
N, Bornstein
SR, Birkenfeld
AL, Linkermann
A, Demir
M, Anker
SD, Filippatos
G, et al.; FIDELIO-DKD and FIGARO-DKD investigators. Efficacy of finerenone in patients with type 2 diabetes, chronic kidney disease and altered markers of liver steatosis and fibrosis: A FIDELITY subgroup analysis.
Diabetes Obes Metab.
2023
Oct
10. Epub ahead of print. [<a href="https://pubmed.ncbi.nlm.nih.gov/37814928" ref="pagearea=cite-ref&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubmed">PubMed<span class="bk_prnt">: 37814928</span></a>]<div><i>(Re-analysis of trials of finerenone in patients with chronic renal disease and diabetes focusing upon the subgroup of patients with evidence of concurrent nonalcoholic fatty liver disease found similar efficacy and safety as in patients without evidence of liver abnormalities and that liver tests did not worsen with treatment).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK597221_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">October 13, 2023</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&amp;targetsite=external&amp;targetcat=link&amp;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-. Finerenone. [Updated 2023 Oct 13].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Finasteride/?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/Fingolimod/?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="table-wrap" id="figobFinerenoneTc"><div id="Finerenone.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK597221/table/Finerenone.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Finerenone.Tc_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><br /><p><b>REPRESENTATIVE TRADE NAMES</b></p>
<p>Finerenone &#x02013; Kerendia&#x000ae;</p>
<p><b>DRUG CLASS</b></p>
<p>Cardiovascular Agents</p>
<p><a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?label=all&#x00026;query=Finerenone" ref="pagearea=body&amp;targetsite=external&amp;targetcat=link&amp;targettype=uri">COMPLETE LABELING</a></p>
<p>Product labeling at DailyMed, National Library of Medicine, NIH</p></td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobFinerenoneTd"><div id="Finerenone.Td" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK597221/table/Finerenone.Td/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Finerenone.Td_lrgtbl__"><table><thead><tr><th id="hd_h_Finerenone.Td_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Finerenone.Td_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NO.</th><th id="hd_h_Finerenone.Td_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Finerenone.Td_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Finerenone.Td_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Finerenone</td><td headers="hd_h_Finerenone.Td_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/163643118" ref="pagearea=body&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubchem">1050477-31-0</a>
</td><td headers="hd_h_Finerenone.Td_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C21-H22-N4-O3</td><td headers="hd_h_Finerenone.Td_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/163643118" title="View this structure in PubChem" class="img_link" ref="pagearea=body&amp;targetsite=entrez&amp;targetcat=link&amp;targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&amp;sid=163643118" alt="image 163643118 in the ncbi pubchem database" /></a>
</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>
<!-- Book content -->
<script type="text/javascript" src="/portal/portal3rc.fcgi/rlib/js/InstrumentNCBIBaseJS/InstrumentPageStarterJS.js"> </script>
<!-- CE8B5AF87C7FFCB1_0191SID /projects/books/PBooks@9.11 portal104 v4.1.r689238 Tue, Oct 22 2024 16:10:51 -->
<span id="portal-csrf-token" style="display:none" data-token="CE8B5AF87C7FFCB1_0191SID"></span>
<script type="text/javascript" src="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/js/3968615.js" snapshot="books"></script></body>
</html>