140 lines
51 KiB
Text
140 lines
51 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="NBK548136">
|
|
<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="/NBK548136/?report=reader">
|
|
<meta name="ncbi_pagename" content="Abiraterone - 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>Abiraterone - 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/Abemaciclib/?report=reader">
|
|
<meta name="jr-next-unit" content="/books/n/livertox/Abrocitinib/?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="Abiraterone">
|
|
<meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
|
|
<meta name="citation_date" content="2023/03/15">
|
|
<meta name="citation_pmid" content="31643466">
|
|
<meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK548136/">
|
|
<link rel="schema.DC" href="http://purl.org/DC/elements/1.0/">
|
|
<meta name="DC.Title" content="Abiraterone">
|
|
<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="2023/03/15">
|
|
<meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK548136/">
|
|
<meta name="description" content="Abiraterone is a steroidal antiandrogen used to treat metastatic, castration-resistant prostate cancer. Abiraterone is associated with an appreciable rate of serum enzyme elevation during therapy and with rare but potentially severe instances of acute liver injury with jaundice.">
|
|
<meta name="og:title" content="Abiraterone">
|
|
<meta name="og:type" content="book">
|
|
<meta name="og:description" content="Abiraterone is a steroidal antiandrogen used to treat metastatic, castration-resistant prostate cancer. Abiraterone is associated with an appreciable rate of serum enzyme elevation during therapy and with rare but potentially severe instances of acute liver injury with jaundice.">
|
|
<meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK548136/">
|
|
<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/Abiraterone/?report=reader">
|
|
<link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK548136/">
|
|
<link href="https://fonts.googleapis.com/css?family=Archivo+Narrow:400,700,400italic,700italic&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="CE8B64897D7B3541000000000069005A.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/NBK548136/?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/Abemaciclib/?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">Abiraterone</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/Abrocitinib/?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/NBK548136/"><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/NBK548136/&text=Abiraterone"><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/NBK548136/?report=classic">Switch to classic view</a><a href="/books/NBK548136/pdf/Bookshelf_NBK548136.pdf">PDF (113K)</a><a href="/books/NBK548136/?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%20NBK548136%20%2F%20sid%3ACE8B5AF87C7FFCB1_0191SID%20%2F%20phid%3ACE8B64897D7B3541000000000069005A.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">✘</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">✘</a></nav><nav id="jr-fip-info-p"><a id="jr-fip-prev" class="wsprkl btn" title="Jump to previuos match">◀</a><button id="jr-fip-matches">no matches 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="_NBK548136_"><span class="title" itemprop="name">Abiraterone</span></h1><p class="fm-aai"><a href="#_NBK548136_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Abiraterone.OVERVIEW"><h2 id="_Abiraterone_OVERVIEW_">OVERVIEW</h2><div id="Abiraterone.Introduction"><h3>Introduction</h3><p>Abiraterone is a steroidal antiandrogen used to treat metastatic, castration-resistant prostate cancer. Abiraterone is associated with an appreciable rate of serum enzyme elevation during therapy and with rare but potentially severe instances of acute liver injury with jaundice.</p></div><div id="Abiraterone.Background"><h3>Background</h3><p>Abiraterone (a" bir a' ter one) acetate is a semi-synthetic inhibitor of CYP17, a critical enzyme in the pathway of androgen production in the testes and adrenal glands. Abiraterone is used to treat metastatic prostate cancer in men who have undergone castration. The additional inhibition of androgenic steroid synthesis in the adrenals inhibits the growth of the androgen-sensitive prostate cancer cells. Therapy with abiraterone has been shown to prolong relapse-free as well as overall survival in men with metastatic, castration-resistant prostate cancer. Because it acts on another step in the pathway of androgen synthesis and action, abiraterone has been used in combination with agents that block androgen receptors such as enzalutamide and apalutamide, but the combination has not been found to be superior to abiraterone alone. Abiraterone was approved for use in the United States in 2011. It is given in combination with prednisone to prevent hypocorticoidism because abiraterone also inhibits the pathway of cortisol synthesis. In patients who have not undergone orchiectomy, abiraterone should be given in combination with a gonadotropin releasing hormone (GnRH). Abiraterone is available as 250 and 500 mg tablets generically and under the brand name Zytiga. The typical dose is 1000 mg daily in combination with 5 mg of prednisone twice daily. Common side effects include fatigue, nausea, vomiting, diarrhea and abdominal discomfort. Inhibition of CYP17 can also lead to symptoms of mineralocorticoid excess such as hypertension, hypokalemia and fluid retention. Rare but potentially severe adverse events include adrenocortical insufficiency, hypoglycemia in patients with diabetes, increased fractures, embryo-fetal toxicity and hepatotoxicity.</p></div><div id="Abiraterone.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Serum aminotransferase elevations occur in up to 13% of patients treated with abiraterone compared with 1% to 8% receiving placebo or a comparator drug, but the abnormalities are generally mild, transient and not associated with symptoms or jaundice. ALT elevations above 5 times the upper limit of normal (ULN) occur in 6% of abiraterone treated vs <1% of placebo treated subjects. While clinically apparent liver injury with jaundice was not reported in the preregistration trials of abiraterone, at least 4 cases of acute liver injury with jaundice were reported after its approval and more widespread clinical use. The clinical features of the liver injury have not been well described, but the latency to onset in reported cases ranged from 4 to 8 weeks and the clinical pattern of illness was acute hepatocellular injury without immune allergic features. Because of the risk of severe acute liver injury with abiraterone therapy, the product label recommends screening for routine liver tests before starting therapy and monitoring of liver tests every 2 weeks for the first 3 months of therapy and monthly thereafter.</p><p>Likelihood score: C (probable rare cause of clinically apparent liver injury).</p></div><div id="Abiraterone.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The cause of hepatic injury from abiraterone is unknown, but may relate to its mechanism of action in inhibition of CYP17. In addition, abiraterone is metabolized in the liver by the cytochrome P450 system, predominantly CYP 3A4 and 2D6, which may lead to formation of a toxic or immunogenic intermediate. Abiraterone is susceptible to drug-drug interactions with inhibitors, inducers or substrates of the CYP 3A4 or 2D6 microsomal enzymes.</p></div><div id="Abiraterone.Outcome_and_Management"><h3>Outcome and Management</h3><p>The severity of the liver injury linked to abiraterone therapy has been generally mild, consisting of transient and asymptomatic elevations in serum aminotransferase levels. The product label recommends measuring aminotransferase levels every 2 weeks for 3 months and monthly thereafter and stopping therapy if levels rise above 5 times ULN. Abiraterone should not be restarted unless levels return to normal. Any elevation in ALT in the presence of jaundice or symptoms should lead to permanent discontinuation. Abiraterone has not been linked to cases of chronic hepatitis or vanishing bile duct syndrome. There is no information on cross sensitivity to hepatic injury between abiraterone and other antiandrogens.</p><p>Drug Class: <a href="/books/n/livertox/?report=reader">Antineoplastic Agents</a>, <a href="/books/n/livertox/Anti-androgens/?report=reader">Antiandrogens</a></p></div></div><div id="Abiraterone.PRODUCT_INFORMATION"><h2 id="_Abiraterone_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figAbirateroneTc"><a href="/books/NBK548136/table/Abiraterone.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figAbirateroneTc" rid-ob="figobAbirateroneTc"><img class="small-thumb" src="/books/NBK548136/table/Abiraterone.Tc/?report=thumb" src-large="/books/NBK548136/table/Abiraterone.Tc/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Abiraterone.Tc"><a href="/books/NBK548136/table/Abiraterone.Tc/?report=objectonly" target="object" rid-ob="figobAbirateroneTc">Table</a></h4><p class="float-caption no_bottom_margin"><i>REPRESENTATIVE TRADE NAMES</i> Abiraterone – Generic, Zytiga®</p></div></div></div><div id="Abiraterone.CHEMICAL_FORMULA_AND_STRUCTU"><h2 id="_Abiraterone_CHEMICAL_FORMULA_AND_STRUCTU_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figAbirateroneTd"><a href="/books/NBK548136/table/Abiraterone.Td/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figAbirateroneTd" rid-ob="figobAbirateroneTd"><img class="small-thumb" src="/books/NBK548136/table/Abiraterone.Td/?report=thumb" src-large="/books/NBK548136/table/Abiraterone.Td/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Abiraterone.Td"><a href="/books/NBK548136/table/Abiraterone.Td/?report=objectonly" target="object" rid-ob="figobAbirateroneTd">Table</a></h4></div></div></div><div id="Abiraterone.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Abiraterone_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 15 March 2023</p><p>Abbreviations: LHRH, luteinizing hormone releasing hormone; PSA, prostate specific-antigen.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Abiraterone.REF.zimmerman.1999">Zimmerman HJ. Hepatotoxic effects of oncotherapeutic and immunosuppressive agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 673-708.<div><i>(Expert review of hepatotoxicity of cancer chemotherapeutic agents published in 1999 before the availability of abiraterone).</i></div></div></li><li><div class="bk_ref" id="Abiraterone.REF.deleve.2013">DeLeve LD. Cancer chemotherapy. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam, Elsevier, 2013, p. 541-68.<div><i>(Review of hepatotoxicity of cancer chemotherapeutic agents; abiraterone is not discussed).</i></div></div></li><li><div class="bk_ref" id="Abiraterone.REF.chabner.2011">Chabner BA, Bertino J, Cleary J, Ortiz T, Lane A, Supko JG, Ryan DP. Cytotoxic agents. Chemotherapy of neoplastic diseases. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, p. 1698.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Abiraterone.REF.danila.2010.1496">Danila DC, Morris MJ, de Bono JS, Ryan CJ, Denmeade SR, Smith MR, Taplin ME, et al. Phase II multicenter study of abiraterone acetate plus prednisone therapy in patients with docetaxel-treated castration-resistant prostate cancer. <span><span class="ref-journal">J Clin Oncol. </span>2010;<span class="ref-vol">28</span>:1496–501.</span> [<a href="/pmc/articles/PMC3040042/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3040042</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20159814" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20159814</span></a>]<div>
|
|
<i>(Among 58 men with castration-resistant, metastatic prostate cancer who had failed docetaxel treatment and were then treated with abiraterone and prednisone, adverse events included fatigue, nausea, vomiting and diarrhea and 3 patients [5%] had ALT elevations, but none were above 3 times ULN).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.ryan.2011.4854">Ryan CJ, Shah S, Efstathiou E, Smith MR, Taplin ME, Bubley GJ, Logothetis CJ, et al. Phase II study of abiraterone acetate in chemotherapy-naive metastatic castration-resistant prostate cancer displaying bone flare discordant with serologic response. <span><span class="ref-journal">Clin Cancer Res. </span>2011;<span class="ref-vol">17</span>:4854–61.</span> [<a href="/pmc/articles/PMC3657705/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3657705</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/21632851" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21632851</span></a>]<div>
|
|
<i>(Among 33 patients with castration-resistant prostate cancer treated with abiraterone and prednisone in continuous 28 day cycles, adverse events were common but usually mild; no mention of ALT elevations or hepatotoxicity).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.fizazi.2012.983">Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, et al. COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. <span><span class="ref-journal">Lancet Oncol. </span>2012;<span class="ref-vol">13</span>:983–92.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/22995653" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22995653</span></a>]<div>
|
|
<i>(Among 1195 men with metastatic, castration-resistant prostate cancer enrolled in a controlled trial of abiraterone with prednisone or prednisone alone, both overall and progression free survival were prolonged in the abiraterone arm while side effects were similar in the two groups, including fatigue [9% vs 10%], anemia [8% vs 8%], back pain [7% vs 10%] and abnormal liver tests above 5 times ULN [3.7% vs 3.6%).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.kluetz.2013.6650">Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, et al. Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. <span><span class="ref-journal">Clin Cancer Res. </span>2013;<span class="ref-vol">19</span>:6650–6.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/24150234" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24150234</span></a>]<div>
|
|
<i>(Summary of clinical results in support of FDA decision to approve abiraterone in combination with prednisone for metastatic, castration-resistant prostate cancer mentions that ALT elevations above 5 times ULN occurred in 6.1% of treated versus 0.7% of control subjects, but that there were no liver related deaths or ALT elevations with jaundice in the preregistration studies [although 2 cases were subsequently reported to the sponsor]).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.rathkopf.2014.815">Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, et al. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). <span><span class="ref-journal">Eur Urol. </span>2014;<span class="ref-vol">66</span>:815–25.</span> [<a href="/pmc/articles/PMC4418928/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4418928</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/24647231" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24647231</span></a>]<div>
|
|
<i>(Among 1088 patients with metastatic, castration-resistant prostate cancer treated with abiraterone and prednisone vs prednisone alone [Fizazi 2012] with further follow up, progression-free but not overall survival was significantly better with abiraterone and side effects included fatigue, back pain, arthralgia, peripheral edema, nausea, constipation and diarrhea; ALT elevations above 5 times ULN occurred in 6% vs 1% of patients and was a cause of some early discontinuations for adverse events).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.caffo.2015.764">Caffo O, De Giorgi U, Fratino L, Lo Re G, Basso U, D'Angelo A, Donini M, et al. Safety and clinical outcomes of patients treated with abiraterone acetate after docetaxel: results of the Italian Named Patient Programme. <span><span class="ref-journal">BJU Int. </span>2015;<span class="ref-vol">115</span>:764–71.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/24988879" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24988879</span></a>]<div>
|
|
<i>(Among 265 Italian patients with metastatic, castration-resistant prostate cancer treated with abiraterone and prednisone, overall mean survival was 17 months and toxicity was rarely dose-limiting; 7 patients [2.6%] developed liver toxicity, but none had ALT values above 5 times ULN).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.sternberg.2014.1263">Sternberg CN, Castellano D, Daugaard G, Géczi L, Hotte SJ, Mainwaring PN, Saad F, et al. Abiraterone Global EAP Investigators. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. <span><span class="ref-journal">Lancet Oncol. </span>2014;<span class="ref-vol">15</span>:1263–8.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/25242048" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25242048</span></a>]<div>
|
|
<i>(Among 2314 patients with metastatic, castration-resistant prostate cancer who participated in a controlled trial and were then enrolled in an early access program and received abiraterone with prednisone for a median of 6 months, 175 [8%] had “grade 3 liver toxicity” but only 13 [1%] had “grade 4”, however, details not provided).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.ryan.2015.152">Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, et al. COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. <span><span class="ref-journal">Lancet Oncol. </span>2015;<span class="ref-vol">16</span>:152–60.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/25601341" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25601341</span></a>]<div>
|
|
<i>(Among 1088 patients with metastatic, castration-resistant prostate cancer treated with abiraterone and prednisone or prednisone alone, overall survival was slightly longer with abiraterone [34.7 vs 30.3 months] and side effects included mild ALT elevations [13% vs 5%] that were rarely greater than 5 times ULN [0.7% vs 0%]; there were no treatment related deaths).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.hou_d_.2015.222">Houédé N, Beuzeboc P, Gourgou S, Tosi D, Moise L, Gravis G, Delva R, et al. Abiraterone acetate in patients with metastatic castration-resistant prostate cancer: long term outcome of the Temporary Authorization for Use programme in France. <span><span class="ref-journal">BMC Cancer. </span>2015;<span class="ref-vol">15</span>:222.</span> [<a href="/pmc/articles/PMC4392747/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4392747</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25884302" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25884302</span></a>]<div>
|
|
<i>(Among 306 patients with metastatic, castration-resistant prostate cancer treated in a French early use program with abiraterone and prednisone, median overall survival was 14.6 months, and 6 patients developed “liver and hepatic” dysfunction; no details provided).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.smith.2015.1277">Smith MR, Rathkopf DE, Mulders PF, Carles J, Van Poppel H, Li J, Kheoh T, et al. Efficacy and safety of abiraterone acetate in elderly (75 years or older) chemotherapy naïve patients with metastatic castration resistant prostate cancer. <span><span class="ref-journal">J Urol. </span>2015;<span class="ref-vol">194</span>:1277–84.</span> [<a href="/pmc/articles/PMC5129174/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5129174</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26151676" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26151676</span></a>]<div>
|
|
<i>(Among 350 elderly men with metastatic, castration-resistant prostate cancer treated with abiraterone and prednisone vs prednisone alone, both overall and progression-free was higher in the abiraterone treated group and “hepatotoxicity” was greater in the elderly than the younger subjects, being above 5 times ULN in 20.9% vs 9.8% in the treated and 4% and 7.4% in the controls).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.van_praet.2016.254">Van Praet C, Rottey S, Van Hende F, Pelgrims G, Demey W, Van Aelst F, Wynendaele W, et al. Abiraterone acetate post-docetaxel for metastatic castration-resistant prostate cancer in the Belgian compassionate use program. <span><span class="ref-journal">Urol Oncol. </span>2016;<span class="ref-vol">34</span>:254.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/26850781" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26850781</span></a>]<div>
|
|
<i>(Among 368 men with metastatic, castration-resistant prostate cancer treated with abiraterone and prednisone in a Belgian compassionate use program, median overall survival was 15 months and side effects include anemia [14%], hypokalemia [ 7%], fatigue [7%] and liver enzyme elevations [3.5%]; no mention of clinically apparent liver injury).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.sun.2016.404">Sun Y, Zou Q, Sun Z, Li C, Du C, Chen Z, Shan Y, et al. Abiraterone acetate for metastatic castration-resistant prostate cancer after docetaxel failure: A randomized, double-blind, placebo-controlled phase 3 bridging study. <span><span class="ref-journal">Int J Urol. </span>2016;<span class="ref-vol">23</span>:404–11.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/26879374" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26879374</span></a>]<div>
|
|
<i>(Among 214 Chinese patients with metastatic, castration-resistant prostate cancer treated with abiraterone and prednisone or prednisone alone, overall survival was greater with abiraterone and adverse events were “generally similar between the two treatment groups”; ALT elevations occurring in 9.8% on abiraterone and 11.3% on placebo).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.fizazi.2017.352">Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, et al. LATITUDE Investigators. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. <span><span class="ref-journal">N Engl J Med. </span>2017;<span class="ref-vol">377</span>(4):352–60.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/28578607" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28578607</span></a>]<div>
|
|
<i>(Among 1199 men with metastatic, castration sensitive prostate cancer on androgen-deprivation therapy who were treated with abiraterone and prednisone vs placebo, both overall and progression free survival were increased by abiraterone as were serious adverse events [28% vs 24%] and ALT elevations [16% vs 13%] which were above 5 times ULN in 5% vs 1%).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.narita.2022.1477">Narita S, Kimura T, Hatakeyama S, Hata K, Yanagisawa T, Maita S, Chiba S, et al. Real-world outcomes and risk stratification in patients with metastatic castration-sensitive prostate cancer treated with upfront abiraterone acetate and docetaxel. <span><span class="ref-journal">Int J Clin Oncol. </span>2022;<span class="ref-vol">27</span>:1477–1486.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/35748967" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35748967</span></a>]<div>
|
|
<i>(Among 301 patients with metastatic castration-sensitive prostate cancer treated with abiraterone or docetaxel, the progression free survival was longer with abiraterone but overall survival was similar in the two groups, while severe adverse reactions were more frequent with docetaxel [75% vs 18%], except for ALT elevations which rose to above 5 times ULN in 4.9% of recipients of abiraterone).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.colomba.2020.117">Colomba E, Marret G, Baciarello G, Lavaud P, Massard C, Loriot Y, Albiges L, et al. Liver tests increase on abiraterone acetate in men with metastatic prostate cancer: natural history, management and outcome. <span><span class="ref-journal">Eur J Cancer. </span>2020;<span class="ref-vol">129</span>:117–122.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/32151941" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32151941</span></a>]<div>
|
|
<i>(Among 25 patients who developed ALT elevations while being treated with abiraterone in a randomized controlled trial [Fizazi et al 2017], peak levels were 1-3 times ULN in 7, 3-5 times ULN in 6, and 5-20 times ULN in 9, resolving in 2 to 14 weeks, half without stopping, 2 of 4 redeveloping ALT elevations upon restarting, but none resulting in jaundice).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.yumiba.2017.479">Yumiba S, Komori K, Iwanishi T, Koida Y, Kobayashi M, Ono Y. <span><span class="ref-journal">Hinyokika Kiyo. </span>2017;<span class="ref-vol">63</span>:479–482.</span> [A case of fulminant hepatitis after administration of abiraterone acetate] [<a href="https://pubmed.ncbi.nlm.nih.gov/29232800" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29232800</span></a>]<div>
|
|
<i>(77 year old Japanese man with prostate cancer developed fatigue 27 days after starting abiraterone [ALT 420 U/L] and developed progressive worsening within days [ALT rising to 1487 U/L, prothrombin index falling to 23%, Alk P and bilirubin levels not provided] and died of liver failure 2 weeks later).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.singh.2018.e505">Singh P, Sinha A, Lama Tamang TG, Chandra AB, Huang YJ. Abiraterone-associated fulminant liver failure. <span><span class="ref-journal">Am J Ther. </span>2018;<span class="ref-vol">25</span>:e505–e506.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/28452846" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28452846</span></a>]<div>
|
|
<i>(73 year old man with metastatic prostate cancer developed jaundice 7-8 weeks after starting abiraterone [ALT 1800 U/L, AST 1200 U/L, Alk P and bilirubin not provided], with progressive liver failure and death within 2 weeks of onset; in discussion mentions two more cases of clinically apparent liver injury believed to be due to abiraterone reported to the sponsor).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.saad.2021.1541">Saad F, Efstathiou E, Attard G, Flaig TW, Franke F, Goodman OB Jr, Oudard S, et al. ACIS Investigators. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. <span><span class="ref-journal">Lancet Oncol. </span>2021;<span class="ref-vol">22</span>:1541–1559.</span> [<a href="/pmc/articles/PMC9377412/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9377412</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34600602" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34600602</span></a>]<div>
|
|
<i>(Among 982 men with metastatic prostate cancer treated with abiraterone [1000 mg with prednisone] with or without apalutamide [240 mg], radiographic progression free survival was longer with combination therapy [22.6 vs 16.6 months], but overall survival was not different [67% vs 69%] and adverse events were more frequent with the combination, including hypertension [17% vs 10%] and ALT elevations [12% vs 4%], but there were no hepatic deaths or mention of clinically apparent liver injury).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.scailteux.2022.336">Scailteux LM, Despas F, Balusson F, Campillo-Gimenez B, Mathieu R, Vincendeau S, Happe A, et al. Hospitalization for adverse events under abiraterone or enzalutamide exposure in real-world setting:aA French population-based study on prostate cancer patients. <span><span class="ref-journal">Br J Clin Pharmacol. </span>2022;<span class="ref-vol">88</span>:336–346.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/34224605" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34224605</span></a>]<div>
|
|
<i>(Among 11,534 patients newly started on abiraterone or enzalutamide therapy for prostate cancer who were enrolled in the French National Health Insurance System Database between 2013 and 2017, liver test abnormalities were more frequent with abiraterone [17% vs 6%] as were acute kidney injury and atrial fibrillation while “hepatitis” was rare [<0.1%]).</i>
|
|
</div></div></li><li><div class="bk_ref" id="Abiraterone.REF.yanagisawa.2022.3">Yanagisawa T, Kimura T, Mori K, Suzuki H, Sano T, Otsuka T, Iwamoto Y, et al. Abiraterone acetate versus nonsteroidal antiandrogen with androgen deprivation therapy for high-risk metastatic hormone-sensitive prostate cancer. <span><span class="ref-journal">Prostate. </span>2022;<span class="ref-vol">82</span>:3–12.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/34559410" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34559410</span></a>]<div>
|
|
<i>(Among 312 men with prostate cancer treated with abiraterone [1000 mg] or bicalutamide [80 mg] daily, overall and cancer specific survival were similar in the two groups, but adverse events were more common with abiraterone [27% vs 21%] as was “impaired liver function” [16% vs 2%], although there were no deaths or severe adverse events attributed to liver injury).</i>
|
|
</div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548136_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">March 15, 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&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-. Abiraterone. [Updated 2023 Mar 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Abemaciclib/?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/Abrocitinib/?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="figobAbirateroneTc"><div id="Abiraterone.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548136/table/Abiraterone.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Abiraterone.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>Abiraterone – Generic, Zytiga®</p>
|
|
<p><b>DRUG CLASS</b></p>
|
|
<p>Antineoplastic Agents</p>
|
|
<p><a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Abiraterone" ref="pagearea=body&targetsite=external&targetcat=link&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="figobAbirateroneTd"><div id="Abiraterone.Td" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548136/table/Abiraterone.Td/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Abiraterone.Td_lrgtbl__"><table><thead><tr><th id="hd_h_Abiraterone.Td_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Abiraterone.Td_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Abiraterone.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_Abiraterone.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_Abiraterone.Td_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Abiraterone</td><td headers="hd_h_Abiraterone.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/135089190" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">154229-19-3</a>
|
|
</td><td headers="hd_h_Abiraterone.Td_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C24-H31-N-O</td><td headers="hd_h_Abiraterone.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/135089190" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=135089190" alt="image 135089190 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>
|