136 lines
32 KiB
Text
136 lines
32 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="NBK605685">
|
|
<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="/NBK605685/?report=reader">
|
|
<meta name="ncbi_pagename" content="REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab - 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>REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab - 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/Quizartinib/?report=reader">
|
|
<meta name="jr-next-unit" content="/books/n/livertox/Rabeprazole/?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="REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab">
|
|
<meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
|
|
<meta name="citation_date" content="2024/06/14">
|
|
<meta name="citation_pmid" content="39110827">
|
|
<meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK605685/">
|
|
<link rel="schema.DC" href="http://purl.org/DC/elements/1.0/">
|
|
<meta name="DC.Title" content="REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab">
|
|
<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="2024/06/14">
|
|
<meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK605685/">
|
|
<meta name="description" content="Atoltivimab, maftivimab, and odesivimab are three human monoclonal antibodies to Zaire ebolavirus that are given in combination and used to treat children and adults with acute Zaire ebolavirus infection. Therapy with atoltivimab, maftivimab, and odesivimab has not been associated with serum aminotransferase elevations nor to instances of clinically apparent liver injury.">
|
|
<meta name="og:title" content="REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab">
|
|
<meta name="og:type" content="book">
|
|
<meta name="og:description" content="Atoltivimab, maftivimab, and odesivimab are three human monoclonal antibodies to Zaire ebolavirus that are given in combination and used to treat children and adults with acute Zaire ebolavirus infection. Therapy with atoltivimab, maftivimab, and odesivimab has not been associated with serum aminotransferase elevations nor to instances of clinically apparent liver injury.">
|
|
<meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK605685/">
|
|
<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/REGN-EB3/?report=reader">
|
|
<link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK605685/">
|
|
<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="CE8EB9927D7FE5510000000000F600CE.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/NBK605685/?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/Quizartinib/?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">REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab: Short Chapter</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/Rabeprazole/?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/NBK605685/"><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/NBK605685/&text=REGN-EB3%20%02013%20Atoltivimab%2C%20Maftivimab%2C%20Odesivimab"><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/NBK605685/?report=classic">Switch to classic view</a><a href="/books/NBK605685/pdf/Bookshelf_NBK605685.pdf">PDF (93K)</a><a href="/books/NBK605685/?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%20NBK605685%20%2F%20sid%3ACE8B5AF87C7FFCB1_0191SID%20%2F%20phid%3ACE8EB9927D7FE5510000000000F600CE.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="_NBK605685_"><span class="title" itemprop="name">REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab</span></h1><div class="subtitle">Short Chapter</div><p class="fm-aai"><a href="#_NBK605685_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><p>
|
|
<i>[Preliminary review chapter based on the FDA Product Labeling and Integrated Review only.]</i>
|
|
</p><div id="REGN-EB3.OVERVIEW"><h2 id="_REGN-EB3_OVERVIEW_">OVERVIEW</h2><div id="REGN-EB3.Introduction"><h3>Introduction</h3><p>Atoltivimab, maftivimab, and odesivimab are three human monoclonal antibodies to Zaire ebolavirus that are given in combination and used to treat children and adults with acute Zaire ebolavirus infection. Therapy with atoltivimab, maftivimab, and odesivimab has not been associated with serum aminotransferase elevations nor to instances of clinically apparent liver injury.</p></div><div id="REGN-EB3.Background"><h3>Background</h3><p>Atoltivimab, maftivimab, and odesivimab are three human monoclonal antibodies to the surface glycoprotein of Zaire ebolavirus that are co-formulated and used in combination to treat adults and children with acute ebolavirus infection. Ebolaviruses are single stranded RNA viruses that have caused multiple outbreaks of severe hemorrhagic fever in Western and Equatorial Africa. Ebolavirus is highly infectious and rapidly progressive. The incubation period ranges from 2 to 21 days and the disease presents with fever, muscle aches, and fatigue followed by diarrhea, vomiting, and abdominal pain. In severe cases, these symptoms are followed by coagulopathy, diffuse bleeding, circulatory collapse, and multiorgan failure. The fatality rate in most outbreaks has averaged 50% but is lower with aggressive supportive therapy. Monoclonal antibodies are the only approved antiviral therapy for ebolavirus infections. The antibodies bind to the major surface glycoprotein of the virus inducing immunologic clearance. All three monoclonal antibodies were found to reduce viral loads and improve survival in rhesus macaques with acute, experimental ebolavirus infection. The combination was used in human studies to avoid development of antiviral resistance and was shown to improve survival in children and adults with ebolavirus infection occurring during an outbreak in the Democratic Republic of the Congo. The combination of the three monoclonal antibodies is referred to as REGN-EB3 and by the proprietary name Inmazeb. REGN-EB3 was given accelerated approval by the FDA under Orphan Drug and Breakthrough Therapy designation in 2020. REGN-EB3 is available in single dose vials of 241.7 mg of atoltivimab, maftivimab, and odesivimab in 14.5 mL (16.67 mg of each per mL); and are available in single dose vials of 483.3 mg of each monoclonal antibody in 14.5 mL (33.33 mg of each per mL). The recommended dose regimen is 50 mg/kg of each as a single intravenous infusion. Common adverse events include infusion reactions, fever, chills, tachycardia, tachypnea, nausea, and vomiting. Serious adverse events include severe hypersensitivity reactions including anaphylaxis.</p></div><div id="REGN-EB3.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Liver injury is frequent in patients with acute ebolavirus infections but there is no evidence that treatment with REGN-EB3 exacerbates the injury. In healthy volunteers, a single intravenous administration of the three monoclonal antibodies did not cause serum aminotransferase or bilirubin elevations. The controlled clinical trial of REGN-EB3 was conducted in the Democratic Republic of Congo in 2018, and adverse events were largely the typical signs and symptoms of acute ebolavirus infection. In the clinical trial conducted in 322 adults and children, serum ALT elevations above 5 times the upper limit of normal (ULN) arose in 10% of REGN-EB3 recipients and 14% of monoclonal antibody control recipients. Since approval of the combination monoclonal antibody therapy in 2020, there have been no reports of clinically apparent liver injury attributed to their use. Prospective, open-label studies of REGN-EB3 in patients with ebolavirus infection continue to be monitored for safety and efficacy.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p></div><div id="REGN-EB3.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>Monoclonal antibodies are degraded by many tissues and metabolized to peptides and amino acids. The antiviral therapy is given as a single infusion. It is unlikely that the monoclonal antibodies could cause either direct or idiosyncratic liver injury. While hypersensitivity reactions to REGN-EB3 might be accompanied by mild elevations in serum enzymes, no such events have been reported.</p><p>Drug Class: <a href="/books/n/livertox/MonoclonalAntibodies/?report=reader">Monoclonal Antibodies</a>, Ebolavirus Agents</p></div></div><div id="REGN-EB3.PRODUCT_INFORMATION"><h2 id="_REGN-EB3_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
|
|
<b>REPRESENTATIVE TRADE NAMES</b>
|
|
</p><p>Atoltivimab, Maftivimab, Odesivimab – Inmazeb®</p><p>
|
|
<b>DRUG CLASS</b>
|
|
</p><p>Monoclonal Antibodies</p><p>
|
|
<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Inmazeb" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
|
|
</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="REGN-EB3.CHEMICAL_FORMULA_AND_STRUCTURE"><h2 id="_REGN-EB3_CHEMICAL_FORMULA_AND_STRUCTURE_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figREGNEB3Tc"><a href="/books/NBK605685/table/REGN-EB3.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img" rid-ob="figobREGNEB3Tc"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="REGN-EB3.Tc"><a href="/books/NBK605685/table/REGN-EB3.Tc/?report=objectonly" target="object" rid-ob="figobREGNEB3Tc">Table</a></h4></div></div></div><div id="REGN-EB3.SELECTED_BIBLIOGRAPHY"><h2 id="_REGN-EB3_SELECTED_BIBLIOGRAPHY_">SELECTED BIBLIOGRAPHY</h2><p>References updated: 14 June 2024</p><p>Abbreviations: ULN, upper limit of the normal range.</p><p><b><i>[Short Chapter</i></b>
|
|
<i>information is based largely on FDA Product Labeling and the FDA Integrated Review accessible from the FDA website</i>
|
|
<a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri"><i>https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm</i></a><i>. All other references have not been fully reviewed and annotated.]</i></p><ul class="first-line-outdent"><li><div class="bk_ref" id="REGN-EB3.REF1">FDA. Integrated Review. 2020. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761169Orig1s000MultidisciplineR.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.accessdata<wbr style="display:inline-block"></wbr>​.fda.gov/drugsatfda_docs<wbr style="display:inline-block"></wbr>​/nda/2020/761169Orig1s000MultidisciplineR.pdf</a><div><i>(FDA summary data on the safety and efficacy of the combination of atoltivimab, maftivimab, and odesivimab [REGN-EB3], submitted in support of the application for approval as therapy of Zaire ebolavirus infection, mentions that ALT elevations arose in 31.8% of 154 patients receiving REGN-EB3 vs 31.0% of 168 receiving a control monoclonal antibody, while ALT values above 5 times ULN arose in 10.4% vs 14.3%).</i></div></div></li><li><div class="bk_ref" id="REGN-EB3.REF.sivapalasingam.2018.884">Sivapalasingam
|
|
S, Kamal
|
|
M, Slim
|
|
R, Hosain
|
|
R, Shao
|
|
W, Stoltz
|
|
R, Yen
|
|
J, et al.
|
|
Safety, pharmacokinetics, and immunogenicity of a co-formulated cocktail of three human monoclonal antibodies targeting Ebola virus glycoprotein in healthy adults: a randomised, first-in-human phase 1 study.
|
|
Lancet Infect Dis.
|
|
2018;18:884-893.
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/29929783" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29929783</span></a>]</div></li><li><div class="bk_ref" id="REGN-EB3.REF.mulangu.2019.2293">Mulangu
|
|
S, Dodd
|
|
LE, Davey
|
|
RT
|
|
Jr, Tshiani Mbaya
|
|
O, Proschan
|
|
M, Mukadi
|
|
D, Lusakibanza Manzo
|
|
M, et al.; PALM Consortium Study Team. A randomized, controlled trial of Ebola virus disease therapeutics.
|
|
N Engl J Med.
|
|
2019;381:2293-2303.
|
|
[<a href="/pmc/articles/PMC10680050/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10680050</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31774950" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31774950</span></a>]</div></li><li><div class="bk_ref" id="REGN-EB3.REF.shears.2020.100038">Shears
|
|
P, Garavan
|
|
C.
|
|
The 2018/19 Ebola epidemic the Democratic Republic of the Congo (DRC): epidemiology, outbreak control, and conflict.
|
|
Infect Prev Pract.
|
|
2020;2:100038.
|
|
[<a href="/pmc/articles/PMC8336035/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8336035</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34368690" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34368690</span></a>]</div></li><li><div class="bk_ref" id="REGN-EB3.REF.markham.2021.175">Markham
|
|
A.
|
|
REGN-EB3: first approval.
|
|
Drugs.
|
|
2021;81:175-178.
|
|
[<a href="/pmc/articles/PMC7799152/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7799152</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33432551" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33432551</span></a>]</div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK605685_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">June 14, 2024</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-. REGN-EB3 – Atoltivimab, Maftivimab, Odesivimab: Short Chapter. [Updated 2024 Jun 14].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Quizartinib/?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/Rabeprazole/?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="figobREGNEB3Tc"><div id="REGN-EB3.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK605685/table/REGN-EB3.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__REGN-EB3.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_REGN-EB3.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_REGN-EB3.Tc_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_REGN-EB3.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_REGN-EB3.Tc_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_REGN-EB3.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Atoltivimab</td><td headers="hd_h_REGN-EB3.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<a href="https://pubchem.ncbi.nlm.nih.gov/substance/381126899" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">1299440-37-1</a>
|
|
</td><td headers="hd_h_REGN-EB3.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Monoclonal Antibody</td><td headers="hd_h_REGN-EB3.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not Available</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 portal107 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>
|