165 lines
37 KiB
Text
165 lines
37 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="NBK612205">
|
|
<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="/NBK612205/?report=reader">
|
|
<meta name="ncbi_pagename" content="Efgartigimod alfa, alfa/Hyaluronidase - 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>Efgartigimod alfa, alfa/Hyaluronidase - 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/Efavirenz/?report=reader">
|
|
<meta name="jr-next-unit" content="/books/n/livertox/Elacestrant/?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="Efgartigimod alfa, alfa/Hyaluronidase">
|
|
<meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
|
|
<meta name="citation_date" content="2025/02/02">
|
|
<meta name="citation_pmid" content="39977572">
|
|
<meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK612205/">
|
|
<link rel="schema.DC" href="http://purl.org/DC/elements/1.0/">
|
|
<meta name="DC.Title" content="Efgartigimod alfa, alfa/Hyaluronidase">
|
|
<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="2025/02/02">
|
|
<meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK612205/">
|
|
<meta name="description" content="Efgartigimod alfa is a neonatal Fc receptor blocker that is used in the treatment of adults with generalized myasthenia gravis who test positive for anti-acetylcholine receptor antibody. Efgartigimod alfa has not been associated with elevations in serum aminotransferase levels or with cases of clinically apparent liver injury.">
|
|
<meta name="og:title" content="Efgartigimod alfa, alfa/Hyaluronidase">
|
|
<meta name="og:type" content="book">
|
|
<meta name="og:description" content="Efgartigimod alfa is a neonatal Fc receptor blocker that is used in the treatment of adults with generalized myasthenia gravis who test positive for anti-acetylcholine receptor antibody. Efgartigimod alfa has not been associated with elevations in serum aminotransferase levels or with cases of clinically apparent liver injury.">
|
|
<meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK612205/">
|
|
<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/Efgartigimod/?report=reader">
|
|
<link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK612205/">
|
|
<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="CE8B47997C8DB5410000000000740061.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/NBK612205/?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/Efavirenz/?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">Efgartigimod alfa, alfa/Hyaluronidase</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/Elacestrant/?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/NBK612205/"><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/NBK612205/&text=Efgartigimod%20alfa%2C%20alfa%2FHyaluronidase"><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/NBK612205/?report=classic">Switch to classic view</a><a href="/books/NBK612205/pdf/Bookshelf_NBK612205.pdf">PDF (90K)</a><a href="/books/NBK612205/?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%20NBK612205%20%2F%20sid%3ACE8B5AF87C7FFCB1_0191SID%20%2F%20phid%3ACE8B47997C8DB5410000000000740061.4">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="_NBK612205_"><span class="title" itemprop="name">Efgartigimod alfa, alfa/Hyaluronidase</span></h1><p class="fm-aai"><a href="#_NBK612205_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Efgartigimod.OVERVIEW"><h2 id="_Efgartigimod_OVERVIEW_">OVERVIEW</h2><div id="Efgartigimod.Introduction"><h3>Introduction</h3><p>Efgartigimod alfa is a neonatal Fc receptor blocker that is used in the treatment of adults with generalized myasthenia gravis who test positive for anti-acetylcholine receptor antibody. Efgartigimod alfa has not been associated with elevations in serum aminotransferase levels or with cases of clinically apparent liver injury.</p></div><div id="Efgartigimod.Background"><h3>Background</h3><p>Efgartigimod alfa (ef” gar tig’ i mod) is a modified, recombinant human IgG1 Fc fragment that binds to the neonatal Fc receptor site on cell surface membranes and prevents immunoglobulin G (IgG) recycling, thus increasing rates of IgG degradation without affecting its production or function. Efgartigimod decreases levels of IgG in the circulation which particularly affects autoantibody levels. Efgartigimod has been evaluated as therapy of several autoimmune diseases but was initially approved only for adults with myasthenia gravis. Myasthenia gravis is a rare autoimmune neuromuscular disease which is characterized by autoantibodies to the acetylcholine receptor. These autoantibodies block acetylcholine neurotransmission and result in weakness in skeletal muscles, particularly those of the eye, face, throat, and limbs. Myasthenia gravis is typically treated with anticholinesterases which prolonged acetylcholine actions, but which are usually only partly effective. Other agents used off label include corticosteroids, azathioprine, tacrolimus, methotrexate, and rituximab. Eculizumab, a monoclonal antibody to complement factor 5, was approved for use in refractory myasthenia gravis in 2017. Efgartigimod alfa was evaluated in adults with refractory myasthenia gravis and found to lead to improvements in muscle function in a high proportion of patients. Efgartigimod alfa was granted accelerated approval for use in myasthenia gravis in the United States in 2021. Current indications are limited to adults who are positive for anti-acetylcholine antibodies (found in 80 to 90% of patients). Efgartigimod alfa is available in solution in single dose vials of 400 mg/20 mL [20 mg/mL] under the brand name Vyvgart. The recommended dose regimen is 10 mg/kg given iv over one hour once weekly for 4 weeks, with further 4-week cycles based upon efficacy and tolerance. In 2023, the combination of efgartigimod alfa with hyaluronidase, which allows for subcutaneous administration, was approved for the same indication, available in single dose vials of 1008 mg of efgartigimod alfa and 11,200 units of hyaluronidase under the brand name Vyvgart Hytrulo. The recommended regimen is one vial given sc in cycles of once weekly for 4 weeks. Common side effects of efgartigimod alfa include headaches, urinary and respiratory tract infections, myalgia, paresthesia, and hematologic adverse reactions. Uncommon but potentially serious adverse events included infusion reactions, hypersensitivity reactions and infections. The two formulations of efgartigimod alfa have similar profiles of adverse events except for types of injection site reactions.</p></div><div id="Efgartigimod.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In the registration studies submitted in support of approval of efgartigimod alfa, there were no serum ALT or AST elevations above 3 times the upper limit of normal (ULN) and no patient developed serum enzyme elevations and jaundice or evidence of clinically apparent liver injury. Since its approval and more widespread use including controlled trials of both intravenous and subcutaneous forms of efgartigimod, there has been no reports of clinically apparent liver injury attributed to their use.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p></div><div id="Efgartigimod.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The mechanism by which efgartigimod alfa alone or in combination with hyaluronidase might cause liver injury is unknown. Efgartigimod alfa is a polypeptide and is metabolized by proteolysis into individual amino acids in cells. Efgartigimod alfa is not metabolized by the cytochrome P450 system and has not been associated with drug-drug interactions. Possible exceptions, however, might be agents that can bind to the human neonatal Fc receptor such as monoclonal antibodies and immunoglobulin products.</p></div><div id="Efgartigimod.Outcome_and_Management"><h3>Outcome and Management</h3><p>Efgartigimod alfa and efgartigimod alfa/hyaluronidase have not been implicated in significant serum aminotransferase elevations or instances of acute liver injury. While minor elevations in serum enzymes may occur during therapy, these are generally transient, asymptomatic, and most likely unrelated to treatment .</p><p>Drug Class: Myasthenia Agents</p><p>Other Drugs in for Myasthenia Gravis: <a href="/books/n/livertox/Eculizumab/?report=reader">Eculizumab</a>, Pyridostigmine</p></div></div><div id="Efgartigimod.PRODUCT_INFORMATION"><h2 id="_Efgartigimod_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
|
|
<b>REPRESENTATIVE TRADE NAMES</b>
|
|
</p><p>Efgartigimod alfa – Vyvgart®</p><p>Efgartigimod alfa/Hyaluronidase – Vyvgart Hytrulo®</p><p>
|
|
<b>DRUG CLASS</b>
|
|
</p><p>Myasthenia Agents</p><p><a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Efgartigimod%20alfa" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a> [E. alfa]</p><p><a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Efgartigimod%20alfa/Hyaluronidase" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a> [E. alfa/hyaluronidase]</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div><div id="Efgartigimod.CHEMICAL_FORMULA_AND_STRUCT"><h2 id="_Efgartigimod_CHEMICAL_FORMULA_AND_STRUCT_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figEfgartigimodTc"><a href="/books/NBK612205/table/Efgartigimod.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img" rid-ob="figobEfgartigimodTc"><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="Efgartigimod.Tc"><a href="/books/NBK612205/table/Efgartigimod.Tc/?report=objectonly" target="object" rid-ob="figobEfgartigimodTc">Table</a></h4></div></div></div><div id="Efgartigimod.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Efgartigimod_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 02 February 2025</p><p>Abbreviations: iv, intravenous; sc, subcutaneous; ULN, upper limit of normal.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Efgartigimod.REF.zimmerman.1999">Zimmerman HJ. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.<div><i>(Expert textbook on hepatotoxicity published in 1999, before the availability of efgartigimod alfa).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF2">FDA. Integrated Review. 2021. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761195Orig1s000IntegratedR.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/2022/761195Orig1s000IntegratedR.pdf</a><div><i>(FDA website with product labels and integrated review of efficacy and safety data on efgartigimod submitted by the sponsor in support of approval in the US, mentions that in the safety database of 246 subjects, adverse events more frequent with efgartigimod vs placebo included urinary tract infections, myalgia, paresthesia, respiratory tract infections, and headache, and that no participant developed ALT or AST elevations above 3 times ULN or any elevations with bilirubin above twice normal).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF.howard.2019.e2661">Howard
|
|
JF
|
|
Jr, Bril
|
|
V, Burns
|
|
TM, Mantegazza
|
|
R, Bilinska
|
|
M, Szczudlik
|
|
A, Beydoun
|
|
S, et al.; Efgartigimod MG Study Group. Randomized phase 2 study of FcRn antagonist efgartigimod in generalized myasthenia gravis.
|
|
Neurology.
|
|
2019;92:e2661-e2673.
|
|
[<a href="/pmc/articles/PMC6556100/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6556100</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31118245" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31118245</span></a>]<div><i>(Among 24 adults with myasthenia gravis treated with efgartigimod [10 mg/kg] or placebo given iv in 4 weekly doses, there was a rapid decrease in total IgG [-40%] and anti-acetylcholine receptor antibodies with efgartigimod treatment, and adverse event rates were 83% in both groups; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF.howard.2021.526">Howard
|
|
JF
|
|
Jr, Bril
|
|
V, Vu
|
|
T, Karam
|
|
C, Peric
|
|
S, Margania
|
|
T, Murai
|
|
H, et al.; ADAPT Investigator Study Group. Safety, efficacy, and tolerability of efgartigimod in patients with generalized myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial.
|
|
Lancet Neurol.
|
|
2021;20:526-536.
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/34146511" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34146511</span></a>]<div><i>(Among 167 adults with myasthenia gravis treated with efgartigimod [10 mg/kg] vs placebo iv in cycles of 4 weekly iv infusions, response rates were 68% vs 30% with the first cycle and adverse event rates 77% vs 84% which were serious in 5% vs 8%, and “there were no clinically meaningful changes in haematology or chemistry parameters”).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF5">Efgartigimod alfa (Vyvgart) for myasthenia gravis.
|
|
Med Lett Drugs Ther.
|
|
2022;64:62-63.
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/35436776" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35436776</span></a>]<div><i>(Concise review of the mechanism of action, clinical efficacy, safety, and costs of efgartigimod alfa shortly after its approval for use in myasthenia gravis in the US, mentions common adverse events of headache, respiratory and urinary tract infections, paresthesia, myalgia, and hematologic abnormalities; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF.broome.2023.1648">Broome
|
|
CM, McDonald
|
|
V, Miyakawa
|
|
Y, Carpenedo
|
|
M, Kuter
|
|
DJ, Al-Samkari
|
|
H, Bussel
|
|
JB
|
|
et al.; ADVANCE Investigator Study Group. Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial.
|
|
Lancet.
|
|
2023;402(10413):1648-1659.
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/37778358" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37778358</span></a>]<div><i>(Among 131 adults with primary immune thrombocytopenia treated with efgartigimod [10 mg/kg] or placebo in weekly iv infusions, clinical responses occurred in 22% vs 5% and adverse events in 93% vs 96% which were serious in 8% vs 16%; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF.howard.2024.1284444">Howard
|
|
JF
|
|
Jr, Bril
|
|
V, Vu
|
|
T, Karam
|
|
C, Peric
|
|
S, De Bleecker
|
|
JL, Murai
|
|
H, et al.; ADAPT+ Study Group. Long-term safety, tolerability, and efficacy of efgartigimod (ADAPT+): interim results from a phase 3 open-label extension study in participants with generalized myasthenia gravis.
|
|
Front Neurol.
|
|
2024;14:1284444.
|
|
[<a href="/pmc/articles/PMC10842202/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10842202</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/38318236" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38318236</span></a>]<div><i>(Among 151 adults with myasthenia gravis enrolled in a long term,, open label extension study of efgartigimod alfa given in cycles of 4 weekly iv infusions [10 mg/kg], clinical responses were maintained and adverse events were mostly mild-to-moderate, resulted in discontinuation in 8%, and fatality in 5, none of which were considered drug- or liver related; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF.howard.2024.e00378">Howard
|
|
JF
|
|
Jr, Vu
|
|
T, Li
|
|
G, Korobko
|
|
D, Smilowski
|
|
M, Liu
|
|
L, Gistelinck
|
|
F, et al.; ADAPT-SC and ADAPT-SC+ Study Groups. Subcutaneous efgartigimod PH20 in generalized myasthenia gravis: A phase 3 randomized noninferiority study (ADAPT-SC) and interim analyses of a long-term open-label extension study (ADAPT-SC+).
|
|
Neurotherapeutics.
|
|
2024;21:e00378.
|
|
[<a href="/pmc/articles/PMC11579873/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC11579873</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/39227284" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39227284</span></a>]<div><i>(Among 145 adults with myasthenia gravis enrolled in an extended open label trial of efgartigimod alfa/hyaluronidase in cycles of 10 mg/kg given sc weekly for 4 weeks [average duration 569 days and up to 17 cycles], adverse events arose in 85%, most frequent symptoms being headache, COVID-19, diarrhea, urinary and respiratory tract infections, fever, nausea, hypertension, and oropharyngeal pain, and “there were no clinically relevant changes from baseline in hematology and chemistry parameters”).</i></div></div></li><li><div class="bk_ref" id="Efgartigimod.REF.allen.2024.1013">Allen
|
|
JA, Lin
|
|
J, Basta
|
|
I, Dysgaard
|
|
T, Eggers
|
|
C, Guptill
|
|
JT, Gwathmey
|
|
KG, et al.; ADHERE Study Group. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial.
|
|
Lancet Neurol.
|
|
2024;23:1013-1024.
|
|
[<a href="https://pubmed.ncbi.nlm.nih.gov/39304241" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39304241</span></a>]<div><i>(Among 221 adults with chronic inflammatory demyelinating polyradiculoneuropathy treated with efgartigimod alfa/hyaluronidase or placebo sc once weekly for 4 weeks, relapses were less frequent with efgartigimod [28% vs 56%], while adverse events arose in 64% vs 56% and severe adverse events in 5% vs 5%; no mention of ALT elevations or hepatotoxicity).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK612205_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">February 2, 2025</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-. Efgartigimod alfa, alfa/Hyaluronidase. [Updated 2025 Feb 2].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Efavirenz/?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/Elacestrant/?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="figobEfgartigimodTc"><div id="Efgartigimod.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK612205/table/Efgartigimod.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Efgartigimod.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Efgartigimod.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Efgartigimod.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_Efgartigimod.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_Efgartigimod.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_Efgartigimod.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Efgartigimod alfa</td><td headers="hd_h_Efgartigimod.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/381128075" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">1821402-21-4</a>
|
|
</td><td headers="hd_h_Efgartigimod.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C2310-H3554-N602-O692-S14</td><td headers="hd_h_Efgartigimod.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 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>
|