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mw-first-heading"><span class="mw-page-title-main">Pegcetacoplan</span></h1> <div id="p-lang-btn" class="vector-dropdown mw-portlet mw-portlet-lang" > <input type="checkbox" id="p-lang-btn-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-p-lang-btn" class="vector-dropdown-checkbox mw-interlanguage-selector" aria-label="Go to an article in another language. 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id="siteSub" class="noprint">From Wikipedia, the free encyclopedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Medication used to treat paroxysmal nocturnal hemoglobinuria</div> <p class="mw-empty-elt"> </p> <div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">Pharmaceutical compound</div> <style data-mw-deduplicate="TemplateStyles:r1269284339">@media screen{html.skin-theme-clientpref-night .mw-parser-output .dark_mode_safe img{background-color:var(--background-color-inverted,#f8f9fa)}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .dark_mode_safe img{background-color:var(--background-color-inverted,#f8f9fa)}}</style> <style data-mw-deduplicate="TemplateStyles:r1257001546">.mw-parser-output .infobox-subbox{padding:0;border:none;margin:-3px;width:auto;min-width:100%;font-size:100%;clear:none;float:none;background-color:transparent}.mw-parser-output .infobox-3cols-child{margin:auto}.mw-parser-output .infobox .navbar{font-size:100%}@media screen{html.skin-theme-clientpref-night .mw-parser-output .infobox-full-data:not(.notheme)>div:not(.notheme)[style]{background:#1f1f23!important;color:#f8f9fa}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .infobox-full-data:not(.notheme) div:not(.notheme){background:#1f1f23!important;color:#f8f9fa}}@media(min-width:640px){body.skin--responsive .mw-parser-output .infobox-table{display:table!important}body.skin--responsive .mw-parser-output .infobox-table>caption{display:table-caption!important}body.skin--responsive .mw-parser-output .infobox-table>tbody{display:table-row-group}body.skin--responsive .mw-parser-output .infobox-table tr{display:table-row!important}body.skin--responsive .mw-parser-output .infobox-table th,body.skin--responsive .mw-parser-output .infobox-table td{padding-left:inherit;padding-right:inherit}}</style><table class="infobox" style="border-spacing:2px;"><caption class="infobox-title"><span title="International nonproprietary name (INN): Pegcetacoplan">Pegcetacoplan</span></caption><tbody><tr><td colspan="2" class="infobox-image"><span class="dark_mode_safe" typeof="mw:File"><a href="/wiki/File:Pegcetacoplan_v01.svg" class="mw-file-description"><img src="//upload.wikimedia.org/wikipedia/commons/thumb/5/5a/Pegcetacoplan_v01.svg/250px-Pegcetacoplan_v01.svg.png" decoding="async" width="250" height="78" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/commons/thumb/5/5a/Pegcetacoplan_v01.svg/375px-Pegcetacoplan_v01.svg.png 1.5x, //upload.wikimedia.org/wikipedia/commons/thumb/5/5a/Pegcetacoplan_v01.svg/500px-Pegcetacoplan_v01.svg.png 2x" data-file-width="1572" data-file-height="492" /></a></span></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;">Clinical data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Drug_nomenclature#Trade_names" title="Drug nomenclature">Trade names</a></th><td class="infobox-data">Empaveli, Aspaveli, Syfovre</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;">Other names</th><td class="infobox-data">APL-2</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/American_Society_of_Health-System_Pharmacists" title="American Society of Health-System Pharmacists">AHFS</a>/<a href="/wiki/Drugs.com" title="Drugs.com">Drugs.com</a></th><td class="infobox-data"><span title="www.drugs.com"><a rel="nofollow" class="external text" href="https://www.drugs.com/monograph/pegcetacoplan.html">Monograph</a></span></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/MedlinePlus" title="MedlinePlus">MedlinePlus</a></th><td class="infobox-data"><span title="medlineplus.gov"><a rel="nofollow" class="external text" href="https://medlineplus.gov/druginfo/meds/a621045.html">a621045</a></span></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">License data</a></th><td class="infobox-data"><style data-mw-deduplicate="TemplateStyles:r1126788409">.mw-parser-output .plainlist ol,.mw-parser-output .plainlist ul{line-height:inherit;list-style:none;margin:0;padding:0}.mw-parser-output .plainlist ol li,.mw-parser-output .plainlist ul li{margin-bottom:0}</style><div class="plainlist"> <ul><li><small><abbr class="country-name" title="United States">US</abbr></small> <a href="/wiki/DailyMed" title="DailyMed">DailyMed</a>: <span title="dailymed.nlm.nih.gov"><a rel="nofollow" class="external text" href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Pegcetacoplan">Pegcetacoplan</a></span></li></ul></div> </td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Pregnancy_category" title="Pregnancy category">Pregnancy<br />category</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"> <ul><li><small><abbr class="country-name" title="Australia">AU</abbr>:</small> B3<sup id="cite_ref-Empaveli_APMDS_1-0" class="reference"><a href="#cite_note-Empaveli_APMDS-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup></li> <li>Not recommended</li></ul> </div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Route_of_administration" title="Route of administration">Routes of<br />administration</a></th><td class="infobox-data"><a href="/wiki/Subcutaneous_infusion" class="mw-redirect" title="Subcutaneous infusion">Subcutaneous</a>, <a href="/wiki/Intravitreal" class="mw-redirect" title="Intravitreal">intravitreal</a></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Drug_class" title="Drug class">Drug class</a></th><td class="infobox-data"><a href="/wiki/Complement_system" title="Complement system">Complement</a> inhibitor</td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Anatomical_Therapeutic_Chemical_Classification_System" title="Anatomical Therapeutic Chemical Classification System">ATC code</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><a href="/wiki/ATC_code_L04" title="ATC code L04">L04AJ03</a> (<span title="www.whocc.no"><a rel="nofollow" class="external text" href="https://www.whocc.no/atc_ddd_index/?code=L04AJ03">WHO</a></span>) <a href="/wiki/ATC_code_S01" title="ATC code S01">S01XA31</a> (<span title="www.whocc.no"><a rel="nofollow" class="external text" href="https://www.whocc.no/atc_ddd_index/?code=S01XA31">WHO</a></span>)</li></ul></div></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;">Legal status</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Regulation_of_therapeutic_goods" title="Regulation of therapeutic goods">Legal status</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"> <ul><li><small><abbr class="country-name" title="Australia">AU</abbr>:</small> <a href="/wiki/Standard_for_the_Uniform_Scheduling_of_Medicines_and_Poisons#Schedule_4" title="Standard for the Uniform Scheduling of Medicines and Poisons">S4</a> (Prescription only)<sup id="cite_ref-Empaveli_APMDS_1-1" class="reference"><a href="#cite_note-Empaveli_APMDS-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="Canada">CA</abbr></small>: <a href="/wiki/Prescription_drug" title="Prescription drug"> ℞-only</a><sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="United Kingdom">UK</abbr>:</small> <a href="/wiki/Prescription_drug" title="Prescription drug">POM</a> (Prescription only)<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="United States">US</abbr>:</small> <a href="/wiki/Boxed_warning" title="Boxed warning"><span style="border:thin solid black;">WARNING</span></a><sup id="cite_ref-FDA-AllBoxedWarnings_3-0" class="reference"><a href="#cite_note-FDA-AllBoxedWarnings-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup>Rx-only<sup id="cite_ref-Empaveli_FDA_label_8-0" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-FDA_Empaveli_9-0" class="reference"><a href="#cite_note-FDA_Empaveli-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Syfovre_FDA_label_10-0" class="reference"><a href="#cite_note-Syfovre_FDA_label-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup></li> <li><small><abbr class="country-name" title="European Union">EU</abbr>:</small> Rx-only<sup id="cite_ref-Aspaveli_EPAR_11-0" class="reference"><a href="#cite_note-Aspaveli_EPAR-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup></li></ul></div> </td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;">Identifiers</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/CAS_Registry_Number" title="CAS Registry Number">CAS Number</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="commonchemistry.cas.org"><a rel="nofollow" class="external text" href="https://commonchemistry.cas.org/detail?cas_rn=2019171-69-6">2019171-69-6</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/DrugBank" title="DrugBank">DrugBank</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.drugbank.ca"><a rel="nofollow" class="external text" href="https://www.drugbank.ca/drugs/DB16694">DB16694</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Unique_Ingredient_Identifier" title="Unique Ingredient Identifier">UNII</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="precision.fda.gov"><a rel="nofollow" class="external text" href="https://precision.fda.gov/uniisearch/srs/unii/TO3JYR3BOU">TO3JYR3BOU</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/KEGG" title="KEGG">KEGG</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.kegg.jp"><a rel="nofollow" class="external text" href="https://www.kegg.jp/entry/D11613">D11613</a></span></li></ul></div></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/ChEMBL" title="ChEMBL">ChEMBL</a></th><td class="infobox-data"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1126788409"><div class="plainlist"><ul><li><span title="www.ebi.ac.uk"><a rel="nofollow" class="external text" href="https://www.ebi.ac.uk/chembl/explore/compound/ChEMBL4298211">ChEMBL4298211</a></span></li></ul></div></td></tr><tr><th colspan="2" class="infobox-header" style="background:#ddd;color:inherit;">Chemical and physical data</th></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Chemical_formula" title="Chemical formula">Formula</a></th><td class="infobox-data"><span title="Carbon">C</span><sub>1970</sub><span title="Hydrogen">H</span><sub>3848</sub><span title="Nitrogen">N</span><sub>50</sub><span title="Oxygen">O</span><sub>947</sub><span title="Sulfur">S</span><sub>4</sub></td></tr><tr><th scope="row" class="infobox-label" style="line-height:1.2em;"><a href="/wiki/Molar_mass" title="Molar mass">Molar mass</a></th><td class="infobox-data"><span class="nowrap"><span data-sort-value="7004435201000000000♠"></span>43<span style="margin-left:.25em;">520</span>.10</span> g·mol<sup>−1</sup></td></tr></tbody></table> <p><b>Pegcetacoplan</b>, sold under the brand name <b>Empaveli</b>, among others, is a <a href="/wiki/Medication" title="Medication">medication</a> used to treat <a href="/wiki/Paroxysmal_nocturnal_hemoglobinuria" title="Paroxysmal nocturnal hemoglobinuria">paroxysmal nocturnal hemoglobinuria</a><sup id="cite_ref-Empaveli_FDA_label_8-1" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Aspaveli_EPAR_11-1" class="reference"><a href="#cite_note-Aspaveli_EPAR-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-pmid36459381_12-0" class="reference"><a href="#cite_note-pmid36459381-12"><span class="cite-bracket">[</span>12<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-pmid35923770_13-0" class="reference"><a href="#cite_note-pmid35923770-13"><span class="cite-bracket">[</span>13<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-pmid35441351_14-0" class="reference"><a href="#cite_note-pmid35441351-14"><span class="cite-bracket">[</span>14<span class="cite-bracket">]</span></a></sup> and <a href="/wiki/Geographic_atrophy" title="Geographic atrophy">geographic atrophy of the retina</a>.<sup id="cite_ref-Syfovre_FDA_label_10-1" class="reference"><a href="#cite_note-Syfovre_FDA_label-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-pmid35860926_15-0" class="reference"><a href="#cite_note-pmid35860926-15"><span class="cite-bracket">[</span>15<span class="cite-bracket">]</span></a></sup> Pegcetacoplan is a <a href="/wiki/Complement_system" title="Complement system">complement</a> inhibitor.<sup id="cite_ref-Empaveli_FDA_label_8-2" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Syfovre_FDA_label_10-2" class="reference"><a href="#cite_note-Syfovre_FDA_label-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup> </p><p>The most common side effects include injection-site reactions, infections, <a href="/wiki/Diarrhea" title="Diarrhea">diarrhea</a>, <a href="/wiki/Abdominal_pain" title="Abdominal pain">abdominal pain</a>, respiratory tract infection, viral infection, and fatigue.<sup id="cite_ref-Empaveli_FDA_label_8-3" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Aspaveli_EPAR_11-2" class="reference"><a href="#cite_note-Aspaveli_EPAR-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> </p><p>Paroxysmal nocturnal hemoglobinuria is characterized by red blood cell destruction, <a href="/wiki/Anemia" title="Anemia">anemia</a> (red blood cells unable to carry enough oxygen to tissues), blood clots, and impaired bone marrow function (not making enough blood cells).<sup id="cite_ref-FDA_Empaveli_9-1" class="reference"><a href="#cite_note-FDA_Empaveli-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> </p><p>Pegcetacoplan is the first treatment for paroxysmal nocturnal hemoglobinuria that binds to and inhibits <a href="/wiki/Complement_component_3" title="Complement component 3">complement protein C3</a>.<sup id="cite_ref-FDA_Empaveli_9-2" class="reference"><a href="#cite_note-FDA_Empaveli-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> Pegcetacoplan was approved for medical use in the United States in May 2021.<sup id="cite_ref-FDA_Empaveli_9-3" class="reference"><a href="#cite_note-FDA_Empaveli-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> The US <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (FDA) considers it to be a <a href="/wiki/First-in-class_medication" title="First-in-class medication">first-in-class medication</a>.<sup id="cite_ref-New_Drug_Therapy_Approvals_2021_16-0" class="reference"><a href="#cite_note-New_Drug_Therapy_Approvals_2021-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> </p><p>In 2024, the American Society of Nephrology Annual Kidney Meeting,<sup id="cite_ref-17" class="reference"><a href="#cite_note-17"><span class="cite-bracket">[</span>17<span class="cite-bracket">]</span></a></sup> the study group who investigating <a class="mw-selflink selflink">pegcetacoplan</a> in the largest multicenter double-blind VALIANT trial, showed its significant benefits in the treatment of patients with C3 glomerulopathy or primary immune complex–mediated membranoproliferative glomerulonephritis <sup id="cite_ref-18" class="reference"><a href="#cite_note-18"><span class="cite-bracket">[</span>18<span class="cite-bracket">]</span></a></sup>.C3 glomerulopathy leads to kidney failure in approximately 50% of patients within 5-10 years of diagnosis, and even when patients do receive a kidney transplant, approximately two thirds experience disease recurrence. Pegcetacoplan introduce a potential “kidney- and life-saving option” for patients with C3 glomerulopathy.<sup id="cite_ref-19" class="reference"><a href="#cite_note-19"><span class="cite-bracket">[</span>19<span class="cite-bracket">]</span></a></sup> </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="Medical_uses">Medical uses</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=1" title="Edit section: Medical uses"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Pegcetacoplan is <a href="/wiki/Indication_(medicine)" title="Indication (medicine)">indicated</a> to treat adults with <a href="/wiki/Paroxysmal_nocturnal_hemoglobinuria" title="Paroxysmal nocturnal hemoglobinuria">paroxysmal nocturnal hemoglobinuria</a>.<sup id="cite_ref-Empaveli_FDA_label_8-4" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-FDA_Empaveli_9-4" class="reference"><a href="#cite_note-FDA_Empaveli-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-Aspaveli_EPAR_11-3" class="reference"><a href="#cite_note-Aspaveli_EPAR-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup> In February 2023, the indication was updated to include the treatment of people with geographic atrophy secondary to age-related macular degeneration.<sup id="cite_ref-Syfovre_FDA_label_10-3" class="reference"><a href="#cite_note-Syfovre_FDA_label-10"><span class="cite-bracket">[</span>10<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-20" class="reference"><a href="#cite_note-20"><span class="cite-bracket">[</span>20<span class="cite-bracket">]</span></a></sup> The medication is given through a subcutaneous infusion for paroxysmal nocturnal hemoglobinuria and through intravitreal injection for age-related macular degeneration.<sup id="cite_ref-Hoy_1423–1430_21-0" class="reference"><a href="#cite_note-Hoy_1423–1430-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Pharmacology">Pharmacology</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=2" title="Edit section: Pharmacology"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Pegcetacoplan acts as a complement inhibitor, specifically targeting complement protein C3, which plays a crucial role in the pathogenesis of paroxysmal nocturnal hemoglobinuria (PNH). In individuals with PNH, there is a heightened and uninhibited <a href="/wiki/Complement_system" title="Complement system">complement</a> activity, which may lead to intravascular (inside blood vessels) or extravascular (within the liver or spleen) <a href="/wiki/Hemolysis" title="Hemolysis">hemolysis</a>.<sup id="cite_ref-Empaveli_FDA_label_8-5" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> By binding to and inhibiting C3, pegcetacoplan helps regulate complement activation, thereby reducing red blood cell destruction, anemia, blood clot formation, and improving bone marrow function. This targeted mechanism of action makes pegcetacoplan the first-in-class medication for the treatment of PNH, offering a promising therapeutic approach to address the underlying complement dysregulation in this condition.<sup id="cite_ref-22" class="reference"><a href="#cite_note-22"><span class="cite-bracket">[</span>22<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Pharmacokinetics">Pharmacokinetics</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=3" title="Edit section: Pharmacokinetics"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>Pegcetacoplan exhibits proportional exposure with increasing doses and reaches peak concentration within 4.5–6 days after a single subcutaneous dose. Steady-state concentrations are achieved in about 4–6 weeks of treatment, with average serum trough concentrations ranging from 655-706 μg/mL. Pegcetacoplan is metabolized into smaller peptides and amino acids and has a median effective elimination half-life of approximately 8.0 days in patients with PNH.<sup id="cite_ref-Hoy_1423–1430_21-1" class="reference"><a href="#cite_note-Hoy_1423–1430-21"><span class="cite-bracket">[</span>21<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Adverse_effects">Adverse effects</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=4" title="Edit section: Adverse effects"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p><a href="/wiki/Meningococcal_disease" title="Meningococcal disease">Meningococcal</a> (a type of bacteria) infections can occur in people taking pegcetacoplan.<sup id="cite_ref-FDA_Empaveli_9-5" class="reference"><a href="#cite_note-FDA_Empaveli-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> Pegcetacoplan may also predispose individuals to serious infections, especially infections caused by encapsulated bacteria.<sup id="cite_ref-FDA_Empaveli_9-6" class="reference"><a href="#cite_note-FDA_Empaveli-9"><span class="cite-bracket">[</span>9<span class="cite-bracket">]</span></a></sup> These infections include but are not limited to <i><a href="/wiki/Streptococcus_pneumoniae" title="Streptococcus pneumoniae">Streptococcus pneumoniae</a></i>, <i><a href="/wiki/Neisseria_meningitidis" title="Neisseria meningitidis">Neisseria meningitidis</a></i>, and <i><a href="/wiki/Haemophilus_influenzae" title="Haemophilus influenzae">Haemophilus influenzae</a></i>.<sup id="cite_ref-Empaveli_FDA_label_8-6" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> Common adverse effects associated with the medication include stomach pain, vomiting, diarrhea, cold sores, common-cold like symptoms, tiredness as well as any itching, redness, or sensitivity at the injection site.<sup id="cite_ref-Empaveli_FDA_label_8-7" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> Pegcetacoplan may cause fetal harm.<sup id="cite_ref-Empaveli_FDA_label_8-8" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> Pegcetacoplan may also interfere with silica reagents in laboratory coagulation panels.<sup id="cite_ref-Empaveli_FDA_label_8-9" class="reference"><a href="#cite_note-Empaveli_FDA_label-8"><span class="cite-bracket">[</span>8<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=5" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The therapeutic efficacy of subcutaneous pegcetacoplan in treating paroxysmal nocturnal hemoglobinuria (PNH) has been established through several clinical trials. Initial phase I and II trials, such as PADDOCK, PALOMINO, and PHAROAH, evaluated pegcetacoplan in PNH patients who had not received a complement inhibitor or had previously received eculizumab. These trials demonstrated that 1–2 years of pegcetacoplan treatment effectively controlled hemolysis and improved quality of life in PNH patients.,<sup id="cite_ref-23" class="reference"><a href="#cite_note-23"><span class="cite-bracket">[</span>23<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-24" class="reference"><a href="#cite_note-24"><span class="cite-bracket">[</span>24<span class="cite-bracket">]</span></a></sup> </p><p>Building upon these findings, the efficacy of pegcetacoplan was further assessed in phase III trials. The PRINCE trial, a 26-week study, focused on complement inhibitor-naïve patients with PNH, while the PEGASUS trial, a 48-week multinational study, included complement inhibitor-treated patients with PNH. In these trials, subcutaneous pegcetacoplan was administered at a dosage of 1080 mg twice weekly, delivered as a 20-mL subcutaneous infusion. Patients had the option to self-administer the medication or have it administered by qualified research personnel.<sup id="cite_ref-25" class="reference"><a href="#cite_note-25"><span class="cite-bracket">[</span>25<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Society_and_culture">Society and culture</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=6" title="Edit section: Society and culture"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <div class="mw-heading mw-heading3"><h3 id="Legal_status">Legal status</h3><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=7" title="Edit section: Legal status"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>The FDA granted the application for pegcetacoplan <a href="/wiki/Orphan_drug" title="Orphan drug">orphan drug</a> designation.<sup id="cite_ref-New_Drug_Therapy_Approvals_2021_16-1" class="reference"><a href="#cite_note-New_Drug_Therapy_Approvals_2021-16"><span class="cite-bracket">[</span>16<span class="cite-bracket">]</span></a></sup> </p><p>In October 2021, the <a href="/wiki/Committee_for_Medicinal_Products_for_Human_Use" title="Committee for Medicinal Products for Human Use">Committee for Medicinal Products for Human Use</a> (CHMP) of the <a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Aspaveli, intended for the treatment of adults with paroxysmal nocturnal hemoglobinuria.<sup id="cite_ref-Aspaveli:_Pending_EC_decision_26-0" class="reference"><a href="#cite_note-Aspaveli:_Pending_EC_decision-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> The applicant for this medicinal product is Swedish Orphan Biovitrum AB (publ).<sup id="cite_ref-Aspaveli:_Pending_EC_decision_26-1" class="reference"><a href="#cite_note-Aspaveli:_Pending_EC_decision-26"><span class="cite-bracket">[</span>26<span class="cite-bracket">]</span></a></sup> Pegcetacoplan was approved for the treatment of <a href="/wiki/Paroxysmal_nocturnal_haemoglobinuria" class="mw-redirect" title="Paroxysmal nocturnal haemoglobinuria">paroxysmal nocturnal haemoglobinuria</a> in the European Union in December 2021.<sup id="cite_ref-Aspaveli_EPAR_11-4" class="reference"><a href="#cite_note-Aspaveli_EPAR-11"><span class="cite-bracket">[</span>11<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-27" class="reference"><a href="#cite_note-27"><span class="cite-bracket">[</span>27<span class="cite-bracket">]</span></a></sup> </p><p>In June 2024, the CHMP recommended the refusal of a marketing authorization for Syfovre, a medicine intended for the treatment of geographic atrophy caused by age-related macular degeneration.<sup id="cite_ref-Syfovre_EPAR_28-0" class="reference"><a href="#cite_note-Syfovre_EPAR-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup><sup id="cite_ref-29" class="reference"><a href="#cite_note-29"><span class="cite-bracket">[</span>29<span class="cite-bracket">]</span></a></sup> The manufacturer requested a re-examination in July 2024.<sup id="cite_ref-Syfovre_EPAR_28-1" class="reference"><a href="#cite_note-Syfovre_EPAR-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> In September 2024, the CHMP continued to refuse a marketing authorization after a re-examination.<sup id="cite_ref-Syfovre_EPAR_28-2" class="reference"><a href="#cite_note-Syfovre_EPAR-28"><span class="cite-bracket">[</span>28<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=8" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist"> <div class="mw-references-wrap mw-references-columns"><ol class="references"> <li id="cite_note-Empaveli_APMDS-1"><span class="mw-cite-backlink">^ <a href="#cite_ref-Empaveli_APMDS_1-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-Empaveli_APMDS_1-1"><sup><i><b>b</b></i></sup></a></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.tga.gov.au/resources/auspmd/empaveli">"Empaveli APMDS"</a>. <a href="/wiki/Therapeutic_Goods_Administration" title="Therapeutic Goods Administration">Therapeutic Goods Administration</a> (TGA). 17 February 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">20 February</span> 2022</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Empaveli+APMDS&rft.pub=Therapeutic+Goods+Administration+%28TGA%29&rft.date=2022-02-17&rft_id=https%3A%2F%2Fwww.tga.gov.au%2Fresources%2Fauspmd%2Fempaveli&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-2">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database">"Updates to the Prescribing Medicines in Pregnancy database"</a>. <a href="/wiki/Therapeutic_Goods_Administration" title="Therapeutic Goods Administration">Therapeutic Goods Administration</a> (TGA). 21 December 2022. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database">Archived</a> from the original on 3 April 2022<span class="reference-accessdate">. Retrieved <span class="nowrap">2 January</span> 2023</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Updates+to+the+Prescribing+Medicines+in+Pregnancy+database&rft.pub=Therapeutic+Goods+Administration+%28TGA%29&rft.date=2022-12-21&rft_id=https%3A%2F%2Fwww.tga.gov.au%2Fresources%2Fresource%2Fguidance%2Fupdates-prescribing-medicines-pregnancy-database&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-FDA-AllBoxedWarnings-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-FDA-AllBoxedWarnings_3-0">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://nctr-crs.fda.gov/fdalabel/ui/spl-summaries/criteria/343802">"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)"</a>. <i>nctr-crs.fda.gov</i>. <a href="/wiki/FDA" class="mw-redirect" title="FDA">FDA</a><span class="reference-accessdate">. Retrieved <span class="nowrap">22 October</span> 2023</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=nctr-crs.fda.gov&rft.atitle=FDA-sourced+list+of+all+drugs+with+black+box+warnings+%28Use+Download+Full+Results+and+View+Query+links.%29&rft_id=https%3A%2F%2Fnctr-crs.fda.gov%2Ffdalabel%2Fui%2Fspl-summaries%2Fcriteria%2F343802&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-4"><span class="mw-cite-backlink"><b><a href="#cite_ref-4">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102229">"Details for: Empaveli"</a>. <i><a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a></i>. 15 February 2023. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20240303051911/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102229">Archived</a> from the original on 3 March 2024<span class="reference-accessdate">. Retrieved <span class="nowrap">3 March</span> 2024</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Health+Canada&rft.atitle=Details+for%3A+Empaveli&rft.date=2023-02-15&rft_id=https%3A%2F%2Fdhpp.hpfb-dgpsa.ca%2Fdhpp%2Fresource%2F102229&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-5"><span class="mw-cite-backlink"><b><a href="#cite_ref-5">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/mutliple-additions-2023-03-08.html">"Notice: Multiple Additions to the Prescription Drug List (PDL) [2023-03-08]"</a>. <i><a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a></i>. 8 March 2023. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20230322024545/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/mutliple-additions-2023-03-08.html">Archived</a> from the original on 22 March 2023<span class="reference-accessdate">. Retrieved <span class="nowrap">21 March</span> 2023</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Health+Canada&rft.atitle=Notice%3A+Multiple+Additions+to+the+Prescription+Drug+List+%28PDL%29+%5B2023-03-08%5D&rft.date=2023-03-08&rft_id=https%3A%2F%2Fwww.canada.ca%2Fen%2Fhealth-canada%2Fservices%2Fdrugs-health-products%2Fdrug-products%2Fprescription-drug-list%2Fnotices-changes%2Fmutliple-additions-2023-03-08.html&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-6"><span class="mw-cite-backlink"><b><a href="#cite_ref-6">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1682951781384">"Summary Basis of Decision for Empaveli"</a>. <i><a href="/wiki/Health_Canada" title="Health Canada">Health Canada</a></i>. 13 April 2023<span class="reference-accessdate">. Retrieved <span class="nowrap">5 June</span> 2023</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=Health+Canada&rft.atitle=Summary+Basis+of+Decision+for+Empaveli&rft.date=2023-04-13&rft_id=https%3A%2F%2Fdhpp.hpfb-dgpsa.ca%2Freview-documents%2Fresource%2FSBD1682951781384&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-7"><span class="mw-cite-backlink"><b><a href="#cite_ref-7">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.medicines.org.uk/emc/product/13369/smpc">"Aspaveli Summary of Product Characteristics (SmPC)"</a>. <i>(emc)</i>. 21 September 2022. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20231220061107/https://www.medicines.org.uk/emc/product/13369/smpc">Archived</a> from the original on 20 December 2023<span class="reference-accessdate">. Retrieved <span class="nowrap">20 December</span> 2023</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=%28emc%29&rft.atitle=Aspaveli+Summary+of+Product+Characteristics+%28SmPC%29&rft.date=2022-09-21&rft_id=https%3A%2F%2Fwww.medicines.org.uk%2Femc%2Fproduct%2F13369%2Fsmpc&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-Empaveli_FDA_label-8"><span class="mw-cite-backlink">^ <a href="#cite_ref-Empaveli_FDA_label_8-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-3"><sup><i><b>d</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-4"><sup><i><b>e</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-5"><sup><i><b>f</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-6"><sup><i><b>g</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-7"><sup><i><b>h</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-8"><sup><i><b>i</b></i></sup></a> <a href="#cite_ref-Empaveli_FDA_label_8-9"><sup><i><b>j</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c23d89e9-b00b-4520-e053-2995a90a95af">"Empaveli- pegcetacoplan injection, solution"</a>. <i><a href="/wiki/DailyMed" title="DailyMed">DailyMed</a></i>. 13 April 2023. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20210713140929/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c23d89e9-b00b-4520-e053-2995a90a95af">Archived</a> from the original on 13 July 2021<span class="reference-accessdate">. Retrieved <span class="nowrap">5 June</span> 2023</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=DailyMed&rft.atitle=Empaveli-+pegcetacoplan+injection%2C+solution&rft.date=2023-04-13&rft_id=https%3A%2F%2Fdailymed.nlm.nih.gov%2Fdailymed%2FdrugInfo.cfm%3Fsetid%3Dc23d89e9-b00b-4520-e053-2995a90a95af&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> <li id="cite_note-FDA_Empaveli-9"><span class="mw-cite-backlink">^ <a href="#cite_ref-FDA_Empaveli_9-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-FDA_Empaveli_9-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-FDA_Empaveli_9-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-FDA_Empaveli_9-3"><sup><i><b>d</b></i></sup></a> <a href="#cite_ref-FDA_Empaveli_9-4"><sup><i><b>e</b></i></sup></a> <a href="#cite_ref-FDA_Empaveli_9-5"><sup><i><b>f</b></i></sup></a> <a href="#cite_ref-FDA_Empaveli_9-6"><sup><i><b>g</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-treatment-adults-serious-rare-blood-disease">"FDA approves new treatment for adults with serious rare blood disease"</a>. 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Retrieved <span class="nowrap">18 February</span> 2023</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=FDA+approves+new+treatment+for+adults+with+serious+rare+blood+disease&rft.pub=U.S.+Food+%26+Drug+Administration+%28FDA%29&rft.date=2021-05-18&rft_id=https%3A%2F%2Fwww.fda.gov%2Fdrugs%2Fdrug-safety-and-availability%2Ffda-approves-new-treatment-adults-serious-rare-blood-disease&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span> <span class="noviewer" typeof="mw:File"><span><img alt="Public Domain" src="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/12px-PD-icon.svg.png" decoding="async" width="12" height="12" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/18px-PD-icon.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/24px-PD-icon.svg.png 2x" data-file-width="196" data-file-height="196" /></span></span> This article incorporates text from this source, which is in the <a href="/wiki/Public_domain" title="Public domain">public domain</a>.</span> </li> <li id="cite_note-Syfovre_FDA_label-10"><span class="mw-cite-backlink">^ <a href="#cite_ref-Syfovre_FDA_label_10-0"><sup><i><b>a</b></i></sup></a> <a href="#cite_ref-Syfovre_FDA_label_10-1"><sup><i><b>b</b></i></sup></a> <a href="#cite_ref-Syfovre_FDA_label_10-2"><sup><i><b>c</b></i></sup></a> <a href="#cite_ref-Syfovre_FDA_label_10-3"><sup><i><b>d</b></i></sup></a></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b4434e61-9ec9-4e0e-bd60-45aaa0a87e64">"Syfovre- pegcetacoplan injection, solution"</a>. <i>DailyMed</i>. 23 February 2023<span class="reference-accessdate">. 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Reproduction is authorized provided the source is acknowledged.</span> </li> <li id="cite_note-27"><span class="mw-cite-backlink"><b><a href="#cite_ref-27">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://ec.europa.eu/health/documents/community-register/html/h1595.htm">"Aspaveli Product information"</a>. <i>Union Register of medicinal products</i>. <a rel="nofollow" class="external text" href="https://web.archive.org/web/20230304103439/https://ec.europa.eu/health/documents/community-register/html/h1595.htm">Archived</a> from the original on 4 March 2023<span class="reference-accessdate">. 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Retrieved <span class="nowrap">12 July</span> 2024</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=European+Medicines+Agency&rft.atitle=Meeting+highlights+from+the+Committee+for+Medicinal+Products+for+Human+Use+%28CHMP%29+24-27+June+2024&rft.date=2024-06-28&rft_id=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fnews%2Fmeeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024&rfr_id=info%3Asid%2Fen.wikipedia.org%3APegcetacoplan" class="Z3988"></span></span> </li> </ol></div></div> <p><span class="noviewer" typeof="mw:File"><span><img alt="Public Domain" src="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/12px-PD-icon.svg.png" decoding="async" width="12" height="12" class="mw-file-element" srcset="//upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/18px-PD-icon.svg.png 1.5x, //upload.wikimedia.org/wikipedia/en/thumb/6/62/PD-icon.svg/24px-PD-icon.svg.png 2x" data-file-width="196" data-file-height="196" /></span></span> This article incorporates <a href="/wiki/Copyright_status_of_works_by_the_federal_government_of_the_United_States" title="Copyright status of works by the federal government of the United States">public domain material</a> from the <a rel="nofollow" class="external text" href="http://www.fda.gov/">United States Department of Health and Human Services</a> </p> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Pegcetacoplan&action=edit&section=9" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li>Clinical trial number <i><a rel="nofollow" class="external text" href="https://www.clinicaltrials.gov/show/NCT03500549">NCT03500549</a></i> for "Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)" at <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a></li> <li>Clinical trial number <i><a rel="nofollow" class="external text" href="https://www.clinicaltrials.gov/show/NCT03525613">NCT03525613</a></i> for "A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration " at <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a></li> <li>Clinical trial number <i><a rel="nofollow" class="external text" href="https://www.clinicaltrials.gov/show/NCT03525600">NCT03525600</a></i> for "Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration " at <a href="/wiki/ClinicalTrials.gov" title="ClinicalTrials.gov">ClinicalTrials.gov</a></li></ul> <div class="navbox-styles"><style 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abbr{color:var(--color-base)!important}@media(prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .navbar li a abbr{color:var(--color-base)!important}}@media print{.mw-parser-output .navbar{display:none!important}}</style><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Immunosuppressants" title="Template:Immunosuppressants"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Immunosuppressants" title="Template talk:Immunosuppressants"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Immunosuppressants" title="Special:EditPage/Template:Immunosuppressants"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="Immunosuppressive_drugs_/_Immunosuppressants_(L04)180" style="font-size:114%;margin:0 4em"><a href="/wiki/Immunosuppressive_drug" title="Immunosuppressive drug">Immunosuppressive drugs</a> / <a href="/wiki/Immunosuppression" title="Immunosuppression">Immunosuppressants</a> (<a href="/wiki/ATC_code_L04" title="ATC code L04">L04</a>)</div></th></tr><tr><th scope="row" class="navbox-group" style="width:1%">Intracellular<br />(initiation)</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Antimetabolite" title="Antimetabolite">Antimetabolites</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i><a href="/wiki/Purine_synthesis_inhibitor" class="mw-redirect" title="Purine synthesis inhibitor">purine synthesis inhibitors</a></i> <ul><li><a href="/wiki/Azathioprine" title="Azathioprine">Azathioprine</a></li> <li><a href="/wiki/Mycophenolic_acid" title="Mycophenolic acid">Mycophenolic acid</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Dihydroorotate_dehydrogenase" title="Dihydroorotate dehydrogenase">dihydroorotate dehydrogenase</a></i> inhibitors <ul><li><a href="/wiki/Leflunomide" title="Leflunomide">Leflunomide</a></li> <li><a href="/wiki/Teriflunomide" title="Teriflunomide">Teriflunomide</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Antifolate" title="Antifolate">antifolate</a></i> <ul><li><a href="/wiki/Methotrexate" title="Methotrexate">Methotrexate</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Macrolide" title="Macrolide">Macrolides</a>/<br />other <a href="/wiki/Interleukin_2" title="Interleukin 2">IL-2</a> inhibitors</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i><a href="/wiki/FKBP" title="FKBP">FKBP</a>/<a href="/wiki/Cyclophilin" title="Cyclophilin">Cyclophilin</a>/<a href="/wiki/Calcineurin" title="Calcineurin">Calcineurin</a></i> <ul><li><a href="/wiki/Ciclosporin" title="Ciclosporin">Ciclosporin</a></li> <li><a href="/wiki/Pimecrolimus" title="Pimecrolimus">Pimecrolimus</a></li> <li><a href="/wiki/Tacrolimus" title="Tacrolimus">Tacrolimus</a></li> <li><a href="/wiki/Voclosporin" title="Voclosporin">Voclosporin</a></li></ul></li></ul> <ul><li><a href="/wiki/Abetimus" title="Abetimus">Abetimus</a></li> <li><a href="/wiki/Gusperimus" title="Gusperimus">Gusperimus</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Immunomodulatory_imide_drug" class="mw-redirect" title="Immunomodulatory imide drug">IMiDs</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Lenalidomide" title="Lenalidomide">Lenalidomide</a></li> <li><a href="/wiki/Pomalidomide" title="Pomalidomide">Pomalidomide</a></li> <li><a href="/wiki/Thalidomide" title="Thalidomide">Thalidomide</a></li> <li><i><a href="/wiki/PDE4_inhibitor" title="PDE4 inhibitor">PDE4 inhibitor</a></i> <ul><li><a href="/wiki/Apremilast" title="Apremilast">Apremilast</a></li></ul></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Intracellular<br />(reception)</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Interleukin_1_receptor_antagonist" class="mw-redirect" title="Interleukin 1 receptor antagonist">IL-1 receptor antagonists</a></th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Anakinra" title="Anakinra">Anakinra</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/MTOR" title="MTOR">mTOR</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Everolimus" title="Everolimus">Everolimus</a></li> <li><a href="/wiki/Ridaforolimus" title="Ridaforolimus">Ridaforolimus</a></li> <li><a href="/wiki/Sirolimus" title="Sirolimus">Sirolimus</a></li> <li><a href="/wiki/Temsirolimus" title="Temsirolimus">Temsirolimus</a></li> <li><a href="/wiki/Umirolimus" title="Umirolimus">Umirolimus</a></li> <li><a href="/wiki/Zotarolimus" title="Zotarolimus">Zotarolimus</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Extracellular</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Antibody" title="Antibody">Antibodies</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Monoclonal_antibody" title="Monoclonal antibody">Monoclonal</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Serum target<br />(noncellular)</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i><a href="/wiki/Complement_component_5" title="Complement component 5">Complement component 5</a></i> <ul><li><a href="/wiki/Eculizumab" title="Eculizumab">Eculizumab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/TNF_inhibitor" title="TNF inhibitor">TNF</a></i> <ul><li><a href="/wiki/Adalimumab" title="Adalimumab">Adalimumab</a></li> <li><a href="/wiki/Afelimomab" title="Afelimomab">Afelimomab</a></li> <li><a href="/wiki/Certolizumab_pegol" title="Certolizumab pegol">Certolizumab pegol</a></li> <li><a href="/wiki/Golimumab" title="Golimumab">Golimumab</a></li> <li><a href="/wiki/Infliximab" title="Infliximab">Infliximab</a></li> <li><a href="/wiki/Nerelimomab" title="Nerelimomab">Nerelimomab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Interleukin" title="Interleukin">Interleukin</a></i> <ul><li><a href="/wiki/Anakinra" title="Anakinra">Anakinra</a></li> <li><a href="/wiki/Basiliximab" title="Basiliximab">Basiliximab</a></li> <li><a href="/wiki/Bimekizumab" title="Bimekizumab">Bimekizumab</a></li> <li><a href="/wiki/Briakinumab" title="Briakinumab">Briakinumab</a></li> <li><a href="/wiki/Brodalumab" title="Brodalumab">Brodalumab</a></li> <li><a href="/wiki/Canakinumab" title="Canakinumab">Canakinumab</a></li> <li><a href="/wiki/Daclizumab" title="Daclizumab">Daclizumab</a></li> <li><a href="/wiki/Guselkumab" title="Guselkumab">Guselkumab</a></li> <li><a href="/wiki/Ixekizumab" title="Ixekizumab">Ixekizumab</a></li> <li><a href="/w/index.php?title=Netakimab&action=edit&redlink=1" class="new" title="Netakimab (page does not exist)">Netakimab</a></li> <li><a href="/wiki/Olokizumab" title="Olokizumab">Olokizumab</a></li> <li><a href="/wiki/Rilonacept" title="Rilonacept">Rilonacept</a></li> <li><a href="/wiki/Risankizumab" title="Risankizumab">Risankizumab</a></li> <li><a href="/wiki/Sarilumab" title="Sarilumab">Sarilumab</a></li> <li><a href="/wiki/Satralizumab" title="Satralizumab">Satralizumab</a></li> <li><a href="/wiki/Secukinumab" title="Secukinumab">Secukinumab</a></li> <li><a href="/wiki/Siltuximab" title="Siltuximab">Siltuximab</a></li> <li><a href="/wiki/Sirukumab" title="Sirukumab">Sirukumab</a></li> <li><a href="/wiki/Spesolimab" title="Spesolimab">Spesolimab</a></li> <li><a href="/wiki/Tildrakizumab" title="Tildrakizumab">Tildrakizumab</a></li> <li><a href="/wiki/Tocilizumab" title="Tocilizumab">Tocilizumab</a></li> <li><a href="/wiki/Ustekinumab" title="Ustekinumab">Ustekinumab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Interleukin_5" title="Interleukin 5">Interleukin 5</a></i> <ul><li><a href="/wiki/Mepolizumab" title="Mepolizumab">Mepolizumab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Immunoglobulin_E" title="Immunoglobulin E">Immunoglobulin E</a></i> <ul><li><a href="/wiki/Omalizumab" title="Omalizumab">Omalizumab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Interferon" title="Interferon">Interferon</a></i> <ul><li><a href="/wiki/Faralimomab" title="Faralimomab">Faralimomab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Interleukin_6" title="Interleukin 6">IL-6</a></i> <ul><li><a href="/wiki/Elsilimomab" title="Elsilimomab">Elsilimomab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Interleukin_12" title="Interleukin 12">IL-12</a>, <a href="/wiki/Interleukin_13" title="Interleukin 13">IL-13</a>, and <a href="/wiki/Interleukin_23" title="Interleukin 23">IL-23</a></i> <ul><li><a href="/wiki/Lebrikizumab" title="Lebrikizumab">Lebrikizumab</a></li> <li><a href="/wiki/Ustekinumab" title="Ustekinumab">Ustekinumab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/Interleukin_17" title="Interleukin 17">IL-17A</a></i> <ul><li><a href="/wiki/Secukinumab" title="Secukinumab">Secukinumab</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Cellular<br />target</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i><a href="/wiki/CD3_(immunology)" title="CD3 (immunology)">CD3</a></i> <ul><li><a href="/wiki/Muromonab-CD3" title="Muromonab-CD3">Muromonab-CD3</a></li> <li><a href="/wiki/Otelixizumab" title="Otelixizumab">Otelixizumab</a></li> <li><a href="/wiki/Teplizumab" title="Teplizumab">Teplizumab</a></li> <li><a href="/wiki/Visilizumab" title="Visilizumab">Visilizumab</a></li></ul></li> <li><i><a href="/wiki/CD4" title="CD4">CD4</a></i> <ul><li><a href="/wiki/Clenoliximab" title="Clenoliximab">Clenoliximab</a></li> <li><a href="/wiki/Keliximab" title="Keliximab">Keliximab</a></li> <li><a href="/wiki/Zanolimumab" title="Zanolimumab">Zanolimumab</a></li></ul></li> <li><i><a href="/wiki/CD11a" class="mw-redirect" title="CD11a">CD11a</a></i> <ul><li><a href="/wiki/Efalizumab" title="Efalizumab">Efalizumab</a></li></ul></li> <li><i><a href="/wiki/CD18" class="mw-redirect" title="CD18">CD18</a></i> <ul><li><a href="/wiki/Erlizumab" title="Erlizumab">Erlizumab</a></li></ul></li> <li><i><a href="/wiki/CD20" title="CD20">CD20</a></i> <ul><li><a href="/wiki/Obinutuzumab" title="Obinutuzumab">Obinutuzumab</a></li> <li><a href="/wiki/Ocrelizumab" title="Ocrelizumab">Ocrelizumab</a> (<a href="/wiki/Ocrelizumab/hyaluronidase" title="Ocrelizumab/hyaluronidase">+hyaluronidase</a>)</li> <li><a href="/wiki/Pascolizumab" title="Pascolizumab">Pascolizumab</a></li> <li><a href="/wiki/Rituximab" title="Rituximab">Rituximab</a></li> <li><a href="/wiki/Ublituximab" title="Ublituximab">Ublituximab</a></li></ul></li> <li><i><a href="/wiki/CD23" title="CD23">CD23</a></i> <ul><li><a href="/wiki/Gomiliximab" class="mw-redirect" title="Gomiliximab">Gomiliximab</a></li> <li><a href="/wiki/Lumiliximab" title="Lumiliximab">Lumiliximab</a></li></ul></li> <li><i><a href="/wiki/CD40_(protein)" title="CD40 (protein)">CD40</a></i> <ul><li><a href="/wiki/Teneliximab" title="Teneliximab">Teneliximab</a></li> <li><a href="/wiki/Toralizumab" title="Toralizumab">Toralizumab</a></li></ul></li> <li><i><a href="/wiki/L-selectin" title="L-selectin">CD62L/L-selectin</a></i> <ul><li><a href="/wiki/Aselizumab" title="Aselizumab">Aselizumab</a></li></ul></li> <li><i><a href="/wiki/CD80" title="CD80">CD80</a></i> <ul><li><a href="/wiki/Galiximab" title="Galiximab">Galiximab</a></li></ul></li> <li><i><a href="/wiki/Basigin" title="Basigin">CD147/Basigin</a></i> <ul><li><a href="/wiki/Gavilimomab" title="Gavilimomab">Gavilimomab</a></li></ul></li> <li><i><a href="/wiki/CD154" title="CD154">CD154</a></i> <ul><li><a href="/wiki/Frexalimab" title="Frexalimab">Frexalimab</a></li> <li><a href="/wiki/Ruplizumab" title="Ruplizumab">Ruplizumab</a></li></ul></li></ul> <ul><li><i>BLyS</i> <ul><li><a href="/wiki/Belimumab" title="Belimumab">Belimumab</a></li></ul></li> <li><i><a href="/wiki/Chloramphenicol_acetyltransferase" title="Chloramphenicol acetyltransferase">CAT</a></i> <ul><li><a href="/wiki/Bertilimumab" title="Bertilimumab">Bertilimumab</a></li> <li><a href="/wiki/Lerdelimumab" title="Lerdelimumab">Lerdelimumab</a></li> <li><a href="/wiki/Metelimumab" title="Metelimumab">Metelimumab</a></li></ul></li> <li><i><a href="/wiki/Integrin" title="Integrin">Integrin</a></i> <ul><li><a href="/wiki/Natalizumab" title="Natalizumab">Natalizumab</a></li> <li><a href="/wiki/Vedolizumab" title="Vedolizumab">Vedolizumab</a></li></ul></li> <li><i><a href="/wiki/Interleukin-6_receptor" title="Interleukin-6 receptor">Interleukin-6 receptor</a></i> <ul><li><a href="/wiki/Tocilizumab" title="Tocilizumab">Tocilizumab</a></li></ul></li> <li><i><a href="/wiki/Lymphocyte_function-associated_antigen_1" title="Lymphocyte function-associated antigen 1">LFA-1</a></i> <ul><li><a href="/wiki/Odulimomab" title="Odulimomab">Odulimomab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/IL-2_receptor" title="IL-2 receptor">IL-2 receptor/CD25</a></i> <ul><li><a href="/wiki/Basiliximab" title="Basiliximab">Basiliximab</a></li> <li><a href="/wiki/Daclizumab" title="Daclizumab">Daclizumab</a></li> <li><a href="/wiki/Inolimomab" title="Inolimomab">Inolimomab</a></li></ul></li></ul> <ul><li><i><a href="/wiki/T_cell" title="T cell">T-lymphocyte</a></i> (<a href="/wiki/Zolimomab_aritox" title="Zolimomab aritox">Zolimomab aritox</a>)</li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Unsorted</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Alemtuzumab" title="Alemtuzumab">Alemtuzumab</a></li> <li><a href="/wiki/Anifrolumab" title="Anifrolumab">Anifrolumab</a></li> <li><a href="/wiki/Atorolimumab" title="Atorolimumab">Atorolimumab</a></li> <li><a href="/w/index.php?title=Begelomab&action=edit&redlink=1" class="new" title="Begelomab (page does not exist)">Begelomab</a></li> <li><a href="/wiki/Cedelizumab" title="Cedelizumab">Cedelizumab</a></li> <li><a href="/wiki/Emapalumab" title="Emapalumab">Emapalumab</a></li> <li><a href="/wiki/Fontolizumab" title="Fontolizumab">Fontolizumab</a></li> <li><a href="/wiki/Inebilizumab" title="Inebilizumab">Inebilizumab</a></li> <li><a href="/wiki/Maslimomab" title="Maslimomab">Maslimomab</a></li> <li><a href="/wiki/Morolimumab" title="Morolimumab">Morolimumab</a></li> <li><a href="/wiki/Ofatumumab" title="Ofatumumab">Ofatumumab</a></li> <li><a href="/wiki/Pexelizumab" title="Pexelizumab">Pexelizumab</a></li> <li><a href="/wiki/Reslizumab" title="Reslizumab">Reslizumab</a></li> <li><a href="/wiki/Rovelizumab" title="Rovelizumab">Rovelizumab</a></li> <li><a href="/wiki/Siplizumab" title="Siplizumab">Siplizumab</a></li> <li><a href="/wiki/Talizumab" title="Talizumab">Talizumab</a></li> <li><a href="/wiki/Telimomab_aritox" title="Telimomab aritox">Telimomab aritox</a></li> <li><a href="/wiki/Teprotumumab" title="Teprotumumab">Teprotumumab</a></li> <li><a href="/wiki/Vapaliximab" title="Vapaliximab">Vapaliximab</a></li> <li><a href="/wiki/Vepalimomab" title="Vepalimomab">Vepalimomab</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Polyclonal_antibodies" title="Polyclonal antibodies">Polyclonal</a></th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Anti-thymocyte_globulin" title="Anti-thymocyte globulin">Anti-thymocyte globulin</a></li> <li><a href="/wiki/Anti-lymphocyte_globulin" title="Anti-lymphocyte globulin">Anti-lymphocyte globulin</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">-cept (<a href="/wiki/Fusion_protein" title="Fusion protein">Fusion</a>)</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i><a href="/wiki/CTLA-4" class="mw-redirect" title="CTLA-4">CTLA-4</a></i> <ul><li><a href="/wiki/Abatacept" title="Abatacept">Abatacept</a></li> <li><a href="/wiki/Belatacept" title="Belatacept">Belatacept</a></li></ul></li> <li><i><a href="/wiki/TNF_inhibitor" title="TNF inhibitor">TNF inhibitor</a></i> <ul><li><a href="/wiki/Etanercept" title="Etanercept">Etanercept</a></li> <li><a href="/w/index.php?title=Opinercept&action=edit&redlink=1" class="new" title="Opinercept (page does not exist)">Opinercept</a></li></ul></li> <li><a href="/wiki/Aflibercept" title="Aflibercept">Aflibercept</a></li> <li><a href="/wiki/Alefacept" title="Alefacept">Alefacept</a></li> <li><a href="/wiki/Rilonacept" title="Rilonacept">Rilonacept</a></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Unsorted</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Avacopan" title="Avacopan">Avacopan</a></li> <li><a href="/wiki/Baricitinib" title="Baricitinib">Baricitinib</a></li> <li><a href="/wiki/Bimekizumab" title="Bimekizumab">Bimekizumab</a></li> <li><a href="/wiki/Blisibimod" title="Blisibimod">Blisibimod</a></li> <li><a href="/wiki/Briakinumab" title="Briakinumab">Briakinumab</a></li> <li><a href="/wiki/Brodalumab" title="Brodalumab">Brodalumab</a></li> <li><a href="/wiki/Canakinumab" title="Canakinumab">Canakinumab</a></li> <li><a href="/wiki/Crovalimab" title="Crovalimab">Crovalimab</a></li> <li><a href="/wiki/Danicopan" title="Danicopan">Danicopan</a></li> <li><a href="/wiki/Darvadstrocel" title="Darvadstrocel">Darvadstrocel</a></li> <li><a href="/wiki/Deucravacitinib" title="Deucravacitinib">Deucravacitinib</a></li> <li><a href="/wiki/Deuruxolitinib" title="Deuruxolitinib">Deuruxolitinib</a></li> <li><a href="/wiki/Dimethyl_fumarate" title="Dimethyl fumarate">Dimethyl fumarate</a></li> <li><a href="/wiki/Diroximel_fumarate" title="Diroximel fumarate">Diroximel fumarate</a></li> <li><a href="/wiki/Efgartigimod_alfa" title="Efgartigimod alfa">Efgartigimod alfa</a> (<a href="/wiki/Efgartigimod_alfa/hyaluronidase" title="Efgartigimod alfa/hyaluronidase">+hyaluronidase</a>)</li> <li><a href="/wiki/Etrasimod" title="Etrasimod">Etrasimod</a></li> <li><a href="/wiki/Filgotinib" title="Filgotinib">Filgotinib</a></li> <li><a href="/wiki/Fingolimod" title="Fingolimod">Fingolimod</a></li> <li><a href="/wiki/Guselkumab" title="Guselkumab">Guselkumab</a></li> <li><a href="/wiki/Iptacopan" title="Iptacopan">Iptacopan</a></li> <li><a href="/w/index.php?title=Itacitinib&action=edit&redlink=1" class="new" title="Itacitinib (page does not exist)">Itacitinib</a></li> <li><a href="/wiki/Ixekizumab" title="Ixekizumab">Ixekizumab</a></li> <li><a href="/w/index.php?title=Netakimab&action=edit&redlink=1" class="new" title="Netakimab (page does not exist)">Netakimab</a></li> <li><a href="/wiki/Olokizumab" title="Olokizumab">Olokizumab</a></li> <li><a href="/wiki/Ozanimod" title="Ozanimod">Ozanimod</a></li> <li><a href="/wiki/Peficitinib" title="Peficitinib">Peficitinib</a></li> <li><a class="mw-selflink selflink">Pegcetacoplan</a></li> <li><a href="/wiki/Pirfenidone" title="Pirfenidone">Pirfenidone</a></li> <li><a href="/wiki/Ponesimod" title="Ponesimod">Ponesimod</a></li> <li><a href="/wiki/Ravulizumab" title="Ravulizumab">Ravulizumab</a></li> <li><a href="/wiki/Risankizumab" title="Risankizumab">Risankizumab</a></li> <li><a href="/wiki/Ritlecitinib" title="Ritlecitinib">Ritlecitinib</a></li> <li><a href="/wiki/Rozanolixizumab" title="Rozanolixizumab">Rozanolixizumab</a></li> <li><a href="/wiki/Sarilumab" title="Sarilumab">Sarilumab</a></li> <li><a href="/wiki/Satralizumab" title="Satralizumab">Satralizumab</a></li> <li><a href="/wiki/Siltuximab" title="Siltuximab">Siltuximab</a></li> <li><a href="/wiki/Siponimod" title="Siponimod">Siponimod</a></li> <li><a href="/wiki/Sirukumab" title="Sirukumab">Sirukumab</a></li> <li><a href="/wiki/Spesolimab" title="Spesolimab">Spesolimab</a></li> <li><a href="/wiki/Sutimlimab" title="Sutimlimab">Sutimlimab</a></li> <li><a href="/wiki/Telitacicept" title="Telitacicept">Telitacicept</a></li> <li><a href="/wiki/Tildrakizumab" title="Tildrakizumab">Tildrakizumab</a></li> <li><a href="/wiki/Tofacitinib" title="Tofacitinib">Tofacitinib</a></li> <li><a href="/wiki/Upadacitinib" title="Upadacitinib">Upadacitinib</a></li></ul> </div></td></tr></tbody></table></div> <div class="navbox-styles"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1236075235"></div><div role="navigation" class="navbox" aria-labelledby="Complement_system89" style="padding:3px"><table class="nowraplinks mw-collapsible autocollapse navbox-inner" style="border-spacing:0;background:transparent;color:inherit"><tbody><tr><th scope="col" class="navbox-title" colspan="2"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1129693374"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1239400231"><div class="navbar plainlinks hlist navbar-mini"><ul><li class="nv-view"><a href="/wiki/Template:Complement_system" title="Template:Complement system"><abbr title="View this template">v</abbr></a></li><li class="nv-talk"><a href="/wiki/Template_talk:Complement_system" title="Template talk:Complement system"><abbr title="Discuss this template">t</abbr></a></li><li class="nv-edit"><a href="/wiki/Special:EditPage/Template:Complement_system" title="Special:EditPage/Template:Complement system"><abbr title="Edit this template">e</abbr></a></li></ul></div><div id="Complement_system89" style="font-size:114%;margin:0 4em"><a href="/wiki/Complement_system" title="Complement system">Complement system</a></div></th></tr><tr><th scope="row" class="navbox-group" style="width:1%">Pathways</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Classical_complement_pathway" title="Classical complement pathway">C</a></li> <li><a href="/wiki/Lectin_pathway" title="Lectin pathway">L</a></li> <li><a href="/wiki/Alternative_complement_pathway" title="Alternative complement pathway">A</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Activators/enzymes</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"></div><table class="nowraplinks navbox-subgroup" style="border-spacing:0"><tbody><tr><th scope="row" class="navbox-group" style="width:1%">Early</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i>C:</i> <a href="/wiki/C1_complex" title="C1 complex">C1</a> <ul><li><a href="/wiki/Complement_component_1q" title="Complement component 1q">C1q</a></li> <li><a href="/wiki/Complement_component_1r" title="Complement component 1r">C1r</a></li> <li><a href="/wiki/Complement_component_1s" title="Complement component 1s">C1s</a></li></ul></li> <li><a href="/wiki/Complement_component_4" title="Complement component 4">C4</a> <ul><li><a href="/wiki/C4A" title="C4A">C4a</a></li> <li><a href="/wiki/C4B" class="mw-redirect" title="C4B">C4b</a></li></ul></li> <li><a href="/wiki/Complement_component_2" title="Complement component 2">C2</a></li></ul> <ul><li><i>L:</i> <a href="/wiki/MASP1_(protein)" title="MASP1 (protein)">MASP1</a>/<a href="/wiki/MASP2_(protein)" title="MASP2 (protein)">MASP2</a></li> <li><a href="/wiki/Mannan-binding_lectin" title="Mannan-binding lectin">MBL</a></li></ul> <ul><li><i>A:</i> <a href="/wiki/Complement_factor_B" title="Complement factor B">Factor B</a></li> <li><a href="/wiki/Factor_D" title="Factor D">Factor D</a></li> <li><a href="/wiki/Properdin" title="Properdin">Factor P/Properdin</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Middle</th><td class="navbox-list-with-group navbox-list navbox-odd" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Complement_component_3" title="Complement component 3">C3</a> <ul><li><a href="/wiki/C3a_(complement)" title="C3a (complement)">C3a</a></li> <li><a href="/wiki/C3b" title="C3b">C3b</a>/<a href="/wiki/IC3b" title="IC3b">iC3b</a></li></ul></li> <li><a href="/wiki/Complement_component_5" title="Complement component 5">C5</a> <ul><li><a href="/wiki/Complement_component_5a" title="Complement component 5a">C5a</a></li> <li><a href="/wiki/Complement_component_5b" class="mw-redirect" title="Complement component 5b">C5b</a></li></ul></li></ul> <ul><li><a href="/wiki/C3-convertase" title="C3-convertase">C3-convertase</a></li> <li><a href="/wiki/C5-convertase" title="C5-convertase">C5-convertase</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Late</th><td class="navbox-list-with-group navbox-list navbox-even" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Complement_membrane_attack_complex" title="Complement membrane attack complex">MAC</a> <ul><li><a href="/wiki/Complement_component_5b" class="mw-redirect" title="Complement component 5b">C5b</a></li> <li><a href="/wiki/Complement_component_6" title="Complement component 6">C6</a></li> <li><a href="/wiki/Complement_component_7" title="Complement component 7">C7</a></li> <li><a href="/wiki/C8_complex" title="C8 complex">C8</a></li> <li><a href="/wiki/Complement_component_9" title="Complement component 9">C9</a></li></ul></li></ul> </div></td></tr></tbody></table><div></div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Inhibitors</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><i>CLA:</i> <a href="/wiki/C1-inhibitor" title="C1-inhibitor">C1-inhibitor</a></li> <li><a href="/wiki/Decay-accelerating_factor" title="Decay-accelerating factor">Decay-accelerating factor</a>/<a href="/wiki/CD59" title="CD59">CD59</a></li> <li><a href="/wiki/Complement_factor_I" title="Complement factor I">Factor I</a></li></ul> <ul><li><i>CL:</i> <a href="/wiki/C4b-binding_protein" title="C4b-binding protein">C4BP</a></li></ul> <ul><li><i>A:</i> <a href="/wiki/Factor_H" title="Factor H">Factor H</a></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="/wiki/Complement_receptor" title="Complement receptor">Complement receptors</a></th><td class="navbox-list-with-group navbox-list navbox-even hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Complement_receptor_1" title="Complement receptor 1">CR1</a></li> <li><a href="/wiki/Complement_receptor_2" title="Complement receptor 2">CR2</a></li> <li><a href="/wiki/Macrophage-1_antigen" title="Macrophage-1 antigen">CR3</a></li> <li><a href="/wiki/Integrin_alphaXbeta2" class="mw-redirect" title="Integrin alphaXbeta2">CR4</a></li> <li><a href="/wiki/Integrin_alpha_M" title="Integrin alpha M">CD11b</a>/<a href="/wiki/CD11c" class="mw-redirect" title="CD11c">CD11c</a>/<a href="/wiki/CD18" class="mw-redirect" title="CD18">CD18</a></li> <li><a href="/wiki/Anaphylatoxin_receptors" title="Anaphylatoxin receptors">Anaphylatoxin</a> <ul><li><a href="/wiki/C3a_receptor" title="C3a receptor">C3a</a></li> <li><a href="/wiki/C5a_receptor" title="C5a receptor">C5a</a></li></ul></li></ul> </div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Function</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em"> <ul><li><a href="/wiki/Cytotoxicity" title="Cytotoxicity">Cytotoxicity</a>(by MAC)</li> <li><a href="/wiki/Immune_adherence" title="Immune adherence">immune adherence</a></li> <li>Inducing <a href="/wiki/Inflammation" title="Inflammation">inflammation</a></li> <li><a href="/wiki/Opsonization" class="mw-redirect" title="Opsonization">Opsonization</a></li></ul> </div></td></tr></tbody></table></div> <style data-mw-deduplicate="TemplateStyles:r1130092004">.mw-parser-output .portal-bar{font-size:88%;font-weight:bold;display:flex;justify-content:center;align-items:baseline}.mw-parser-output .portal-bar-bordered{padding:0 2em;background-color:#fdfdfd;border:1px solid #a2a9b1;clear:both;margin:1em auto 0}.mw-parser-output .portal-bar-related{font-size:100%;justify-content:flex-start}.mw-parser-output .portal-bar-unbordered{padding:0 1.7em;margin-left:0}.mw-parser-output .portal-bar-header{margin:0 1em 0 0.5em;flex:0 0 auto;min-height:24px}.mw-parser-output .portal-bar-content{display:flex;flex-flow:row wrap;flex:0 1 auto;padding:0.15em 0;column-gap:1em;align-items:baseline;margin:0;list-style:none}.mw-parser-output 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