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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Moxetumomab Pasudotox - LiverTox - NCBI Bookshelf</title>
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<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
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<meta name="citation_title" content="Moxetumomab Pasudotox">
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<meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
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<meta name="citation_date" content="2019/04/12">
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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="_NBK548901_"><span class="title" itemprop="name">Moxetumomab Pasudotox</span></h1><p class="fm-aai"><a href="#_NBK548901_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="MoxetumomabPasudotox.OVERVIEW"><h2 id="_MoxetumomabPasudotox_OVERVIEW_">OVERVIEW</h2><div id="MoxetumomabPasudotox.Introduction"><h3>Introduction</h3><p>Moxetumomab pasudotox is a mouse monoclonal antibody to CD22 conjugated with a toxic fragment of Pseudomonas exotoxin A which is used in the therapy of resistant forms of hairy cell leukemia. Moxetumomab pasudotox has been linked to transient serum enzyme elevations during therapy, but has not been linked to instances of clinically apparent liver injury with jaundice.</p></div><div id="MoxetumomabPasudotox.Background"><h3>Background</h3><p>Moxetumomab (mox" e toom' oh mab) pasudotox (pa soo' doe tox) is a recombinant mouse monoclonal antibody to the human CD22 cell surface marker which is highly expressed on the malignant B cells of hairy cell leukemia. The monoclonal antibody is conjugated to a fragment of a bacterial toxin, Pseudomonas exotoxin PE38 (pasudotox). When moxetumomab binds to CD22 on malignant B cells, it is internalized and the pasudotox is released by the action of lysosomal enzymes on the linker molecule that joins the monoclonal antibody and cytotoxic molecule. The intracellular exotoxin results in apoptotic cell death. This monoclonal antibody conjugate has been shown to be effective in inducing remissions in relapsed or refractory hairy cell leukemia and was given accelerated approval for this indication in the United States in 2018. Moxetumomab pasudotox is available in single dose vials of 1 mg of lyophilized powder under the brand name Lumoxiti. The recommended dose is 0.04 mg/kg by intravenous infusion over 30 minutes on days 1, 3 and 5 of each 28-day cycle. Premedication with acetaminophen, an antihistamine and H2 receptor blocker is recommended as well as careful attention to maintaining adequate hydration. Common side effects include infusion reactions, edema, nausea, fatigue, headache, fever, diarrhea, constipation and anemia. Less common but serious side effects include severe infusion reactions, hemolytic uremic syndrome, capillary leak syndrome, renal toxicity and electrolyte imbalance.</p></div><div id="MoxetumomabPasudotox.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In publications on trials of moxetumomab pasudotox in hairy cell leukemia, serum ALT or AST elevations were frequent during therapy arising in 14% to 19% of patients, but to above 5 times the upper limit of normal (ULN) in only 3.8% to 5.5%. Serial testing for ALT and AST during moxetumomab therapy shows regular and reproducible elevations occurring with each cycle of treatment, peaking at or around day 8 and falling back to baseline by day 21. Hyperbilirubinemia was also common during moxetumomab therapy (6.3%), but there were no reported instances of clinically apparent liver injury with symptoms and jaundice that were attributed to the monoclonal-toxin conjugate. The major severe adverse reactions to moxetumomab pasudotox therapy were hemolytic uremic syndrome and capillary leak syndrome, both of which may be associated with mild-to-moderate serum enzyme elevations, but significant liver injury with jaundice is rare. In addition, moxetumomab pasudotox has not been linked to sinusoidal obstruction syndrome, a common complication of other monoclonal-toxin conjugates.</p><p>Likelihood score: E* (unproven but suspected possible cause of clinically apparent liver injury).</p></div><div id="MoxetumomabPasudotox.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The serum enzyme elevations that occur during moxetumomab pasudotox therapy is not known, but it is likely direct toxicity of the conjugate.</p></div><div id="MoxetumomabPasudotox.Outcome_and_Managem"><h3>Outcome and Management</h3><p>The serum enzyme elevations during moxetumomab pasudotox therapy are common but generally transient, mild and asymptomatic and rarely require dose modification or delay in therapy. Elevations of ALT or AST above 5 times the ULN should lead to more careful monitoring and suspension of further infusions, at least until levels return to normal or near normal values.</p><p>Drug Class: <a href="/books/n/livertox/AntineoplasticAgents/?report=reader">Antineoplastic Agents</a>, <a href="/books/n/livertox/MonoclonalAntibodies/?report=reader">Monoclonal Antibodies</a></p></div></div><div id="MoxetumomabPasudotox.PRODUCT_INFORMATION"><h2 id="_MoxetumomabPasudotox_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div id="MoxetumomabPasudotox.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Moxetumomab Pasudotox – Lumoxiti®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Antineoplastic Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Moxetumomab" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></div><div id="MoxetumomabPasudotox.CHEMICAL_FORMULA_AN"><h2 id="_MoxetumomabPasudotox_CHEMICAL_FORMULA_AN_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figMoxetumomabPasudotoxT1"><a href="/books/NBK548901/table/MoxetumomabPasudotox.T1/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figMoxetumomabPasudotoxT1" rid-ob="figobMoxetumomabPasudotoxT1"><img class="small-thumb" src="/books/NBK548901/table/MoxetumomabPasudotox.T1/?report=thumb" src-large="/books/NBK548901/table/MoxetumomabPasudotox.T1/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="MoxetumomabPasudotox.T1"><a href="/books/NBK548901/table/MoxetumomabPasudotox.T1/?report=objectonly" target="object" rid-ob="figobMoxetumomabPasudotoxT1">Table</a></h4></div></div></div><div id="MoxetumomabPasudotox.ANNOTATED_BIBLIOGRA"><h2 id="_MoxetumomabPasudotox_ANNOTATED_BIBLIOGRA_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 12 April 2019</p><ul class="first-line-outdent"><li><div class="bk_ref" id="MoxetumomabPasudotox.R1">DeLeve LD. Gemtuzumab ozogamicin. Liver sinusoidal endothelial cells and liver injury. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2011, pp. 142-3.<div><i>(Review of agents that damage liver sinusoidal cells including gemtuzumab ozogamicin; mentions that CD33 which is present on leukemic blast cells is also present on liver sinusoidal endothelial cells; moxetumomab is not discussed, but there is no evidence linking CD22 or moxetumomab pasudotox to similar effects).</i></div></div></li><li><div class="bk_ref" id="MoxetumomabPasudotox.R2">Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway-targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="MoxetumomabPasudotox.R3">
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<a href="https://www.accessdata.fda.gov/scripts/cder/daf/" 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/scripts/cder/daf/</a>
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<div>
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<i>(FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA scientific review of the new drug application for safety and efficacy; mentions that serum ALT or AST elevations arose in 21-39% of patients treated with moxetumomab and were above 5 times ULN in 1.3-3.1%, but no patient developed acute liver injury with jaundice).</i>
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</div></div></li><li><div class="bk_ref" id="MoxetumomabPasudotox.R4">Dhillon S. Moxetumomab pasudotox: first global approval. Drugs 2018; 78 (16): 1763-7. [<a href="/pmc/articles/PMC6323103/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6323103</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30357593" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30357593</span></a>]<div><i>(Review of the current status of therapy of hairy cell leukemia and the development, structure, mechanism of action, pharmacology, clinical efficacy and safety of moxetumomab pasudotox; mentions serious adverse events of fever, sepsis, hemolytic uremic syndrome, capillary leak syndrome and renal dysfunction; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="MoxetumomabPasudotox.R5">Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Karlin L, Robak T, Gladstone DE, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia 2018; 32: 1768-77. [<a href="/pmc/articles/PMC6087717/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6087717</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30030507" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30030507</span></a>]<div><i>(Among 80 adults with relapsed or refractory hairy cell leukemia treated with moxetumomab pasudotox, durable complete responses occurred in 30% and clinical remissions in 80%, while adverse events included peripheral edema [39%], nausea [35%], fatigue [34%], headache [33%], hemolytic uremic syndrome [7.5%] and capillary leak syndrome [5%]; ALT elevations arose in 21%, but only 1.3% were above 5 times ULN and no patient had clinically apparent liver injury with jaundice).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548901_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">April 12, 2019</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-. Moxetumomab Pasudotox. [Updated 2019 Apr 12].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/MoveFree/?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/Moxifloxacin/?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="boxed-text" id="figobMoxetumomabPasudotoxBPI"><div id="MoxetumomabPasudotox.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Moxetumomab Pasudotox – Lumoxiti®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Antineoplastic Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Moxetumomab" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></article><article data-type="table-wrap" id="figobMoxetumomabPasudotoxT1"><div id="MoxetumomabPasudotox.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548901/table/MoxetumomabPasudotox.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__MoxetumomabPasudotox.T1_lrgtbl__"><table><thead><tr><th id="hd_h_MoxetumomabPasudotox.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_MoxetumomabPasudotox.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NO.</th><th id="hd_h_MoxetumomabPasudotox.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_MoxetumomabPasudotox.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_MoxetumomabPasudotox.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Moxetumomab Pasudotox</td><td headers="hd_h_MoxetumomabPasudotox.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135350821" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">1020748-57-5</a>
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</td><td headers="hd_h_MoxetumomabPasudotox.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">Monoclonal Antibody</td><td headers="hd_h_MoxetumomabPasudotox.T1_1_1_1_4" rowspan="1" colspan="1" style="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>
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