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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Ublituximab - 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="Ublituximab">
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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="2025/01/24">
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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="_NBK612207_"><span class="title" itemprop="name">Ublituximab</span></h1><p class="fm-aai"><a href="#_NBK612207_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Ublituximab.OVERVIEW"><h2 id="_Ublituximab_OVERVIEW_">OVERVIEW</h2><div id="Ublituximab.Introduction"><h3>Introduction</h3><p>Ublituximab is a chimeric monoclonal antibody to CD20, a cell surface marker found on B lymphocytes and plasma cells, which is used to treat adults with relapsing multiple sclerosis. Ublituximab has not been linked to liver enzyme elevations during therapy or to instances of clinically apparent liver injury, but like other monoclonal antibodies to CD20, ublituximab can cause reactivation of hepatitis B.</p></div><div id="Ublituximab.Background"><h3>Background</h3><p>Ublituximab (ue” bli tux’ i mab) is a chimeric, glygcoengineered monoclonal IgG1 antibody to the CD20 antigen which is used to treat adults with relapsing multiple sclerosis (MS). Ublituximab binds to the cell surface marker CD20 on B lymphocytes and causes their depletion resulting in a decrease in spontaneous autoantibody production. This monoclonal antibody has been shown to be effective in reducing disease activity in patients with severe forms of relapsing multiple sclerosis, a disease marked by immune dysregulation and production of pathogenic autoantibodies and immune complexes. Ublituximab was approved for use in the United States in 2022 and current indications are for treatment of adult patients with relapsing forms of multiple sclerosis including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Ublituximab was the third monoclonal antibody to CD20 approve for use in multiple sclerosis, the others being ofatumumab (Arzerra: 2009) and ocrelizumab (Ocrevus: 2017). Ublituximab is available in under the brand name Briumvi in single dose vials of 150 mg in 6 mL (25 mg/mL). The recommended dose regimen is an initial intravenous infusion of 150 mg followed by an infusion of 450 mg 2 weeks later and then 450 mg every 24 weeks. Premedication with methylprednisone and an antihistamine is recommended for the first two infusions and patients should be monitored for hypersensitivity reactions for at least one hour. Thereafter, premedication should be used as needed for patients who had troublesome reactions during the first two infusions. Other adverse effects include infections, reduction in immunoglobulin levels, bronchitis, cough, fatigue, headache, insomnia, nausea, and herpes zoster. Rare but potentially serious side effects include severe hypersensitivity reactions (angioedema or anaphylaxis), severe infections, reactivation of hepatitis B and other viral (herpes simplex and zoster), fungal, and mycobacterial infections, and possibly fetal-embryonal toxicity. Screening for hepatitis B virus infection and immunoglobulins is recommended before starting therapy. The potential of reactivation of tuberculosis is not clear. Patients receiving ublituximab should receive all appropriate vaccines (inactivated and live) well before starting therapy. Because of the possibility of fetal injury, women of child-bearing potential should be screened for pregnancy before and practice an effective means of birth control during and for six months after ublituximab therapy.</p></div><div id="Ublituximab.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In preregistration controlled trials, elevations in serum aminotransferase levels above 3 times the ULN arose in 3.5% of patients receiving ublituximab vs 4.2% of those on teriflunomide, the comparative agent. Two patients receiving ublituximab developed marked ALT and AST elevations accompanied by jaundice, but both were shown to be due to an unrelated cause, one due to acute hepatitis C and the other due to chronic hepatitis B (possibly caused by reactivation). Since its approval and more widescale use, there have been no case reports of liver injury with jaundice linked to ublituximab therapy. Because ublituximab is immunosuppressive, it may cause reactivation of hepatitis B in susceptible persons. Reactivation of hepatitis B can be severe and is sometimes fatal, as has occurred with other monoclonal antibodies directed against CD20 such ofatumumab, ocrelizumab, and rituximab.</p><p>Likelihood score: D (possible cause of clinically apparent liver injury as a result of reactivation of hepatitis B).</p></div><div id="Ublituximab.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>There is little evidence that ublituximab is a cause of idiosyncratic liver injury and mechanisms by which it might occur is not clear but might result from immune modulation. Ublituximab suppresses B cell reactivity and is capable of inducing reactivation of hepatitis B in susceptible patients.</p></div><div id="Ublituximab.Outcome_and_Management"><h3>Outcome and Management</h3><p>The serum aminotransferase elevations that have been reported during ublituximab therapy were generally transient, mild and asymptomatic and did not require dose modification or delay in therapy. Elevations above 5 times the upper limit of normal should lead to a careful search for other causes of liver injury and more careful monitoring. Because ublituximab is given every 24 weeks, suspension of infusions while waiting for further diagnostic results or for levels returning to normal or near normal levels is usually unnecessary. There is no evidence of cross sensitivity to hepatic reactions among the various monoclonal antibodies. Although the product label for ublituximab does not recommend baseline screening or regular monitoring of liver tests, it is reasonable to include a metabolic panel with routine liver tests as well as a complete blood count before starting therapy and at the 24-week intervals when the agent is administered. Because ublituximab is immunosuppressive, it may cause reactivation of hepatitis B in susceptible persons. Patients should be screened for hepatitis B virus (HBV) serologic markers before starting therapy. Ublituximab is contraindicated in patients with active hepatitis B, and patients with anti-HBc without HBsAg in serum should be considered for prophylaxis against reactivation or monitored closely for early evidence of an appearance of HBV DNA in serum, which should prompt antiviral therapy with an agent with potent activity against HBV.</p><p>Drug Class: <a href="/books/n/livertox/MonoclonalAntibodies/?report=reader">Monoclonal Antibodies</a></p><p>Other Anti-CD20 Monoclonal Antibodies for Multiple Sclerosis: <a href="/books/n/livertox/Ocrelizumab/?report=reader">Ocrelizumab</a>, <a href="/books/n/livertox/Ofatumumab/?report=reader">Ofatumumab</a>, <a href="/books/n/livertox/Rituximab/?report=reader">Rituximab</a></p></div></div><div id="Ublituximab.PRODUCT_INFORMATION"><h2 id="_Ublituximab_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Ublituximab – Briumvi®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Immunosuppressive Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?label=all&query=Ublituximab" 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 id="Ublituximab.CHEMICAL_FORMULA_AND_STRUCTU"><h2 id="_Ublituximab_CHEMICAL_FORMULA_AND_STRUCTU_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figUblituximabTc"><a href="/books/NBK612207/table/Ublituximab.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img" rid-ob="figobUblituximabTc"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="Ublituximab.Tc"><a href="/books/NBK612207/table/Ublituximab.Tc/?report=objectonly" target="object" rid-ob="figobUblituximabTc">Table</a></h4></div></div></div><div id="Ublituximab.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Ublituximab_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 24 January 2025</p><p>Abbreviations: HBV, hepatitis B virus.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Ublituximab.REF.zimmerman.1999">Zimmerman HJ. Drugs used to treat rheumatic and musculospastic disease. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 517-54.<div><i>(Expert review of hepatotoxicity published in 1999, before the availability of most monoclonal antibody therapies).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.reuben.2011">Reuben A. Hepatotoxicity of immunosuppressive drugs. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2011, pp. 569-91.<div><i>(Review of hepatotoxicity of immunosuppressive agents does not mention ublituximab).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.krensky.2018">Krensky AM, Azzi JR, Hafler DA. Immunosuppressants and toleragens. 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. 637-53.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF4">FDA. Clinical Review. 2022. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761238Orig1s000MedR.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.accessdata<wbr style="display:inline-block"></wbr>​.fda.gov/drugsatfda_docs<wbr style="display:inline-block"></wbr>​/nda/2023/761238Orig1s000MedR.pdf</a><div><i>(FDA website with product labels and initial multidiscipline clinical review of the safety and efficacy of ublituximab based on results from studies provided by the sponsor in support of its approval as therapy of relapsing multiple sclerosis, mentions that ALT elevations above 3 times ULN arose in 3.5% of patients on ublituximab vs 4.2% of teriflunomide, and 2 cases of marked ALT elevations with jaundice in those on ublituximab were due to acute hepatitis C and chronic hepatitis B [possibly reactivation] and not to drug induced liver injury).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.lovettracke.2019.187">Lovett-Racke
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AE, Gormley
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M, Liu
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Y, Yang
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Y, Graham
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C, Wray
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S, Racke
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MK, et al.
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B cell depletion with ublituximab reshapes the T cell profile in multiple sclerosis patients.
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J Neuroimmunol.
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2019;332:187-197.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31077854" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31077854</span></a>]<div><i>(Analysis of lymphocyte subsets in 40 patients with multiple sclerosis receiving ublituximab demonstrated that the depletion of B cells by the cytolytic monoclonal antibody caused shifts in lymphocyte subsets suggesting that immune regulation was restored).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.fox.2021.420">Fox
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E, Lovett-Racke
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AE, Gormley
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M, Liu
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Y, Petracca
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M, Cocozza
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S, Shubin
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R, et al.
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A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis.
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Mult Scler.
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2021;27:420-429.
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[<a href="/pmc/articles/PMC7897779/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7897779</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/32351164" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32351164</span></a>]<div><i>(Among 48 patients with relapsing multiple sclerosis treated with ublituximab in 6 dosing regimens, B cell depletion of 95% occurred in all within 2 weeks and the annualized relapse rate decreased [from 1.45 to 0.07], and while 58% had at least one adverse event, none were serious or resulted in discontinuation; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.faissner.2022.803">Faissner
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S, Gold
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R. Efficacy and safety of multiple sclerosis drugs approved since 2018 and future developments.
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CNS Drugs.
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2022;36:803-817.
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[<a href="/pmc/articles/PMC9307218/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9307218</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/35869335" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35869335</span></a>]<div><i>(Review of the mechanism of action, efficacy, and safety of newly approved drugs for multiple sclerosis including preliminary data on ublituximab; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.steinman.2022.704">Steinman
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L, Fox
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E, Hartung
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HP, Alvarez
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E, Qian
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P, Wray
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S, Robertson
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D, et al.; ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus teriflunomide in relapsing multiple sclerosis.
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N Engl J Med.
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2022;387:704-714.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/36001711" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36001711</span></a>]<div><i>(Among 1096 adults with relapsing multiple sclerosis treated in two controlled trials of ublituximab vs teriflunomide for up to 95 weeks, the annualized relapse rates were .08 to .09 vs .18 to .19; no mention of ALT elevations or clinically apparent liver injury with jaundice).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF9">Ublituximab (Briumvi) for relapsing multiple sclerosis.
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Med Lett Drugs Ther.
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2023;65:36-38.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/36877282" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36877282</span></a>]<div><i>(Concise review of the mechanism of action, clinical efficacy, safety, and costs of ublituximab mentions that one patient treated with ublituximab in registration trials developed reactivation of hepatitis B and that its use is contraindicated in patients with active HBV infection).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.lee.2023.455">Lee
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A.
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Ublituximab: first approval.
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Drugs.
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2023;83:455-459.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/36920653" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36920653</span></a>]<div><i>(Review of the mechanism of action, history of development, pharmacology, clinical efficacy, and safety of ublituximab shortly after its approval for use in multiple sclerosis in the US mentions that serious adverse events can include infusion reactions and severe infections; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.gandelman.2024.e200241">Gandelman
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S, Lenzi
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KA, Markowitz
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C, Berger
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JR. A proposed approach to screening and surveillance labs for patients with multiple sclerosis on anti-CD20 therapy.
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Neurol Clin Pract.
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2024;14:e200241.
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[<a href="/pmc/articles/PMC10775160/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10775160</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/38204588" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38204588</span></a>]<div><i>(Proposal for screening and monitoring laboratory tests in patients with multiple sclerosis receiving monoclonal anti-CD4, including ublituximab, recommends baseline liver tests, complete blood count, absolute B cell count, immunoglobulin levels, HBV markers, varicella zoster virus IgG, JC virus status, and vaccination history and regular monitoring of liver tests and complete blood counts thereafter at 6 month intervals; women of child-bearing potential receiving ublituximab should also have baseline and 6 monthly pregnancy testing).</i></div></div></li><li><div class="bk_ref" id="Ublituximab.REF.carlson.2024.285">Carlson
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AK, Amin
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M, Cohen
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JA. Drugs targeting CD20 in multiple sclerosis: pharmacology, efficacy, safety, and tolerability.
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Drugs.
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2024;84:285-304.
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[<a href="/pmc/articles/PMC10982103/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10982103</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/38480630" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38480630</span></a>]<div><i>(Four monoclonal anti-CD20 are currently used to treat multiple sclerosis including ofatumumab, ocrelizumab, ublituximab, and [off-label] rituximab which have different molecular structures, target epitopes, pharmacology, dose regimens and mode of administration, mechanisms of B cell depletion, risks and immunogenicity; and none have been directly compared for efficacy and safety).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK612207_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">January 24, 2025</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Ublituximab. [Updated 2025 Jan 24].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Turmeric/?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/Ubrogepant/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="table-wrap" id="figobUblituximabTc"><div id="Ublituximab.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK612207/table/Ublituximab.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Ublituximab.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Ublituximab.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Ublituximab.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NO.</th><th id="hd_h_Ublituximab.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Ublituximab.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Ublituximab.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Ublituximab</td><td headers="hd_h_Ublituximab.Tc_1_1_1_2" rowspan="1" colspan="1" style="background-color:rgb(248,249,250);text-align:left;vertical-align:top;">1174014-05-1</td><td headers="hd_h_Ublituximab.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Monoclonal Antibody</td><td headers="hd_h_Ublituximab.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not Available</td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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