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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Alefacept - 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_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
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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="_NBK548345_"><span class="title" itemprop="name">Alefacept</span></h1><p class="fm-aai"><a href="#_NBK548345_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Alefacept.OVERVIEW"><h2 id="_Alefacept_OVERVIEW_">OVERVIEW</h2><div id="Alefacept.Introduction"><h3>Introduction</h3><p>Alefacept is a recombinant fusion protein of lymphocyte function associated antigen-3 (LFA-3) and immunoglobulin G dimer that acts to block the activation of T cells, and is an immunosuppressive agent that was previously used to treat moderate-to-severe plaque psoriasis. Alefacept is associated with a low rate of serum enzyme elevations during therapy and to rare instances of clinically apparent acute liver injury.</p></div><div id="Alefacept.Background"><h3>Background</h3><p>Alefacept (a lef' a sept) is a recombinant fusion protein that combines the lymphocyte function associated antigen-3 (LFA3) with the heavy chain of immunoglobulin G. The fusion protein inhibits the binding of endogenous LFA3 to CD2 cells interfering with activation of memory T cells which play an important role in the pathogenesis of inflammatory autoimmune diseases. In controlled clinical trials, alefacept therapy improved symptoms and skin lesions in patients with refractory psoriasis. Alefacept was approved for use in the United States in 2003 and was the first biological agent approved for treatment of psoriasis. However, because of the availability of better tolerated and more effective biologics for psoriasis, alefacept was withdrawn from use by its sponsor in 2011. Alefacept had been available as a solution for parenteral administration in single use vials of 7.5 or 15 mg under the brand name Amevive. Alefacept was given once weekly, either intramuscularly in a dose of 15 mg or intravenously in a dose of 7.5 mg for 12 weeks. Repeat courses were recommended for patients who responded to therapy and then relapsed. Alefacept also showed activity in treatment and prevention of graft rejection after transplantation but was never approved for that use. Common side effects included headache, dizziness, nausea, myalgias, injection site reactions and infections. Rare, but potentially severe adverse reactions included lymphopenia, serious infections, hypersensitivity reactions and an increased risk for malignancy.</p></div><div id="Alefacept.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In prelicensure controlled trials, serum ALT or AST elevations greater than 3 times the upper limit of normal (ULN) occurred in <2% of alefacept and a similar proportion of placebo treated subjects. The elevations were usually mild-to-moderate in severity, asymptomatic and self-limited in course. ALT elevations accompanied by jaundice and symptoms were not reported in the premarketing studies. Subsequent to its approval and more wide scale use, however, cases of marked serum enzyme elevations, acute hepatitis and acute liver failure have been reported to the sponsor. These cases have not been reported in the literature and the strength of the association of these episodes with alefacept use has not been evaluated critically. The clinical features, characteristics, course and outcome of these episodes of hepatitis have not been described.</p><p>Likelihood score: E* (unproven but suspected rare cause of liver injury).</p></div><div id="Alefacept.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The mechanism of possible liver injury due to alefacept is unknown. Alefacept is a recombinant protein and unlikely to have intrinsic hepatotoxicity. However, because it is a potent immunomodulatory agent, it may be capable of causing reactivation of hepatitis B or autoimmune liver injury.</p></div><div id="Alefacept.Outcome_and_Management"><h3>Outcome and Management</h3><p>Liver injury attributed to alefacept has ranged from uncommon instances of transient serum enzyme elevations without symptoms or jaundice to rare cases of acute clinically apparent liver injury.</p><p>Drug Class: Dermatologic Agents, <a href="/books/n/livertox/PsoriasisDrugs/?report=reader">Psoriasis Agents</a></p></div></div><div id="Alefacept.PRODUCT_INFORMATION"><h2 id="_Alefacept_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Alefacept – Amevive®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Dermatologic Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Alefacept" 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="Alefacept.CHEMICAL_FORMULA_AND_STRUCTURE"><h2 id="_Alefacept_CHEMICAL_FORMULA_AND_STRUCTURE_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figAlefaceptTc"><a href="/books/NBK548345/table/Alefacept.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figAlefaceptTc" rid-ob="figobAlefaceptTc"><img class="small-thumb" src="/books/NBK548345/table/Alefacept.Tc/?report=thumb" src-large="/books/NBK548345/table/Alefacept.Tc/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Alefacept.Tc"><a href="/books/NBK548345/table/Alefacept.Tc/?report=objectonly" target="object" rid-ob="figobAlefaceptTc">Table</a></h4></div></div></div><div id="Alefacept.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Alefacept_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 15 September 2021</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Alefacept.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 mentions that "the biological immunosuppressants are largely free from hepatotoxicity, with the exception of the TNF alpha antagonists").</i></div></div></li><li><div class="bk_ref" id="Alefacept.REF.krensky.2018">Krensky AM, Azzi JR, Hafler DA. Immunosuppressants and tolerogens. 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="Alefacept.REF.ellis.2001.248">Ellis CN, Krueger GG., Alefacept Clinical Study Group. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. <span><span class="ref-journal">N Engl J Med. </span>2001;<span class="ref-vol">345</span>:248–55.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/11474662" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11474662</span></a>]<div>
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<i>(Among 229 patients with psoriasis treated with various doses of intravenous alefacept or placebo weekly for 12 weeks, clinical responses occurred in 38-53% of alefacept vs 21% of placebo recipients, adverse events were generally mild and "laboratory tests showed no significant changes in serum chemical... values in any study groups").</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.krueger.2002.821">Krueger GG, Papp KA, Stough DB, Loven KH, Gulliver WP, Ellis CN., Alefacept Clinical Study Group. A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. <span><span class="ref-journal">J Am Acad Dermatol. </span>2002;<span class="ref-vol">47</span>:821–33.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/12451365" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12451365</span></a>]<div>
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<i>(Abstract; among 553 patients with chronic plaque psoriasis treated with two 12 week courses of one weekly alefacept or placebo, clinical responses occurred in 28% of alefacept vs 8% of placebo treated subjects and side effects were mild; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.ortonne.2003.12">Ortonne JP. Clinical response to alefacept: results of a phase 3 study of intramuscular administration of alefacept in patients with chronic plaque psoriasis. <span><span class="ref-journal">J Eur Acad Dermatol Venereol. </span>2003;<span class="ref-vol">17</span> Suppl 2:12–6.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/12795770" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12795770</span></a>]<div>
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<i>(Among 507 patients with psoriasis treated with 10 or 15 mg per week of alefacept or placebo for 12 weeks, clinical responses occurred in 12% and 21% of alefacept vs 5% of placebo recipients, and "minor elevations in serum aminotransferase levels were noted in all 3 groups", but there were no hepatic severe adverse events).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF6">Alefacept (Amevive) for treatment of psoriasis. <span><span class="ref-journal">Med Lett Drugs Ther. </span>2003;<span class="ref-vol">45</span>(1154):31–2.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/12717339" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12717339</span></a>]<div>
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<i>(Concise summary of the mechanism of action, efficacy, safety and cost of alefacept shortly after its approval for use in psoriasis in the US, does not mention ALT elevations or liver injury as side effects).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.goffe.2005.1912">Goffe B, Papp K, Gratton D, Krueger GG, Darif M, Lee S, Bozic C, et al. An integrated analysis of thirteen trials summarizing the long-term safety of alefacept in psoriasis patients who have received up to nine courses of therapy. <span><span class="ref-journal">Clin Ther. </span>2005;<span class="ref-vol">27</span>:1912–21.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/16507377" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16507377</span></a>]<div>
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<i>(In a pooled analysis of adverse events from 13 controlled trials of alefacept which enrolled 1869 patients with psoriasis, common side effects were headache and nasopharyngitis and pruritus, but were rarely severe or required discontinuation and there were "no clinically relevant trends with respect to changes from baseline in laboratory parameters"; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.scheinfeld.2005.975">Scheinfeld N. Alefacept: a safety profile. <span><span class="ref-journal">Expert Opin Drug Saf. </span>2005;<span class="ref-vol">4</span>:975–85.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/16255657" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16255657</span></a>]<div>
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<i>(Review of clinical trials of alefacept mentions that ALT elevations have occurred on treatment "but do not appear to be clinically significant" and that cases of hepatitis with jaundice have been reported; in clinical trials in more than 2000 patients, there have been no cases of exacerbation of hepatitis B or C).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.tha_i.2005.1048">Thaçi D, Pätzold S, Kaufmann R, Boehncke WH. Treatment of psoriasis with alefacept in patients with hepatitis C infection: a report of two cases. <span><span class="ref-journal">Br J Dermatol. </span>2005;<span class="ref-vol">152</span>:1048–50.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/15888169" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15888169</span></a>]<div>
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<i>(Two men, ages 29 and 63 years, with chronic hepatitis C and psoriasis were treated with weekly injections of alefacept for 12 weeks and had no worsening in serum ALT or HCV RNA levels or other adverse reaction).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.mease.2006.1638">Mease PJ, Gladman DD, Keystone EC., Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. <span><span class="ref-journal">Arthritis Rheum. </span>2006;<span class="ref-vol">54</span>:1638–45.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/16646026" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16646026</span></a>]<div>
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<i>(Among 146 patients with psoriatic arthritis and normal liver tests in a 12 week controlled trial, 1 of 93 treated with alefacept and methotrexate vs 1 of 59 on methotrexate alone developed ALT elevations above 3 times ULN, but both patients recovered without intervention or stopping therapy).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.perlmutter.2008.116">Perlmutter A, Cather J, Franks B, Jaracz E, Menter A. Alefacept revisited: Our 3-year clinical experience in 200 patients with chronic plaque psoriasis. <span><span class="ref-journal">J Am Acad Dermatol. </span>2008;<span class="ref-vol">58</span>:116–24.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/17997502" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17997502</span></a>]<div>
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<i>(Analysis of 201 patients with psoriasis treated with alefacept in a total of 296 courses, therapy was stopped early in one patient who was also on methotrexate because of serum enzyme elevations, but no details provided).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.castelosoccio.2009.22">Castelo-Soccio L, Van Voorhees AS. Long-term efficacy of biologics in dermatology. <span><span class="ref-journal">Dermatol Ther. </span>2009;<span class="ref-vol">22</span>:22–33.</span> [<a href="/pmc/articles/PMC2880851/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2880851</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/19222514" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19222514</span></a>]<div>
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<i>(Review of long term efficacy of various biologics used to treat psoriasis, including alefacept and the anti-tumor necrosis factor agents; no discussion of hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.mease.2009.402">Mease PJ, Reich K., Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. <span><span class="ref-journal">J Am Acad Dermatol. </span>2009;<span class="ref-vol">60</span>:402–11.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/19028407" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19028407</span></a>]<div>
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<i>(Among 160 patients who enrolled in an extension phase study of alefacept for psoriatic arthritis, increased AST levels [1-3 times ULN] occurred in 30% of patients, but were above 3 times ULN in only 2% during the open-label extension phase).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.ahn.2013.315">Ahn CS, Gustafson CJ, Sandoval LF, Davis SA, Feldman SR. Cost effectiveness of biologic therapies for plaque psoriasis. <span><span class="ref-journal">Am J Clin Dermatol. </span>2013;<span class="ref-vol">14</span>:315–26.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/23696234" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23696234</span></a>]<div>
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<i>(In a systematic review and assessment of five biologic agents approved for use in the therapy of psoriasis [adalimumab, etanercept, infliximab, ustekinumab, and alefacept], alefacept was found to be the least cost effective).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.chalasani.2015.1340">Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al. United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. <span><span class="ref-journal">Gastroenterology. </span>2015;<span class="ref-vol">148</span>:1340–1352.</span> [<a href="/pmc/articles/PMC4446235/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4446235</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25754159" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25754159</span></a>]<div>
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<i>(Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, no cases were attributed to alefacept).</i>
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</div></div></li><li><div class="bk_ref" id="Alefacept.REF.r_nholt.2017.2297">Rønholt K, Iversen L. Old and new biological therapies for psoriasis. <span><span class="ref-journal">Int J Mol Sci. </span>2017;<span class="ref-vol">18</span>:2297.</span> [<a href="/pmc/articles/PMC5713267/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5713267</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29104241" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29104241</span></a>]<div>
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<i>(Review of biologics used to treat psoriasis; alefacept was the first biologic approved for use in psoriasis in the US, but was withdrawn because of relative lack of efficacy compared to other biologics).</i>
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</div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548345_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">September 15, 2021</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-. Alefacept. [Updated 2021 Sep 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Alectinib/?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/Alemtuzumab/?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="figobAlefaceptTc"><div id="Alefacept.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548345/table/Alefacept.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Alefacept.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Alefacept.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Alefacept.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_Alefacept.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_Alefacept.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_Alefacept.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Alefacept</td><td headers="hd_h_Alefacept.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135340378" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">222535-22-0</a>
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</td><td headers="hd_h_Alefacept.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Recombinant Protein</td><td headers="hd_h_Alefacept.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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