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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]" /><meta name="citation_title" content="Burosumab" /><meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases" /><meta name="citation_date" content="2018/08/08" /><meta name="citation_pmid" content="31643797" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK548478/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Burosumab" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases" /><meta name="DC.Date" content="2018/08/08" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK548478/" /><meta name="description" content="Burosumab is a human monoclonal antibody to fibroblast growth factor 23 (FGF23) which is used in the treatment of X-linked hypophosphatemia. Burosumab therapy has not been associated with serum enzyme elevations during therapy nor has it been implicated in cases of clinically apparent drug induced liver injury with jaundice." /><meta name="og:title" content="Burosumab" /><meta name="og:type" content="book" /><meta name="og:description" content="Burosumab is a human monoclonal antibody to fibroblast growth factor 23 (FGF23) which is used in the treatment of X-linked hypophosphatemia. Burosumab therapy has not been associated with serum enzyme elevations during therapy nor has it been implicated in cases of clinically apparent drug induced liver injury with jaundice." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK548478/" /><meta name="og:site_name" content="NCBI Bookshelf" /><meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/livertox/Burosumab/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK548478/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_print.min.css" type="text/css" /><style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} </style><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/book-toc.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script>
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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. </p></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK548478_"><span class="title" itemprop="name">Burosumab</span></h1><p class="small">Last Update: <span itemprop="dateModified">August 8, 2018</span>.</p></div><div class="body-content whole_rhythm" itemprop="text"><div id="Burosumab.OVERVIEW"><h2 id="_Burosumab_OVERVIEW_">OVERVIEW</h2><div id="Burosumab.Introduction"><h3>Introduction</h3><p>Burosumab is a human monoclonal antibody to fibroblast growth factor 23 (FGF23) which is used in the treatment of X-linked hypophosphatemia. Burosumab therapy has not been associated with serum enzyme elevations during therapy nor has it been implicated in cases of clinically apparent drug induced liver injury with jaundice.</p></div><div id="Burosumab.Background"><h3>Background</h3><p>Burosumab (bur oh' sue mab) is a recombinant, human IgG1 monoclonal antibody to fibroblast growth factor 23 (FGF23) which is used in the treatment of X-linked hypophosphatemia which is associated with excessive FGF23 production. X-linked hypophosphatemia is the most common cause of congenital rickets and is caused by mutations in genes that regulate FGF23 production which result in excessive circulating levels that cause phosphate wasting and poor bone mineralization. Patients have limb deformities, frequent fractures, short stature and musculoskeletal pain and stiffness. Binding of the monoclonal antibody to circulating FGF23 blocks its activity and results in increases in serum phosphate, decreases in alkaline phosphatase and improvements in clinical symptoms and rickets severity. Burosumab was approved for use in the United States in 2018, and current indications are for adults and children above 1 year of age with X-linked hypophosphatemia. Burosumab is available in single use vials of 10, 20 or 30 mg/mL under the brand name Crysvita. It is given subcutaneously and the dose and frequency of administration (every 2 or 4 weeks) varies by age and body weight. Side effects of are uncommon but can include injection site reactions, headache and back and leg pains. Rare, potentially severe side effects include severe hypersensitivity reactions and hyperphosphatemia.</p></div><div id="Burosumab.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In prelicensure clinical trials, burosumab was not associated with changes in serum aminotransferase levels during therapy and rates of most adverse reactions were similar in patients who received burosumab as placebo. There have been no published reports of clinically apparent acute liver injury attributed to burosumab therapy.</p><p>Likelihood score: E (unlikely cause of clinically apparent liver injury).</p></div><div id="Burosumab.Mechanism_of_Liver_Injury"><h3>Mechanism of Liver Injury</h3><p>Burosumab is a human monoclonal antibody and is unlikely to be inherently hepatotoxic. While most recombinant proteins are metabolized by the liver, the metabolism leads largely to small peptides and amino acids which may be reused to synthesize proteins and are unlikely to be toxic or immunogenic. Inhibition of FGF23 does not appear to have an adverse effect on liver function.</p><p>Drug Class: Genetic Disorder Agents, <a href="/books/n/livertox/MonoclonalAntibodies/">Monoclonal Antibodies</a></p></div></div><div id="Burosumab.PRODUCT_INFORMATION"><h2 id="_Burosumab_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div id="Burosumab.BPI" class="box"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Burosumab – Crysvita®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Genetic Disorder Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Burosumab" 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="Burosumab.CHEMICAL_FORMULA_AND_STRUCTURE"><h2 id="_Burosumab_CHEMICAL_FORMULA_AND_STRUCTURE_">CHEMICAL FORMULA AND STRUCTURE</h2><div id="Burosumab.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548478/table/Burosumab.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Burosumab.T1_lrgtbl__"><table><thead><tr><th id="hd_h_Burosumab.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_Burosumab.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Burosumab.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Burosumab.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Burosumab.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Burosumab</td><td headers="hd_h_Burosumab.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/381127714" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">1610833-03-8</a>
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</td><td headers="hd_h_Burosumab.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">Monoclonal Antibody</td><td headers="hd_h_Burosumab.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">Not Available</td></tr></tbody></table></div></div></div><div id="Burosumab.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Burosumab_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 08 August 2018</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Burosumab.R1">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, well before the availability of most monoclonal antibody therapies).</i></div></div></li><li><div class="bk_ref" id="Burosumab.R2">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; "the biological immuno-suppressants are largely free from hepatotoxicity, with the exception of the TNF alpha antagonists"; burosumab is not specifically mentioned).</i></div></div></li><li><div class="bk_ref" id="Burosumab.R3">Friedman PA. Agents affecting mineral ion homeostasis and bone turnover. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 1275-306.<div><i>(Textbook of pharmacology).</i></div></div></li><li><div class="bk_ref" id="Burosumab.R4">
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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).</i>
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</div></div></li><li><div class="bk_ref" id="Burosumab.R5">Insogna KL, Briot K, Imel EA, Kamenický P, Ruppe MD, Portale AA, Weber T, et al.; AXLES 1 Investigators. A randomized, double-blind, placebo-controlled, phase 3 trial evaluating the efficacy of burosumab, an anti-FGF23 antibody, in adults with X-linked hypophosphatemia: week 24 primary analysis. J Bone Miner Res 2018; 33: 1383-93. [<a href="https://pubmed.ncbi.nlm.nih.gov/29947083" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29947083</span></a>]<div><i>(Among 134 adults with X-linked hypophosphatemia treated with burosumab or placebo every 4 weeks for 24 weeks, serum phosphate levels rose into the normal range [in 94% vs 8%] and stiffness and pain scores improved with burosumab, while adverse event rates were similar in the 2 groups; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Burosumab.R6">Kinoshita Y, Fukumoto S. X-Linked hypophosphatemia and FGF23-related hypophosphatemic diseases: prospect for new treatment. Endocr Rev 2018; 39: 274-91. [<a href="https://pubmed.ncbi.nlm.nih.gov/29381780" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29381780</span></a>]<div><i>(Review of the molecular basis, pathogenesis, clinical features and therapy of FGF23 related hypophosphatemic syndromes).</i></div></div></li><li><div class="bk_ref" id="Burosumab.R7">Lamb YN. Burosumab: first global approval. Drugs 2018; 78: 707-14. [<a href="https://pubmed.ncbi.nlm.nih.gov/29679282" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29679282</span></a>]<div><i>(Review of the mechanism of action, development, pharmacology, clinical efficacy and safety of burosumab shortly after its approval for use in X-linked hypophosphatemia).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div>
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