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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 class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="All Drug Records" href="/books/n/livertox/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" alt="Cover of LiverTox" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK609622_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK609622_dtls__"><div>Bethesda (MD): <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>; 2012-.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/livertox/">Drug Records</a></li></ul></div><div class="bk_noprnt"><form method="get" action="/books/n/livertox/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/livertox/Avelumab/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/livertox/Axitinib/" title="Next page in this title">Next ></a></div></div></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="_NBK609622_"><span class="title" itemprop="name">Axatilimab</span></h1><p class="small">Last Update: <span itemprop="dateModified">November 7, 2024</span>.</p></div><div class="body-content whole_rhythm" itemprop="text"><div id="Axatilimab.OVERVIEW"><h2 id="_Axatilimab_OVERVIEW_">OVERVIEW</h2><div id="Axatilimab.Introduction"><h3>Introduction</h3><p>Axatilimab is a humanized monoclonal antibody to the colony stimulating factor-1 receptor that is used to treat patients with chronic graft-versus-host disease who have active disease despite having received at least two previous systemic therapies. Axatilimab therapy is often accompanied by transient serum enzyme elevations, but it has not been linked to instances of clinically apparent liver injury with jaundice.</p></div><div id="Axatilimab.Background"><h3>Background</h3><p>Axatilimab (axe” a til’ i mab) is a humanized monoclonal IgG4 antibody directed against the colony stimulating factor-1 receptor (CSF-1R) which is used to treat adults with active, refractory chronic graft-vs-host disease (GvHD). Axatilimab binds to CSF-1R on monocytes and macrophages, blocking their activation and induction of proinflammatory cytokines and fibrogenic genes. This monoclonal antibody was shown to decrease disease activity in an animal model of GvHD. In human trials, axatilimab induced clinical responses in over 70% of patients with chronic GvHD who had received at least 2 previous systemic lines of therapy. Axatilimab was approved for use in the United States in 2024, the fourth agent approved for treatment of chronic GvHD, others being ibrutinib, belumosudil, and rituximab. Current indications for axatilimab are treatment of chronic GvHD despite at least previous systemic therapies in adults and pediatric patients weighing 40 kg or more. Axatilimab is available under the brand name Niktimvo in single dose vials of 50 mg in 1 mL. The recommended dose is 0.3 mg/kg body weight (maximal 35 mg) given as an intravenous infusion over 30 minutes every 2 weeks. Adverse effects can include infusion reactions for which premedication with an antihistamine and antipyretics is recommended in patients who experienced a previous infusion reaction to axatilimab. Other common adverse events include fatigue, musculoskeletal pain, headache, dizziness, nausea, diarrhea, cough, fever, dyspnea, and increased risk of bacterial, fungal and viral infections. Laboratory abnormalities can include elevations in liver enzymes, creatine kinase, amylase, lipase, and calcium, and decreases in hemoglobin and serum phosphate. Uncommon but potentially serious side effects include severe hypersensitivity reactions (angioedema or anaphylaxis), severe infections, and embryo-fetal toxicity.</p></div><div id="Axatilimab.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In preregistration controlled trials, elevations in serum aminotransferase levels arose in 12.7% of patients treated with 0.3 mg/kg and in higher rates with higher doses, 21.5% at 1 mg/kg and 40% at 3 mg/kg. Elevations in aminotransferase levels above 5 times the ULN occurred in only 1.3% of patients and all of the elevations were transient and none required drug discontinuation or was accompanied by jaundice. Since its approval, there have been no case reports of liver injury with jaundice linked to axatilimab therapy but clinical experience with the drug has been limited. Furthermore, patients with chronic GvHD frequently have elevations in serum enzymes because of graft-vs-host injury to the liver. Reactivation of hepatitis B as well as immune-mediated hepatitis can occur with use of immunosuppressive monoclonal antibodies such as infliximab and adalimumab, but instances have not been reported with axatilimab.</p><p><a class="def" href="/books/n/livertox/glossary/def-item/glossary.likelihood-score/">Likelihood score</a>: E (unlikely cause of clinically apparent liver injury).</p></div><div id="Axatilimab.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>Serum <a class="def" href="/books/n/livertox/glossary/def-item/glossary.alanine-aminotransferase-alt-/">ALT</a> elevations may be a direct result of inhibition of CSF-1R because elevations occur in many enzyme levels including alkaline phosphatase, <a class="def" href="/books/n/livertox/glossary/def-item/glossary.gamma-glutamyl-transpeptidase-ggt-/">GGT</a>, creatine phosphatase, amylase and lipase, but rarely result in organ injury. These transient laboratory abnormalities may be explained by Kupffer cells depletion and reduced clearance function following CSF-1R blockade. Graft-vs-host disease commonly affects the liver, and liver test abnormalities during axatilimab therapy may be due to the underlying disease rather than the drug therapy. For this reason, patients should be assessed for the presence of liver involvement before starting therapy for chronic GvHD.</p></div><div id="Axatilimab.Outcome_and_Management"><h3>Outcome and Management</h3><p>It is appropriate to monitor patients with chronic GvHD for liver test abnormalities before starting and at intervals during therapy. The serum aminotransferase elevations that were reported during axatilimab 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 clinical assessment of the possible causes and more careful monitoring and suspension of further infusions, at least until levels return to normal or near normal levels or until the underlying cause is identified. There is no evidence of cross sensitivity to hepatic reactions among the various monoclonal antibodies or small molecule therapies for GvHD.</p><p>Drug Class: <a href="/books/n/livertox/MonoclonalAntibodies/">Monoclonal Antibodies</a></p><p>Other Drugs for GvHD: <a href="/books/n/livertox/Belumosudil/">Belumosudil</a>, <a href="/books/n/livertox/Ibrutinib/">Ibrutinib</a>, <a href="/books/n/livertox/Ruxolitinib/">Ruxolitinib</a></p></div></div><div id="Axatilimab.PRODUCT_INFORMATION"><h2 id="_Axatilimab_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
|
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<b>REPRESENTATIVE TRADE NAMES</b>
|
||
</p><p>Axatilimab – Niktimvo®</p><p>
|
||
<b>DRUG CLASS</b>
|
||
</p><p>Immunosuppressive Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?label=all&query=Axatilimab" 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="Axatilimab.CHEMICAL_FORMULA_AND_STRUCTUR"><h2 id="_Axatilimab_CHEMICAL_FORMULA_AND_STRUCTUR_">CHEMICAL FORMULA AND STRUCTURE</h2><div id="Axatilimab.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK609622/table/Axatilimab.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Axatilimab.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Axatilimab.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Axatilimab.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_Axatilimab.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_Axatilimab.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_Axatilimab.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Axatilimab</td><td headers="hd_h_Axatilimab.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">2155851-88-8</td><td headers="hd_h_Axatilimab.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Monoclonal Antibody</td><td headers="hd_h_Axatilimab.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Not Available</td></tr></tbody></table></div></div></div><div id="Axatilimab.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Axatilimab_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 07 November 2024</p><p>Abbreviations: CSF-1R, colony stimulating factor-1 receptor; GvHD, graft-vs-host disease.</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Axatilimab.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="Axatilimab.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 before the availability of axatilimab).</i></div></div></li><li><div class="bk_ref" id="Axatilimab.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="Axatilimab.REF.multidiscipline_review">FDA.
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Multi-Discipline Review. <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761411Orig1s000TOC.cfm" 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/2024/761411Orig1s000TOC.cfm</a><div><i>(FDA website with product labels and initial multidiscipline clinical review of the safety and efficacy of axatilimab based on results from registration trials in support of its approval as therapy of chronic graft-vs-host disease [GvHD] mentions that in the safety cohort of 279 patients treated with axatilimab, ALT elevations arose in 12.7% of patients on 0.3 mg/kg, 21.5% on 1 mg/kg, and 40% on 3 mg/kg and values rose above 5 times ULN in 1.3%, 1.9% and 2.5%, but there were no ALT elevations with jaundice or serious hepatic adverse events).</i></div></div></li><li><div class="bk_ref" id="Axatilimab.REF.kitko.2023.1864">Kitko
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CL, Arora
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M, DeFilipp
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Z, Zaid
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MA, Di Stasi
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A, Radojcic
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V, Betts
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CB, et al.
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Axatilimab for chronic graft-versus-host disease after failure of at least two prior systemic therapies: results of a phase I/II study.
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J Clin Oncol.
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2023;41:1864-1875.
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[<a href="/pmc/articles/PMC10082302/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10082302</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36459673" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36459673</span></a>]<div><i>(Among 40 patients 6 years of age or older with active, chronic GvHD after at least 2 systemic lines of therapy treated with varying doses of axatilimab intravenously every 4 weeks, the overall response rate was 80% and dose limiting toxicities included myopathy and pancreatitis; and while ALT, AST, Alk P, lipase, and amylase elevations were frequent they were without end-organ damage).</i></div></div></li><li><div class="bk_ref" id="Axatilimab.REF.wolff.2024.1002">Wolff
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D, Cutler
|
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C, Lee
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SJ, Pusic
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I, Bittencourt
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H, White
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J, Hamadani
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M, et al.; AGAVE-201 Investigators. Axatilimab in recurrent or refractory chronic graft-versus-host disease.
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N Engl J Med.
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2024;391:1002-1014.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/39292927" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39292927</span></a>]<div><i>(Among 241 adults with active, chronic GvHD after at least 2 systemic lines of therapy who were treated with 0.3, 1 or 3 mg/kg intravenously every 2 weeks, the overall response rate was 74%, 67%, and 50% and adverse events were more frequent and severe with higher doses, and ALT elevations arose in 13%, 22%, and 39%, and drug discontinuation for adverse events occurred in 6%, 22%, and 18% of patients).</i></div></div></li><li><div class="bk_ref" id="Axatilimab.REF.sarantopoulos.2024.1053">Sarantopoulos
|
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S.
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Targeting CSF1R in chronic GVHD – lessons in translation.
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N Engl J Med.
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2024;391:1053-1055.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/39292932" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39292932</span></a>]<div><i>(Editorial in response to Wolff [2024] providing the background to the development of therapies targeting CSF1, which acts on its receptor on monocytes and macrophages leading to secretion of proinflammatory cytokines and profibrotic effects that account for some of the chronic tissue damage in GvHD and the inhibition of which led to improvements in disease in a mouse model).</i></div></div></li><li><div class="bk_ref" id="Axatilimab.REF.mohty.2024.1055">Mohty
|
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M.
|
||
CSF1R blockade for refractory chronic graft-versus-host disease.
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||
N Engl J Med.
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2024;391:1055-1059.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/39292933" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39292933</span></a>]<div><i>(Brief review of the clinical features and pathophysiology of GvHD and the role of CSF1R in its chronic complications).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div>
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<div class="col-lg-3 col-12 centered-lg">
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<p><a href="https://www.nlm.nih.gov/web_policies.html" class="text-white">Web Policies</a><br />
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<a href="https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office" class="text-white">FOIA</a><br />
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<a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" class="text-white" id="vdp">HHS Vulnerability Disclosure</a></p>
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</div>
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<div class="col-lg-3 col-12 centered-lg">
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||
<p><a class="supportLink text-white" href="https://support.nlm.nih.gov/">Help</a><br />
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<a href="https://www.nlm.nih.gov/accessibility.html" class="text-white">Accessibility</a><br />
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<a href="https://www.nlm.nih.gov/careers/careers.html" class="text-white">Careers</a></p>
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<li>
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<a class="text-white" href="https://www.nih.gov/">NIH</a>
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<a class="text-white" href="https://www.hhs.gov/">HHS</a>
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