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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Asenapine - 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="Asenapine">
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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="2023/06/05">
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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="_NBK548092_"><span class="title" itemprop="name">Asenapine</span></h1><p class="fm-aai"><a href="#_NBK548092_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Asenapine.OVERVIEW"><h2 id="_Asenapine_OVERVIEW_">OVERVIEW</h2><div id="Asenapine.Introduction"><h3>Introduction</h3><p>Asenapine is a second generation (atypical) antipsychotic agent that is taken sublingually and used in the treatment of schizophrenia and manic or mixed episodes associated with bipolar 1 disorder. Asenapine is associated with a low rate of transient and mild serum aminotransferase elevations during therapy but has not been linked to instances of clinically apparent acute liver injury.</p></div><div id="Asenapine.Background"><h3>Background</h3><p>Asenapine (a sen' a peen) is a second generation antipsychotic agent which appears to act as a dopamine type 2 (D2) and serotonin (5-HT)-2A receptor antagonist. It is a somewhat unique antipsychotic agent that has a tetracyclic structure similar to that of mirtazapine, and it is administered as a sublingual tablet, being poorly absorbed by the oral route. Several randomized controlled trials have shown that sublingual asenapine improves symptoms of schizophrenia with effects comparable to risperidone and olanzapine. It also has beneficial activity in acute manic and mixed episodes associated with bipolar 1 disorder. Asenapine was approved for use in the United States in 2009 and is available in sublingual tablets of 2.5, 5 and 10 mg generically and under the brand name Saphris. The typical maintenance dose in adults is 2.5 to 10 mg twice daily. Asenapine is also available for treatment of schizophrenia as a transdermal formulation available in doses of 3.8, 5.7 and 7.6 mg per 24 hours under the brand name Secuado. The recommended initial dose of the transdermal patch is 3.8/24 hours, which can be increased to 5.7/24 hours and 7.6 mg/24 hours based upon effect and tolerance. Common side effects of asenapine include dizziness, somnolence, fatigue, nausea, anxiety, restlessness (akathisia) and weight gain. Rare, but potentially severe adverse reactions (mentioned in most antipsychotic and antidepressant product labels) include tardive dyskinesia, major neurologic events, neuroleptic malignant syndrome, orthostatic hypotension, seizures, neutropenia, hypersensitivity reactions, prolongation of the QTc interval, increased cerebrovascular events, and suicidal ideation or behavior. Asenapine also has a boxed warning of increased mortality in elderly patients with dementia-related psychosis.</p></div><div id="Asenapine.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Liver test abnormalities occur in 1% to 2.5% of patients receiving asenapine, but similar rates are reported with placebo therapy (0.6% to 1.3%) and with comparator agents. The ALT elevations are usually mild, transient and often resolve even without dose modification or drug discontinuation. There has been a single case report of cholestatic serum enzyme elevations arising 3 to 4 weeks after starting asenapine, resolving within a month of stopping. Thus, asenapine may be a rare cause of mild cholestatic liver injury.</p><p>Likelihood score: D (possible rare cause of clinically apparent liver injury).</p></div><div id="Asenapine.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The mechanism by which asenapine might cause serum enzyme elevations or liver injury is not known. Asenapine is metabolized to some extent by the cytochrome P450 system (CYP 2D6 and 3A4), but is an uncommon cause of significant drug-drug interactions with agents that inhibit or induce these microsomal enzymes.</p></div><div id="Asenapine.Outcome_and_Management"><h3>Outcome and Management</h3><p>The serum aminotransferase elevations that occur with asenapine therapy are usually self-limited and often do not require dose modification or discontinuation. No instances of acute liver failure, chronic hepatitis or vanishing bile duct syndrome have been attributed to asenapine. Cross sensitivity to liver related or other hypersensitivity reactions between asenapine and other antipsychotic agents have not been demonstrated.</p><p>Drug Class: <a href="/books/n/livertox/AntipsychoticAgents/?report=reader">Antipsychotic Agents</a>, Atypicals</p></div></div><div id="Asenapine.PRODUCT_INFORMATION"><h2 id="_Asenapine_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Asenapine – Saphris®, Secuado®</p><p>
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<b>DRUG CLASS</b>
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</p><p>Antipsychotic Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Asenapine" 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="Asenapine.CHEMICAL_FORMULA_AND_STRUCTURE"><h2 id="_Asenapine_CHEMICAL_FORMULA_AND_STRUCTURE_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figAsenapineTc"><a href="/books/NBK548092/table/Asenapine.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figAsenapineTc" rid-ob="figobAsenapineTc"><img class="small-thumb" src="/books/NBK548092/table/Asenapine.Tc/?report=thumb" src-large="/books/NBK548092/table/Asenapine.Tc/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Asenapine.Tc"><a href="/books/NBK548092/table/Asenapine.Tc/?report=objectonly" target="object" rid-ob="figobAsenapineTc">Table</a></h4></div></div></div><div id="Asenapine.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Asenapine_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 05 June 2023</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Asenapine.REF.meyer.2018">Meyer JM. Pharmacotherapy of psychosis and mania. 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. 279-302.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Asenapine.REF.larry.2007">Larry D. Hepatotoxicity of psychotropic drugs and drugs of abuse. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 2nd ed. New York: Informa Healthcare USA, 2007, pp. 507-26.<div><i>(Review of hepatotoxicity of psychiatric agents, does not discuss asenapine).</i></div></div></li><li><div class="bk_ref" id="Asenapine.REF.potkin.2007.1492">Potkin SG, Cohen M, Panagides J. Efficacy and tolerability of asenapine in acute schizophrenia: a placebo- and risperidone-controlled trial. <span><span class="ref-journal">J Clin Psychiatry. </span>2007;<span class="ref-vol">68</span>:1492–500.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/17960962" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17960962</span></a>]<div>
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<i>(Among 174 patients with acute schizophrenia treated with sublingual asenapine [5 mg] or risperidone [3 mg] or placebo twice daily for 6 weeks, symptom scores improved more with asenapine and risperidone than with placebo, although adverse event rates were similar; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.parsons.2009.103">Parsons B, Allison DB, Loebel A, Williams K, Giller E, Romano S, Siu C. Weight effects associated with antipsychotics: a comprehensive database analysis. <span><span class="ref-journal">Schizophr Res. </span>2009;<span class="ref-vol">110</span>:103–10.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/19321312" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19321312</span></a>]<div>
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<i>(Analysis of weight gain in 21 placebo controlled trials [~3300 patients]; average monthly weight gain in pounds was +0.1 with placebo, +0.8 olanzapine, 0.6 risperidone, -0.3 ziprasidone; a 5% increase in weight occurred after one year in 13% of placebo, 39% haloperidol, 20% ziprasidone, 45% risperidone and 60% olanzapine treated subjects; no mention of asenapine).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.mcintyre.2009.673">McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. <span><span class="ref-journal">Bipolar Disord. </span>2009;<span class="ref-vol">11</span>:673–86.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/19839993" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19839993</span></a>]<div>
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<i>(Among 480 adults with an acute manic or mixed episode in a prospective controlled trial for 3 weeks, there was rapid improvement in symptoms with sublingual asenapine [5 mg] and oral olanzapine [3 mg] compared to placebo twice daily; ALT levels increase by 12 U/L on average with asenapine, 33 U/L with olanzapine, but decrease by 7 U/L with placebo, although none of the changes were considered “clinically relevant”).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.mcintyre.2010.27">McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. <span><span class="ref-journal">J Affect Disord. </span>2010;<span class="ref-vol">122</span>(1-2):27–38.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/20096936" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20096936</span></a>]<div>
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<i>(Among 488 adults with acute mania and bipolar 1 disorder treated with asenapine, olanzapine or placebo for 3 weeks, symptoms score improved more in the asenapine than placebo recipients and “mean changes from baseline in laboratory values…were not clinically significant”).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF7">Asenapine (Saphris) sublingual tablets for schizophrenia and bipolar disorder. <span><span class="ref-journal">Med Lett Drugs Ther. </span>2010;<span class="ref-vol">52</span>:9–10.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/20216523" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20216523</span></a>]<div>
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<i>(Concise review of the mechanism of action, pharmacology, efficacy, safety and costs of asenapine as therapy of schizophrenia and bipolar disorder shortly after its approval for use in the US, mentions side effects of akathisia, oral hypoesthesia, somnolence, dizziness and weight gain; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.potkin.2011.14">Potkin SG. Asenapine: a clinical overview. <span><span class="ref-journal">J Clin Psychiatry. </span>2011;<span class="ref-vol">72</span> Suppl 1:14–8.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/22217438" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22217438</span></a>]<div>
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<i>(Review and overview of the pharmacology, clinical efficacy and safety of sublingual asenapine for treatment of schizophrenia and acute mania mentions occasional hypersensitivity reactions and problems of weight gain with long term therapy; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF9">Asenapine: a less effective, yet more dangerous neuroleptic! <span><span class="ref-journal">Prescrire Int. </span>2012;<span class="ref-vol">21</span>:229–32.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/23185842" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23185842</span></a>]<div>
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<i>(Short commentary on use of asenapine in bipolar disorders mentions that asenapine has more adverse side effects than other neuroleptics, and these include oral hypoesthesia and hypersensitivity reactions that can be severe).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.cazorla.2012.247">Cazorla P, Mackle M, Zhao J, Ha X, Szegedi A. Safety and tolerability of switching to asenapine from other antipsychotic agents: pooled results from two randomized multicenter trials in stable patients with persistent negative symptoms in schizophrenia. <span><span class="ref-journal">Neuropsychiatr Dis Treat. </span>2012;<span class="ref-vol">8</span>:247–57.</span> [<a href="/pmc/articles/PMC3383320/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3383320</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/22745558" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22745558</span></a>]<div>
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<i>(Among 949 adults with schizophrenia who were switched from standard antipsychotic agents to asenapine or olanzapine in two 26-week controlled trials, common side effects in the first month included somnolence [10% vs 13%], insomnia [17% vs 12%], and headache [14% vs 10%], while serious adverse events occurred in 12% on asenapine and 6% on olanzapine, although no specifics given or mention made of ALT elevations).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.schoemaker.2012.196">Schoemaker J, Stet L, Vrijland P, Naber D, Panagides J, Emsley R. Long-term efficacy and safety of asenapine or olanzapine in patients with schizophrenia or schizoaffective disorder: an extension study. <span><span class="ref-journal">Pharmacopsychiatry. </span>2012;<span class="ref-vol">45</span>:196–203.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/22454251" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22454251</span></a>]<div>
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<i>(Among 440 patients with schizophrenia or schizoaffective disorder who were continued on asenapine or olanzapine after a 52 week controlled trial, adverse events were common, but less frequent than during the initial year of treatment, and there were “no major changes in laboratory variables including … liver enzymes”).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.potkin.2013.442">Potkin SG, Phiri P, Szegedi A, Zhao J, Alphs L, Cazorla P. Long-term effects of asenapine or olanzapine in patients with persistent negative symptoms of schizophrenia: a pooled analysis. <span><span class="ref-journal">Schizophr Res. </span>2013;<span class="ref-vol">150</span>:442–9.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/24075603" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24075603</span></a>]<div>
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<i>(Among 502 patients with schizophrenia treated with asenapine or olanzapine in two clinical trials for 26 weeks with another 26 week extension study, adverse events were not discussed in detail and no mention made of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF13">Drugs for psychiatric disorders. <span><span class="ref-journal">Treat Guidel Med Lett. </span>2013;<span class="ref-vol">11</span>(130):53–64.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/23715100" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23715100</span></a>]<div>
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<i>(Concise review of safety, efficacy and role of drugs for psychiatric disorders mentions that asenapine is a second generation antipsychotic agent whose adverse side effects include insomnia, somnolence, nausea, vomiting and weight gain; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.kemp.2014.238">Kemp DE, Zhao J, Cazorla P, Landbloom RP, Mackle M, Snow-Adami L, Szegedi A. Weight change and metabolic effects of asenapine in patients with schizophrenia and bipolar disorder. <span><span class="ref-journal">J Clin Psychiatry. </span>2014;<span class="ref-vol">75</span>:238–45.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/24499969" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 24499969</span></a>]<div>
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<i>(Among 1748 patients with schizophrenia or bipolar illness treated in 17 clinical trials, post hoc analyses of weight change showed greater gain with asenapine than placebo during the initial 4 week period [1.2 vs 0.4 kg], but less than with olanzapine [0.9 vs 3.0 kg]; no mention of changes of ALT levels with weight gain).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.musil.2015.73">Musil R, Obermeier M, Russ P, Hamerle M. Weight gain and antipsychotics: a drug safety review. <span><span class="ref-journal">Expert Opin Drug Saf. </span>2015;<span class="ref-vol">14</span>:73–96.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/25400109" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25400109</span></a>]<div>
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<i>(Extensive systematic review of the literature on the problem of weight gain during therapy with antipsychotic agents mentions that asenapine has been linked to weight gain and increase in body weight of 7% or more occurs in 3.7-39.2% of patients).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.landbloom.2016.103">Landbloom RL, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, et al. Asenapine: Efficacy and safety of 5 and 10 mg bid in a 3-week, randomized, double-blind, placebo-controlled trial in adults with a manic or mixed episode associated with bipolar I disorder. <span><span class="ref-journal">J Affect Disord. </span>2016;<span class="ref-vol">190</span>:103–10.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/26496015" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26496015</span></a>]<div>
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<i>(Among 367 patients with a manic or mixed episode associated with bipolar 1 disorder treated with asenapine [5 or 10 mg] or placebo twice daily for 3 weeks, symptoms were somewhat more improved with asenapine than placebo, while adverse events were more frequent, particularly somnolence [20% and 26% vs 4%] and oral hypoesthesia [16% and 29% vs 2%], although “no patients had elevated liver enzymes that met criteria for potential drug-induced liver injury”).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.findling.2015.384">Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, et al. Safety and efficacy from an 8 week double-blind trial and a 26 week open-label extension of asenapine in adolescents with schizophrenia. <span><span class="ref-journal">J Child Adolesc Psychopharmacol. </span>2015;<span class="ref-vol">25</span>:384–96.</span> [<a href="/pmc/articles/PMC4491161/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4491161</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26091193" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26091193</span></a>]<div>
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<i>(Among 306 adolescents with schizophrenia treated with asenapine [2.5 or 5 mg] or placebo twice daily for 8 weeks, some symptom scores improved with the higher dose of asenapine compared to placebo, but adverse events were also more common including akathisia, dizziness, oral hypoesthesia, insomnia and weight gain; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.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>:1340–52.e7.</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 patients with drug induced liver injury seen over a ten year period at 8 US medical centers, one case was attributed to olanzapine, but none to asenapine or other atypical antipsychotic medications).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.schultz.2015.500">Schultz K, Wang L, Barr A, Vila Rodriguez F. A case of pseudo-Stauffer's syndrome related to asenapine use. <span><span class="ref-journal">Schizophr Res. </span>2015;<span class="ref-vol">169</span>:500–1.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/26549631" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26549631</span></a>]<div>
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<i>(50 year old man developed abnormal liver tests 24 days after starting asenapine [bilirubin and ALT not given; Alk P 508 U/L, GGT 904 U/L], which persisted despite stopping valproate and then resolved within a month of stopping asenapine).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.findling.2016.367">Findling RL, Landbloom RL, Mackle M, Wu X, Snow-Adami L, Chang K, Durgam S. Long-term safety of asenapine in pediatric patients diagnosed with bipolar I disorder: A 50-week open-label, flexible-dose trial. <span><span class="ref-journal">Paediatr Drugs. </span>2016;<span class="ref-vol">18</span>:367–78.</span> [<a href="/pmc/articles/PMC5018262/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5018262</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27461426" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27461426</span></a>]<div>
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<i>(Among 321 pediatric patients [ages 10 to 17 years] with bipolar disorder were treated with sublingual asenapine for up to one year, side effects were generally mild but led to early discontinuation in 15% of patients; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.ketter.2017.384">Ketter TA, Durgam S, Landbloom R, Mackle M, Wu X, Mathews M. Long-term safety and tolerability of asenapine: A double-blind, uncontrolled, long-term extension trial in adults with an acute manic or mixed episode associated with bipolar I disorder. <span><span class="ref-journal">J Affect Disord. </span>2017;<span class="ref-vol">207</span>:384–92.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/27755982" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27755982</span></a>]<div>
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<i>(Among 164 adults with bilar disorder enrolled in a 26 week extension study after a placebo controlled 3 week trial of asenapine, adverse events were mostly neuropsychiatric and weight gain; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.szegedi.2018.71">Szegedi A, Durgam S, Mackle M, Yu SY, Wu X, Mathews M, Landbloom RP. Randomized, double-blind, placebo-controlled trial of asenapine maintenance therapy in adults with an acute manic or mixed episode associated with bipolar I disorder. <span><span class="ref-journal">Am J Psychiatry. </span>2018;<span class="ref-vol">175</span>:71–79.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/28946761" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28946761</span></a>]<div>
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<i>(Among 253 patients with acute manic or mixed episodes treated with asenapine [10 mg twice daily] for 12-16 weeks and if they responded were then continued therapy or were switched to placebo, recurrence of manic, mixed, or depressive episodes were less frequent with continuing sublingual asenapine than switching to placebo, and adverse event rates were similar; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.citrome.2020">Citrome L, Walling DP, Zeni CM, Starling BR, Terahara T, Kuriki M, Park AS, et al. Efficacy and safety of HP-3070, an asenapine transdermal system, in patients with schizophrenia: a phase 3, randomized, placebo-controlled study. J Clin Psychiatry. 2020;82:20m13602. [<a href="https://pubmed.ncbi.nlm.nih.gov/33326711" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33326711</span></a>]<div><i>(Among 614 patients with an acute exacerbation of schizophrenia treated with transdermal asenapine [3.8 or 7.6 mg/24 hours] or placebo for 6 weeks, symptom scores improved more with both doses of asenapine compared with placebo and adverse event rates were similar with no serious adverse events; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Asenapine.REF24">In brief: An asenapine patch (Secuado) for schizophrenia. <span><span class="ref-journal">Med Lett Drugs Ther. </span>2021;<span class="ref-vol">63</span>(1615):7–8.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/33647000" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33647000</span></a>]<div>
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<i>(Concise review of the mechanism of action, clinical efficacy, toxicity and cost of transdermal asenapine shortly after its approval as therapy of schizophrenia in the US; no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Asenapine.REF.zeiss.2022.440">Zeiss R, Hafner S, Schönfeldt-Lecuona C, Connemann BJ, Gahr M. Drug-associated liver injury related to antipsychotics: exploratory analysis of pharmacovigilance data. <span><span class="ref-journal">J Clin Psychopharmacol. </span>2022;<span class="ref-vol">42</span>:440–444.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/35730552" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35730552</span></a>]<div>
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<i>(Review of the VigiBase data base of individual case safety reports on antipsychotics and liver injury found positive hepatic safety signals for olanzapine and clozapine but none for risperidone, quetiapine, ziprasidone, asenapine, aripiprazole, brexpiprazole, and cariprazine).</i>
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</div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548092_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">June 5, 2023</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-. Asenapine. [Updated 2023 Jun 5].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/Asciminib/?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/Ashwagandha/?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="figobAsenapineTc"><div id="Asenapine.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548092/table/Asenapine.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Asenapine.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Asenapine.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Asenapine.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NUMBER</th><th id="hd_h_Asenapine.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_Asenapine.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_Asenapine.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Asenapine</td><td headers="hd_h_Asenapine.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/135119080" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">65576-45-6</a>
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</td><td headers="hd_h_Asenapine.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C17-H16-Cl-N-O</td><td headers="hd_h_Asenapine.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/135119080" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=135119080" alt="image 135119080 in the ncbi pubchem database" /></a>
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