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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Omalizumab - Drugs and Lactation Database (LactMed®) - NCBI Bookshelf</title>
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<meta name="citation_inbook_title" content="Drugs and Lactation Database (LactMed®) [Internet]">
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<meta name="citation_title" content="Omalizumab">
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<meta name="citation_publisher" content="National Institute of Child Health and Human Development">
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<meta name="citation_date" content="2025/01/15">
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<meta name="citation_keywords" content="Omalizumab">
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<meta name="citation_keywords" content="Xolair">
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<meta name="citation_keywords" content="Immunoglobulin G (human-mouse monoclonal E25 clone pSV1E26 gamma-chain anti-human immunoglobulin E Fc region), disulfide with human-mouse monoclonal E25 clone pSVIE126 kappa-chain, dimer">
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<meta name="citation_keywords" content="Immunoglobulin G, anti-(human immunoglobin E FC region) (human-mouse monoclonal E25 clone PSVIE26 gamma-chain), disulfide with human-mouse monoclonal E25 clone PSVIE26 kappa-chain, dimer">
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<meta name="description" content="Preliminary evidence indicates that the amount of omalizumab in milk is very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[1] Many infants have been breastfed during maternal omalizumab therapy, with no increase in infectious complications. Omalizumab is considered acceptable to use during breastfeeding.[2-5] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[6]">
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<meta name="og:description" content="Preliminary evidence indicates that the amount of omalizumab in milk is very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[1] Many infants have been breastfed during maternal omalizumab therapy, with no increase in infectious complications. Omalizumab is considered acceptable to use during breastfeeding.[2-5] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[6]">
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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="_NBK501801_"><span class="title" itemprop="name">Omalizumab</span></h1><p class="fm-aai"><a href="#_NBK501801_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 3 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 242138-07-4</p><div id="LM890.Drug_Levels_and_Effects"><h2 id="_LM890_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM890.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Preliminary evidence indicates that the amount of omalizumab in milk is very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[<a class="bibr" href="#LM890.REF.1" rid="LM890.REF.1">1</a>] Many infants have been breastfed during maternal omalizumab therapy, with no increase in infectious complications. Omalizumab is considered acceptable to use during breastfeeding.[<a class="bibr" href="#LM890.REF.2" rid="LM890.REF.2">2</a>-<a class="bibr" href="#LM890.REF.5" rid="LM890.REF.5">5</a>] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[<a class="bibr" href="#LM890.REF.6" rid="LM890.REF.6">6</a>]</p></div><div id="LM890.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> A woman received omalizumab 5 weekly doses of omalizumab 150 mg subcutaneously during pregnancy until 28 weeks of gestation. Breastmilk omalizumab levels were determined on days 4 and 5 postpartum, which were 85 and 86 days after the last dose of omalizumab. Four concentrations in milk were below 2 mcg/L and one was just over 8 mcg/L.[<a class="bibr" href="#LM890.REF.7" rid="LM890.REF.7">7</a>]</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="LM890.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>A manufacturer-based omalizumab pregnancy registry has followed pregnant and nursing mothers for several years. Of 230 infants followed, 154 were breastfed while their mothers were taking omalizumab. Another 32 were breastfed without being exposed to the drug in milk and 44 were not breastfed. No difference in serious adverse events were seen among the three groups of infants. Infections occurred at a similar rate in all groups.[<a class="bibr" href="#LM890.REF.8" rid="LM890.REF.8">8</a>]</p><p>Several case reports of infants being breastfed during maternal omalizumab therapy have been published. No adverse effects have been found.[<a class="bibr" href="#LM890.REF.9" rid="LM890.REF.9">9</a>-<a class="bibr" href="#LM890.REF.13" rid="LM890.REF.13">13</a>]</p><p>A woman with cystic fibrosis and severe, persistent asthma was started on omalizumab 600 mg subcutaneously every 2 weeks. She was maintained on this regimen for 5 years when she became pregnant. The regimen was continued during pregnancy and postpartum. She breastfed (extent not stated) for 8 months. At 10 months of age, her infant was in good health.[<a class="bibr" href="#LM890.REF.14" rid="LM890.REF.14">14</a>]</p></div><div id="LM890.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM890.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>(Asthma) <a href="/books/n/lactmed/LM1358/?report=reader">Benralizumab</a>, <a href="/books/n/lactmed/LM1201/?report=reader">Mepolizumab</a></p></div><div id="LM890.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM890.REF.1">Anderson
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PO. Monoclonal antibodies during breastfeeding.
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Breastfeed Med
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2021;16:591-3.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/33956488" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33956488</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="LM890.REF.2">Türk
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M, Carneiro-Leao
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L, Kolkhir
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P, et al.
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How to treat patients with chronic spontaneous urticaria with omalizumab: Questions and answers.
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J Allergy Clin Immunol Pract
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2020;8:113-24.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31374358" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31374358</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="LM890.REF.3">Middleton
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PG, Gade
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EJ, Aguilera
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C, et al.
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ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases.
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Eur Respir J
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2020;55:1901208.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31699837" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31699837</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM890.REF.4">Bendien
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SA, de Kruif
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MD, Feitsma
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H, et al.
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Summary of the Dutch Multidisciplinary Practice Guideline on Asthma and Pregnancy.
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J Allergy Clin Immunol Pract
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2024;12:1751-62.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/38513758" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38513758</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM890.REF.5">Naftel
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J, Jackson
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DJ, Coleman
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M, et al.
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An international consensus on the use of asthma biologics in pregnancy.
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Lancet Respir Med
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2024.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/39216499" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39216499</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="LM890.REF.6">Krysko
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KM, Dobson
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R, Alroughani
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R, et al.
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Family planning considerations in people with multiple sclerosis.
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Lancet Neurol
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2023;22:350-66.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/36931808" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36931808</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="LM890.REF.7">Saito
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J, Yakuwa
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N, Sandaiji
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N, et al.
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Omalizumab concentrations in pregnancy and lactation: A case study.
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J Allergy Clin Immunol Pract
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2020;8:3603-4.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/32544544" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32544544</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="LM890.REF.8">López Leon, S, Kaufman
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DG, Howard
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M, et al.
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Safety outcomes among infants exposed to omalizumab via breastfeeding: Results from the Xolair Pregnancy Registry (Expect).
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Pharmacoepidemiol Drug Saf
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2019;28 (Suppl 2):374-5. doi:10.1002/pds.4864 [<a href="http://dx.crossref.org/10.1002/pds.4864" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="LM890.REF.9">Ensina
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LF, Cusato-Ensina
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AP, Camelo-Nunes
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IC, et al.
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Omalizumab as third-line therapy for urticaria during pregnancy.
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J Investig Allergol Clin Immunol
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2017;27:326-7.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/29057743" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29057743</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="LM890.REF.10">González-Medina
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M, Curto-Barredo
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L, Labrador-Horrillo
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M, et al.
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Omalizumab use during pregnancy for chronic spontaneous urticaria (CSU): Report of two cases.
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J Eur Acad Dermatol Venereol
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2017;31:e245-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/27868240" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27868240</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="LM890.REF.11">Losappio
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LM, Mirone
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C, Schroeder
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JW, et al.
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Omalizumab use in chronic spontaneous urticaria during pregnancy and a four years' follow-up: A case report.
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Case Rep Dermatol
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2020;12:174-7.
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[<a href="/pmc/articles/PMC7588681/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7588681</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33173477" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33173477</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="LM890.REF.12">Majou
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D, Moreira
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B, Martin
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C, et al.
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Safety of omalizumab during pregnancy and breast-feeding with assessment of placental transfer: A case report.
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Allergy Asthma Immunol Res
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2021;13:515-6.
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[<a href="/pmc/articles/PMC7984957/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7984957</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33733644" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33733644</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>13.</dt><dd><div class="bk_ref" id="LM890.REF.13">Liao
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SL, Yu
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M, Zhao
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ZT, et al.
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Case report: Omalizumab for chronic spontaneous urticaria in pregnancy.
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Front Immunol
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2021;12:652973.
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[<a href="/pmc/articles/PMC8007859/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8007859</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33796115" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33796115</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>14.</dt><dd><div class="bk_ref" id="LM890.REF.14">Riberi
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L, Pizzimenti
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S, Riccardi
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E, et al.
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Beneficial effects and safety of omalizumab during pregnancy in a patient with cystic fibrosis.
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J Cyst Fibros
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2022;21:S91. doi:10.1016/S1569-1993(22)00433-7 [<a href="http://dx.crossref.org/10.1016/S1569-1993(22)00433-7" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl></dl></div></div><div id="LM890.Substance_Identification"><h2 id="_LM890_Substance_Identification_">Substance Identification</h2><div id="LM890.Substance_Name"><h3>Substance Name</h3><p>Omalizumab</p></div><div id="LM890.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>242138-07-4</p></div><div id="LM890.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Anti-Allergic Agents</p><p>Anti-Asthmatic Agents</p><p>Antibodies, Monoclonal</p><p>Antibodies, Anti-Idiotypic</p></div></div><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.</p></p></div></dd></dl></dl></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK501801_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">January 15, 2025</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a><p class="small"><b>Attribution Statement:</b> LactMed is a registered trademark of the U.S. Department of Health and Human Services.</p></div></div><h3>Publisher</h3><p><a href="https://www.nlm.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Child Health and Human Development</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Omalizumab. [Updated 2025 Jan 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM1439/?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/lactmed/omaveloxolone/?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></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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