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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>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. </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="_NBK500904_"><span class="title" itemprop="name">Dupilumab</span></h1><p class="small">Last Revision: <span itemprop="dateModified">January 15, 2025</span>.</p><p><em>Estimated reading time: 3 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 1190264-60-8</p><div id="LM1314.Drug_Levels_and_Effects"><h2 id="_LM1314_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM1314.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Evidence indicates that dupilumab is acceptable to use during breastfeeding. Because dupilumab is a large protein molecule with a molecular weight of about 147,000 Da, the amount in milk is likely to be very low.[<a class="bk_pop" href="#LM1314.REF.1">1</a>] It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[<a class="bk_pop" href="#LM1314.REF.2">2</a>] Expert opinions consider dupilumab acceptable during breastfeeding.[<a class="bk_pop" href="#LM1314.REF.3">3</a>-<a class="bk_pop" href="#LM1314.REF.5">5</a>] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[<a class="bk_pop" href="#LM1314.REF.6">6</a>] Until more data become available, dupilumab should be used with caution while nursing a newborn or preterm infant.</p></div><div id="LM1314.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> A woman began receiving dupilumab 300 mg subcutaneously every 2 weeks starting 2.5 months after delivery. A milk sample 3 days after a dose had a dupilumab concentration of 1.1 mg/L, which was 1.3% of the simultaneous maternal plasma concentration.[<a class="bk_pop" href="#LM1314.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="LM1314.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>A woman with atopic eczema received dupilumab subcutaneously in a dose of 300 mg every 2 weeks during pregnancy and postpartum. She breastfed her infant (extent not stated) for at least 4 months during which no complications were reported.[<a class="bk_pop" href="#LM1314.REF.8">8</a>,<a class="bk_pop" href="#LM1314.REF.9">9</a>] Seven months after delivery, she became pregnant again and continued dupilumab at the same dose throughout the pregnancy and lactation. No complications were seen during breastfeeding.[<a class="bk_pop" href="#LM1314.REF.10">10</a>]</p><p>Eight women with atopic dermatitis received dupilumab during pregnancy and breastfeeding. Two breastfed for 1 month, one for 7.2 months, one for 8.8 months, one for 10 months, one for 11.5 months, one for 14.5 months, and one for 16.1 months. None of the babies had developed atopic dermatitis at the time of publication and no adverse effects were reported.[<a class="bk_pop" href="#LM1314.REF.11">11</a>]</p><p>A woman in Portugal with long-standing atopic dermatitis began dupilumab therapy (dose not stated) with good results. She became pregnant and continued dupilumab. She delivered a healthy infant and breastfed for 8 months (extent not stated). The breastfed infant had no complications.[<a class="bk_pop" href="#LM1314.REF.12">12</a>]</p><p>A woman with long-standing atopic dermatitis began receiving dupilumab 300 mg every 2 weeks. When she became pregnant 24 months later, she stopped the drug, but had a disease flare in 2 weeks. The drug was restarted and she continued receiving it throughout the pregnancy and postpartum. She breastfed (extent and duration not stated) her infant. At 18 months of age, the infant had no complications.[<a class="bk_pop" href="#LM1314.REF.13">13</a>]</p><p>Investigators in Portugal reported a retrospective study of moderate-to-severe atopic dermatitis treated with dupilumab during pregnancy and breastfeeding in three tertiary medical centers. Two women with atopic dermatitis and allergic rhinitis took dupilumab for 9 and 18 months, respectively, while breastfeeding their infants. The exact dosage and extent of breastfeeding were not specified. The infants showed normal development and weight gain.[<a class="bk_pop" href="#LM1314.REF.14">14</a>]</p></div><div id="LM1314.Effects_on_Lactation_and_Breastmi"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM1314.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="LM1314.REF.1">Stratigakis
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A, Paty
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D, Zou
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P, et al.
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A regression approach for assessing large molecular drug concentration in breast milk.
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Reprod Breed
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2023;3:199-207. doi:10.1016/j.repbre.2023.10.003 [<a href="http://dx.crossref.org/10.1016/j.repbre.2023.10.003" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="LM1314.REF.2">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><dt>3.</dt><dd><div class="bk_ref" id="LM1314.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><dt>4.</dt><dd><div class="bk_ref" id="LM1314.REF.4">Deleuran
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M, Dézfoulian
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B, Elberling
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J, et al.
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Systemic anti-inflammatory treatment of atopic dermatitis during conception, pregnancy and breastfeeding: Interdisciplinary expert consensus in Northern Europe.
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J Eur Acad Dermatol Venereol
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2024;38:31-41.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37818828" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37818828</span></a>]</div></dd><dt>5.</dt><dd><div class="bk_ref" id="LM1314.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><dt>6.</dt><dd><div class="bk_ref" id="LM1314.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><dt>7.</dt><dd><div class="bk_ref" id="LM1314.REF.7">Dekkers
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C, El Amrani
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M, van Luin
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M, et al.
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Limited excretion of dupilumab into breastmilk: A case report.
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J Eur Acad Dermatol Venereol
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2023;37:e1154-e55.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37143362" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37143362</span></a>]</div></dd><dt>8.</dt><dd><div class="bk_ref" id="LM1314.REF.8">Kage
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P, Simon
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JC, Treudler
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R. A case of atopic eczema treated safely with dupilumab during pregnancy and lactation.
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J Eur Acad Dermatol Venereol
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2020;34:e256-e57.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31990389" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31990389</span></a>]</div></dd><dt>9.</dt><dd><div class="bk_ref" id="LM1314.REF.9">Treudler
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R, Kage
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P, Simon
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JC. A case of atopic eczema treated safely with dupilumab during pregnancy and lactation
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Allergy
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2020;75 (Suppl. 109):432. doi:10.1111/all.14508 [<a href="https://pubmed.ncbi.nlm.nih.gov/31990389" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31990389</span></a>] [<a href="http://dx.crossref.org/10.1111/all.14508" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd><dt>10.</dt><dd><div class="bk_ref" id="LM1314.REF.10">Kage
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P, Simon
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JC, Treudler
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R. Case of atopic eczema treated with dupilumab throughout conception, pregnancy, and lactation.
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J Dermatol
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2021;48:E484-5.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/34342905" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34342905</span></a>]</div></dd><dt>11.</dt><dd><div class="bk_ref" id="LM1314.REF.11">Escolà
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H, Figueras-Nart
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I, Bonfill-Orti
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M, et al.
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Dupilumab for atopic dermatitis during pregnancy and breastfeeding: Clinical experience in 13 patients.
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J Eur Acad Dermatol Venereol
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2023;37:e1156-e60.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37143399" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37143399</span></a>]</div></dd><dt>12.</dt><dd><div class="bk_ref" id="LM1314.REF.12">Alvarenga
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JM, Maria Lé
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A, Torres
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T. Dupilumab for atopic dermatitis during pregnancy and breastfeeding: A case report.
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Actas Dermo-Sifiliograficas
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2024;115:1100-2.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/37858861" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37858861</span></a>]</div></dd><dt>13.</dt><dd><div class="bk_ref" id="LM1314.REF.13">Di Lernia
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V, Peccerillo
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F. Long-term follow-up of dupilumab treatment during conception, pregnancy and lactation.
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Indian J Dermatol
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2024;69:193-95.
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[<a href="/pmc/articles/PMC11149818/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC11149818</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/38841220" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 38841220</span></a>]</div></dd><dt>14.</dt><dd><div class="bk_ref" id="LM1314.REF.14">Xará
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J, Farinha
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P, Lé
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AM, et al.
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Pregnancy and breastfeeding outcome in patients with atopic dermatitis treated with dupilumab: The clinical experience of three centers.
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Int J Dermatol
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2024;63:e335-e37.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/39090818" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39090818</span></a>]</div></dd></dl></div></div><div id="LM1314.Substance_Identification"><h2 id="_LM1314_Substance_Identification_">Substance Identification</h2><div id="LM1314.Substance_Name"><h3>Substance Name</h3><p>Dupilumab</p></div><div id="LM1314.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>1190264-60-8</p></div><div id="LM1314.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Biological Response Modifiers</p><p>Immunologic Adjuvants</p><p>Antibodies, Monoclonal</p></div></div><div><dl class="temp-labeled-list small"><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></div><div id="bk_toc_contnr"></div></div></div>
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