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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Ustekinumab - 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="Ustekinumab">
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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="Stelara">
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<meta name="citation_keywords" content="ustekinumab-kfce">
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<meta name="citation_keywords" content="Yesintek">
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<meta name="citation_keywords" content="Steqeyma">
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<meta name="citation_keywords" content="ustekinumab-stba">
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<meta name="citation_keywords" content="UNII-FU77B4U5Z0">
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<meta name="citation_keywords" content="CNTO1275">
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<meta name="citation_keywords" content="CNTO 1275">
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<meta name="citation_keywords" content="Immunoglobulin G1, anti-(human interleukin-12 subunit beta (IL-12B, CLMF p40, NKSF2)) (human monoclonal CNTO 1275 gamma1-chain), disulfide with human monoclonal CNTO 1275 kappa-chain, dimer">
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<meta name="description" content="Ustekinumab is usually either not detectable in breastmilk or detectable at very low levels in breastmilk. 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 safely breastfed during maternal treatment with ustekinumab. If ustekinumab is required by the mother, it is not a reason to discontinue breastfeeding and some experts and professional organizations consider it acceptable during breastfeeding.[2-8] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[9]">
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<meta name="og:description" content="Ustekinumab is usually either not detectable in breastmilk or detectable at very low levels in breastmilk. 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 safely breastfed during maternal treatment with ustekinumab. If ustekinumab is required by the mother, it is not a reason to discontinue breastfeeding and some experts and professional organizations consider it acceptable during breastfeeding.[2-8] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[9]">
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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="_NBK500594_"><span class="title" itemprop="name">Ustekinumab</span></h1><p class="fm-aai"><a href="#_NBK500594_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 6 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 815610-63-0</p><div id="LM1032.Drug_Levels_and_Effects"><h2 id="_LM1032_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM1032.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Ustekinumab is usually either not detectable in breastmilk or detectable at very low levels in breastmilk. 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="#LM1032.REF.1" rid="LM1032.REF.1">1</a>] Many infants have been safely breastfed during maternal treatment with ustekinumab. If ustekinumab is required by the mother, it is not a reason to discontinue breastfeeding and some experts and professional organizations consider it acceptable during breastfeeding.[<a class="bibr" href="#LM1032.REF.2" rid="LM1032.REF.2">2</a>-<a class="bibr" href="#LM1032.REF.8" rid="LM1032.REF.8">8</a>] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[<a class="bibr" href="#LM1032.REF.9" rid="LM1032.REF.9">9</a>]</p></div><div id="LM1032.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 6 women receiving ustekinumab provided milk samples at 1, 12, 24, and 48 hours after drug administration. Some also provided samples at 72, 96, 120, and 168 hours after drug administration. Four of the women had detectable (>0.01 mg/L) ustekinumab levels in milk. Peak concentrations in breastmilk ranged from 0.72 to 1.57 mg/L and occurred at 12 to 72 hours after the dose. Only 3 of the women had a detectable concentration in milk beyond 48 hours.[<a class="bibr" href="#LM1032.REF.10" rid="LM1032.REF.10">10</a>]</p><p>A woman with treatment-refractory Crohn’s disease was treated during pregnancy with ustekinumab until the third trimester. It was reinitiated 7 weeks postpartum with a loading dose of 390 mg intravenously, then 90 mg every 8 weeks. A breastmilk sample taken 16 weeks after the dose was 3.2 mg/L. After the third dose, breastmilk levels of ustekinumab were 0.82 mg/L within the first day after the dose, 0.18 mg/L at 3 weeks after the third dose and 0.16 mg/L at 4 weeks after the third dose.[<a class="bibr" href="#LM1032.REF.11" rid="LM1032.REF.11">11</a>]</p><p>Three mothers taking ustekinumab for Crohn’s disease had breastmilk levels of ustekinumab measured 1 hour after a dose and sequentially for up to 2 weeks after the dose. In one patient who was receiving a dose of 90 mg every 4 weeks, the trough milk sample contained 43 mcg/L of ustekinumab and attained a peak level of 43.1 mcg/L two days after the dose. The milk level dropped to 16.7 mcg/L at 4 days after the dose, then rose again to 26.3 mcg/L at 5 days after the dose. The other two women were receiving a dosage of 90 mg every 8 weeks. One had a trough ustekinumab milk level of 40 mcg/L. After the dose, the milk level gradually rose to a level of 45.1 mcg/L at 6 days after the dose. The third woman, who had not had any doses during pregnancy, had a trough milk value of 3 mcg/L. It rose to a peak of 7.4 mcg/L on day 3 and then plateaued between 5.4 and 6.6 mcg/L on days 4 to 6 after the dose.[<a class="bibr" href="#LM1032.REF.12" rid="LM1032.REF.12">12</a>]</p><p>A pregnant woman with ulcerative colitis received ustekinumab 90 mg 4 times during pregnancy with the last dose at 29 weeks gestation She was also treated with mesalamine 4.8 grams daily during pregnancy and lactation. Postpartum, amlodipine 10 mg daily was begun for hypertension and at 5 days postpartum ampicillin-sulbactam was begun intravenously for suspected endometritis. Subcutaneous ustekinumab was restarted at 48 days postpartum and first detected in milk on day 49 at 1.5 mcg/L. On day 57, the milk concentration was 13.6 mcg/L. Milk concentrations then declined to 10.8, 7.9 and 3.4 mcg/L on days 64, 71 and 78 postpartum, respectively.[<a class="bibr" href="#LM1032.REF.13" rid="LM1032.REF.13">13</a>]</p><p><i>Infant Levels.</i> Sixty-nine breastfed infants were born to mothers who received ustekinumab during pregnancy and postpartum. The estimated mean half-life of ustekinumab in infants was 23.2 days (95% CI 21.5 to 24.9 days).[<a class="bibr" href="#LM1032.REF.14" rid="LM1032.REF.14">14</a>]</p></div><div id="LM1032.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>One woman receiving ustekinumab for severe psoriasis breastfed her infant. No adverse effects were reported in the infant, although the dosage of ustekinumab and the extent of breastfeeding were not reported.[<a class="bibr" href="#LM1032.REF.15" rid="LM1032.REF.15">15</a>]</p><p>In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 6 women received a ustekinumab while breastfeeding their infants. Among those who received ustekinumab or another biologic agent while breastfeeding, infant growth, development or infection rate was no different from infants whose mothers received no treatment. An additional 68 women received a biologic agent plus a thiopurine. Infant outcomes were similar in this group.[<a class="bibr" href="#LM1032.REF.10" rid="LM1032.REF.10">10</a>]</p><p>A woman with treatment-refractory Crohn’s disease was treated during pregnancy with ustekinumab until the third trimester. It was reinitiated 7 weeks postpartum with a loading dose of 390 mg intravenously, then 90 mg every 8 weeks. She breastfed her infant (extent and duration not reported). Follow-up of the infant at 12 months of age was normal.[<a class="bibr" href="#LM1032.REF.11" rid="LM1032.REF.11">11</a>]</p><p>A woman with severe psoriasis was treated with ustekinumab 45 mg subcutaneously every 12 weeks until pregnancy was confirmed. After delivery ustekinumab was restarted while she was breastfeeding (extent and duration not stated). The infant reportedly had no complications and a normal growth curve.[<a class="bibr" href="#LM1032.REF.16" rid="LM1032.REF.16">16</a>]</p><p>Three mothers taking ustekinumab for Crohn’s disease breastfed (extent not stated) their infants. Their dosages were 90 mg every 4 weeks in one and 90 mg every 8 weeks in the other two. Infants were followed for 3 to 6 months and no developmental delays or excess infections of hospital admissions were noted.[<a class="bibr" href="#LM1032.REF.12" rid="LM1032.REF.12">12</a>]</p><p>A pregnant woman with ulcerative colitis received ustekinumab 90 mg 4 times during pregnancy with the last dose at 29 weeks gestation. She was also treated with mesalamine 4.8 grams daily during pregnancy and lactation. Postpartum, amlodipine 10 mg daily was begun for hypertension and at 5 days postpartum ampicillin-sulbactam was begun intravenously for suspected endometritis. Subcutaneous ustekinumab was restarted at 7 weeks postpartum. The infant was partially (>50%) breastfed for 3 months. The infant had no adverse drug events at the 1 and 3-month checkups and received routine infant vaccinations with no adverse events.[<a class="bibr" href="#LM1032.REF.13" rid="LM1032.REF.13">13</a>]</p><p>The DUMBO registry in Spain followed 526 newborns whose mothers had inflammatory bowel disease. During breastfeeding 4% of the mothers were receiving ustekinumab. Of children breastfed at least until month 6 and whose mothers were taking a biologic, 60% received the 1<sup>st</sup> and 2<sup>nd</sup> dose of rotavirus vaccine, and 17% the 3rd dose. Of children breastfed at least until month 12 and whose mothers were taking a biologic, 97% received the 1<sup>st</sup> dose of MMR vaccine; and from children breastfed at least until month 15 and whose mothers were under biologics, 84% received the 1<sup>st</sup> dose of varicella vaccine. No serious adverse events related to live vaccines were reported.[<a class="bibr" href="#LM1032.REF.17" rid="LM1032.REF.17">17</a>]</p><p>In a prospective, multicenter study, 20 infants were born to mothers taking ustekinumab during pregnancy. Of these, 18 were breastfed for a median of 7 months (range 0.5 to 27 months). Infants were followed for at least 6 months and a median of 18 months. All children had normal growth and normal psychomotor development. All but one child exposed to ustekinumab receive mandatory vaccinations with non-live vaccines without any serious or unexpected adverse events.[<a class="bibr" href="#LM1032.REF.18" rid="LM1032.REF.18">18</a>]</p></div><div id="LM1032.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="LM1032.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>(Psoriasis) <a href="/books/n/lactmed/LM513/?report=reader">Adalimumab</a>, <a href="/books/n/lactmed/LM752/?report=reader">Certolizumab Pegol</a>, <a href="/books/n/lactmed/LM105/?report=reader">Etanercept</a>, <a href="/books/n/lactmed/LM476/?report=reader">Infliximab</a>, <a href="/books/n/lactmed/LM1293/?report=reader">Phototherapy</a>, <a href="/books/n/lactmed/LM539/?report=reader">Tretinoin</a></p></div><div id="LM1032.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM1032.REF.1">Anderson
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[<a href="https://pubmed.ncbi.nlm.nih.gov/35708729" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35708729</span></a>]</div></dd></dl></dl></div></div><div id="LM1032.Substance_Identification"><h2 id="_LM1032_Substance_Identification_">Substance Identification</h2><div id="LM1032.Substance_Name"><h3>Substance Name</h3><p>Ustekinumab</p></div><div id="LM1032.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>815610-63-0</p></div><div id="LM1032.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Antibodies, Monoclonal</p><p>Dermatologic Agents</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="_NBK500594_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-. Ustekinumab. [Updated 2025 Jan 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM510/?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/LM982/?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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