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<meta name="citation_title" content="Eculizumab">
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<meta name="citation_date" content="2024/11/15">
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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="_NBK501921_"><span class="title" itemprop="name">Eculizumab</span></h1><p class="fm-aai"><a href="#_NBK501921_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 4 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 219685-50-4</p><div id="LM999.Drug_Levels_and_Effects"><h2 id="_LM999_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM999.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Maternal dosages of eculizumab usually produce undetectable 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="#LM999.REF.1" rid="LM999.REF.1">1</a>] No adverse effects attributable to eculizumab have been reported in infants who were breastfed during maternal therapy. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[<a class="bibr" href="#LM999.REF.2" rid="LM999.REF.2">2</a>]</p></div><div id="LM999.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> Two women began treatment with eculizumab for paroxysmal nocturnal hemoglobinuria during pregnancy and continued receiving the drug postpartum while breastfeeding their infants. Serum and breastmilk samples were obtained at 12 hours and 5 days after their last dose. Eculizumab was not detectable (assay limit not specified) in breastmilk despite therapeutic serum concentrations.[<a class="bibr" href="#LM999.REF.3" rid="LM999.REF.3">3</a>]</p><p>A woman treated with eculizumab 900 mg twice weekly for paroxysmal nocturnal hemoglobinuria during pregnancy had her breastmilk tested for the presence of the drug. She received a dose one day after delivery. A milk sample one day later had detectable eculizumab, but in an amount less than 35 mg/L. Eight more breastmilk samples taken up to 12 days postpartum and 13 days after the postpartum dose had no detectable eculizumab.[<a class="bibr" href="#LM999.REF.4" rid="LM999.REF.4">4</a>]</p><p>Twenty-five women were identified who were taking eculizumab for paroxysmal nocturnal hemoglobinuria during breastfeeding. Ten of the women receiving unstated dosages of the drug had a breastmilk sample tested for eculizumab, which was undetectable (<5 mg/L) in all samples.[<a class="bibr" href="#LM999.REF.5" rid="LM999.REF.5">5</a>]</p><p>A woman with paroxysmal nocturnal hemoglobinuria was found to be pregnant at 20 weeks of gestation. She was treated with eculizumab 900 mg weekly starting at 30 weeks of gestation and then 1200 mg every 2 weeks beginning at 34 weeks of gestation. The drug was continued at this dosage throughout the pregnancy and for 3 months postpartum. The patient delivered at 36 weeks of gestation and eculizumab was undetectable (assay limit not specified) in breastmilk at that time.[<a class="bibr" href="#LM999.REF.6" rid="LM999.REF.6">6</a>] The time between the last dose and measurement of milk levels was not stated.</p><p>Three cases of Japanese women treated for paroxysmal nocturnal hemoglobinuria reportedly were given eculizumab during pregnancy and postpartum. The dosage was 900 mg every 2 weeks in two cases and unstated in the third. Eculizumab was undetectable (assay limit not specified) in breastmilk in all cases, apparently at the time of delivery.[<a class="bibr" href="#LM999.REF.7" rid="LM999.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="LM999.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>Two women began treatment with eculizumab during pregnancy and continued receiving the drug postpartum while breastfeeding their infants. One infant had no complications up to 30 weeks of follow-up. The other infant developed neutropenia up to 12 weeks of age, but it was not attributed to eculizumab.[<a class="bibr" href="#LM999.REF.3" rid="LM999.REF.3">3</a>]</p><p>A group of authors associated with the manufacturer of the drug reported that 25 patients had breastfed while taking eculizumab for paroxysmal nocturnal hemoglobinuria. Infant outcomes were not stated.[<a class="bibr" href="#LM999.REF.5" rid="LM999.REF.5">5</a>]</p><p>One center reported a cohort of 14 women who received eculizumab for paroxysmal nocturnal hemoglobinuria during pregnancy. Ten of the infants were breastfed (extent not stated) with no reported complications.[<a class="bibr" href="#LM999.REF.8" rid="LM999.REF.8">8</a>,<a class="bibr" href="#LM999.REF.9" rid="LM999.REF.9">9</a>]</p><p>A mother with paroxysmal nocturnal hemoglobinuria became pregnant while on eculizumab and continued the drug during pregnancy and lactation. During the third trimester and immediately postpartum she was receiving 1200 mg weekly. One month postpartum, her dosage was decreased to 900 mg every 2 weeks. She continued to breastfeed her baby for six months (extent not stated). At 3 months and one year of age of age, the infant was developing normally for her age.[<a class="bibr" href="#LM999.REF.10" rid="LM999.REF.10">10</a>,<a class="bibr" href="#LM999.REF.11" rid="LM999.REF.11">11</a>]</p><p>Academic and manufacturer personnel analyzed the manufacturer’s pharmacovigilance database. There were 31 reports of mothers breastfeeding their infants during eculizumab therapy, 20 patients with paroxysmal nocturnal hemoglobinuria and 11 patients with atypical hemolytic uremic syndrome. Neither dosages nor extent of breastfeeding were reported, and some of the cases might have been reported elsewhere previously. None of the breastfed infants had any adverse effects.[<a class="bibr" href="#LM999.REF.12" rid="LM999.REF.12">12</a>]</p><p>One center reported their experience with women who received eculizumab for hemolytic-uremic syndrome. Four of the women became pregnant and subsequently breastfed their infants (extent and duration not stated). No long-term complications were seen in the infants.[<a class="bibr" href="#LM999.REF.13" rid="LM999.REF.13">13</a>]</p><p>A woman with neuromyelitis optica spectrum disorder was receiving eculizumab, tacrolimus and prednisolone in unspecified dosages. Two years and 3 months after starting eculizumab, she conceived and delivered a healthy fullterm infant. At 6 months postpartum, the infant was reported to have no developmental problems.[<a class="bibr" href="#LM999.REF.14" rid="LM999.REF.14">14</a>]</p><p>A woman with both paroxysmal nocturnal hemoglobinuria and hereditary protein C deficiency was treated during pregnancy and postpartum with eculizumab, with a postpartum dose of 900 mg every 2 weeks. She breastfed her infant (extent not stated) with no reported complications.[<a class="bibr" href="#LM999.REF.15" rid="LM999.REF.15">15</a>]</p></div><div id="LM999.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="LM999.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM999.REF.1">Anderson
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P.
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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="LM999.REF.2">Krysko
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K, 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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[<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>3.</dt><dd><div class="bk_ref" id="LM999.REF.3">Sarris I, Gandhi S, Koumis A, et al. Pregnancy outcome and safety of breastfeeding in two patients with paroxysmal nocturnal haemoglobinuria (PNH) treated with eculizumab. Arch Dis Child Fetal Neonatal Ed 2012;97:PP.43. doi:10.1136/fetalneonatal-2012-301809.388 [<a href="http://dx.crossref.org/10.1136/fetalneonatal-2012-301809.388" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM999.REF.4">Ando
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Y, Kida
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M, Saika
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M, et al.
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Pregnancy and delivery in a PNH patient treated with eculizumab.
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Rinsho Ketsueki
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2014;55:2288-93.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/25501409" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25501409</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM999.REF.5">Kelly
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R, Hochsmann
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B, Szer
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J, et al.
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Eculizumab in pregnant patients with paroxysmal nocturnal hemoglobinuria.
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N Engl J Med
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26352814" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26352814</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="LM999.REF.6">Sharma
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R, Keyzner
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A, Liu
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J, et al.
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Successful pregnancy outcome in paroxysmal nocturnal hemoglobinuria (PNH) following escalated eculizumab dosing to control breakthrough hemolysis.
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Leuk Res Rep
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2015;4:36-8.
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[<a href="/pmc/articles/PMC4454784/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4454784</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26052501" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26052501</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="LM999.REF.7">Miyasaka
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N, Miura
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O, Kawaguchi
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T, et al.
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Pregnancy outcomes of patients with paroxysmal nocturnal hemoglobinuria treated with eculizumab: A Japanese experience and updated review.
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Int J Hematol
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2016;103:703-12.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26857155" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26857155</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="LM999.REF.8">Vinogradova
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M, Kulagin
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A, Kirsanova
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T, et al.
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Pregnancy outcomes in paroxysmal nocturnal hemoglobinuria depending on the therapeutic approach.
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Br J Haematol
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2017;176 (Suppl):94-5. doi:10.1111/bjh.14613 [<a href="http://dx.crossref.org/10.1111/bjh.14613" 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="LM999.REF.9">Vinogradova
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M, Kulagin
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A, Shmakov
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R, et al.
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The pregnancy course and outcomes during targeted therapy of paroxysmal nocturnal hemoglobinuria.
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Blood
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2016;128:2397. doi:10.1182/blood.V128.22.2397.2397 [<a href="http://dx.crossref.org/10.1182/blood.V128.22.2397.2397" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="LM999.REF.10">Aydin
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S, Audisio
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E, Iovino
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G, et al.
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Breakthrough hemolysis controlled by eculizumab escalation during pregnancy in paroxysmal noctural hemoglobinuria (PNH): A single case report.
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Haematologica
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2017;102 (Suppl 3):58. <a href="http://www.haematologica.org/content/102/s3/1.full.pdf+html" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>​.haematologica<wbr style="display:inline-block"></wbr>​.org/content/102/s3/1.full.pdf+html</a></div></dd></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="LM999.REF.11">Frairia
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C, Aydin
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S, Audisio
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E, et al.
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Breakthrough hemolysis and thromboembolism controlled by eculizumab during pregnancy in paroxysmal noctural hemoglobinuria (PNH): A single institution experience.
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HemaSphere
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2018;2 (Suppl 2):835-6. doi:10.1097/HS9.0000000000000060 [<a href="http://dx.crossref.org/10.1097/HS9.0000000000000060" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="LM999.REF.12">Socié
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G, Caby-Tosi
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M, Marantz
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J, et al.
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Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10-year pharmacovigilance analysis.
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Br J Haematol
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2019;185:297-310.
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[<a href="/pmc/articles/PMC6594003/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6594003</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30768680" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30768680</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>13.</dt><dd><div class="bk_ref" id="LM999.REF.13">Amisha
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F, Konda
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M, Malik
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P, et al.
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Clinical-laboratory- genetic profile and outcomes of patients with atypical hemolytic uremic syndrome and restrictive use of eculizumab: A single center experience and a brief review.
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Blood
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2021;138 (Suppl. 1):3159. doi:10.1182/blood-2021-145076 [<a href="http://dx.crossref.org/10.1182/blood-2021-145076" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>14.</dt><dd><div class="bk_ref" id="LM999.REF.14">Fujimoto
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T, Maeda
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Y. Eculizumab use throughout pregnancy in two patients with aquaporin-4-positive neuromyelitis optica spectrum disorder.
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Clin Exp Neuroimmunol
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2024;15:126-9. doi:10.1111/cen3.12784 [<a href="http://dx.crossref.org/10.1111/cen3.12784" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>15.</dt><dd><div class="bk_ref" id="LM999.REF.15">Dereme
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J, Goodyer
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M, Baud
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D, et al.
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Targeted management of coexistent severe thrombophilias-A case report of a successful pregnancy despite paroxysmal nocturnal hemoglobinuria and hereditary protein C deficiency.
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EJHaem
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2024;5:1048-52.
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[<a href="/pmc/articles/PMC11474299/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC11474299</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/39415927" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 39415927</span></a>]</div></dd></dl></dl></div></div><div id="LM999.Substance_Identification"><h2 id="_LM999_Substance_Identification_">Substance Identification</h2><div id="LM999.Substance_Name"><h3>Substance Name</h3><p>Eculizumab</p></div><div id="LM999.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>219685-50-4</p></div><div id="LM999.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="_NBK501921_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">November 15, 2024</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-. Eculizumab. [Updated 2024 Nov 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM568/?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/edotreotide_Ga-68/?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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