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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="citation_inbook_title" content="Drugs and Lactation Database (LactMed®) [Internet]" /><meta name="citation_title" content="Epoetin Alfa" /><meta name="citation_publisher" content="National Institute of Child Health and Human Development" /><meta name="citation_date" content="2023/09/15" /><meta name="citation_pmid" content="30000431" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK501372/" /><meta name="citation_keywords" content="binocrit" /><meta name="citation_keywords" content="Abseamed" /><meta name="citation_keywords" content="Procrit" /><meta name="citation_keywords" content="Epogen" /><meta name="citation_keywords" content="Eprex" /><meta name="citation_keywords" content="Epoetinum alfa" /><meta name="citation_keywords" content="Epogen/procrit" /><meta name="citation_keywords" content="Epoetin alpha" /><meta name="citation_keywords" content="Epoetina alfa" /><meta name="citation_keywords" content="Epoetine alfa" /><meta name="citation_keywords" content="Erythropoietin alfa" /><meta name="citation_keywords" content="Erythropoietin-alfa" /><meta name="citation_keywords" content="r-HuEPO" /><meta name="citation_keywords" content="ERYPO" /><meta name="citation_keywords" content="EPOETIN ALFA" /><meta name="citation_keywords" content="Epoetine alfa [INN-French]" /><meta name="citation_keywords" content="Epoetinum alfa [INN-Latin]" /><meta name="citation_keywords" content="Epoetina alfa [INN-Spanish]" /><meta name="citation_keywords" content="Erythropoietin-alfa, recombinant" /><meta name="citation_keywords" content="HSDB 7584" /><meta name="citation_keywords" content="DRG-0062" /><meta name="citation_keywords" content="Epoetin Alfa [USAN:INN:BAN:JAN]" /><meta name="citation_keywords" content="HX 575" /><meta name="citation_keywords" content="Epoetin-alpha (genetical recombination)" /><meta name="citation_keywords" content="1-165-Erythropoietin (human clone lambdaHEPOFL13 protein moiety), glycoform alpha" /><meta name="citation_keywords" content="113427-24-0" /><meta name="citation_keywords" content="EPO" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Epoetin Alfa" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute of Child Health and Human Development" /><meta name="DC.Date" content="2023/09/15" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK501372/" /><meta name="description" content="The excretion of exogenous epoetin alfa (recombinant human erythropoietin; EPO) in breastmilk has not been studied. Erythropoietin is a normal component of human milk. Although some studies have shown an improve response of postpartum anemia when epoetin alfa was used with iron therapy, current consensus is that epoetin alfa has no clinically important effect on the increase in hemoglobin concentration over iron alone.[1] No adverse reactions were reported in the breastfed infants of mothers who received epoetin alfa. Based on theoretical considerations, the manufacturer recommends avoiding the use of epoetin alfa multiple-dose vials for lactating women because of its benzyl alcohol content and to avoid breastfeeding for 2 weeks after a dose that contains benzyl alcohol. No special precautions are required during breastfeeding if mothers receive epoetin alfa from a single-use vial without preservatives.[2]" /><meta name="og:title" content="Epoetin Alfa" /><meta name="og:type" content="book" /><meta name="og:description" content="The excretion of exogenous epoetin alfa (recombinant human erythropoietin; EPO) in breastmilk has not been studied. Erythropoietin is a normal component of human milk. Although some studies have shown an improve response of postpartum anemia when epoetin alfa was used with iron therapy, current consensus is that epoetin alfa has no clinically important effect on the increase in hemoglobin concentration over iron alone.[1] No adverse reactions were reported in the breastfed infants of mothers who received epoetin alfa. Based on theoretical considerations, the manufacturer recommends avoiding the use of epoetin alfa multiple-dose vials for lactating women because of its benzyl alcohol content and to avoid breastfeeding for 2 weeks after a dose that contains benzyl alcohol. 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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="_NBK501372_"><span class="title" itemprop="name">Epoetin Alfa</span></h1><p class="small">Last Revision: <span itemprop="dateModified">September 15, 2023</span>.</p><p><em>Estimated reading time: 3 minutes</em></p></div><div class="body-content whole_rhythm" itemprop="text"><p>CASRN: 113427-24-0</p><div id="LM496.Drug_Levels_and_Effects"><h2 id="_LM496_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM496.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>The excretion of exogenous epoetin alfa (recombinant human erythropoietin; EPO) in breastmilk has not been studied. Erythropoietin is a normal component of human milk. Although some studies have shown an improve response of postpartum anemia when epoetin alfa was used with iron therapy, current consensus is that epoetin alfa has no clinically important effect on the increase in hemoglobin concentration over iron alone.[<a class="bk_pop" href="#LM496.REF.1">1</a>] No adverse reactions were reported in the breastfed infants of mothers who received epoetin alfa. Based on theoretical considerations, the manufacturer recommends avoiding the use of epoetin alfa multiple-dose vials for lactating women because of its benzyl alcohol content and to avoid breastfeeding for 2 weeks after a dose that contains benzyl alcohol. No special precautions are required during breastfeeding if mothers receive epoetin alfa from a single-use vial without preservatives.[<a class="bk_pop" href="#LM496.REF.2">2</a>]</p><p>Some authors have hypothesized that erythropoietin in milk might help maintain the integrity of the lining of the mammary epithelium and the infant gastrointestinal tract, thereby reducing the risk of mother-to-child transmission of HIV infection (MTCT).[<a class="bk_pop" href="#LM496.REF.3">3</a>] A case-control study in Tanzania supports the protective role of erythropoietin in breastmilk against MTCT.[<a class="bk_pop" href="#LM496.REF.4">4</a>] Erythropoietin might also have a modest beneficial effect on the infant's red cell production.[<a class="bk_pop" href="#LM496.REF.5">5</a>]</p></div><div id="LM496.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> Relevant published information on exogenous administration of epoetin alfa was not found as of the revision date. However, breastmilk normally contains erythropoietin. Erythropoietin concentrations in human milk are in the range of approximately 4 to 5 units/L in the first 1 to 2 months postpartum and increase to 20 to 40 units/L by the third month and to 100 to 150 units/L by 12 months.[<a class="bk_pop" href="#LM496.REF.3">3</a>]</p><p><i>Infant Levels.</i> Published information on absorption of epoetin alfa from breastmilk was not found as of the revision date. However, several studies in which oral doses of epoetin alfa and other recombinant forms of erythropoietin were given to preterm infants found that epoetin is absorbed to a small extent. Increases in hematocrit in infants treated with oral epoetin alfa have been small to negligible.[<a class="bk_pop" href="#LM496.REF.5">5</a>-<a class="bk_pop" href="#LM496.REF.10">10</a>] However, one study found that hospitalized preterm infants taking enteral feedings and given 400 units daily of recombinant human erythropoietin by mouth with ferrous sulfate had higher reticulocyte counts and serum erythropoietin concentrations upon hospital discharge than control infants given only ferrous sulfate.[<a class="bk_pop" href="#LM496.REF.11">11</a>]</p></div><div id="LM496.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>Enhancement of gastrointestinal tract maturation has been proposed as a function of erythropoietin in breastmilk.[<a class="bk_pop" href="#LM496.REF.3">3</a>,<a class="bk_pop" href="#LM496.REF.11">11</a>]</p><p>In a study of 40 women with postpartum anemia, 19 of 20 women who received iron and subcutaneous recombinant human erythropoietin (generic name and brand not specified) 200 IU/kg daily for 15 days were able to breastfeed their infants. This regimen is more aggressive than the approved three times/week regimen. In the control group that received only oral iron and folic acid, only 10 were able to breastfeed their infants. No adverse reactions were reported among the infants of women who receive epoetin.[<a class="bk_pop" href="#LM496.REF.2">2</a>]</p></div><div id="LM496.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>In small studies, epoetin alfa administration decreased serum prolactin in patients with amyotrophic lateral sclerosis,[<a class="bk_pop" href="#LM496.REF.12">12</a>] but had no effect in normal subjects or in patients with renal failure undergoing chronic ambulatory peritoneal dialysis.[<a class="bk_pop" href="#LM496.REF.13">13</a>,<a class="bk_pop" href="#LM496.REF.14">14</a>] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.</p></div><div id="LM496.References"><h3>References</h3><dl class="temp-labeled-list"><dt>1.</dt><dd><div class="bk_ref" id="LM496.REF.1">Milman
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N.
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Postpartum anemia II: prevention and treatment.
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Ann Hematol
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2012;91:143-54.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/22160256" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22160256</span></a>]</div></dd><dt>2.</dt><dd><div class="bk_ref" id="LM496.REF.2">Makrydimas
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G, Lolis
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D, Lialios
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G, et al.
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Recombinant human erythropoietin treatment of postpartum anemia. Preliminary results.
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Eur J Obstet Gynecol Reprod Biol
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1998;81:27-31.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/9846709" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9846709</span></a>]</div></dd><dt>3.</dt><dd><div class="bk_ref" id="LM496.REF.3">Semba
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RD, Juul
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SE. Erythropoietin in human milk: Physiology and role in infant health.
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J Hum Lact
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2002;18:252-61.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12192960" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12192960</span></a>]</div></dd><dt>4.</dt><dd><div class="bk_ref" id="LM496.REF.4">Arsenault
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JE, Aboud
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S, Manji
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KP, et al.
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Vitamin supplementation increases risk of subclinical mastitis in HIV-infected women.
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J Nutr
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2010;140:1788-92.
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[<a href="/pmc/articles/PMC2937574/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2937574</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20739447" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20739447</span></a>]</div></dd><dt>5.</dt><dd><div class="bk_ref" id="LM496.REF.5">Pasha
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YZ, Ahmadpolir-Kacho
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M, Hajiahmadi
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M, Hosseini
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M. Enteral erythropoietin increases plasma erythropoietin level in preterm infants: A randomized controlled trial.
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Indian Pediatr
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2008;45:25-8.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/18250501" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18250501</span></a>]</div></dd><dt>6.</dt><dd><div class="bk_ref" id="LM496.REF.6">Calhoun
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DA, Christensen
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RD. Hematopoietic growth factors in neonatal medicine: The use of enterally administered hematopoietic growth factors in the neonatal intensive care unit.
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Clin Perinatol
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2004;31:169-82.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/15183665" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15183665</span></a>]</div></dd><dt>7.</dt><dd><div class="bk_ref" id="LM496.REF.7">Ballin
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A, Bilker-Reich
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A, Arbel
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E, et al.
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Erythropoietin, given enterally, stimulates erythropoiesis in premature infants.
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Lancet
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1999;353:1849.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10359412" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10359412</span></a>]</div></dd><dt>8.</dt><dd><div class="bk_ref" id="LM496.REF.8">Juul
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SE. Enterally dosed recombinant human erythropoietin does not stimulate erythropoiesis in neonates.
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J Pediatr
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2003;143:321-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/14517513" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 14517513</span></a>]</div></dd><dt>9.</dt><dd><div class="bk_ref" id="LM496.REF.9">Juul
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SE, Christensen
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RD. Absorption of enteral recombinant human erythropoietin by neonates.
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Ann Pharmacother
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2003;37:782-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12773061" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12773061</span></a>]</div></dd><dt>10.</dt><dd><div class="bk_ref" id="LM496.REF.10">Britton
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JR, Christensen
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RD. Enteral administration of recombinant erythropoietin to preterm infants.
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J Perinatol
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1995;15:281-3.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/8558334" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8558334</span></a>]</div></dd><dt>11.</dt><dd><div class="bk_ref" id="LM496.REF.11">Miller
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M, Iliff
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P, Stoltzfus
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RJ, Humphrey
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J. Breastmilk erythropoietin and mother-to-child HIV transmission through breastmilk.
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Lancet
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2002;360:1246-8.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12401271" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12401271</span></a>]</div></dd><dt>12.</dt><dd><div class="bk_ref" id="LM496.REF.12">Tokgöz
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B, Utas
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C, Dogukan
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A, et al.
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Influence of long term erythropoietin therapy on the hypothalamic-pituitary-thyroid axis in patients undergoing CAPD.
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Ren Fail
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2002;24:315-23.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12166698" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12166698</span></a>]</div></dd><dt>13.</dt><dd><div class="bk_ref" id="LM496.REF.13">Bernini
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GP, Mariotti
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F, Brogi
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G, et al.
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Effects of erythropoietin administration on prolactin secretion in normal subjects.
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Nephron
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1993;65:522-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/8302403" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8302403</span></a>]</div></dd><dt>14.</dt><dd><div class="bk_ref" id="LM496.REF.14">Markianos
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M, Kosmidis
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ML, Sfagos
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C. Reductions in plasma prolactin during acute erythropoietin administration.
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Neuro Endocrinol Lett
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2006;27:355-8.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/16816832" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16816832</span></a>]</div></dd></dl></div></div><div id="LM496.Substance_Identification"><h2 id="_LM496_Substance_Identification_">Substance Identification</h2><div id="LM496.Substance_Name"><h3>Substance Name</h3><p>Epoetin Alfa</p></div><div id="LM496.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>113427-24-0</p></div><div id="LM496.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Colony-Stimulating Factors</p><p>Hematinics</p><p>Hematopoietic Cell Growth Factors</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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<noscript><img alt="statistics" src="/stat?jsdisabled=true&ncbi_db=books&ncbi_pdid=book-part&ncbi_acc=NBK501372&ncbi_domain=lactmed&ncbi_report=printable&ncbi_type=fulltext&ncbi_objectid=&ncbi_pcid=/NBK501372/?report=printable&ncbi_app=bookshelf" /></noscript>
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<script type="text/javascript" src="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/js/3879255/4121861/3501987/4008961/3893018/3821238/3400083/3426610.js" snapshot="books"></script></body>
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