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<meta name="citation_title" content="Stavudine">
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<meta name="citation_keywords" content="sanilvudine">
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<meta name="citation_keywords" content="Zerit">
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<meta name="citation_keywords" content="Estavudina">
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<meta name="citation_keywords" content="Stavudinum">
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<meta name="citation_keywords" content="Zerit XR">
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<meta name="citation_keywords" content="Zerut XR">
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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="_NBK501533_"><span class="title" itemprop="name">Stavudine</span></h1><p class="fm-aai"><a href="#_NBK501533_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: 3056-17-5</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/134982948" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=134982948" alt="image 134982948 in the ncbi pubchem database" /></a><div id="LM643.Drug_Levels_and_Effects"><h2 id="_LM643_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM643.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Stavudine is not a recommended agent during breastfeeding.[<a class="bibr" href="#LM643.REF.1" rid="LM643.REF.1">1</a>] Achieving and maintaining viral suppression with antiretroviral therapy decreases breastfeeding transmission risk to less than 1%, but not zero. Individuals with HIV who are on antiretroviral therapy with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision. If a viral load is not suppressed, banked pasteurized donor milk or formula is recommended.[<a class="bibr" href="#LM643.REF.2" rid="LM643.REF.2">2</a>,<a class="bibr" href="#LM643.REF.3" rid="LM643.REF.3">3</a>]</p></div><div id="LM643.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> One study measured stavudine in breastmilk samples from nursing mothers who had been randomized to receive the drug as part of a clinical trial to evaluate maternal to child transmission of HIV infection. The dosages, dosage regimens and time of breastmilk sample collection times were not reported. The stavudine milk to plasma ratio was found to be 1.73 in 2 patients.[<a class="bibr" href="#LM643.REF.4" rid="LM643.REF.4">4</a>]</p><p>Fifty-two mothers who were taking stavudine either 30 mg (<60 kg) or 40 mg (>60 kg) twice daily had milk samples analyzed for stavudine. Exact timing of the previous dose was not available. Stavudine was detectable in 44 samples of whole milk and 45 samples of skim milk. The median stavudine concentrations were 151 mcg/L in whole milk and 190 mcg/L in skim milk. The average infant intake of stavudine via breastmilk was estimated to be 22.7 mcg/kg daily.[<a class="bibr" href="#LM643.REF.5" rid="LM643.REF.5">5</a>]</p><p>Twenty-eight mothers who were receiving stavudine 30 mg twice daily as part of a combination antiretroviral regimen provided a total of 93 milk samples at birth, 1 month, 3 months and/or 6 months postpartum. Milk samples were collected at a median of 4.5 hours (range 3.5 to 6 hours) after the previous dose. The median breastmilk stavudine concentration was 105 mcg/L (range 34 to 117 mcg/L).[<a class="bibr" href="#LM643.REF.6" rid="LM643.REF.6">6</a>]</p><p><i>Infant Levels.</i> Fifty-two infants whose mothers who were taking stavudine either 30 mg (<60 kg) or 40 mg (>60 kg) twice daily had blood samples analyzed for stavudine. Exact timing of the mothers' previous dose was not available. Stavudine was undetectable (<5 mcg/L) in all but 7 of the infants with an estimated stavudine intake from milk of 22.7 mcg/kg daily. In the 7 infants who had detectable serum concentrations, all had serum concentrations less than 10 mcg/L and their median serum concentration was 5% (range 1 to 15%) of their mothers' serum concentration.[<a class="bibr" href="#LM643.REF.4" rid="LM643.REF.4">4</a>]</p><p>Breastfed infants of 28 mothers who were receiving stavudine 30 mg twice daily as part of a combination antiretroviral regimen had a total of 30 blood samples analyzed at 1 month, 3 months and/or 6 months postpartum. Samples were collected at a median of 4.5 hours (range 3.5 to 6 hours) after the previous maternal dose and a median of 30 minutes (range 20 to 60 minutes) after the previous nursing. The infants' stavudine plasma concentrations ranged from 0 to 2.5 mcg/L, which was a median of 4% (range 0 to 8%) of the maternal serum concentration.[<a class="bibr" href="#LM643.REF.6" rid="LM643.REF.6">6</a>]</p></div><div id="LM643.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM643.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>Gynecomastia has been reported among men receiving highly active antiretroviral therapy. Gynecomastia is unilateral initially, but progresses to bilateral in about half of cases. No alterations in serum prolactin were noted and spontaneous resolution usually occurred within one year, even with continuation of the regimen.[<a class="bibr" href="#LM643.REF.7" rid="LM643.REF.7">7</a>-<a class="bibr" href="#LM643.REF.9" rid="LM643.REF.9">9</a>] Some case reports and in vitro studies have suggested that protease inhibitors might cause hyperprolactinemia and galactorrhea in some male patients,[<a class="bibr" href="#LM643.REF.10" rid="LM643.REF.10">10</a>,<a class="bibr" href="#LM643.REF.11" rid="LM643.REF.11">11</a>] although this has been disputed.[<a class="bibr" href="#LM643.REF.12" rid="LM643.REF.12">12</a>] One case series found an incidence of gynecomastia of 2.4 cases per person annually among men receiving highly active antiretroviral therapy; 70% of the affected patients were taking stavudine. Gynecomastia was unilateral initially, but progressed to bilateral in 53% of cases. No alterations in serum prolactin were noted and spontaneous resolution usually occurred within one year, even with continuation of the regimen.[<a class="bibr" href="#LM643.REF.7" rid="LM643.REF.7">7</a>] The relevance of these findings to nursing mothers is not known. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.</p></div><div id="LM643.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p><a href="/books/n/lactmed/LM646/?report=reader">Lamivudine</a>, <a href="/books/n/lactmed/LM647/?report=reader">Nelfinavir</a>, <a href="/books/n/lactmed/LM645/?report=reader">Nevirapine</a>, <a href="/books/n/lactmed/LM649/?report=reader">Zidovudine</a></p></div><div id="LM643.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM643.REF.1">World Health Organization. HIV and infant feeding: Update. 2007. <a href="http://whqlibdoc.who.int/publications/2007/9789241595964_eng.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://whqlibdoc<wbr style="display:inline-block"></wbr>​.who<wbr style="display:inline-block"></wbr>​.int/publications/2007<wbr style="display:inline-block"></wbr>​/9789241595964_eng.pdf</a></div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="LM643.REF.2">World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: Recommendations for a public health approach. 2021. <a href="https://www.who.int/publications/i/item/9789240031593" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.who.int/publications<wbr style="display:inline-block"></wbr>​/i/item/9789240031593</a> [<a href="https://pubmed.ncbi.nlm.nih.gov/34370423" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34370423</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="LM643.REF.3">Department of Health and Human Services. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. 2024. <a href="https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/perinatal-hiv/guidelines-perinatal.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https:<wbr style="display:inline-block"></wbr>​//clinicalinfo<wbr style="display:inline-block"></wbr>​.hiv.gov/sites/default<wbr style="display:inline-block"></wbr>​/files/guidelines/documents<wbr style="display:inline-block"></wbr>​/perinatal-hiv<wbr style="display:inline-block"></wbr>​/guidelines-perinatal.pdf</a></div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM643.REF.4">Rezk
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NL, White
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N, Bridges
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AS, et al.
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Studies on antiretroviral drug concentrations in breast milk: Validation of a liquid chromatography-tandem mass spectrometric method for the determination of 7 anti-human immunodeficiency virus medications.
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Ther Drug Monit
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2008;30:611-9.
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[<a href="/pmc/articles/PMC2901847/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2901847</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/18758393" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18758393</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM643.REF.5">Fogel
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JM, Taha
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TE, Sun
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J, et al.
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Stavudine (d4T) concentrations in women receiving post-partum antiretroviral treatment and their breastfeeding infants.
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J Acquir Immune Defic Syndr
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2012;60:462-5.
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[<a href="/pmc/articles/PMC3404155/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3404155</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/22614899" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22614899</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="LM643.REF.6">Palombi
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L, Pirillo
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MF, Andreotti
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M, et al.
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Antiretroviral prophylaxis for breastfeeding transmission in Malawi: drug concentrations, virological efficacy and safety.
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Antivir Ther
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2012;17:1511-9.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/22910456" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22910456</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="LM643.REF.7">García-Benayas
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T, Blanco
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F, Martin-Carbonero
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L, et al.
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Gynecomastia in HIV-infected patients receiving antiretroviral therapy.
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AIDS Res Hum Retroviruses
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2003;19:739-41.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/14585204" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 14585204</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="LM643.REF.8">Pantanowitz
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L, Evans
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D, Gross
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PD, et al.
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HIV-related gynecomastia.
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Breast J
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2003;9:131-2.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12603389" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12603389</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="LM643.REF.9">Evans
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DL, Pantanowitz
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L, Dezube
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BJ, et al.
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Breast enlargement in 13 men who were seropositive for human immunodeficiency virus.
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Clin Infect Dis
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2002;35:1113-9.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12384846" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12384846</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="LM643.REF.10">Hutchinson
|
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J, Murphy
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M, Harries
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R, et al.
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Galactorrhoea and hyperprolactinaemia associated with protease-inhibitors.
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Lancet
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2000;356:1003-4.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/11041407" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11041407</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="LM643.REF.11">Orlando
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G, Brunetti
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L, Vacca
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M. Ritonavir and saquinavir directly stimulate anterior pituitary prolactin secretion, in vitro.
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Int J Immunopathol Pharmacol
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2002;15:65-8.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12593790" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12593790</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="LM643.REF.12">Montero
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A, Bottasso
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OA, Luraghi
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MR, et al.
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Galactorrhoea, hyperprolactinaemia, and protease inhibitors.
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Lancet
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2001;357:473-5.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/11273087" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11273087</span></a>]</div></dd></dl></dl></div></div><div id="LM643.Substance_Identification"><h2 id="_LM643_Substance_Identification_">Substance Identification</h2><div id="LM643.Substance_Name"><h3>Substance Name</h3><p>Stavudine</p></div><div id="LM643.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>3056-17-5</p></div><div id="LM643.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Anti-Infective Agents</p><p>Antiviral Agents</p><p>Anti-HIV Agents</p><p>Anti-Retroviral Agents</p><p>Reverse Transcriptase Inhibitors</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="_NBK501533_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">July 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-. Stavudine. [Updated 2024 Jul 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM862/?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/LM932/?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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