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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="_NBK501548_"><span class="title" itemprop="name">Emtricitabine</span></h1><p class="fm-aai"><a href="#_NBK501548_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: 143491-57-0</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/135022892" 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=135022892" alt="image 135022892 in the ncbi pubchem database" /></a><div id="LM657.Drug_Levels_and_Effects"><h2 id="_LM657_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM657.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Emtricitabine has been relatively well studied during breastfeeding and it is sometime used in treating HIV-positive mothers who are breastfeeding. 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="#LM657.REF.1" rid="LM657.REF.1">1</a>,<a class="bibr" href="#LM657.REF.2" rid="LM657.REF.2">2</a>]</p><p>For use in treating maternal hepatitis B, no difference exist in infection rates between breastfed and formula-fed infants born to hepatitis B-infected women, as long as the infant receives hepatitis B immune globulin and hepatitis B vaccine at birth. Mothers with hepatitis B are encouraged to breastfeed their infants after their infants receive these preventative measures.[<a class="bibr" href="#LM657.REF.3" rid="LM657.REF.3">3</a>,<a class="bibr" href="#LM657.REF.4" rid="LM657.REF.4">4</a>] With HIV pre-exposure prophylaxis with tenofovir 200 mg and emtricitabine 300 mg, infants receive only about 0.5% of a therapeutic dose of emtricitabine. During long-term maternal use of emtricitabine 200 mg daily, breastfed infants usually have undetectable blood concentrations.</p></div><div id="LM657.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> Five exclusively breastfeeding mothers received oral emtricitabine 200 mg plus tenofovir 300 mg and nevirapine 200 mg at the start of labor, then oral emtricitabine 200 mg and tenofovir 300 mg daily for 7 days postpartum. A total of 16 concurrent maternal blood and milk samples were collected on days 1, 2, 3, and 7 postpartum between 10 minutes and 21 hours after the mothers' doses. Median peak and trough emtricitabine concentrations in breastmilk were 679 mcg/L and 177 mcg/L, respectively. The authors estimated that an exclusively breastfed infant would receive about 2% of the proposed infant dose for emtricitabine and achieve infant serum concentrations that might result in the emergence of viral resistance to emtricitabine.[<a class="bibr" href="#LM657.REF.5" rid="LM657.REF.5">5</a>]</p><p>Fifty HIV-negative women who were nursing their infants were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days. On days 7 and 10 of therapy, peak milk samples were obtained 1 to 2 hours after a dose and trough samples were obtained 23 to 24 hours after the previous dose. The median peak milk emtricitabine concentration was 212.5 mcg/L and the trough concentration was 183 mcg/L. These values represent an estimated daily dosage of 27.5 to 31.5 mcg/kg, which is approximately 0.5% of the proposed infant therapeutic dosage.[<a class="bibr" href="#LM657.REF.6" rid="LM657.REF.6">6</a>]</p><p>Emtricitabine was measured in 6 HIV-positive nursing mothers after a 300 mg dose during ongoing therapy. The peak breastmilk level was 872 mcg/L (range 696 to 1063 mcg/L) at a median of 3 hours.[<a class="bibr" href="#LM657.REF.7" rid="LM657.REF.7">7</a>]</p><p>Sixteen Nigerian women took emtricitabine 200 mg once daily as part of a combination therapy for HIV. Expressed milk samples were taken before the dose and at 0.5, 1, 2, 4, 8 and 12 hours after the dose. The median peak breastmilk concentration from dried breastmilk spots was 843 mcg/L (IQR 702 to 1132 mcg/L) at a median of 4 hours after the dose (IQR 2 to 8 hours).[<a class="bibr" href="#LM657.REF.8" rid="LM657.REF.8">8</a>]</p><p>Twenty-nine mothers taking emtricitabine 200 mg once daily provided milk samples at a median of 15.5 hours after a dose. The median drug concentration in milk was 803 mcg/L, which resulted in an estimated infant dosage of 120 mcg/kg daily and a relative infant dose of 4.02% of the maternal weight-adjusted dosage.[<a class="bibr" href="#LM657.REF.9" rid="LM657.REF.9">9</a>]</p><p><i>Infant Levels.</i> Fifty HIV-negative women who were nursing their infants were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days. A single infant blood sample was obtained after the mother's 7th dose. Of 49 infant blood samples collected, 47 had detectable concentrations of emtricitabine, with a median plasma concentration of 13.2 mcg/L. Infants under 13 weeks of age had a statistically significant lower plasma concentration than those who were 13 weeks of age or older, 16.6 mcg/L and 10.5 mcg/L, respectively.[<a class="bibr" href="#LM657.REF.6" rid="LM657.REF.6">6</a>]</p><p>Emtricitabine 300 mg daily was given to 6 HIV-positive nursing mothers. One breastfed infant had a detectable emtricitabine serum level of 17.5 mcg/L.[<a class="bibr" href="#LM657.REF.7" rid="LM657.REF.7">7</a>]</p><p>Sixteen Nigerian women took emtricitabine 200 mg once daily as part of a combination therapy for HIV. Their exclusively breastfed infants were fed on demand and had blood samples taken at 2 and 8 hours after the dose. Dried blood spots were analyzed and only 3 samples contained quantifiable (>16.6 mcg/L) blood levels of 17.5, 18.8, and 19.4 mcg/L.[<a class="bibr" href="#LM657.REF.8" rid="LM657.REF.8">8</a>]</p><p>Eleven infants were breastfed by mothers taking _, although the extent of breastfeeding was not sated. Infant serum concentrations taken 2 to 20 hours after maternal drug intake at 1 month of age ranged from 0 to 49 mcg/L.[<a class="bibr" href="#LM657.REF.9" rid="LM657.REF.9">9</a>]</p></div><div id="LM657.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>In a study of 50 infants breastfed by HIV-negative women who were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days, 2 infants reportedly had diarrhea lasting 2 to 3 days. No other side effects were reported.[<a class="bibr" href="#LM657.REF.6" rid="LM657.REF.6">6</a>]</p></div><div id="LM657.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="LM657.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>(Hepatitis B) <a href="/books/n/lactmed/LM646/?report=reader">Lamivudine</a>, <a href="/books/n/lactmed/LM658/?report=reader">Tenofovir</a></p></div><div id="LM657.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM657.REF.1">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>2.</dt><dd><div class="bk_ref" id="LM657.REF.2">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>3.</dt><dd><div class="bk_ref" id="LM657.REF.3">Visvanathan
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K, Dusheiko
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G, Giles
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M, et al.
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Managing HBV in pregnancy. Prevention, prophylaxis, treatment and follow-up: Position paper produced by Australian, UK and New Zealand key opinion leaders.
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Gut
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2016;65:340-50.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26475631" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26475631</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM657.REF.4">Dionne-Odom
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J, Tita
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AT, Silverman
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NS. #38: Hepatitis B in pregnancy screening, treatment, and prevention of vertical transmission.
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Am J Obstet Gynecol
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2016;214:6-14.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26454123" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26454123</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM657.REF.5">Benaboud
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S, Pruvost
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A, Coffie
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PA, et al.
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Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d'Ivoire, in the ANRS 12109 TEMAA Study, step 2.
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Antimicrob Agents Chemother
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2011;55:1315-7.
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[<a href="/pmc/articles/PMC3067089/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3067089</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/21173182" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21173182</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="LM657.REF.6">Mugwanya
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KK, Hendrix
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CW, Mugo
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NR, et al.
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Pre-exposure prophylaxis use by breastfeeding HIV-uninfected women: A prospective short-term study of antiretroviral excretion in breast milk and infant absorption.
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PLoS Med
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2016;13:e1002132.
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[<a href="/pmc/articles/PMC5038971/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5038971</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27676257" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27676257</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="LM657.REF.7">Waitt
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C, Diliiy Penchala
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S, Olagunju
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A, et al.
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Development, validation and clinical application of a method for the simultaneous quantification of lamivudine, emtricitabine and tenofovir in dried blood and dried breast milk spots using LC–MS/MS.
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J Chromatogr B Analyt Technol Biomed Life Sci
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2017;1060:300-7.
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[<a href="/pmc/articles/PMC5588985/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5588985</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28651173" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28651173</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="LM657.REF.8">Waitt
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C, Olagunju
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A, Nakalema
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S, et al.
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Plasma and breast milk pharmacokinetics of emtricitabine, tenofovir and lamivudine using dried blood and breast milk spots in nursing African mother-infant pairs.
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J Antimicrob Chemother
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2018;73:1013-9.
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[<a href="/pmc/articles/PMC5890695/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5890695</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29309634" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29309634</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="LM657.REF.9">Aebi-Popp
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K, Kahlert
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CR, Crisinel
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PA, et al.
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Transfer of antiretroviral drugs into breastmilk: A prospective study from the Swiss Mother and Child HIV Cohort Study.
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J Antimicrob Chemother
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2022;77:3436-42.
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[<a href="/pmc/articles/PMC9704434/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9704434</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36177836" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36177836</span></a>]</div></dd></dl></dl></div></div><div id="LM657.Substance_Identification"><h2 id="_LM657_Substance_Identification_">Substance Identification</h2><div id="LM657.Substance_Name"><h3>Substance Name</h3><p>Emtricitabine</p></div><div id="LM657.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>143491-57-0</p></div><div id="LM657.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="_NBK501548_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-. Emtricitabine. [Updated 2024 Jul 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM1376/?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/LM1173/?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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