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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Diroximel Fumarate - 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="Diroximel Fumarate">
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<meta name="citation_publisher" content="National Institute of Child Health and Human Development">
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<meta name="citation_keywords" content="2-(2,5-Dioxopyrrolidin-1-yl)ethyl methyl (2E)-but- 2-enedioate">
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<meta name="description" content="No information is available on the clinical use of diroximel fumarate during breastfeeding. However, amounts of the active metabolite of diroximel fumarate, monomethyl fumarate, in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. Based on clinical data in over 20 infants exposed to dimethyl fumarate in breastmilk, diroximel fumarate is acceptable to use during breastfeeding, at least after one month of age.[1] Breastfed infants should be monitored for adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Some authors also recommend monitoring breastfed infants for flushing, vomiting and diarrhea.[2,3]">
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<meta name="og:description" content="No information is available on the clinical use of diroximel fumarate during breastfeeding. However, amounts of the active metabolite of diroximel fumarate, monomethyl fumarate, in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. Based on clinical data in over 20 infants exposed to dimethyl fumarate in breastmilk, diroximel fumarate is acceptable to use during breastfeeding, at least after one month of age.[1] Breastfed infants should be monitored for adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Some authors also recommend monitoring breastfed infants for flushing, vomiting and diarrhea.[2,3]">
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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="_NBK569615_"><span class="title" itemprop="name">Diroximel Fumarate</span></h1><p class="fm-aai"><a href="#_NBK569615_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 2 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 1577222-14-0</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/393666646" 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=393666646" alt="image 393666646 in the ncbi pubchem database" /></a><div id="diroximel_fumarate.Drug_Levels_and_Effec"><h2 id="_diroximel_fumarate_Drug_Levels_and_Effec_">Drug Levels and Effects</h2><div id="diroximel_fumarate.Summary_of_Use_during"><h3>Summary of Use during Lactation</h3><p>No information is available on the clinical use of diroximel fumarate during breastfeeding. However, amounts of the active metabolite of diroximel fumarate, monomethyl fumarate, in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. Based on clinical data in over 20 infants exposed to dimethyl fumarate in breastmilk, diroximel fumarate is acceptable to use during breastfeeding, at least after one month of age.[<a class="bibr" href="#diroximel_fumarate.REF.1" rid="diroximel_fumarate.REF.1">1</a>] Breastfed infants should be monitored for adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Some authors also recommend monitoring breastfed infants for flushing, vomiting and diarrhea.[<a class="bibr" href="#diroximel_fumarate.REF.2" rid="diroximel_fumarate.REF.2">2</a>,<a class="bibr" href="#diroximel_fumarate.REF.3" rid="diroximel_fumarate.REF.3">3</a>]</p></div><div id="diroximel_fumarate.Drug_Levels"><h3>Drug Levels</h3><p>Diroximel fumarate is not found in the plasma because it is rapidly converted to the active drug, monomethyl fumarate, which has a half-life of about 1 hour.</p><p><i>Maternal Levels.</i> Two nursing mothers with relapsing-remitting multiple sclerosis began the closely related drug dimethyl fumarate 240 mg orally twice daily after discontinuing breastfeeding. They continued pumping milk and on day 8 of therapy, they each provided milk samples at 1, 2, 4, 8 and 12 hours after a dose. Peak monomethyl fumarate milk levels were 3.7 mcg/L in one mother and 11.2 mcg/L in the other and occurred at about 2 hours after the dose. Average milk levels were 2.7 mcg/L and 7.5 mcg/L, respectively. These values indicate that the infants would receive daily dosages of about 0.8 mcg/kg and 1.13 mcg/kg, respectively, or weight-adjusted relative infant dosages of 0.007% and 0.019% of the maternal dosage.[<a class="bibr" href="#diroximel_fumarate.REF.3" rid="diroximel_fumarate.REF.3">3</a>]</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="diroximel_fumarate.Effects_in_Breastfed"><h3>Effects in Breastfed Infants</h3><p>Twenty-six women taking dimethyl fumarate for relapsing-remitting multiple sclerosis were followed during 29 pregnancies from 2015 to 2020. Dimethyl fumarate was administered through week 24 of pregnancy and resumed 1 month after delivery. Twenty-two of 26 mothers breastfed (extent not stated) for 4 to 7 months. Infants were monitored up to the third year of life for infections and developmental disorders. All children were the 70th and 95th percentile for height and weight. The authors concluded that continuing dimethyl fumarate while breastfeeding is safe,[<a class="bibr" href="#diroximel_fumarate.REF.1" rid="diroximel_fumarate.REF.1">1</a>] although infants were not exposed during the first month of life.</p></div><div id="diroximel_fumarate.Effects_on_Lactation"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="diroximel_fumarate.Alternate_Drugs_to_Co"><h3>Alternate Drugs to Consider</h3><p>(Multiple Sclerosis) <a href="/books/n/lactmed/LM306/?report=reader">Glatiramer</a>, <a href="/books/n/lactmed/LM555/?report=reader">Immune Globulin</a>, <a href="/books/n/lactmed/LM307/?report=reader">Interferon Beta</a></p></div><div id="diroximel_fumarate.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="diroximel_fumarate.REF.1">Borriello
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G, Ianniello
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A. Efficacy, safety and tolerability of dimethylfumarate during pregnancy and breastfeeding.
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Mult Scler Relat Disord
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2022;67:103949. doi:10.1016/j.msard.2022.103951 [<a href="http://dx.crossref.org/10.1016/j.msard.2022.103951" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="diroximel_fumarate.REF.2">Almas
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S, Vance
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J, Baker
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T, et al.
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Management of multiple sclerosis in the breastfeeding mother.
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Mult Scler Int
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2016;2016:6527458.
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[<a href="/pmc/articles/PMC4757692/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4757692</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/26966579" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26966579</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="diroximel_fumarate.REF.3">Ciplea
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AI, Datta
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P, Rewers-Felkins
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K, et al.
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Dimethyl fumarate transfer into human milk.
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Ther Adv Neurol Disord
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2020;13:1756286420968414.
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[<a href="/pmc/articles/PMC7607748/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7607748</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/33193814" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33193814</span></a>]</div></dd></dl></dl></div></div><div id="diroximel_fumarate.Substance_Identificat"><h2 id="_diroximel_fumarate_Substance_Identificat_">Substance Identification</h2><div id="diroximel_fumarate.Substance_Name"><h3>Substance Name</h3><p>Diroximel Fumarate</p></div><div id="diroximel_fumarate.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>1577222-14-0</p></div><div id="diroximel_fumarate.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Dermatologic Agents</p><p>Immunosuppressive Agents</p><p>Radiation-Sensitizing 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="_NBK569615_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">May 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-. Diroximel Fumarate. [Updated 2024 May 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM635/?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/LM97/?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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