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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.

Cover of Drugs and Lactation Database (LactMed®)

Drugs and Lactation Database (LactMed®) [Internet].

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Last Revision: August 16, 2021.

Estimated reading time: 1 minute

CASRN: 97682-44-5

image 135032920 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

Limited data indicate that irinotecan is found in breastmilk for 2 days and its active metabolite is found in breastmilk for up to a week after a dose of 60 mg/square meter, although the highest amounts occur during the first 4 days after a dose. Higher maternal doses have not been studied and the oral absorption and toxicity in breastfed infants are not known. Based on this limited evidence, it appears that breastfeeding should be avoided for at least a week after a dose of irinotecan 60 mg/square meter. Higher dosages probably require a longer abstinence period. Some authors recommend discontinuing breastfeeding during irinotecan therapy.[1] Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[2] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.[3]

Drug Levels

Irinotecan is metabolized to the active metabolite, 7-ethyl-10-hydroxycamptothecin (SN-38), which is further conjugated with glucuronic acid.

Maternal Levels. A woman with cervical cancer discovered during pregnancy was treated with irinotecan 60 mg/square meter plus nedaplatin 80 mg/square meter. She had been nursing her infant prior to chemotherapy and collected morning breastmilk samples on days 2 to 7 following the first dose of irinotecan. Irinotecan was detectable in breastmilk on days 2 and 3 after the dose in concentrations of 399 and 60.21 mcg/L, respectively. Irinotecan was undetectable (<0.1 mcg/L) on day 4 and after. SN-38 was also measured, but not its glucuronide. SN-38 was highest in breastmilk on day 2, with a concentration of 3.9 mcg/L. Levels fell, but were still measurable on days 6 and 7, with concentrations of 0.16 and 0.2 mcg/L, respectively.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.


Nakagawa J, Terui K, Hosoi K, et al. Passage of irinotecan and its active metabolite, SN-38, into human milk. J Clin Pharm Ther. 2016;41:579–82. [PubMed: 27477206]
Urbaniak C, McMillan A, Angelini M, et al. Effect of chemotherapy on the microbiota and metabolome of human milk, a case report. Microbiome. 2014;2:24. [PMC free article: PMC4109383] [PubMed: 25061513]
Stopenski S, Aslam A, Zhang X, et al. After chemotherapy treatment for maternal cancer during pregnancy, is breastfeeding possible? Breastfeed Med. 2017;12:91–7. [PubMed: 28170295]

Substance Identification

Substance Name


CAS Registry Number

97682-44-5 86639-52-3

Drug Class

Breast Feeding


Antineoplastic Agents

Enzyme Inhibitors

Topoisomerase I Inhibitors

Disclaimer: 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.

Copyright Notice

Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Bookshelf ID: NBK500877PMID: 29999936


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