The Basics

What is Irinotecan?

Used to treat colon cancer and small cell lung cancer.

Brand names for Irinotecan

Camptosar Inj

How Irinotecan is classified

Antineoplastic Agents, Enzyme Inhibitors, Topoisomerase I Inhibitors

Irinotecan During Pregnancy

Irinotecan pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Irinotecan while pregnant

Based on findings from animal studies and its mechanism of action, CAMPTOSAR can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. Available postmarketing and published data reporting the use of CAMPTOSAR in pregnant women, are insufficient and confounded by the concomitant use of other cytotoxic drugs, to evaluate for any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, intravenous administration of irinotecan to rats and rabbits during the period of organogenesis resulted in embryofetal mortality and teratogenicity in pregnant animals at exposures lower than the human exposure based on AUC at the clinical dose of 125 mg/m² (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively

Taking Irinotecan While Breastfeeding

What are recommendations for lactation if you're taking Irinotecan?

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]

Maternal / infant drug levels

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]

Possible effects of Irinotecan on milk supply

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

Possible alternatives to Irinotecan

None listed

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. 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. PMID: 27477206
2. 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. PMID: 25061513
3. 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. PMID: 28170295

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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