The Basics

What is Methotrexate?

Used to treat severe psoriasis and to treat severe active rheumatoid arthritis.

Brand names for Methotrexate

Trexall

How Methotrexate is classified

Abortifacient Agents – Nonsteroidal, Antimetabolites, Antineoplastic, Antirheumatic Agents, Folic Acid Antagonists, Immunosuppressive Agents

Methotrexate During Pregnancy

Methotrexate 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 Methotrexate while pregnant

Contraindicated in pregnancy. It is abortifacient and increases the risk of aminopterin syndrome, which is characterized by fetal central nervous system, skeletal, and cardiac abnormalities

Taking Methotrexate While Breastfeeding

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

Most sources consider breastfeeding to be contraindicated during maternal high-dose antineoplastic drug therapy with methotrexate. An abstinence period of at least 1 week after chemotherapy doses of methotrexate has been suggested.[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] Limited information indicates that a maternal dose of methotrexate up to 92 mg (1.12 mg/kg) produces low levels in milk, leading some authors to state that low single or weekly doses, such as those used for ectopic pregnancy or rheumatoid arthritis, are of low risk to the breastfed infant,[4][5][6][7][8] although some expert opinion warns against this use.[9][10][11][12][13] Withholding breastfeeding for 24 hours after a weekly low lose of methotrexate may decrease the infant’s dose by 40%.[14][15] If breastfeeding during long-term, low-dose methotrexate use is undertaken, monitoring of the infant’s complete blood count and differential could be considered.

Maternal / infant drug levels

Most sources consider breastfeeding to be contraindicated during maternal high-dose antineoplastic drug therapy with methotrexate. An abstinence period of at least 1 week after chemotherapy doses of methotrexate has been suggested.[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] Limited information indicates that a maternal dose of methotrexate up to 92 mg (1.12 mg/kg) produces low levels in milk, leading some authors to state that low single or weekly doses, such as those used for ectopic pregnancy or rheumatoid arthritis, are of low risk to the breastfed infant,[4][5][6][7][8] although some expert opinion warns against this use.[9][10][11][12][13] Withholding breastfeeding for 24 hours after a weekly low lose of methotrexate may decrease the infant’s dose by 40%.[14][15] If breastfeeding during long-term, low-dose methotrexate use is undertaken, monitoring of the infant’s complete blood count and differential could be considered.

Possible effects of Methotrexate on milk supply

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

Possible alternatives to Methotrexate

(Rheumatoid Arthritis) Auranofin, Etanercept, Gold Sodium Thiomalate, Hydroxychloroquine, Infliximab, Penicillamine, Sulfasalazine.

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. Pistilli B, Bellettini G, Giovannetti E et al. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: How should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013;39:207-11. PMID: 23199900
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
4. Johns DG, Rutherford LD et al. Secretion of methotrexate in human milk. Am J Obstet Gynecol. 1972;112:978-80. PMID: 5042796
5. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Can Fam Physician. 2000;46:1753-7. PMID: 11013791
6. Ostensen M. Management of early aggressive rheumatoid arthritis during pregnancy and lactation. Expert Opin Pharmacother. 2009;10:1469-79. PMID: 19505214
7. Tanaka T, Walsh W, Verjee Z et al. Methotrexate use in a lactating woman with an ectopic pregnancy. Birth Defects Res A Clin Mol Teratol. 2009;85:494. Abstract. Assay sensitivity per Shinya Ito, MD. DOI: doi:10.1002/bdra.20605
8. Thorne JC, Nadarajah T, Moretti M, Ito S. Methotrexate use in a breastfeeding patient with rheumatoid arthritis. J Rheumatol. 2014;41:2332. PMID: 25362724
9. Nguyen GC, Seow CH, Maxwell C et al. The Toronto Consensus Statements for the Management of IBD in Pregnancy. Gastroenterology. 2016;150:734-57. PMID: 26688268
10. Mahadevan U, Matro R. Care of the pregnant patient with inflammatory bowel disease. Obstet Gynecol. 2015;126:401-12. PMID: 26241432
11. Kavanaugh A, Cush JJ, Ahmed MS et al. Proceedings from the American College of Rheumatology Reproductive Health Summit: The management of fertility, pregnancy, and lactation in women with autoimmune and systemic inflammatory diseases. Arthritis Care Res (Hoboken). 2015;67:313-25. PMID: 25385050
12. van der Woude CJ, Ardizzone S, Bengtson MB et al. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015;9:107-24. PMID: 25602023
13. Flint J, Panchal S, Hurrell A et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016;55:1693-7. PMID: 26750124
14. Delaney S, Colantonio D, Ito S. Methotrexate in breast milk. Birth Defects Res. 2017;109 (Special Issue: SI):711. Abstract. DOI: doi:10.1002/bdr2.1061
15. Baker T, Datta P, Rewers-Felkins K et al. High-dose methotrexate treatment in a breastfeeding mother with placenta accreta: A case report. Breastfeed Med. 2018;13:450-2. PMID: 29985651

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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