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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Last Revision: April 18, 2022.

Estimated reading time: 1 minute

CASRN: 1190264-60-8

Drug Levels and Effects

Summary of Use during Lactation

Preliminary evidence indicates that dupilumab indicates that it may be safe during breastfeeding. Because dupilumab is a large protein molecule with a molecular weight of about 147,000 Da, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, dupilumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Dupilumab is a human immunoglobulin G4 (IgG4) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1,2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with Holder pasteurization having little effect on IgG4 activity.[3] None of the studies measured IgG activity.

Drug Levels

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

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

Effects in Breastfed Infants

A woman with atopic eczema received dupilumab subcutaneously in a dose of 300 mg every 2 weeks during pregnancy and postpartum. She breastfed her infant (extent not stated) for at least 4 months during which no complications were reported.[4,5] Seven months after delivery, she became pregnant again and continued dupilumab at the same dose throughout the pregnancy and lactation. No complications were seen during breastfeeding.[6]

Effects on Lactation and Breastmilk

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


Koenig A, de Albuquerque Diniz EM, Barbosa SF, et al. Immunologic factors in human milk: The effects of gestational age and pasteurization. J Hum Lact. 2005;21:439–43. [PubMed: 16280560]
Adhisivam B, Vishnu Bhat B, Rao K, et al. Effect of Holder pasteurization on macronutrients and immunoglobulin profile of pooled donor human milk. J Matern Fetal Neonatal Med. 2019;32:3016–9. [PubMed: 29587541]
Rodríguez-Camejo C, Puyol A, Fazio L, et al. Antibody profile of colostrum and the effect of processing in human milk banks: Implications in immunoregulatory properties. J Hum Lact. 2018;34:137–47. [PubMed: 28586632]
Kage P, Simon JC, Treudler R. A case of atopic eczema treated safely with dupilumab during pregnancy and lactation. J Eur Acad Dermatol Venereol. 2020;34:e256–e257. [PubMed: 31990389]
Treudler R, Kage P, Simon JC. A case of atopic eczema treated safely with dupilumab during pregnancy and lactation. Allergy. 2020;75 Suppl. 109:432. [PubMed: 31990389] [CrossRef]
Kage P, Simon JC, Treudler R. Case of atopic eczema treated with dupilumab throughout conception, pregnancy, and lactation. J Dermatol. 2021;48:E484–5. [PubMed: 34342905]

Substance Identification

Substance Name


CAS Registry Number


Drug Class

Breast Feeding


Milk, Human

Biological Response Modifiers

Immunologic Adjuvants

Antibodies, Monoclonal

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.


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