The Basics
What is Daratumumab?
Used to treat multiple myeloma.
Brand names for Daratumumab
Darzalex
How Daratumumab is classified
Antibodies – Monoclonal (Humanized), Antineoplastic Agents
Daratumumab During Pregnancy
Daratumumab pregnancy category
Category Not AssignedNote 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 Daratumumab while pregnant
N/A
Taking Daratumumab While Breastfeeding
What are recommendations for lactation if you're taking Daratumumab?
No information is available on the clinical use of daratumumab during breastfeeding. Because daratumumab is a large protein molecule with a molecular weight of 148,000, 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, daratumumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Daratumumab is a human immunoglobulin G1 (IgG1) kappa 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 IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.
Maternal / infant drug levels
No information is available on the clinical use of daratumumab during breastfeeding. Because daratumumab is a large protein molecule with a molecular weight of 148,000, 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, daratumumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Daratumumab is a human immunoglobulin G1 (IgG1) kappa 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 IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.
Possible effects of Daratumumab on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Daratumumab
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. 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. PMID: 16280560
2. 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. 2018;1-4. PMID: 29587541
3. Rodriguez-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. PMID: 28586632
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.
