Golimumab use while Breastfeeding
Drugs containing Golimumab: Simponi, Simponi Aria
Medically reviewed by Drugs.com. Last updated on Feb 11, 2021.
Golimumab Levels and Effects while Breastfeeding
Summary of Use during Lactation
Little information is available on the clinical use of golimumab during breastfeeding. Because golimumab is a large protein molecule with a molecular weight of about 150,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, golimumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Most experts feel that the drug is probably acceptable to use during nursing.[1-6]
Golimumab 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%.[7,8] 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%. None of the studies measured IgG activity.
Maternal Levels. In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 1 woman receiving golimumab provided milk samples at 1, 12, 24, 48, 72, 96, 120, and 168 hours after drug administration. Golimumab was not detected (<12 mcg/L) in any of the samples.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 1 woman received a golimumab while breastfeeding her infant. Among those who received golimumab or another biologic agent while breastfeeding, infant growth, development or infection rate was no different from infants whose mothers received no treatment. An additional 68 women received a biologic agent plus a thiopurine. Infant outcomes were similar in this group.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
Nguyen GC, Seow CH, Maxwell C, et al. The Toronto Consensus Statements for the Management of IBD in Pregnancy. Gastroenterology. 2016;150:734–57. [PubMed: 26688268]
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. [PubMed: 25602023]
Matro R, Martin CF, Wolf D, et al. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology. 2018;155:696–704. [PubMed: 29857090]
Mahadevan U, Robinson C, Bernasko N, et al. Inflammatory bowel disease in pregnancy clinical care pathway: A report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019;156:1508–24. [PubMed: 30658060]
Picardo S, Seow CH. A pharmacological approach to managing inflammatory bowel disease during conception, pregnancy and breastfeeding: Biologic and oral small molecule therapy. Drugs. 2019;79:1053–63. [PubMed: 31183768]
Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020;72:529–56. [PubMed: 32090480]
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]
CAS Registry Number
Antibodies, Monoclonal, Humanized
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