Summary of Use during Lactation

Limited information on golimumab indicates that it is almost undetectable in breastmilk. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[1] Anti-TNF agents appear to reduce the levels of tumor necrosis factor and IP-10 in the milk of mothers with inflammatory bowel disease in the early postpartum period.[2] Waiting for at least 2 weeks postpartum to resume therapy suspended during pregnancy may minimize transfer to the infant.[3] However, in infants of mothers who received other monoclonal antibodies during late pregnancy, continued use while breastfeeding did not prolong their elimination by the infant. Most experts and guidelines consider golimumab to be probably acceptable to use during nursing.[4-12] Anti-TNF agents reduce the levels of tumor necrosis factor and IP-10 in the milk of mothers with inflammatory bowel disease in the early postpartum period.[2] This reduction in TNF might lead to decreased milk production, so extra lactation support might be necessary in women taking golimumab.

Drug Levels

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.[6]

A lactating woman was receiving golimumab 50 mg subcutaneously every 4 weeks for inflammatory bowel disease. She collected milk samples at 3 and 5 days after the fourth dose had barely detectable levels of golimumab (limit of quantification <0.1 mcg/L).[13]

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.[6]

A multicenter study in Spain prospectively followed women treated for inflammatory bowel disease with biological agents, mostly anti-TNF agents. Overall, 29% of infants exposed to a biologic agent were also exposed to azathioprine or mercaptopurine and almost all were exposed during both pregnancy and lactation. One infant was exposed to golimumab during lactation for 52.1 weeks. No adverse impact of biologics exposure was found on the psychomotor development of infants for up to 1 year of age.[14]

Effects on Lactation and Breastmilk

An analysis of the US Food and Drug Administration’s FAERS database of 7,022 spontaneous adverse reaction reports of anti-TNF drugs found that they may cause an increased risk of lactation insufficiency and disorders. Drugs that were studied included adalimumab, infliximab, golimumab, certolizumab, and etanercept. The authors noted that TNF alpha is involved in milk production, adding biological plausibility to the findings.[15]

Alternate Drugs to Consider

(Inflammatory Bowel Disease) Adalimumab, Certolizumab Pegol, Infliximab; (Rheumatoid Arthritis) Adalimumab, Certolizumab Pegol, Etanercept, Infliximab

References

1.

Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med 2021;16:591–3. [PubMed: 33956488]

2.

Sepiashvili L, Brydon A, Koroshegyi C, et al. Reduction of tumor necrosis factor (TNF) in milk of women receiving anti-TNF antibody. Pediatr Res 2025;97:1935–42. [PubMed: 39487320]

3.

Krysko KM, Dobson R, Alroughani R, et al. Family planning considerations in people with multiple sclerosis. Lancet Neurol 2023;22:350–66. [PubMed: 36931808]

4.

Nguyen GC, Seow CH, Maxwell C, et al. The Toronto Consensus Statements for the Management of IBD in Pregnancy. Gastroenterology 2016;150:734–57.e1. [PubMed: 26688268]

5.

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]

6.

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]

7.

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]

8.

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]

9.

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]

10.

Yeung J, Gooderham MJ, Grewal P, et al. Management of plaque psoriasis with biologic therapies in women of child-bearing potential consensus paper. J Cutan Med Surg 2020;24 (1_Suppl):3S–14S. [PubMed: 32500730]

11.

Russell MD, Dey M, Flint J, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford) 2023;62:e48–e88. [PMC free article: PMC10070073] [PubMed: 36318966]

12.

Mahadevan U, Seow CH, Barnes EL, et al. Global consensus statement on the management of pregnancy in inflammatory bowel disease. Clin Gastroenterol Hepatol 2025;23 (11S):S1–S60. [PubMed: 40874901]

13.

Saito J, Yakuwa N, Hosokawa Y, et al. Establishment of a measurement system to evaluate breast milk transfer of biological agents using dry filter paper: A multi-institutional study. Br J Clin Pharmacol 2024;90:146–57. [PubMed: 37548054]

14.

Palomino L, Rodríguez-Belvís MV, Casanova MJ, et al. Psychomotor development in infants following maternal exposure to biologics: Results from the DUMBO registry. Clin Gastroenterol Hepatol 2026;24:1688–701. [PubMed: 40518059]

15.

Yan Z, Chen H, Sun J, et al. Divergent safety profiles of TNF inhibitors in pregnancy: A comprehensive pharmacovigilance analysis of the FAERS database. J Autoimmun 2026;160:103553. [PubMed: 41932089]

Substance Name

Golimumab

CAS Registry Number

476181-74-5

Drug Class

Breast Feeding

Lactation

Milk, Human

Antirheumatic Agents

Antibodies, Monoclonal, Humanized

Tumor Necrosis Factor Inhibitors