Golimumab During Breastfeeding
Golimumab is compatible with breastfeeding and should not influence the decision to breastfeed, nor should breastfeeding influence the decision to continue this medication. 1
Primary Recommendation
The 2020 American College of Rheumatology guidelines conditionally recommend continuing golimumab therapy during breastfeeding, grouping it with other TNF inhibitors (infliximab, etanercept, adalimumab) as compatible options. 1 This recommendation is reinforced by the 2016 Toronto Consensus statements, which concluded that anti-TNF therapy should not influence breastfeeding decisions and vice versa. 1
Evidence Supporting Safety
Drug Transfer to Breast Milk
- Golimumab was not detected in breast milk in the one case studied, suggesting minimal to no transfer. 2
- Other TNF inhibitors show similarly low transfer: infliximab was detected in only 19 of 29 women (maximum 0.74 μg/mL), adalimumab in 2 of 21 women (maximum 0.71 μg/mL), and certolizumab in 3 of 13 women (maximum 0.29 μg/mL). 2
- The large molecular weight of TNF inhibitors limits their passage into breast milk. 3
Infant Safety Outcomes
- The PIANO registry found no significant increase in infections among infants exposed to anti-TNF therapy during breastfeeding. 1, 3
- A multicenter prospective study of 824 women with IBD showed that breastfed infants of mothers on biologics had infection rates of 39% versus 39% in unexposed controls (P > .99), and developmental milestone scores were identical (87 vs 86, P = .9992). 2
- Rates of infection and developmental milestones did not differ among infants whose mothers received biologics, immunomodulators, or combination therapy compared with unexposed infants. 2
Clinical Decision Algorithm
Continue Golimumab If:
- The mother requires ongoing disease control for rheumatic or inflammatory bowel disease 1
- The mother wishes to breastfeed 1
- The disease would likely flare if medication is discontinued 1
No Need To:
- Discard breast milk at any time point 1
- Time breastfeeding around medication administration 1
- Monitor infant drug levels routinely 2
Critical Infant Vaccination Consideration
If the mother received golimumab during pregnancy (especially the third trimester), defer live vaccinations in the infant until 6 months of age. 1, 3 This includes:
- BCG vaccination (if indicated) should be withheld until at least 6 months 1
- Rotavirus vaccine should not be given at all 1
- Non-live vaccinations may proceed according to standard schedules 1
This precaution applies because third-trimester exposure results in high placental transfer and significant neonatal drug levels, not because of breastfeeding exposure. 1
Important Caveats
- The evidence quality is very low, based primarily on case reports, small case series, and registry data rather than randomized trials. 1
- Theoretical concerns exist about whether Fc receptors in newborn gut tissues could lead to local absorption of anti-TNF therapy, though no clinical evidence supports harm. 1
- Discontinuing golimumab postpartum may lead to disease flare, which poses greater risk to both mother and infant than continued breastfeeding on medication. 1
Benefits of Continued Breastfeeding
Breastfeeding itself may be protective against disease relapse in the mother and may reduce the risk of early-onset IBD in offspring. 1 The decision should weigh the substantial benefits of breastfeeding against the minimal theoretical risks of drug exposure. 1, 4
Human data from the British Society of Gastroenterology confirms that golimumab is associated with low risk of adverse maternal and neonatal outcomes. 1