Summary:
Infants exposed to infliximab in utero (i.e., during pregnancy)

• Infliximab crosses the placenta and has been detected in infant serum up to 12 months after birth. After in utero exposure, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
• Live vaccines (e.g., BCG vaccine) should not be given to infants after in utero exposure to infliximab for 12 months after birth.
• If there is a clear clinical benefit for the individual infant, administration of a live vaccine might be considered at an earlier timepoint if infant infliximab serum levels are undetectable or if infliximab administration was limited to the first trimester of pregnancy.

Infants exposed to infliximab via breast milk

• Infliximab has been detected at low levels in breast milk. It has also been detected in infant serum after exposure to infliximab via breast milk.
• Administration of a live vaccine to a breastfed infant while the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable.