European PRAC drafts direct healthcare professional communication (DHPC) containing advice to postpone use of live vaccines in infants exposed to infliximab during pregnancy or via breastfeeding
The draft DHPC, which will be forwarded to the CHMP for approval, recommends live vaccines should not be given to infants for 12 months after birth if they have been exposed to infliximab during pregnancy, or if they are breastfed while the mother is receiving the medicine.
Source:
European Medicines Agency
SPS commentary:
The DHPC notes that if infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier time point if there is a clear clinical benefit for the individual infant.
The current UK SPC for Remicade states that administration of live vaccines to infants exposed to infliximab in utero is not recommended for at least 6 months after birth, and that women must not breastfeed for at least 6 months after treatment.