The pregnancy section has been updated with data on a large number (~2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, which did not indicate an increase in the rate of malformation in the newborn. SPC now advises that adalimumab should only be used during pregnancy if clearly needed.
SPC now states that limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level, thus no effects on the breastfed newborns/infants are anticipated.
Lichenoid skin reaction has been added to SPC as a rare adverse reaction.