Revised SPC: Humira (adalimumab) 20 mg / 0.2 ml Solution for Injection in Pre-Filled Syringe

Data from a prospective registry have been added to the pregnancy section. The data from prospectively collected pregnancies exposed to adalimumab does not indicate an increase in the rate of malformation in the newborn. The SPC now states it can be used during breastfeeding.

Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn. Adalimumab should only be used during pregnancy if clearly needed.

 

The information on breastfeeding has also been updated, to take into account new data that indicates 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. Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breastfed newborns/infants are anticipated. Consequently, Humira can be used during breastfeeding.