The PRAC believes that a warning should be added to the product information for ustekinumab regarding the use of live vaccines in infants whose mothers took the drug during pregnancy. The advice is based on various studies and an assessment by the marketing authorization holder.
The drug can cross the placenta and has been shown in the serum of babies who have it in utero have been exposed to. The risk of infection may be increased in infants exposed during pregnancy. In the current product information, women are already advised not to get pregnant both during and for at least fifteen weeks after the last treatment with the drug.
Ustekinumab is an interleukin inhibitor, which neutralizes the biological activity of IL-12 and IL-23 in the activation of immune cells. It is indicated in the treatment of plaque psoriasis, psoriatic arthritis, moderate to severe active Crohn’s disease and ulcerative colitis.