Ustekinumab is a disease modifying, biological drug used to treat psoriatic arthritis, plaque psoriasis, Crohns disease, and ulcerative colitis. It is given by sub cutaneous injection.
It has a molecular weight 149,000, poor oral bioavailability and milk plasma ratio 0.001 – 0.027
Ustekinumab is a recombinant human monoclonal TNF antibody that binds specifically to TNF- α.
It is likely that any small amounts in milk are destroyed in the baby’s gut. Three studies have shown very low levels in milk but the babies showed no evidence of increased rates of infection or other effects on physical or mental health.
BNF states that “specialist sources indicate use with caution; negligible amounts present in milk which are likely to be destroyed in the infant’s gastro-intestinal tract. In newborn or premature infants there may be greater intestinal absorption. “
Ustekinumab is compatible with breastfeeding due to poor bio-availability and hence low-level absorption by the infant. It should be avoided in the first few days post partum when the gaps between the cells are wide open to facilitate transfer of immunoglobulins.
If it is used in pregnancy live vaccines should be avoided in the baby – normally rotavirus because immunity may be compromised. If not used in pregnancy when the rotavirus is given, the breastfeeding mother needs to wear gloves for 2 weeks to avoid picking up the live viral fragments shed in faeces. This alert card may be useful to have within the red book to remind professionals.
References
- Klenske E, Osaba L, Nagore D, Rath T, Neurath MF, Atreya R. Drug Levels in the Maternal Serum, Cord Blood and Breast Milk of a Ustekinumab-Treated Patient with Crohn’s Disease. J Crohns Colitis. 2019;13(2):267-269.
- Saito J, Kaneko K, Kawasaki H, et al. Ustekinumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk, and infant serum. J Pharm Health Care Sci. 2022;8(1):18.
- Bar-Gil Shitrit A, Ben-Horin S, Mishael T, et al. Detection of Ustekinumab in Breast Milk of Nursing Mothers With Crohn Disease. Inflamm Bowel Dis. 2021;27(5):742-745
- https://www.ncbi.nlm.nih.gov/books/NBK500594
- https://e-lactancia.org/breastfeeding/ustekinumab/product/
