Is Ustekinumab Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Ustekinumab? Is Ustekinumab safe for nursing mother and child? Does Ustekinumab extracts into breast milk? Does Ustekinumab has any long term or short term side effects on infants? Can Ustekinumab influence milk supply or can Ustekinumab decrease milk supply in lactating mothers?

Human-like monoclonal antibody IgG 1 that binds to Interleukins types 12 and 23. Used for treatment of severe Plaque Psoriasis and Psoriatic Arthritis. Still under research for treatment of Crohn's Disease and Multiple Sclerosis. At latest update, relevant published information on excretion into breast milk were not found. Because of a high molecular weight, excretion into breast milk in significant amount is highly unlikely. A low oral bioavailability makes absorption from the breast milk into infant's plasma to be seemingly nil or scanty, except for premature infants and in early post-natal period in which an increased absorption may occur.

Limited published information is available on the clinical use of ustekinumab during breastfeeding. It is usually either not detectable in breastmilk or detectable at very low levels. Absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. If ustekinumab is required by the mother, it is not a reason to discontinue breastfeeding and some experts consider it a good choice in nursing women with psoriasis.[1][2][3] Until more data become available, ustekinumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Ustekinumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[4][5] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[6] None of the studies measured IgG activity.

One woman receiving ustekinumab for severe psoriasis breastfed her infant. No adverse effects were reported in the infant, although the dosage of ustekinumab and the extent of breastfeeding were not reported.[9] In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 6 women received a ustekinumab while breastfeeding their infants. Among those who received ustekinumab or another biologic agent while breastfeeding, infant growth, development or infection rate was no different from infants whose mothers received no treatment. An additional 68 women received a biologic agent plus a thiopurine. Infant outcomes were similar in this group.[7] A woman with treatment-refractory Crohn's disease was treated during pregnancy with ustekinumab until the third trimester. It was reinitiated 7 weeks postpartum with a loading dose of 390 mg intravenously, then 90 mg every 8 weeks. She breastfed her infant (extent and duration not reported). Follow-up of the infant at 12 months of age was normal.[8]