Is Simponi Safe in Breastfeeding

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

Little information is available on the clinical use of Simponi during breastfeeding. Because Simponi is a large protein molecule with a molecular weight of about 150,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, Simponi should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Most experts feel that the drug is probably safe during nursing.[1][2][3][4][5] Simponi 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%.[6][7] 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%.[8] None of the studies measured IgG activity.

In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 1 woman received a Simponi while breastfeeding her infant. Among those who received Simponi 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.[5]