Is Cyltezo (Adalimumab-adbm) Safe in Breastfeeding

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

IgG1-monoclonal antibody directed against tumor necrosis factor used for treatment of auto-immune diseases like Rheumatoid Arthritis. Minimal or low excretion into breast milk due to high molecular weight. In breastfed babies whose mothers were on this medication plasma levels were undetectable and failed to show side effects. It should be avoid in the first two post-partum weeks since pass of significant amounts of IgG to the milk can occur in the first 3 - 4 post-partum days.

Limited information indicates that maternal Cyltezo (Adalimumab-adbm) injections produce low levels in breastmilk and do not adversely affect the nursing infant. Because Cyltezo (Adalimumab-adbm) is a large protein molecule with a molecular weight of about 148,000, absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Most experts feel that the drug is probably safe during nursing.[1][2][3][4][5][6][7][8] However, until more data become available, Cyltezo (Adalimumab-adbm) should be used with caution while nursing a newborn or preterm infant.

One woman with Crohn's disease received Cyltezo (Adalimumab-adbm) 40 mg subcutaneously every week during pregnancy and breastfeeding (extent not stated). Her infant demonstrated normal growth and development at 6 months of age.[12] The authors reported a brief follow-up stating that the woman also breastfed her second infant during Cyltezo (Adalimumab-adbm) therapy with no adverse consequences.[13] Another woman with Crohn's disease received Cyltezo (Adalimumab-adbm) 40 mg subcutaneously every 2 weeks during pregnancy and breastfeeding (extent not stated). Her infant demonstrated normal growth and development at 6 months of age.[14] Two women nursed their infants (extent not stated) while receiving Cyltezo (Adalimumab-adbm) 40 mg subcutaneously at unstated intervals for inflammatory bowel disease. They breastfed for at least 21 weeks and 8 weeks, respectively, but the total duration was not stated. At 14.5 and 15 months of age, respectively, neither infant had any signs of adverse drug reactions, allergic reactions or severe infections leading to hospitalization. Developmental milestones were reached on time by both infants.[10] A pregnant woman received Cyltezo (Adalimumab-adbm) 40 mg every 2 weeks for Crohn's disease until week 16 of pregnancy. Her infant was exclusively breastfed until 4 months of age and the drug was reinstituted on day 24 postpartum. At 7 months of age, the infant was healthy with normal growth and development. The infant had no infections requiring antibiotics or hospitalization.[11] A case-control study of women with chronic arthritic conditions found 2 women who received Cyltezo (Adalimumab-adbm) during pregnancy and lactation (extent not stated). No differences were observed in the 2 infants' growth parameters, developmental milestones, vaccinations and diseases in the first year of life compared to those not exposed to the drugs with lactation.[15] A woman receiving Cyltezo (Adalimumab-adbm) for severe psoriasis breastfed 2 infants following 2 pregnancies. No adverse effects were reported in the infant, although the dosage of Cyltezo (Adalimumab-adbm) and the extent of breastfeeding were not reported.[16] In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 99 women received Cyltezo (Adalimumab-adbm) while breastfeeding their infants. Among those who received Cyltezo (Adalimumab-adbm) 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.[8]