Infants exposed to certolizumab pegol in breast milk had a safety profile consistent with non-certolizumab pegol-exposed infants of similar age. Using this highly sensitive assay, certolizumab pegol was undetectable in 56% of milk samples collected. When detected, certolizumab pegol concentrations were less than three times the lower limit of quantification, which was <1% of the expected plasma concentration of a therapeutic dose. This finding indicates that there is no or minimal certolizumab pegol transfer from plasma to breast milk. The relative infant dose was below 0.5% of the maternal dose—<10% is considered unlikely to be of clinical concern. These findings indicate that continuing certolizumab pegol treatment is compatible with breastfeeding.
No serious adverse drug events occurred in the infants and mothers during the study.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
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