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Aims: Information on breastfeeding and safety of biologics in infants is lacking due to difficulties in case collection. We evaluated methods for determining the concentration of biologics in breast milk using a dry filter method that can simplify the collection, storage and transport of breast milk. Methods: To generate dried filter paper (DFP) samples, approximately 30 μL of breast milk was placed onto a Whatman 903 card and punched out. After extraction, the supernatant was measured using an enzyme‐linked immunosorbent assay. Three concentrations of each drug were prepared in liquid breast milk (LBM) and DFP samples to determine their stability up to 28 days after storage at 2–8°C or −20°C for LBM and 25 ± 5°C for DFP. LBM and DFP samples were also provided by nursing mothers using biologics during lactation, and drug concentrations in both samples were compared. The agreement between the two measurement methods was confirmed by Bland–Altman analysis. Results: Breast milk was provided by 12 mothers who used biologics (tocilizumab, abatacept, etanercept, golimumab, sarilumab and belimumab). The coefficients of variation for within‐run and between‐run precision for the six drugs were within 15% for both LBM and DFP, and accuracy was within 90%–110% of the quality controls. After 28 days, concentrations remained at more than 90%. The difference between the values obtained by each method was within the acceptable range of error (−12.1 to +16.6 ng/mL). Conclusions: A method for determining the concentration of biologics using DFP is expected to help improve pharmacotherapy for lactating women. [ABSTRACT FROM AUTHOR]

Introduction: Remdesivir was originally developed to treat Ebola hemorrhagic fever, and its efficacy in treating coronavirus disease 2019 was detected during a preliminary analysis of a randomized controlled trial. It is known that Severe Acute Respiratory Syndrome Coronavirus 2 is not transmitted through human milk, but data about the presence of remdesivir in human milk have been lacking. Main issue: In this case study, we determined the human milk-to-serum drug concentration ratio and the relative dose of Remdesivir in one participant. Management: The participant, a 28-year-old primipara, was found to have Coronavirus 2 infection in 2019, 2 days after delivery. She was given Remdesivir. The Remdesivir concentration in maternal serum and human milk was measured, and the milk-to-serum drug concentration ratio was found to be low (0.089), as was the relative infant dose (0.0070). The participant could not breastfeed her infant during her Coronavirus 2 infection treatment because in Japan anyone with COVID-19 was completely quarantined. However, she was able to resume breastfeeding after discharge and breastfed her infant for 6 months with supplements. Conclusion: Given the low amount of Remdesivir in the participant's milk, the inclusion of antibodies to Severe Acute Respiratory Syndrome Coronavirus 2, which can be expected to protect the infant from infection, and various other benefits of human milk, suggests that breastfeeding is safe during treatment with Remdesivir. [ABSTRACT FROM AUTHOR]

The demand for tocilizumab is increasing in women who wish to bear children and who have active rheumatoid arthritis. Described here is a woman with rheumatoid arthritis who discontinued her tocilizumab therapy at the end of the first trimester and resumed it after delivery and where tocilizumab levels in maternal serum, infant serum, and the breast milk were measured. Tocilizumab was not detected in maternal serum just before delivery, or in umbilical cord blood or infant serum after birth. Tocilizumab levels in colostrum after intravenous injection were 0.57% of those in serum. Tocilizumab treatment in the first trimester was not associated with a significant drug level in the fetus at delivery and no fetal complications were noted. [ABSTRACT FROM AUTHOR]

The article discusses a study that measured abatacept concentrations in the breast milk of a 41-year-old nursing mother with rheumatoid arthritis and examined the safety of her breastfed infant. Highlights include the approval of the study by the ethics committee of the National Center for Child Health and Development, her treatment with tocilizumab and certolizumab pegol before switching to abatacept treatment, and the infant Apgar scores at one and five minutes.

The article discusses research which investigated safety of tocilizumab use during pregnancy and lactation. Topics explored include the intravenous tocilizumab dosage administered to a pregnant woman with adult-onset Still's disease (AOSD), measurement of tocilizumab concentrations in maternal serum, cord blood, and breast milk, and the health condition of the infant following exposure to tocilizumab.