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. 2022 Jul;21(4):725-727.
doi: 10.1016/j.jcf.2021.12.004. Epub 2021 Dec 22.

Drug exposure to infants born to mothers taking Elexacaftor, Tezacaftor, and Ivacaftor

Bethany Collins  1 , Christopher Fortner  2 , Amanda Cotey  3 , Charles R Jr Esther  4 , Aaron Trimble  5
Affiliations

Drug exposure to infants born to mothers taking Elexacaftor, Tezacaftor, and Ivacaftor

Bethany Collins et al. J Cyst Fibros. 2022 Jul.

Abstract

Elexacaftor, tezacaftor, ivacaftor (ETI) have been associated with marked clinical improvements in adults with CF, which appears to be associated with increased fertility. However, maternal and fetal effects of therapy continued during pregnancy are not well understood. We collected maternal blood, infant blood, cord blood, and breast milk from 3 mother-infant pairs from women who elected to remain on ETI therapy while pregnant. Our results demonstrated relatively high levels of ETI in cord blood, suggesting placental transfer of these compounds, as well as low levels of ETI in breast milk and infant blood, suggesting further transfer of these compounds to breast-fed infants in the postnatal period. These data underscore the need for larger studies on the effects of modulator surrounding reproduction.

Keywords: Breast milk; Elexacaftor; Ivacaftor; Pregnancy; Tezacaftor.

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Conflict of interest statement

Declaration of Competing Interest Drs. Trimble and Fortner report the following personal financial relationships with commercial interests relevant to this article within the past 3 years: As faculty in institutions within the CF Therapeutics Development Network, Dr. Trimble and Fortner have been site Principal Investigator on studies for Vertex. Dr. Fortner reports receiving compensation for speaking engagements for Vertex.

Figures

Figure 1.
Figure 1.
Aggregate maternal plasma, infant plasma, and breast milk concentrations of ETI from all 3 subject pairs on logarithmic sale. Samples from the same subject are denoted with connecting lines. Since perinatal samples were obtained from only two subjects, the range of these two values are denoted with error bars.
See this image and copyright information in PMC

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