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. 2022 Nov;21(6):1074-1076.
doi: 10.1016/j.jcf.2022.10.004. Epub 2022 Oct 18.

Congenital bilateral cataracts in newborns exposed to elexacaftor-tezacaftor-ivacaftor in utero and while breast feeding

Raksha Jain  1 , Alvit Wolf  2 , Michal Molad  3 , Jennifer Taylor-Cousar  4 , Charles R Esther Jr  5 , Michal Shteinberg  6
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Free article

Congenital bilateral cataracts in newborns exposed to elexacaftor-tezacaftor-ivacaftor in utero and while breast feeding

Raksha Jain et al. J Cyst Fibros. 2022 Nov.
Free article

Abstract

Elexacaftor-tezacaftor-ivacaftor (ETI) is known to pass through the placenta and into breast milk in mothers who continue on this therapy while pregnant and breast feeding. Toxicity studies of ivacaftor in rats demonstrated infant cataracts, but cataracts were not reported in human infants exposed to ivacaftor. We describe 3 cases of infants exposed to elexacaftor-tezacaftor-ivacaftor (ETI) in utero and while breast feeding who were found to have bilateral congenital cataracts within six months of birth. None of the infants had significant visual impairment from the cataracts nor any report of elevated liver function testing. These data highlight the need to counsel females who continue ETI throughout pregnancy and while breast feeding to consider cataract screen for their infants.

Keywords: Breast feeding; Cataract; Elexacaftor-tezacaftor-ivacaftor; Pregnant.

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Conflict of interest statement

Declaration of Competing Interest RJ reports grants from CFF, during the conduct of the study; personal fees from Vertex Innovation Awards committee, outside the submitted work. MM and AW have nothing to disclose. JTC reports grants and personal fees from Vertex, grants and personal fees from 4DMT, personal fees from AbbVie, personal fees from Santhera, personal fees from Polarean, personal fees from Insmed, outside the submitted work; and She serves as a non-voting member of the CFF Board of Trustees, and on the CF Foundation's Clinical Research Executive Committee, Clinical Research Advisory Board, and as Chair Emeritus of the CF TDN's Sexual Health, Reproduction and Gender Research-Working Group, on the ATS Scientific Advisory and Clinical Problems Assembly Programming Committees, and on the Scientific Advisory Board for Emily's Entourage. CRE reports grants from NIH, CFF, during the conduct of the study; .MS reports a grant from the Israeli CF foundation during the conduct of the study; grants, personal fees and non-financial support from GSK, grants and personal fees from Novartis, personal fees from Bohringer- Ingelheim, personal fees from Astra Zeneca, personal fees from Kamada, personal fees from Vertex pharmaceuticals, personal fees from Teva, non-financial support from Actelion, non-financial support from Rafa, personal fees from Zambon, personal fees from Bonus therapeutics, outside the submitted work .

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