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Title: Measured fetal and neonatal exposure to Lumacaftor and Ivacaftor during pregnancy and while breastfeeding.

Authors: Trimble, Aaron; McKinzie, Cameron; Terrell, Mary; Stringer, Elizabeth; Esther Jr, Charles R

Published In J Cyst Fibros, (2018 11)

Abstract: With the growing class of CFTR modulator therapy available to more patients and with increasing pregnancies in individuals with CF, there is a growing need to understand the effects of these agents during pregnancy. There are few reports of their continued use in the literature, although it is likely that this is not an uncommon occurrence. We report the uncomplicated and successful pregnancy of a woman treated with lumacaftor/ivacaftor, as well as the clinical course of the infant during the first 9 months of life. We also report drug levels in plasma from the mother, cord blood, breast milk, and infant to estimate fetal and infant drug exposure.

PubMed ID: 29866531 Exiting the NIEHS site

MeSH Terms: Adult; Aminophenols*/administration & dosage; Aminophenols*/blood; Aminophenols*/pharmacokinetics; Aminopyridines*/administration & dosage; Aminopyridines*/blood; Aminopyridines*/pharmacokinetics; Benzodioxoles*/administration & dosage; Benzodioxoles*/blood; Benzodioxoles*/pharmacokinetics; Breast Feeding/methods; Chloride Channel Agonists/administration & dosage; Chloride Channel Agonists/blood; Chloride Channel Agonists/pharmacokinetics; Cystic Fibrosis Transmembrane Conductance Regulator/genetics; Cystic Fibrosis/blood*; Cystic Fibrosis/diagnosis; Cystic Fibrosis/drug therapy; Cystic Fibrosis/genetics; Drug Combinations; Drug Monitoring/methods; Female; Fetal Blood/chemistry; Humans; Infant, Newborn; Liver Function Tests/methods; Milk, Human/chemistry*; Pregnancy; Pregnancy Complications/blood*; Pregnancy Complications/diagnosis; Pregnancy Complications/drug therapy; Pregnancy Complications/genetics; Prenatal Exposure Delayed Effects*/blood; Prenatal Exposure Delayed Effects*/chemically induced; Prenatal Exposure Delayed Effects*/diagnosis; Quinolones*/administration & dosage; Quinolones*/blood; Quinolones*/pharmacokinetics; Treatment Outcome

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