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

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

doi:10.1016/j.jcf.2018.05.009

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

J Cyst Fibros. 2018 Nov;17(6):779-782. doi: 10.1016/j.jcf.2018.05.009. Epub 2018 Jun 1.

Authors

Aaron Trimble¹, Cameron McKinzie², Mary Terrell³, Elizabeth Stringer⁴, Charles R Esther Jr³

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, The University of North Carolina at Chapel Hill, 4 th Floor Bioinformatics, CB 7020, Chapel Hill, NC, 27516, United States. Electronic address: [email protected].
² Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, 301 Pharmacy Lane, CB 7355, Chapel Hill, NC 27599, United States.
³ Division of Pediatric Pulmonology, The University of North Carolina at Chapel Hill, 450 MacNider CB 7217, Chapel Hill, NC 27599, United States.
⁴ Department of Obstetrics & Gynecology, The University of North Carolina at Chapel Hill, 3009 Old Clinic Building, CB 7570, Chapel Hill, NC 27599, United States.

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.

Keywords: CFTR modulators; Ivacaftor; Lumacaftor; Pregnancy.

Publication types

Case Reports
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

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 / blood*
Cystic Fibrosis / diagnosis
Cystic Fibrosis / drug therapy
Cystic Fibrosis / genetics
Cystic Fibrosis Transmembrane Conductance Regulator / 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

Substances

Aminophenols
Aminopyridines
Benzodioxoles
Chloride Channel Agonists
Drug Combinations
Quinolones
lumacaftor, ivacaftor drug combination
Cystic Fibrosis Transmembrane Conductance Regulator

Abstract

Publication types

MeSH terms

Substances

Grants and funding