Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers
University of Minnesota
Summary
This study aims to evaluate the pharmacokinetic changes during pregnancy, postpartum, and in breast milk in cystic fibrosis patients receiving a cystic fibrosis transmembrane conductance regulator (CTFR) modulator, including Elexacaftor, Tezacaftor, Ivacaftor, or Lumacaftor.
Description
The advent of cystic fibrosis transmembrane conductance regulator (CFTR) therapy has significantly increased the life expectancy for individuals with cystic fibrosis (CF). As a result, adults with CF are more likely to have families than they have in the past. Although the overall pregnancy rate among women with CF age 18-44 is declining (mirroring trends in the general population), the overall number of pregnancies is increasing due to the increasing number of adults with CF. However, little is known about CFTR modulator use in pregnant or breastfeeding mothers, as outlined in a recent revi…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female 18 years of age and older * Female who has a diagnosis of cystic fibrosis * Female who is taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum Exclusion Criteria: * Female \< 18 years of age * Female with cystic fibrosis who is not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum * Participant has contraindication to breastfeeding or not planning to breastfeed
Location
- University of MinnesotaMinneapolis, Minnesota