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Measured Fetal and Neonatal Exposure to Lumacaftor and Ivacaftor During Pregnancy and While Breastfeeding

Overview
Journal J Cyst Fibros
Publisher Elsevier
Specialty Pulmonary Medicine
Date 2018 Jun 6
PMID 29866531
Citations 24
Authors
Aaron Trimble
Cameron McKinzie
Mary Terrell
Elizabeth Stringer
Charles R Esther Jr
Affiliations
Soon will be listed here.
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.

Citing Articles

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Development and clinical implementation of an LC-HRMS method for ivacaftor, lumacaftor, tezacaftor and elexacaftor in human plasma and breast milk.

Hansson A, Wadstrom H, Eliasson E, Al Shakirchi M, de Monestrol I, Barclay V Anal Bioanal Chem. 2024; 416(26):5565-5577.

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Maternal, newborn and breast milk concentrations of elexacaftor/tezacaftor/ivacaftor in a F508del heterozygous woman with cystic fibrosis following successful pregnancy.

Ripani P, Mucci M, Pantano S, Di Sabatino M, Collini F, Ferri G Front Med (Lausanne). 2023; 10:1274303.

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Jain R, Kazmerski T, Taylor-Cousar J Curr Opin Pulm Med. 2023; 29(6):595-602.

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References
1.
Wainwright C, Elborn J, Ramsey B, Marigowda G, Huang X, Cipolli M . Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015; 373(3):220-31. PMC: 4764353. DOI: 10.1056/NEJMoa1409547. View
2.
McKone E, Borowitz D, Drevinek P, Griese M, Konstan M, Wainwright C . Long-term safety and efficacy of ivacaftor in patients with cystic fibrosis who have the Gly551Asp-CFTR mutation: a phase 3, open-label extension study (PERSIST). Lancet Respir Med. 2014; 2(11):902-910. DOI: 10.1016/S2213-2600(14)70218-8. View
3.
Taylor-Cousar J, Munck A, McKone E, van der Ent C, Moeller A, Simard C . Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del. N Engl J Med. 2017; 377(21):2013-2023. DOI: 10.1056/NEJMoa1709846. View
4.
Kroon M, Akkerman-Nijland A, Rottier B, Koppelman G, Akkerman O, Touw D . Drugs during pregnancy and breast feeding in women diagnosed with Cystic Fibrosis - An update. J Cyst Fibros. 2017; 17(1):17-25. DOI: 10.1016/j.jcf.2017.11.009. View
5.
Ramsey B, Davies J, McElvaney N, Tullis E, Bell S, Drevinek P . A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011; 365(18):1663-72. PMC: 3230303. DOI: 10.1056/NEJMoa1105185. View