Mental status changes during elexacaftor/tezacaftor / ivacaftor therapy

Authors

Suyeon Heo, Chicago State University College of Pharmacy, 9501 S. King Drive Douglas Hall 206, Chicago, IL 60628, United States. Electronic address: sheo@csu.edu.
David C. Young, University of Utah, Department of Pharmacotherapy, Salt Lake City, UT, 30 South 2000 East Room 4916, Salt Lake City, UT 84112, United States. Electronic address: david.young@hsc.utah.edu.
Julie Safirstein, Hospital of the University of Pennsylvania, Department of Pharmacy, Philadelphia, PA, 3400 Civic Center Boulevard, Philadelphia, PA 19104, United States. Electronic address: julie.safirstein@pennmedicine.upenn.edu.
Brian Bourque, Dartmouth-Hitchcock, Dartmouth-Hitchcock Specialty Pharmacy, Lebanon, NH, 1 Medical Center Drive, Lebanon, NH 03766, United States. Electronic address: Brian.Bourque@hitchcock.org.
Martine H. Antell, University of Vermont, Department of Pharmacy, Burlington, VT, 111 Colchester Ave, Burlington, VT 05401, United States. Electronic address: Martine.Antell@uvmhealth.org.
Stefanie Diloreto, Maine Medical Center, Department of Pharmacy, Portland, ME, 22 Bramhall St., Portland, ME 04102, United States. Electronic address: sdiloreto@mmc.org.
Shannon M. Rotolo, University of Chicago Medicine, Department of Pharmacy, Chicago, IL, 5841 S Maryland Avenue, MC0010, Chicago, IL 60637, United States. Electronic address: shannon.rotolo@uchospitals.edu.

Document Type

Article

Publication Date

3-1-2022

Journal Title

Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society

Abstract

Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA, Trikafta) is the newest Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator drug approved by the Food and Drug Administration. Post-marketing reports with earlier CFTR modulators suggest these medications can impact mood, and in clinical trials an adverse effect of headache was reported with all currently approved CFTR modulators. However, there are no other documented reports of mental status changes during clinical trials or in post-marketing reports with elexacaftor/tezacaftor/ivacaftor. In this case series, we describe 6 patients who reported "mental fogginess" or other mental status changes shortly after initiation of this drug. The mechanism of this patient-reported side effect is still unclear. All patients noticed a change within the first 3 months of therapy. The management differed in each case, with all four cystic fibrosis (CF) care teams utilizing a patient-centered decision-making approach to address this concern.

First Page

339

Last Page

343

Recommended Citation

Heo S, Young DC, Safirstein J, et al. Mental status changes during elexacaftor/tezacaftor / ivacaftor therapy. J Cyst Fibros. 2022;21(2):339-343. doi:10.1016/j.jcf.2021.10.002