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Multicenter Study
. 2025 Aug:169:110440.
doi: 10.1016/j.yebeh.2025.110440. Epub 2025 May 2.

Cenobamate and pregnancy: A-single level 4 epilepsy center experience

Anthony D Jimenez  1 , Isabel Toghramadjian  2 , Chinenye M Okafor  3 , Aurelie Hanin  4 , Xin Zhou  5 , Maria Kristina C Dorotan  1 , Poojith Nuthalapati  1 , Sagune Sakya  6 , Lawrence J Hirsch  1 , Hamada H Altalib  7 , Aaron Lazorwitz  8 , Aline Herlopian  9
Affiliations
Multicenter Study

Cenobamate and pregnancy: A-single level 4 epilepsy center experience

Anthony D Jimenez et al. Epilepsy Behav. 2025 Aug.

Abstract

Objective: Data on Cenobamate (CNB) use in females of childbearing age with epilepsy (FCAWE) and during pregnancy is limited. We report four patients who became pregnant on CNB and its pharmacokinetic profile during pregnancy.

Methods: Single-center retrospective chart review of FCAWE receiving CNB between 2020 and 2024. Data on contraceptive use, pregnancy outcomes, and medication levels were analyzed.

Results: 147 out of 215 adult female patients received CNB were FCAWE. Thirty-three patients had documented use of contraceptive methods. Four unintended pregnancies occurred. Contraceptive methods included condoms (n = 1), hormonal contraceptive (n = 2), and no contraception (n = 1). One had a live early-term birth, two had elective terminations due to medical comorbidities, and one had spontaneous miscarriage. The child born had no reported congenital malformations or developmental delays up to 5 months of age. One patient had ASM levels measured throughout pregnancy and post-partum period, displaying a trend towards decreased concentration-to-dose ratio (CDR) during pregnancy compared to baseline and similar levels in the one-month post-partum period.

Discussion: While our report remains anecdotal and preliminary given the very small sample size, we underscore the importance of pre-conceptual counseling in FCAWE to prevent unintended pregnancies and undesired outcomes, particularly when using ASM with limited data regarding teratogenicity. We also shed light on drug level monitoring during pregnancy.

Keywords: Cenobamate; Contraception; Epilepsy; Pregnancy; Serum levels; Unintended.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ADJ, IT, AHa, XZ, CMO, PN, SS have no conflicts of interest to declare. A.L. Chief Medical Advisor for Dama Health, scientific advisory board member for 3Daughters. A.H. consultancy fees from Medtronic and UCB. Royalties from Springer Nature publisher for authoring “Epilepsy Surgery: A Practical Case-based Approach” textbook and Natus for speaking and training sessions. LJH: Consultation fees for advising from Accure, Ceribell, Gilead, Marinus, Natus, Neurelis, Neuropace, Rapport Therapeutics, and UCB; Royalties from Wolters-Kluwer for authoring chapters for UpToDate-Neurology, and from Wiley for co-authoring the book “Atlas of EEG in Critical Care”, 1(st) and 2(nd) editions; and honoraria for speaking or training sessions from Neuropace, Natus, and UCB. HA: No conflict of interest. Research funding from UCB, National Institute for Mental Health, Department of Defense's Congressionally Directed Medical Research Programs Epilepsy Research Program.

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