The First Documented Use of Cenobamate During Pregnancy and Lactation
Abstract number :
2.438
Submission category :
4. Clinical Epilepsy / 4E. Women's Issues
Year :
2023
Submission ID :
1325
Source :
www.aesnet.org
Presentation date :
12/3/2023 12:00:00 AM
Published date :
Authors :
Presenting Author: Brian Blankenship, MD – University of Missouri - Columbia
Ashir Mehra, MD – University of Missouri - Columbia; Bryce Hoelscher, MD – University of Missouri - Columbia; Komal Ashraf, MD – University of Missouri - Columbia
Rationale: Cenobamate, approved by the Food and Drug Administration (FDA) for focal onset epilepsy in adults, is highly efficacious. However, all trials of this novel antiepileptic to date excluded pregnant and lactating subjects. We present a 30-year-old female with known medically refractory, intractable focal onset epilepsy who was started on cenobamate and later found to be pregnant.
Methods: Our patient was started on cenobamate and had reached 100mg daily dose (seventh week of titration) when she was confirmed to be seven weeks and five days pregnant. The risks and benefits of continuing cenobamate were discussed and the patient was informed of the lack of data regarding safety/efficacy in the setting of pregnancy/lactation. The patient expressed an adequate understanding of the same and requested to be continued on the medication throughout her pregnancy. Cenobamate was gradually titrated to 200mg daily and 4mg of folic acid was added to her medical regimen. Maternal and fetal monitoring was done via frequent outpatient visits. Biophysical profiles (BPPs) were done weekly and were 8/8 throughout. Estimated fetal weight averaged in the 36th percentile throughout the pregnancy.
Results: During the pregnancy, the patient’s seizure frequency reduced to less than one per week and the duration of her postictal confusion was notably shorter. After delivery, her seizure frequency reduced further to one spell every other month. Six months after delivery, the patient continues to be healthy. The child, now 12 months of age, has been closely followed by a pediatrician and has met all expected developmental milestones.
Conclusions: Our patient had a reduction in her seizure frequency after cenobamate was added to her anti-epileptic regimen. She and her child had an unremarkable pregnancy, delivery, and postpartum period. This data was shared with the North American Anti-Epileptic Drug Pregnancy Registry and should be used to guide further conversations with patients with refractory focal onset epilepsy wanting to become, or found to be, pregnant. Moving forward, a larger study population involving pregnant and nursing humans is needed to definitively establish the risk-to-benefit ratio of cenobamate in the obstetric population.
Funding: None.
Clinical Epilepsy