Amenamevir Transfer into Breast Milk in Patients with Herpes Simplex Virus Infection: A Brief Report of a Prospective Multicenter Study
5 affiliations
- 1The Japan Drug Information Institute in Pregnancy, Integrated Center for Women's Health National Center for Child Health and Development Tokyo Japan
- 2Department of Pharmacy National Center for Child Health and Development Tokyo Japan
- 3Aoki Obstetrics and Gynecology Clinic Tokyo Japan
- 4Tokyo Mother's Clinic Tokyo Japan
- 5Medical Affairs Department Maruho Co. Ltd. Osaka Japan
Abstract
Patient–initiated therapy (PIT) is a treatment approach in which patients with recurrent herpes simplex self–administer medication at the onset of prodromal symptoms. PIT, which allows patients to receive medication in advance and initiate treatment at any time, is a therapeutic approach that alleviates the burden of urgent clinic visits for acute diseases like herpes simplex and benefits many people. Furthermore, its utility is particularly high for breastfeeding women for whom clinic visits can sometimes be difficult. When PIT is used in breastfeeding patients, potential drug transfer into breast milk and infant exposure must be considered. However, no studies have evaluated the extent of amenamevir transfer into human breast milk or its safety in infants. In this study, the relative infant dose (RID) was estimated from breast milk concentrations after a single oral dose of amenamevir. In the two cases evaluated, the estimated RID values were below 1%. This preliminary data suggest low estimated transfer of amenamevir into human milk after PIT. However, because breastfeeding was interrupted and infant exposure was not evaluated, clinical safety in breastfed infants remains undetermined.
Trial Registration: Japan Registry of Clinical Trials identifier: jRCTs031230591
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BibTeX
@article{koinuma2026amenamevir,
title = {{Amenamevir Transfer into Breast Milk in Patients with Herpes Simplex Virus Infection: A Brief Report of a Prospective Multicenter Study}},
author = {Sachi Koinuma and Mikako Goto and Jumpei Saito and Hiroaki Aoki and Satoshi Hayashi and Tomoyoshi Takeshita},
journal = {The Journal of Dermatology},
year = {2026},
month = aug,
doi = {10.1111/1346-8138.70474},
url = {https://doi.org/10.1111/1346-8138.70474},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Amenamevir Transfer into Breast Milk in Patients with Herpes Simplex Virus Infection: A Brief Report of a Prospective Multicenter Study
AU - Sachi Koinuma
AU - Mikako Goto
AU - Jumpei Saito
AU - Hiroaki Aoki
AU - Satoshi Hayashi
AU - Tomoyoshi Takeshita
PY - 2026
DA - 2026/08/31
JO - The Journal of Dermatology
DO - 10.1111/1346-8138.70474
UR - https://doi.org/10.1111/1346-8138.70474
AB - Patient–initiated therapy (PIT) is a treatment approach in which patients with recurrent herpes simplex self–administer medication at the onset of prodromal symptoms. PIT, which allows patients to receive medication in advance and initiate treatment at any time, is a therapeutic approach that alleviates the burden of urgent clinic visits for acute diseases like herpes simplex and benefits many people. Furthermore, its utility is particularly high for breastfeeding women for whom clinic visits can sometimes be difficult. When PIT is used in breastfeeding patients, potential drug transfer into breast milk and infant exposure must be considered. However, no studies have evaluated the extent of amenamevir transfer into human breast milk or its safety in infants. In this study, the relative infant dose (RID) was estimated from breast milk concentrations after a single oral dose of amenamevir. In the two cases evaluated, the estimated RID values were below 1%. This preliminary data suggest low estimated transfer of amenamevir into human milk after PIT. However, because breastfeeding was interrupted and infant exposure was not evaluated, clinical safety in breastfed infants remains undetermined. Trial Registration: Japan Registry of Clinical Trials identifier: jRCTs031230591
SN - 0385-2407
SN - 1346-8138
ER -