دورية أكاديمية
Very low monomethyl fumarate exposure via human milk: a case report-a contribution from the ConcePTION project.
| العنوان: | Very low monomethyl fumarate exposure via human milk: a case report-a contribution from the ConcePTION project. |
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| المؤلفون: | Van Neste M; Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.; Child & Youth Institute, KU Leuven, Leuven, Belgium., Nauwelaerts N; Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium., Ceulemans M; Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.; Child & Youth Institute, KU Leuven, Leuven, Belgium.; Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands., Cuppers B; Teratology Information Service, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands., Annaert P; Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.; BioNotus GCV, Niel, Belgium., Smits A; Child & Youth Institute, KU Leuven, Leuven, Belgium.; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.; Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium., Allegaert K; Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.; Child & Youth Institute, KU Leuven, Leuven, Belgium.; Department of Development and Regeneration, KU Leuven, Leuven, Belgium.; Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, Netherlands. |
| المصدر: | Frontiers in public health [Front Public Health] 2024 Jul 02; Vol. 12, pp. 1393752. Date of Electronic Publication: 2024 Jul 02 (Print Publication: 2024). |
| نوع المنشور: | Case Reports; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Frontiers Editorial Office Country of Publication: Switzerland NLM ID: 101616579 Publication Model: eCollection Cited Medium: Internet ISSN: 2296-2565 (Electronic) Linking ISSN: 22962565 NLM ISO Abbreviation: Front Public Health Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Lausanne : Frontiers Editorial Office |
| مواضيع طبية MeSH: | Milk, Human*/chemistry , Fumarates*, Humans ; Female ; Adult ; Breast Feeding ; Infant, Newborn ; Multiple Sclerosis/drug therapy ; Immunosuppressive Agents ; Infant ; Maleates |
| مستخلص: | Introduction: While breastfeeding is recommended, knowledge regarding medicine transfer to human milk and its safety for nursing infants is limited. Only one paper has previously described dimethyl fumarate (DMF) transfer during breastfeeding in two patients at 5 and 6 months postpartum, respectively. The current case report describes maternal pharmacokinetic data of monomethyl fumarate (MMF), the active metabolite of DMF, and infant exposure estimations of MMF at 3 months postpartum. Methods: A 32-year-old Caucasian woman started DMF therapy (120 mg, 2x/day) for multiple sclerosis at 3 months postpartum, after weaning her infant from breastfeeding. On day 99 after birth, the patient collected four milk samples over 24 h after 6 days of treatment at the initial dose. Additionally, a single maternal blood sample was collected to calculate the milk-to-plasma (M/P) ratio. The samples were analyzed using liquid chromatography coupled with the mass spectrometry method. Results: A wide range of measured steady-state concentrations of MMF (5.5-83.5 ng/mL) was observed in human milk samples. Estimated daily infant dosage values for MMF, calculated with 150 and 200 mL/kg/day human milk intake, were 5.76 and 7.68 μg/kg/day, and the relative infant doses were 0.16 and 0.22%. The observed mean M/P ratio was 0.059, similar to the M/P ratio predicted using the empirical Koshimichi model (0.06). Discussion: Combining this case report with the two previously described cases, the estimated infant exposure is low, albeit with relevant intra- and inter-patient variabilities. Research should further focus on infant exposure and safety. Competing Interests: PA is co-owner of the company BioNotus GCV. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Several authors declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision. (Copyright © 2024 Van Neste, Nauwelaerts, Ceulemans, Cuppers, Annaert, Smits and Allegaert.) |
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| فهرسة مساهمة: | Keywords: breastfeeding; case report; dimethyl fumarate; human milk; lactation; monomethyl fumarate; multiple sclerosis; pharmacokinetics |
| المشرفين على المادة: | 0 (Fumarates) 0RQ6CXO9KD (citraconic acid) 0 (Immunosuppressive Agents) 0 (Maleates) |
| تواريخ الأحداث: | Date Created: 20240717 Date Completed: 20240717 Latest Revision: 20240718 |
| رمز التحديث: | 20240718 |
| مُعرف محوري في PubMed: | PMC11250615 |
| DOI: | 10.3389/fpubh.2024.1393752 |
| PMID: | 39015385 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2296-2565 |
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| DOI: | 10.3389/fpubh.2024.1393752 |