Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project
Introduction: Quantitative information on disposition of maternal medicines in human milk remains a major knowledge gap. This case report presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertens...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-06-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.881084/full |
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| author | Nina Nauwelaerts Michael Ceulemans Michael Ceulemans Michael Ceulemans Neel Deferm An Eerdekens Bart Lammens Yeghig Armoudjian Kristel Van Calsteren Kristel Van Calsteren Karel Allegaert Karel Allegaert Karel Allegaert Karel Allegaert Loes de Vries Pieter Annaert Pieter Annaert Anne Smits Anne Smits Anne Smits |
| author_facet | Nina Nauwelaerts Michael Ceulemans Michael Ceulemans Michael Ceulemans Neel Deferm An Eerdekens Bart Lammens Yeghig Armoudjian Kristel Van Calsteren Kristel Van Calsteren Karel Allegaert Karel Allegaert Karel Allegaert Karel Allegaert Loes de Vries Pieter Annaert Pieter Annaert Anne Smits Anne Smits Anne Smits |
| author_sort | Nina Nauwelaerts |
| collection | DOAJ |
| description | Introduction: Quantitative information on disposition of maternal medicines in human milk remains a major knowledge gap. This case report presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertension (PAH) during lactation.Case presentation: A 43-year old mother was treated with sildenafil (20 mg, 3x/day) and bosentan (125 mg, 2x/day) for PAH. Her 21-months old infant received breastfeeding in combination with adequate complementary foods. Milk samples were collected over 24 h, at day 637 and 651 after delivery. The observed average steady-state concentrations of sildenafil (2.84 μg/L) and bosentan (49.0 μg/L) in human milk were low. The Daily Infant Dosage ingested by the nursing infant through human milk was 0.02 μg/kg/day for sildenafil and 0.29 μg/kg/day for bosentan at day 637, and 0.03 μg/kg/day and 0.60 μg/kg/day at day 651. The Relative Infant Dose calculated for an exclusively breastfed infant with an estimated milk intake of 150 ml/kg/day, was 0.06% for sildenafil and 0.24% for bosentan. General health outcome of the infant, reported by the mother, was uneventful until the sampling days.Conclusion: Low medicine concentrations were found in human milk expressed 21 months after delivery after maternal intake of 20 mg sildenafil three times daily and 125 mg bosentan twice daily. General health of the nursing infant until sampling was reported as optimal by the mother. |
| first_indexed | 2024-04-12T14:07:41Z |
| format | Article |
| id | doaj.art-7f67a12edf6c4b4ab5cd7e6f95c87085 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T14:07:41Z |
| publishDate | 2022-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-7f67a12edf6c4b4ab5cd7e6f95c870852022-12-22T03:30:01ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-06-011310.3389/fphar.2022.881084881084Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION ProjectNina Nauwelaerts0Michael Ceulemans1Michael Ceulemans2Michael Ceulemans3Neel Deferm4An Eerdekens5Bart Lammens6Yeghig Armoudjian7Kristel Van Calsteren8Kristel Van Calsteren9Karel Allegaert10Karel Allegaert11Karel Allegaert12Karel Allegaert13Loes de Vries14Pieter Annaert15Pieter Annaert16Anne Smits17Anne Smits18Anne Smits19Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumL-C&Y, KU Leuven Child & Youth Institute, Leuven, BelgiumTeratology Information Service, Netherlands Pharmacovigilance Centre Lareb, ‘s Hertogenbosch, NetherlandsDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumNeonatal Intensive Care Unit, University Hospitals Leuven, Leuven, BelgiumBioNotus GCV, Niel, BelgiumBioNotus GCV, Niel, BelgiumGynaecology and Obstetrics, UZ Leuven, Leuven, BelgiumDepartment of Development and Regeneration, KU Leuven, Leuven, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumL-C&Y, KU Leuven Child & Youth Institute, Leuven, BelgiumDepartment of Development and Regeneration, KU Leuven, Leuven, BelgiumDepartment of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, NetherlandsTeratology Information Service, Netherlands Pharmacovigilance Centre Lareb, ‘s Hertogenbosch, NetherlandsDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumBioNotus GCV, Niel, BelgiumL-C&Y, KU Leuven Child & Youth Institute, Leuven, BelgiumNeonatal Intensive Care Unit, University Hospitals Leuven, Leuven, BelgiumDepartment of Development and Regeneration, KU Leuven, Leuven, BelgiumIntroduction: Quantitative information on disposition of maternal medicines in human milk remains a major knowledge gap. This case report presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertension (PAH) during lactation.Case presentation: A 43-year old mother was treated with sildenafil (20 mg, 3x/day) and bosentan (125 mg, 2x/day) for PAH. Her 21-months old infant received breastfeeding in combination with adequate complementary foods. Milk samples were collected over 24 h, at day 637 and 651 after delivery. The observed average steady-state concentrations of sildenafil (2.84 μg/L) and bosentan (49.0 μg/L) in human milk were low. The Daily Infant Dosage ingested by the nursing infant through human milk was 0.02 μg/kg/day for sildenafil and 0.29 μg/kg/day for bosentan at day 637, and 0.03 μg/kg/day and 0.60 μg/kg/day at day 651. The Relative Infant Dose calculated for an exclusively breastfed infant with an estimated milk intake of 150 ml/kg/day, was 0.06% for sildenafil and 0.24% for bosentan. General health outcome of the infant, reported by the mother, was uneventful until the sampling days.Conclusion: Low medicine concentrations were found in human milk expressed 21 months after delivery after maternal intake of 20 mg sildenafil three times daily and 125 mg bosentan twice daily. General health of the nursing infant until sampling was reported as optimal by the mother.https://www.frontiersin.org/articles/10.3389/fphar.2022.881084/fullcase reportsildenafilbosentanpulmonary arterial hypertensionpharmacokineticslactation |
| spellingShingle | Nina Nauwelaerts Michael Ceulemans Michael Ceulemans Michael Ceulemans Neel Deferm An Eerdekens Bart Lammens Yeghig Armoudjian Kristel Van Calsteren Kristel Van Calsteren Karel Allegaert Karel Allegaert Karel Allegaert Karel Allegaert Loes de Vries Pieter Annaert Pieter Annaert Anne Smits Anne Smits Anne Smits Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project Frontiers in Pharmacology case report sildenafil bosentan pulmonary arterial hypertension pharmacokinetics lactation |
| title | Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project |
| title_full | Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project |
| title_fullStr | Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project |
| title_full_unstemmed | Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project |
| title_short | Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project |
| title_sort | case report bosentan and sildenafil exposure in human milk a contribution from the conception project |
| topic | case report sildenafil bosentan pulmonary arterial hypertension pharmacokinetics lactation |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.881084/full |
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