Производитель «Модены» сообщил о рисках врожденных дефектов у детей
Компания АО «Фармсинтез» информирует об особенностях применения препарата «Модена» (МНН — финголимод) у беременных женщин. Письмо об этом опубликовано на сайте Росздравнадзора 11 октября.
«Модена» является иммунодепрессивным средством, которое назначается пациентам с ремиттирующим рассеянным склерозом (РРС) для уменьшения частоты клинических обострений болезни и снижения риска прогрессирования нетрудоспособности.
Пострегистрационные исследования применения этого ЛС показали высокий риск врождённых дефектов у детей, если их матери принимали финголимод во время беременности. Наиболее часто встречавшимися врождёнными аномалиями у детей, подвергшихся воздействию препарата, были пороки сердца (дефект межпредсердной или межжелудочковой перегородки, тетрада Фалло), почек, костей и мышц.
Производитель обращает внимание на то, что перед началом лечения препаратом потенциальной пациентке обязательно необходимо провести тест на беременность. Женщины с сохранённым репродуктивным потенциалом должны быть проинформированы о потенциальном риске для плода и о необходимости применять эффективную контрацепцию в течение всего периода лечения, а также в течение трёх месяцев после его окончания. Это обусловлено длительным периодом выведения финголимода и сохраняющимся риском для плода.
В случае, если во время терапии наступила беременность, необходимо отменить приём препарата и обеспечить дальнейший тщательный контроль за течением наступившей во время терапии препаратом беременности со стороны медицинских специалистов. Грудное вскармливание во время терапии финголимодом также запрещено.
Ранее компания ОАО «Гедеон Рихтер» сообщила об изменении срока годности гипотензивного средства «Эквапресс».
12 октября 2022
Фото: © Raliada / Фотобанк Фотодженика
Выпуск: №226, октябрь 2022855 просмотров
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