Безопасно. Совместимый. Минимальный риск для грудного вскармливания и ребёнка.
IgG1 моноклонально-антитело против альфа-фактора некроза опухоли (TNFα), который используется для лечения аутоиммунных заболеваний, таких как болезнь Крона, язвенной колит, ревматоидный артрит, анкилозирующий спондилит, псориатический артрит и псориаз. Внутривенное введение, начальная доза, 2 и 6 недель и каждые 8 недель
Его фармакокинетические данные (очень высокая молекулярная масса и высокое связывание с плазменными белками) объясняют экскрецию в грудном молоке в неопределяемом количестве (Mahadevan 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009) или клинически незначительный . (Matro 2018, Glosen 2014, Fritzsche 2012, Ben-horn 2011)
Уровни младенцев в плазме, которые лечат матерями, которые получали инфликсимаб, стали неопределимыми или очень низкими . >
ни короткие, ни долгосрочные неблагоприятные воздействия на развитие, иммунологический ответ и/или скорость инфекции, ни измененный ответ на вакцинацию младенцев, чьи матери принимали инфликсимаб, были обнаружены . (Махадеван 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009, Tursi 2010, Puig 2010, Correia 2010, Fritzsche 2012, Steenholdt 2012)
Поскольку ему не хватает пероральной биодоступности, кажется затруднительным, любой проход к плазме младенца посредством проглатываемого грудного молока (Amin 2018, BAE 2012) , за исключением преждевременных детей и немедленного периода неоната, в котором может быть повышенной проницаемостью кишечника.
Многочисленные эксперты и научные общества ревматологии, гастроэнтерологии и дерматологии считают, что это препарат с очень низким риском, и, следовательно, совместимый во время кормления грудью. 2018, Amin 2018, Briggs 2017, Nguyen 2016, Flint 2016, Gotestam 2016, Van der Houde 2015, Nielsen 2014, Hyrich 2014, Mahadevan 2011)
Некоторые агентства рекомендуют против введения живых вакцин для младенцев, в то время как мать получает инфликсимаб, если только уровень инфксусного в сыворотке для младенца не обнаруживается.
| Наименование | Значение | Ед.изм. |
|---|---|---|
| T½ | 192 - 228 | час |
| БПП | ≈ 0 | % |
| Молекулярная масса | 144.190 | Да |
| Относительная доза | 0 | % |
| ПТД | 0 | % |
| Связывание с белками | 97 | % |
| Соотношение М/П | 0.003 | - |
| Теоретическая доза | 0 | мг/кг/сут |
См. ниже информацию об этих сопутствующих препаратах:
Материнский ревматоидный артрит (РА) ◐ Умеренный риск
Материнское воспалительное заболевание кишечника (ВЗК) ◐ Умеренный риск
Альтернатив: не найдено
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