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Eculizumab Pregnancy and Breastfeeding Warnings

Eculizumab is also known as: Soliris

Eculizumab Pregnancy Warnings

Eculizumab has been assigned to pregnancy category C by the FDA. Animal studies using an analogue of eculizumab have revealed evidence of increased rates of developmental abnormalities and fetal death when administered at higher than normal human doses. There are no controlled data in human pregnancy. Eculizumab is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Eculizumab Breastfeeding Warnings

There are no data on the excretion of eculizumab in human milk. The manufacturer suggests that since other antibodies are excreted into human milk, eculizumab may also be present in breast milk. However, eculizumab is not expected to enter infant circulation in significant amounts. The manufacturer recommends that caution be used when administering eculizumab to nursing women.

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