Soliris Use In Pregnancy & Lactation

The use of adequate contraception to prevent pregnancy and for at least 5 months after the last dose of treatment with eculizumab should be considered for women of childbearing potential.
Pregnancy: There are no well-controlled studies in pregnant women treated with eculizumab. Data on a limited number of pregnancies exposed to eculizumab (less than 300 pregnancy outcomes) indicate there is no increased risk of foetal malformation or foetal-neonatal toxicity. However, due to the lack of well-controlled studies, uncertainties remain. Therefore, an individual risk benefit analysis is recommended before starting and during treatment with eculizumab in pregnant women. Should such a treatment be considered necessary during pregnancy, a close maternal and foetal monitoring according to local guidelines is recommended.
Animal reproduction studies have not been conducted with eculizumab (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Human IgG are known to cross human placental barrier, and thus eculizumab may potentially cause terminal complement inhibition in the foetal circulation. Therefore, SOLIRIS should be given to a pregnant woman only if clearly needed.
Breastfeeding: No effects on the breastfed newborn / infant are anticipated as limited data available suggest that eculizumab is not excreted into human breast milk. However, due to the limitations of the available data, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eculizumab and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition.
Fertility: No specific study of eculizumab on fertility has been conducted.