Soliris is classified as FDA Pregnancy Category C, which means that the risk to the fetus cannot be ruled out. Women who are pregnant or planning to become pregnant should discuss the potential risks and benefits of Soliris with their healthcare provider. Soliris may cross the placenta and affect the developing fetus. It is not known whether Soliris is excreted in human milk, and breastfeeding while using Soliris is not recommended.