The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry
collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes,
fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be
solicited at selected gestational time points. Structural and functional birth defects
identified in the perinatal period through one year of life will be collected and classified.
This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk
Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all
mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.