Label Changes for:
Myfortic (mycophenolic acid) delayed-release tablets
September 2012
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
September 2012
MEDICATION GUIDE (NEW)
June 2012
BOXED WARNING
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS
- Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning.
