Label Changes for:

CellCept (mycophenolate mofetil) Capsules, Tablets, Oral Suspension and CellCept (mycophenolate mofetil hydrochloride) for Injection

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 WARNINGS

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.
 
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