Label Changes for:

Myfortic (mycophenolic acid) 180 mg and 360 mg delayed-release tablet

July 2009

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

WARNINGS

Pure Red Cell Aplasia
  • Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (MMF) in combination with other immunosuppressive agents.  MMF is metabolized to mycophenolic acid (MPA), the active ingredient in Myfortic and the active form of the drug...

ADVERSE REACTIONS 

Postmarketing Experience
  • Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents.

MEDICATION GUIDE

What are the possible side effects of Myfortic?

  • Myfortic can cause serious side effects...

What is the most important information I should know about Myfortic?

  • Stomach and intestinal bleeding can happen in people who take Myfortic. Bleeding can be severe and you may have to be hospitalized for treatment...
  • ...Your healthcare provider will do blood tests before you start taking Myfortic and during treatment with Myfortic to check your blood cell counts...
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