Safety Alerts & Recalls

What does this mean?

Myfortic is used to prevent organ transplant rejection. For most patients, the benefits of Myfortic will outweigh the possible risk of Pure Red Cell Aplasia. Symptoms of Pure Red Cell Aplasia include fatigue, lethargy, tiredness, and/or abnormal paleness of the skin. If you are taking Myfortic, you can watch for these symptoms and contact your doctor immediately if they occur.

If you have any questions or concerns about Myfortic or this alert, please follow up with your doctor.

Safety Information Added to the Myfortic Prescribing Information

Novartis notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (MMF) in combination with other immunosuppressive agents. In the body, MMF is converted to mycophenolic acid (MPA), the active ingredient in Myfortic.

Pure Red Cell Aplasia is a type of anemia where the bone marrow slows or stops production of red blood cells. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2009-09-04
Last Updated: 2009-12-05

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