For Referrers: October 2013 REMS Letter Mycophenolates

Dear Ms. Patient,

As a recipient of a transplant, you are taking immunosuppressive medications to prevent rejection of your kidney/liver. As you know, these medications have a number of potential side effects. We have recently been notified by the Food and Drug Administration (FDA) of one particular potential side effect of any form of mycophenolic acid (MPA, CellCept®, Myfortic®) that is important to women who can become pregnant. The FDA has established that MPA can potentially cause birth defects and fetal loss in pregnant mothers who are taking MPA during their pregnancy. This notice is only intended for women who could become pregnant.

What you need to do:

You should inform your transplant physician or transplant nurse coordinator if you are planning to become pregnant and discuss the potential risks of using MPA. You should do this before you become pregnant. If you wish to become pregnant, we can consider a change in your immunosuppressive regimen to decrease these risks.

Even if you are not planning a pregnancy, but potentially could become pregnant (are of childbearing potential), the FDA recommends you use two forms of contraception if you are taking MPA. If you choose not to use contraception, you should discuss taking an alternative to MPA with a member of the transplant team.

If you would like to have additional information, we will be happy to provide you with a booklet endorsed by the FDA. You may also find additional information at the FDA website https://www.MycophenolateREMS.com or call 1-800-617-8191. You may also call your transplant nurse cordinator. If you want to speak to a transplant physician about any of these issues, including planning a pregnancy, you should call your coordinator to make an appointment to be seen in the transplant clinic.

Sincerely,

University of Iowa Organ Transplant Center