Special Alerts:

[Updated 07/01/2008] Novartis informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the mycophenolate sodium (Myfortic) prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with mycophenolate sodium.

[Updated 07/01/2008] Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the mycophenolate mofetil (CellCept) prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with mycophenolate mofetil. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate, http://www.fda.gov/medwatch/safety/2008/Myfortic_DHCP_june2008.pdf, http://rocheusa.com/products/cellcept/CellceptLetterPML_May2008.pdf and http://www.fda.gov/cder/drug/early_comm/mycophenolate.htm.

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

[Posted 05/16/2008] FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. Mycophenolate mofetil, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking mycophenolate mofetil following an organ transplant to prevent organ rejection. However, some mothers taking mycophenolate mofetil were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. mycophenolate mofetil and mycophenolic acid increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy.

FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure. See the FDA Healthcare Professional Information Sheet containing considerations and recommendations for clinicians prior to prescribing mycophenolate mofetil or mycophenolic acid to women of childbearing potential. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#MMF and http://www.fda.gov/cder/drug/InfoSheets/HCP/mycophelolateHCP.htm.

[Posted 04/10/2008] FDA informed healthcare professionals that the Agency is investigating a potential association between the use of mycophenolate mofetil (CellCept) and mycophenolate sodium (Myfortic), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took mycophenolate mofetil or mycophenolate sodium, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information. As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public.

Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate and http://www.fda.gov/cder/drug/early_comm/mycophenolate.htm.