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.
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If you are a woman of child-bearing potential, you will be required to use two forms of
birth control to
Although mycophenolate mofetil can cause harm to an unborn baby, not treating the mother after a transplant could pose a greater risk to the mother's health. Mycophenolate mofetil is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.
Using mycophenolate mofetil can make it easier for you to bleed from an injury or get sick from being around others who are ill. You may also have an increased risk of cancer. Your blood will need to be tested on a weekly or monthly basis while using this medication. Do not miss any scheduled appointments.
Do not open the mycophenolate mofetil capsule or crush or chew a tablet. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin.Mycophenolate mofetil lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
Mycophenolate mofetil is used to prevent your body from rejecting a kidney, liver, or heart transplant. This medication is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication.
Mycophenolate mofetil may also be used for other purposes not listed in this medication guide.
Before using mycophenolate mofetil, tell your doctor if you are allergic to any drugs, or if you have:
a stomach ulcer or other disorders of your stomach or intestines;
a viral, bacterial, or fungal infection; or
a rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.
FDA pregnancy category D. This medication can cause harm to an unborn baby, especially if used during the first trimester of pregnancy.If you are a woman of child-bearing potential, you will be required to receive contraceptive counseling and to start using two forms of birth control 4 weeks before the start of your treatment with mycophenolate mofetil. You will also need to have a negative pregnancy test within 1 week before your treatment begins.
Unless you have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. Adolescent girls who have entered puberty are also considered to be of child-bearing potential, even if not yet sexually active.
Use twoAlthough mycophenolate mofetil can cause harm to an unborn baby, not treating the mother with this medication after a transplant could pose a greater risk to the mother's health. Mycophenolate mofetil is sometimes given to pregnant women who are unable to take other needed transplant medications. Your doctor will decide whether you should receive this medication.
Your name may need to be listed on a national transplant pregnancy registry if you use mycophenolate mofetil during pregnancy. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether mycophenolate mofetil had any effect on the baby.
It is not known whether mycophenolate mofetil passes into breast milk or if it could harm a nursing baby. Do not use mycophenolate mofetil without telling your doctor if you are breast-feeding a baby.The oral liquid form of this medication may contain phenylalanine. Talk to your doctor before using this form of mycophenolate mofetil if you have phenylketonuria (PKU).
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