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Myfortic News

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by Drugs.com

THURSDAY, Nov. 12, 2015 – Kidney failure and having a kidney transplant may increase the risk for certain types of cancer, a new study suggests. Poor kidney function and immune system-suppressing drugs may be behind this increased risk, according to Elizabeth Yanik, of the U.S. National Cancer Institute, and colleagues. For the study, published in the Nov. 12 online edition of the Journal of the American Society of Nephrology, the researchers looked at data from more than 200,000 U.S. kidney transplant candidates and recipients. Along with finding that these patients are at increased risk for certain types of cancer, the investigators also identified clear patterns of risk associated with different types of treatment. However, the associations seen in the study do not prove cause-and-effect. The risk of kidney and thyroid cancers was especially high when kidney failure patients were on ... Read more

Related support groups: Cancer, Methotrexate, Renal Failure, CellCept, Gilenya, Tysabri, Imuran, Xolair, Orencia, Chronic Kidney Disease, Revlimid, Leflunomide, Arava, Azathioprine, Afinitor, Tecfidera, Mycophenolate Mofetil, Peritoneal dialysis, Aubagio, Benlysta

Kidney Transplant Rejection Drugs Tied to Pregnancy Risks in Study

Posted 23 Oct 2013 by Drugs.com

WEDNESDAY, Oct. 23 – Drugs meant to reduce the risk of organ rejection may increase the risk of miscarriage and birth defects when taken by female kidney transplant patients, according to a new study. The drugs – called mycophenolic acid products – reduce the risk of organ rejection by suppressing the immune system. The study included 163 female transplant patients who discontinued mycophenolic acid products prior to conception and 114 who conceived while taking the anti-rejection drugs. Those who stopped taking mycophenolic acid products before they became pregnant had more live births (79 percent vs. 43 percent), fewer miscarriages (19 percent vs. 52 percent) and a lower rate of birth defects (6 percent vs. 14 percent) than those who were taking the drugs when they conceived. Women who stopped the anti-rejection drugs before they became pregnant did not have an increased risk of ... Read more

Related support groups: CellCept, Mycophenolate Mofetil, Organ Transplant - Rejection Prophylaxis, Myfortic, Rejection Prophylaxis, Mycophenolic Acid

FDA Medwatch Alert: Myfortic (mycophenolic acid)

Posted 24 Mar 2009 by Drugs.com

[UPDATE 03/24/2009] FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle. Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.[Posted 02/12/2009] FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic ... Read more

Related support groups: Myfortic

FDA Medwatch Alert: Myfortic (mycophenolate acid)

Posted 1 Jul 2008 by Drugs.com

[UPDATE 07/01/2008] Novartis informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the Myfortic prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic.[UPDATE 06/26/2008] Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept. Read more

Related support groups: Myfortic

FDA Medwatch Alert: Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)

Posted 16 May 2008 by Drugs.com

[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. MMF, 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 MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF 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. MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during ... Read more

Related support groups: CellCept, Myfortic

FDA Medwatch Alert: Myfortic (mycophenolic acid) Delayed Release Tablets

Posted 27 Nov 2007 by Drugs.com

[Posted 11/27/2007] Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration.A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as ... Read more

Related support groups: Myfortic

FDA Medwatch Alert: Immunosuppressant Drugs: Required Labeling Changes

Posted 14 Jul 2009 by Drugs.com

Sirolimus (marketed as Rapamune), Cyclosporine (marketed as Sandimmune and generics), Cyclosporine modified (marketed as Neoral and generics), Mycophenolate mofetil (marketed as Cellcept and generics), Mycophenolic acid (marketed as Myfortic)   The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in ... Read more

Related support groups: CellCept, Myfortic, Rapamune, Gengraf

FDA Medwatch Alert: CellCept (mycophenolate mofetil), Myfortic (mycophenolate acid)

Posted 10 Apr 2008 by Drugs.com

[Posted 04/10/2008] FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and 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 CellCept or Myfortic, 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 ... Read more

Related support groups: CellCept, Myfortic

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Further Information

Related Condition Support Groups

Dermatomyositis, Rejection Prophylaxis

Myfortic Patient Information at Drugs.com