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CellCept News

Kidney Woes Tied to Raised Cancer Risk, Study Finds

Posted 12 Nov 2015 by

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, Gilenya, Tysabri, CellCept, Imuran, Xolair, Chronic Kidney Disease, Orencia, Revlimid, Arava, Leflunomide, Tecfidera, Azathioprine, Afinitor, Peritoneal dialysis, Entyvio, Aubagio, Mycophenolate Mofetil

Drug Combo Helps Lupus-Related Kidney Condition

Posted 10 Nov 2014 by

MONDAY, Nov. 10, 2014 – A combination of drugs may offer a better way to combat a serious kidney complication that commonly affects people with lupus, a new study from China suggests. In a trial of more than 300 Chinese patients with the condition, known as lupus nephritis, those who were given a trio of powerful drugs were more likely to see a complete remission. After six months, 46 percent were in full remission, versus 26 percent of patients given an intravenous drug called cyclophosphamide. "These are important results," said Dr. David Wofsy, a rheumatologist at the University of California, San Francisco, who was not involved in the study. But there are some big questions that still need to be answered, he added. One is whether lupus patients of other races and ethnicities would get the same benefits as these Chinese patients. The genetics of lupus vary, Wofsy explained, and ... Read more

Related support groups: CellCept, Lupus Erythematosus, Mycophenolate Mofetil, Cytoxan, Cyclophosphamide, Neosar, Cytoxan Lyophilized

Kidney Transplant Rejection Drugs Tied to Pregnancy Risks in Study

Posted 23 Oct 2013 by

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, Organ Transplant - Rejection Prophylaxis, Mycophenolate Mofetil, Myfortic, Mycophenolic Acid, Rejection Prophylaxis

New Guidelines Issued for Severe Lupus

Posted 3 May 2012 by

THURSDAY, May 3 – When diagnosed with lupus, one in three people already has kidney inflammation, and during the first 10 years with the disease as many as 60 percent of patients will have some kidney problems. Because kidney inflammation (also called lupus nephritis) is so common in people with lupus, the American College of Rheumatology has issued new guidelines for the screening and management of this potentially devastating complication of lupus. "Without treatment, lupus nephritis can lead to end-stage-renal disease, which requires dialysis or a kidney transplant. But, not all types are this serious. It depends on the pattern of damage to the kidneys," said the lead author of the new guidelines, Dr. Bevra Hahn, a professor of medicine and chief of rheumatology at the David Geffen School of Medicine at the University of California, Los Angeles. Hahn said the course of lupus ... Read more

Related support groups: Prednisone, Lisinopril, Losartan, Systemic Lupus Erythematosus, Methylprednisolone, Benicar, Diovan, Prednisolone, Plaquenil, Hydrocortisone, Ramipril, Medrol, Cortisone, Dexamethasone, Triamcinolone, Hydroxychloroquine, Valsartan, Enalapril, Betamethasone, Cozaar

Newer Drug Seems Better at Controlling Lupus Kidney Complication

Posted 16 Nov 2011 by

WEDNESDAY, Nov. 16 – A newer immune-suppressing drug called mycophenolate mofetil (CellCept) is better at controlling a serious kidney complication from lupus than another commonly used therapy, a new study suggests. People taking mycophenolate were about half as likely to progress to treatment failure as were people taking azathioprine (Imuran), according to the researchers. "This study was looking at maintenance therapy for people with lupus nephritis. Was the older drug azathioprine similar or better to the newer drug mycophenolate mofetil [MMF]? We found that MMF was better overwhelmingly," said study author Dr. Mary Anne Dooley, an associate professor of medicine at the University of North Carolina at Chapel Hill. "There were fewer flares of recurrent nephritis in the group receiving MMF, and more people on MMF went into complete remission. All of the parameters we looked at were ... Read more

Related support groups: Systemic Lupus Erythematosus, CellCept, Imuran, Azathioprine, Mycophenolate Mofetil, Azasan

FDA Medwatch Alert: CellCept (mycophenolate mofetil) - Feb 12, 2009

Posted 12 Feb 2009 by

[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 by Novartis.[January 2009 - Dear Healthcare Provider Letter - Roche][January 2009 - Dear Pharmacist Letter - Roche] Read more

Related support groups: CellCept

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

Posted 16 May 2008 by

[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: CellCept (mycophenolate mofetil) - Oct 29, 2007

Posted 29 Oct 2007 by

[Posted 10/29/2007] Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Labeling changes include the following sections: BOXED WARNING, WARNINGS/Pregnancy and Pregnancy Exposure Prevention, PRECAUTIONS/Information for Patients, and ... Read more

Related support groups: CellCept

FDA Medwatch Alert: CellCept (mycophenolate mofetil) - Feb 22, 2007

Posted 22 Feb 2007 by

Indication: Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants [Posted 02/22/2007] Roche and FDA notified cardiac transplant healthcare practitioners about a clinical study (Heart Spare The Nephron) that was terminated due to an observed increased incidence of grade IIIA acute rejection in heart transplant patients switched from calcineurin inhibitor and CellCept to Rapamune (sirolimus) and CellCept at 12 weeks post heart transplantation. The safety and efficacy of CellCept in combination with sirolimus following withdrawal of initial calcineurin inhibitor therapy has not been established. [February 2007 – Letter – Roche] Read more

Related support groups: CellCept

FDA Medwatch Alert: Immunosuppressant Drugs: Required Labeling Changes

Posted 14 Jul 2009 by

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

[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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Nephrotic Syndrome, Organ Transplant - Rejection Prophylaxis

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