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New Guidelines Issued for Severe Lupus
Posted 3 May 2012 by Drugs.com
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: Lisinopril, Prednisone, Diovan, Benicar, Systemic Lupus Erythematosus, Losartan, Prednisolone, Plaquenil, Methylprednisolone, Micardis, Cozaar, Hydrocortisone, Cortisone, Medrol, CellCept
Newer Drug Seems Better at Controlling Lupus Kidney Complication
Posted 16 Nov 2011 by Drugs.com
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: 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, Gengraf, Rapamune
FDA Medwatch Alert: CellCept (mycophenolate mofetil)
Posted 12 Feb 2009 by Drugs.com
[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 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
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
FDA Medwatch Alert: CellCept (mycophenolate mofetil)
Posted 29 Oct 2007 by Drugs.com
[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)
Posted 22 Feb 2007 by Drugs.com
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
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Related Condition Support Groups
Organ Transplant -- Rejection Prophylaxis, Nephrotic Syndrome, Inflammatory Bowel Disease