Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Female users of childbearing potential must use contraception. Use of CellCept during pregnancy is associated with increased risk of pregnancy loss and congenital malformations.
CellCept (mycophenolate mofetil) is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Renal, Cardiac, and Hepatic Transplant: CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication.
Published Studies Related to Cellcept (Mycophenolate Mofetil)
Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium. [2011.08.27]
BACKGROUND: In renal transplant (RT) recipients, treatment with enteric-coated mycophenolate sodium (EC-MPS) improves gastrointestinal (GI) tolerability compared with mycophenolate mofetil (MMF). The impact of conversion from MMF to EC-MPS on patient's health-related quality of life (HRQoL) using GI-specific instruments has been scarcely evaluated in randomized trials... CONCLUSIONS: In RT patients with GI undesirable effects due to MMF, switching from MMF to EC-MPS may enable an increase in the maximum tolerated dose of mycophenolic acid and reduce GI complications, thus enhancing patients' GI HRQoL.
Relationship of tacrolimus exposure and mycophenolate mofetil dose with renal function after renal transplantation. [2011.07.15]
INTRODUCTION: The most common immunosuppressive treatment in de novo renal transplantation is a triple regimen that includes tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, and that may also include antibody induction. Whether nephrotoxicity is an issue with tacrolimus at the currently used dosages remains an open question... CONCLUSION: Tacrolimus seems to have a moderate but consistent nephrotoxic effect even in modern efficient immunosuppressive regimens where it is used at lower doses than in previous years.
Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplantation with tacrolimus and steroid avoidance: four-year analysis. [2011.06.15]
BACKGROUND: Our single-center, open-labeled randomized trial of 150 adult, primary kidney transplant recipients receiving 2 g mycophenolate mofetil (group A, n=75) versus 1.440 g enteric-coated mycophenolate sodium (group B, n=75), with reduced maintenance tacrolimus dosing, steroid elimination at 1 week, and combined rabbit antithymocyte globulin/daclizumab induction, previously showed at 1 year posttransplant low biopsy-proven acute rejection (BPAR), acceptably high renal function, and no differences in incidence of symptomatic gastrointestinal (GI) side effects between the two groups. This report includes 3 additional years of follow-up with similar endpoints as in the original study... CONCLUSIONS: This is the first long-term, randomized trial comparing enteric-coated mycophenolate sodium versus mycophenolate mofetil along with reduced maintenance tacrolimus dosing and steroid avoidance, which resulted in similarly low-BPAR rates, acceptably high renal function at 48 months, and an equivalent side effect profile.
Reduced-dose tacrolimus with mycophenolate mofetil vs. standard-dose tacrolimus in liver transplantation: a randomized study. [2011.05]
We conducted a multicenter randomized study in liver transplantation to compare standard-dose tacrolimus to reduced-dose tacrolimus with mycophenolate mofetil to reduce the occurrence of tacrolimus side effects. Two primary outcomes (censored criteria) were monitored during 48 weeks post-transplantation: occurrence of renal dysfunction or arterial hypertension or diabetes (evaluating benefit) and occurrence of acute graft rejection (evaluating risk)...
Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial. [2011.04]
As part of the Spare-the-Nephron trial, we evaluated the combination mycophenolate mofetil (MMF) and sirolimus (SRL) as a calcineurin inhibitor (CNI)-free regimen for the preservation of renal function in renal allograft recipients. This 2-year, open-label, multicenter trial randomized 299 patients of which 151 were maintained on MMF and a CNI, 148 on MMF plus SRL (n=120, tacrolimus; n=31, cyclosporine)...
Clinical Trials Related to Cellcept (Mycophenolate Mofetil)
A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . . [Terminated]
The purpose of this study is to investigate the safety and effectiveness of a medication
called CellCept in treating refractory (has not responded to other treatments) interstitial
CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants
work in the body by reducing the immune system's ability to produce certain reactions that
can cause inflammation. In some people, the inflammation produced by their immune system can
damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the
U. S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant.
When used in combination with other drugs, CellCept helps to prevent the rejection of the
transplanted organ and is used widely in patients who have received kidney, liver and heart
transplants. CellCept is also frequently used but not FDA approved for the treatment of
severe rheumatoid arthritis which is a disease caused when the body's immune system acts
against healthy tissues in the joints.
Due to its special activity, CellCept may be useful in treating certain inflammatory diseases
or conditions like interstitial cystitis.
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS. [Terminated]
This study will assess the safety, efficacy and effect on quality of life of switching kidney
transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a
higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS
(<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the
CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4
doses. The anticipated time on study treatment is <3 months, and the target sample size is
Myfortic vs. Cellcept in Kidney Transplant Recipients [Completed]
The comparison the incidence of G. I. toxicity between Myfortic® vs. Cellcept® in 150
sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first
and second living or deceased donor renal transplant recipients.
Study of Therapeutic Monitoring of CellCept (Mycophenolate Mofetil) After Kidney Transplantation [Completed]
This 3 arm study will evaluate the efficacy and safety of various dosing regimens of CellCept
combined with various dosing regimens of cyclosporine or tacrolimus in kidney transplantation
patients. Patients will be randomized to one of 3 dosing regimens to receive
concentration-controlled CellCept with reduced cyclosporine or tacrolimus,
concentration-controlled CellCept with standard cyclosporine or tacrolimus, or fixed-dose
CellCept (1g bid) with standard cyclosporine or tacrolimus. The anticipated time on study
treatment is 1-2 years, and the target sample size is 500+ individuals.
A Study of CellCept (Mycophenolate Mofetil) in Management of Patients With Lupus Nephritis. [Active, not recruiting]
This 2 arm study will assess the efficacy of CellCept compared to cyclophosphamide in
inducing a response in patients with lupus nephritis, and the long term efficacy of CellCept
compared to azathioprine in maintaining remission and renal function. Patients will be
randomized to receive either CellCept (1. 5g bid) or cyclophosphamide (0. 5-1. 0g/m2 in monthly
pulses) in the induction phase. Those patients meeting criteria for response will be
re-randomized for entry into the maintenance phase, to receive either CellCept (1g bid) or
azathioprine (2mg/kg/day). The anticipated time on study treatment is 2+ years, and the
target sample size is 100-500 individuals.
Reports of Suspected Cellcept (Mycophenolate Mofetil) Side Effects
Kidney Transplant Rejection (23),
Transplant Rejection (20),
Urinary Tract Infection (13),
Cytomegalovirus Infection (12), more >>
Page last updated: 2011-12-09