CELLCEPT SUMMARY
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.
|
NEWS HIGHLIGHTSMedia Articles Related to Cellcept (Mycophenolate Mofetil)
mycophenolate mofetil-oral, Cellcept
Source: MedicineNet Bullous Pemphigoid Specialty [2005.03.02]
Title: mycophenolate mofetil-oral, Cellcept
Category: Medications
Created: 3/2/2005
Last Editorial Review: 3/2/2005
Independent Study Utilizing Cyclic Levulan PDT Finds 95 Percent Reduction In New Squamous Cell Carcinoma Lesions In Solid Organ Transplant Recipients
Source: Dermatology News From Medical News Today [2009.11.11]
The results of an independent investigator study just published in the online version of Dermatologic Surgery demonstrate that Levulan(®) Photodynamic Therapy (PDT) may reduce the rate of recurrence of squamous cell carcinomas (SCCs) in solid organ transplant recipients (SOTRs), a population with a high incidence of nonmelanoma skin cancer.
Published Studies Related to Cellcept (Mycophenolate Mofetil)
Impact of daclizumab, low-dose cyclosporine, mycophenolate mofetil and steroids on renal function after kidney transplantation. [2009.09.22]
BACKGROUND: Early and long-term use of cyclosporine A (CsA) leads to increased risks of renal toxicity. We hypothesized that administration of daclizumab in combination with mycophenolate mofetil (MMF) allows a relevant reduction in the dose of CsA... CONCLUSION: We demonstrate here that high-dose daclizumab in combination with lower CsA levels in adult renal transplant recipients is as or more effective than standard regimen (CsA, MMF, steroids) and may result in better outcomes at 12 months post-transplant with no increase in adverse reactions.
Effect of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium on maximum tolerated dose and gastrointestinal symptoms following kidney transplantation. [2009.08]
Despite the potential tolerability advantage of enteric-coated mycophenolate sodium (EC-MPS), no prospective, randomized trial has evaluated whether conversion from mycophenolate mofetil (MMF) to EC-MPS permits mycophenolic acid dose to be increased or gastrointestinal side-effects to be ameliorated...
Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network. [2009.07.16]
Acute graft-versus-host disease (aGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation...
Fixed- or controlled-dose mycophenolate mofetil with standard- or reduced-dose calcineurin inhibitors: the opticept trial. [2009.07]
Mycophenolate mofetil (MMF) was developed with cyclosporine as a fixed-dose immunosuppressant. More recent data indicate a relationship between mycophenolic acid (MPA) exposure in individuals and clinical endpoints of rejection and toxicity.Thus, MMF(CC) with low-dose CNI resulted in outcomes not inferior to those with standard CNI exposure and MMF(FD), indicating potential utility of MMF(CC) in CNI-sparing regimens.
Evaluation of mycophenolate mofetil for initial treatment of chronic graft-versus-host disease. [2009.05.21]
We conducted a double-blind, randomized multicenter trial to determine whether the addition of mycophenolate mofetil (MMF) improves the efficacy of initial systemic treatment of chronic graft-versus-host disease (GVHD). The primary endpoint was resolution of chronic GVHD and withdrawal of all systemic treatment within 2 years, without secondary treatment...
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
cystitis.
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
<100 individuals.
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.
|
