WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)].
Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.4)].
Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.5, 5.6)].
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Myfortic. Patients receiving Myfortic 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 [see Warnings and Precautions (5.3)].
Myfortic® (mycophenolic acid) delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Myfortic is an immunosuppressive agent.
Myfortic® (mycophenolic acid) delayed-release tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.
Published Studies Related to Myfortic (Mycophenolic Acid)
Mycophenolic acid-related diarrhea is not associated with polymorphisms in SLCO1B nor with ABCB1 in renal transplant recipients. [2011.08.29]
OBJECTIVE: We investigated the association between genetic polymorphisms in ABCB1 and SLCO1B and mycophenolic acid (MPA) pharmacokinetics, and MPA-related diarrhea and leukopenia in 338 kidney transplant recipients... CONCLUSION: Genotyping for ABCB1 or SLCO1B pretransplantation is unlikely to be of clinical value for individualization of MPA therapy.
How delayed graft function impacts exposure to mycophenolic acid in patients after renal transplantation. [2011.04]
INTRODUCTION: Mycophenolic acid (MPA) plasma concentrations are highly variable on standard-dose mycophenolate mofetil therapy. At creatinine clearances below 25 mL/min, MPA clearance increases as a result of a higher nonprotein-bound fraction. Patients with delayed graft function (DGF) after renal transplantation are exposed to low total MPA concentrations, when risk of rejection is highest. This study investigated the influence of DGF on MPA exposure and on clinical outcome... CONCLUSION: Patients with DGF have significantly lower dose-corrected MPA AUC in the first month after renal transplantation, presumably as a result of enhanced MPA clearance on account of the elevated MPA free fraction. Because patients with DGF have a higher rate of acute rejection and lower MPA exposure, higher dosing of mycophenolate mofetil in such patients may improve outcome. However, the already increased incidence of opportunistic infections in patients with DGF is a concern.
Population pharmacokinetics of mycophenolic acid in pediatric renal transplant patients using parametric and nonparametric approaches. [2011.03]
Mycophenolic acid (MPA) is an immunosuppressive drug widely used in the prevention of acute rejection in pediatric renal transplant recipients and is characterized by a wide inter-individual variability in its pharmacokinetics. The aim of this study was to compare population pharmacokinetic modeling of MPA in pediatric renal transplant recipients given mycophenolate mofetil, the ester prodrug of MPA, using parametric and nonparametric population methods...
Pharmacokinetics of sotrastaurin combined with tacrolimus or mycophenolic acid in de novo kidney transplant recipients. [2011.02.15]
BACKGROUND: Sotrastaurin is a protein kinase C inhibitor in the development for prevention of organ rejection after renal transplantation... CONCLUSIONS: Sotrastaurin pharmacokinetics were similar when combined with reduced-exposure or standard-exposure tacrolimus or with MPA. Tacrolimus exposure was significantly increased by sotrastaurin in the initial weeks posttransplant by a pharmacokinetic interaction.
The role of proton pump inhibitors on early mycophenolic acid exposure in kidney transplantation: evidence from the CLEAR study. [2011.02]
CONCLUSION: PPI therapy in combination with mycophenolate mofetil does not appear to have a significant impact on full MPA exposure. Because MPA pharmacokinetics were not significantly impacted when a 3-g, 5-day loading dose of mycophenolate mofetil was used in combination with PPI therapy, this strategy may be required for adequate MPA exposure whether or not a patient receives PPI comedication.
Clinical Trials Related to Myfortic (Mycophenolic Acid)
Myfortic in High MELD Liver Transplantation [Completed]
The objective of the study is to determine the efficacy and safety of Everolimus conversion
in liver transplantation. Most large US liver centers transplant patients with high Model
for End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant
trials in the US do not include patients with high MELD scores making it difficult to
extrapolate these trial data to the patients cared for at larger liver transplant centers.
The greatest potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the
avoidance of the side-effects of calcineurin-inhibitors, namely, renal insufficiency,
diabetes and hypertension. Therefore, this protocol is designed to study the efficacy and
safety of everolimus and Myfortic in liver transplant patients with high MELD scores at two
large centers with a vast experience in the administration of mTOR inhibitors.
Study of Gastrointestinal Side Effects in African American Kidney Transplant Recipients Treated With CellCept or Myfortic [Terminated]
Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness
to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients.
However, Myfortic has been thought to possibly be associated with fewer gastrointestinal
side effects. CellCept and Myfortic pharmacokinetics (how the drug is absorbed and broken
down) have not been well-studied in African American kidney transplant recipients. The
investigators are interested in studying Myfortic and CellCept pharmacokinetics and
gastrointestinal side effects in African American kidney transplant recipients.
Influence of Pantoprazole to the Bioavailability of Myfortic® and CellCept® [Recruiting]
The object of this pharmakokinetic study is to analyze wether pantoprazole as a proton pump
inhibitor influences the bioavailability of two different tablet formulations of
mycophenolic acid applied either as mycophenolate mofetil or mycophenolate Sodium.
Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis [Completed]
We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus
arthritis. In this study, patients with lupus will be randomly assigned to receive
mycophenolate mofetil or placebo (inert pills) for three months. At the end of three months
all patients will receive mycophenolate mofetil for three additional months. The
effectiveness on arthritis and other symptoms of lupus will be measured by joint counts and
by the BILAG instrument (a measure of overall lupus disease activity. Additionally special
blood tests aimed at understanding the biologic effects of mycophenolate mofetil will also
be performed at some visits. The primary outcome measurement will be the safety and
effectiveness of this treatment (as compared to placebo) at the three month point. The trial
will continue in a blinded fashion (neither the investigator or the participants know who is
getting mycophenolate and who is getting placebo) until 24 patients have completed the first
three months of the protocol.
Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients [Terminated]
The purpose of the study is to further investigate how much of the drug substance
"mycophenolate mofetil" can be found in the blood of patients with kidney or renal
transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side
effects of the two products will be compared. All information already available on these
products indicates that the safety profiles of the two products will be the same.
Reports of Suspected Myfortic (Mycophenolic Acid) Side Effects
Kidney Transplant Rejection (56),
Blood Creatinine Increased (40),
Renal Failure (28),
Renal Failure Acute (24),
Urinary Tract Infection (22), more >>
Page last updated: 2011-12-09