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)
Patient Reported Outcomes in Renal Transplant Patients Tolerating Gastrointestinal (GI) Symptoms Converted to Myfortic (EC-MPS) [Active, not recruiting]
Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related
gastrointestinal (GI) symptoms are not being spontaneously reported. It is postulated that a
conversion to enteric-coated mycophenolate sodium (EC-MPS.,Myfortic) from MMF will reduce the
objectively measured GI symptom burden and improve GI-related quality of life.
Primary Objective: To determine the incidence of GI-related symptoms and the health related
quality of life of renal transplant patients that are currently tolerating MMF. Assessed by
GSRS and GIQLI.
Secondary Objective: To determine the impact on GI symptoms and the health related quality of
life of renal transplant patients converted from MMF to Myfortic. Assessed by GSRS and
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients [Recruiting]
To compare the safety and efficacy of Prograf« with Myfortic« to Advagraf« extended release
tacrolimus with Myfortic« in de novo liver transplant recipients.
Pharmacokinetic Profile of Myfortic (Enteric Coated Mycophenolate Sodium) in a Rapid Steroid Withdrawal Protocol [Recruiting]
Mycophenolate sodium (Myfortic«) is an antiproliferative immunosuppressant used in
transplantation. It was developed with the intention of improving the gastrointestinal side
effect profile of mycophenolate mofetil (CellCept«). Mycophenolate sodium is formulated as
an enteric coated tablet that releases mycophenolic acid (MPA) which in turn inhibits
inosine monophosphate dehydrogenase (IMPDH).1 Through inhibition of IMPDH the de novo
pathway of purine synthesis, which T and B lymphocytes rely on for proliferation, is
blocked. 1 The pharmacokinetic profile of mycophenolate sodium has mainly been studied in
combination with cyclosporine and steroids. 2 There is little information on the
pharmacokinetics of mycophenolate sodium in combination with tacrolimus3 and currently no
published information in steroid withdrawal. The metabolism and pharmacokinetics of
mycophenolic acid differ when combined with cyclosporine or tacrolimus, leading to increased
area under the curve (AUC) and Cmin with tacrolimus. 4 The decrease in AUC with cyclosporine
is due to an inhibition of MPAG excretion5, thus preventing the enterohepatic recirculation
of MPAG and conversion back to MPA that is seen with tacrolimus. Mycophenolate sodium
pharmacokinetics in the fed state have demonstrated a decrease of 33% in Cmax compared to a
fasting state, as well as a delay in Tmax and lag time. 1 However AUC, representing systemic
exposure to MPA, was not significantly effected by food. 1 The AUC values may vary by 20% or
greater when mycophenolate sodium is administered with food. All current published data on
the pharmacokinetics of MPA have been in patients receiving chronic corticosteroids as part
of their immunosuppression regimen. As immunosuppression minimization, and especially
corticosteroid withdrawal, become more popular it is important to understand how
mycophenolate sodium and its metabolites behave in a 2 drug maintenance immunosuppression
regimen. We propose to study the pharmacokinetic profile of mycophenolate sodium in patients
on tacrolimus dose adjusted based on levels, and a steroid withdrawal protocol.
The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis [Recruiting]
To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as
compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary
outcomes are complete and partial renal remission, as assessed by renal function, urinary
sediment and proteinuria in patients with International Society of Nephrology/ Renal
Pathology Society (ISN/RPS) class III or IV lupus nephritis.
Multicenter, Open-label Study to Assess Whether Treatment With Myfortic´┐Ż(EC-MPS) Allows Higher Dose Optimization Versus Cellcept´┐Ż (MMF) Leading to a Dose Reduction of Tacrolimus [Recruiting]
The objective of the study is to demonstrate that Myfortic« allows higher dose optimization
than MMF leading tacrolimus minimization in maintenance renal transplant patients
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