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Mycophenolate Sodium (mycophenolate + sodium)

Distribution by Scientific Domains

Medical Sciences	100%

Kinds of Mycophenolate Sodium

enteric-coated mycophenolate sodium

Selected Abstracts

Pharmacokinetic and Pharmacodynamic Comparison of Enteric-Coated Mycophenolate Sodium and Mycophenolate Mofetil in Maintenance Renal Transplant Patients

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 4 2007
K. Budde
The aim of this single-center crossover substudy was to assess pharmacokinetics and pharmacodynamics [inosine 5,-monophosphate dehydrogenase (IMPDH) activity] of enteric-coated mycophenolate sodium (EC-MPS) and mycophenolate mofetil (MMF) at steady-state conditions. Stable maintenance renal transplant patients on 1 g MMF b.i.d. participating in a double-blind, multicenter study, were randomized to receive EC-MPS (720 mg b.i.d.) or continue receiving MMF (1000 mg b.i.d.) for 12 months. Thereafter, all patients (n = 18) received 720 mg EC-MPS b.i.d. Area under the plasma mycophenolic acid (MPA) concentration,time curve with EC-MPS (57.4 ± 15.0 ,g h/mL) fulfilled bioequivalence criteria (geometric mean 0.98 (90% CI: 0.87,1.11) compared to MMF (58.4 ± 14.1 ,g h/mL). Consistent with the delayed release characteristics of EC-MPS, peak MPA concentration (geometric mean 0.89; 90% CI: 0.70,1.13) occurred approximately 0.5 h later (p < 0.05) and predose MPA levels (geometric mean 2.10; 90% CI: 1.51,2.91) were higher and more variable, not fulfilling bioequivalence criteria. IMPDH activity inversely followed MPA concentrations and was inhibited to a similar degree (approximately 85%) by both formulations. The calculated value for 50% IMPDH inhibition was identical for both drugs. In conclusion, equimolar doses of EC-MPS and MMF produce equivalent MPA exposure, while the delayed release formulation of EC-MPS exhibits more variable predose levels and Tmax. Overall, IMPDH activity reflected MPA pharmacokinetics. [source]

Efficacy of enteric-coated mycophenolate sodium in patients with active lupus nephritis

NEPHROLOGY, Issue 4 2008
SIU-KA MAK
SUMMARY: Background: The ideal treatment of lupus nephritis has yet to be defined. Both cyclophosphamide and mycophenolate mofetil have been used with encouraging results, but adverse events are frequently seen. There are no data on the use of enteric-coated mycophenolate sodium. Methods: We retrospectively reviewed 12 patients with active forms of lupus nephritis (1 class III, 7 class IV and 4 class V) treated with enteric-coated mycophenolate sodium combined with corticosteroids. Results: The mean age of the patients was 32.3 ± 11.2 years and the average length of follow up was 25.9 ± 8.9 months. The mean serum creatinine clearance was 93 ± 30.1 mL/min per 1.73 m2 and the mean proteinuria level was 4.5 ± 3.6 g/day. All had features that warranted aggressive treatment. Mycophenolate sodium was given for 12.9 ± 9.7 months with an averaged starting dose of 1350 ± 163 mg/day. Six patients attained complete remission and six attained partial remission with treatment. The mean interval to attain first remission (complete or partial) was 8.3 ± 5.7 weeks. At last follow up, all patients were in complete or partial remission. Apart from herpes zoster that developed in one patient, no other significant side-effects were encountered. Conclusion: Enteric-coated mycophenolate sodium was effective and well-tolerated in the treatment of active lupus nephritis. [source]

A case of Cogan,s syndrome resolved with mycophenolate sodium

EUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 8 2008
E. Di Leo
No abstract is available for this article. [source]

Treatment of bullous pemphigoid with enteric-coated mycophenolate sodium

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 4 2007
U Tursen
[source]

Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in liver transplant patients presenting gastrointestinal disorders: A pilot study

LIVER TRANSPLANTATION, Issue 9 2006
Jérôme Dumortier
Gastrointestinal (GI) disorders are one of the main adverse events in patients treated by mycophenolic acid (MPA). The aim of this prospective study was to evaluate the effect of conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) in liver transplant patients presenting GI side-effects Since January 2003, stable liver transplant patients receiving MMF and presenting GI disorders, without evidence of other origin than MMF were enrolled. Conversion was performed without a washout period at an equimolar daily dosage. Thirty-six patients were included after a median delay of 45 months after liver transplantation (LT) (16 women and 20 men, median age of 47 years). Diarrhoea was the main clinical symptom (n = 28, 77.7%). At the time of inclusion, patients were treated with MMF since 18 months (range 3-28) and GI disorders were known for 9 months (range 3-12). After a median follow-up of 12 months after conversion, GI disorders were resolved in 20 patients (55%), improved in 6 patients (17%) and not modified or worsened in 10 patients (28%). Our results strongly suggest that conversion from MMF to EC-MPS in liver transplant patients can improve gastrointestinal disorders in a majority of the patients, and therefore might be considered as the best therapeutic option. Liver Transpl 12:1342-1346, 2006. © 2006 AASLD. [source]

Efficacy of enteric-coated mycophenolate sodium in patients with active lupus nephritis

Efficacy and safety of conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium in Mexican renal transplant children

PEDIATRIC TRANSPLANTATION, Issue 6 2010
H. Reyes
Reyes H, Hernández AM, Valverde S, Cataneo A, Mendoza A, Barrera I, Ortíz L, García-Roca P, Lopéz-Martínez B, Castañeda-Hernández G, Medeiros M. Efficacy and safety of conversion of mycophenolate mofetil to enteric-coated mycophenolate sodium in Mexican renal transplant children. Pediatr Transplantation 2010: 14:746,752. © 2010 John Wiley & Sons A/S. Abstract:, The aim of the study was to evaluate the efficacy and safety of the conversion of MMF to EC-MPS in pediatric renal transplant recipients. We included 12 patients with stable graft function who were receiving MMF treatment. In the first visit, a complete medical examination was performed, which included a GSRS, a nine-point pharmacokinetic profile, samples for renal, liver and hematological tests and evaluation of IMPDH2 gene expression. The patients were transferred to an equimolar dose of EC-MPS. Two wk later, a clinical evaluation and blood collection, as in the first visit were performed. There was no change in serum creatinine, leukocyte count, serum albumin, or transaminase levels, but we found a statistically significant reduction of hemoglobin after conversion (13.2 ± 1.6 g/dL with MMF vs. 12.5 ± 1.3 g/dL when receiving EC-MPS). The GSRS total mean score was 16 ± 12 with MMF vs. 8 ± 5 with EC-MPA (p < 0.05). There was no statistically significant difference between formulations in the gene expression of IMPDH 2, in the AUC0-12h or in Cmax. However, peak concentration occurred later with EC-MPS. [source]

Benefits of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in pediatric renal transplant patients with stable graft function

PEDIATRIC TRANSPLANTATION, Issue 2 2009
Rejane De Paula Meneses
Abstract:, Conversion from MMF to EC-MPS may reduce GI complications and permit increased MPA dosing with a concomitant reduction in CNI dose. In a prospective trial, paediatric renal transplant patients with stable graft function were converted from MMF to EC-MPS and followed-up for 12 months. Data from 28 patients (mean age 13.9 ± 3.1 yr) were available for analysis. Mean EC-MPS dose increased significantly from conversion to month 12 (668 ± 81 mg/m2/day vs. 747 ± 98 mg/m2/day, p < 0.001). CsA-ME dose (n = 23) decreased from 5.3 ± 1.7 mg/kg/day at conversion to 4.6 ± 1.4 mg/kg/day at month 12 (p = 0.010). cGFR increased from 69.5 ± 23.3 mL/min/1.73 m2 at the time of conversion to 80.7 ± 30.7 mL/min/1.73 m2 at month 12 (p = 0.007). The number of patients reporting at least one GI event during six months prior to conversion was 15/28 (53.6%), declining to 8/28 (28.6%) at month 6 post-conversion and 5/28 (17.8%) at month 12. This single-arm study suggests that conversion of paediatric renal transplant patients from MMF to EC-MPS does not compromise efficacy and leads to improved GI tolerability. MPA dose increased and CsA-ME dose decreased significantly, with an associated improvement in calculated GFR. A large-scale controlled trial is required to confirm these promising findings. [source]

Pharmacokinetic and Pharmacodynamic Comparison of Enteric-Coated Mycophenolate Sodium and Mycophenolate Mofetil in Maintenance Renal Transplant Patients

Renal function with delayed or immediate cyclosporine microemulsion in combination with enteric-coated mycophenolate sodium and steroids: results of follow up to 30 months post-transplant

CLINICAL TRANSPLANTATION, Issue 3 2007
Georges Mourad
Abstract:, Background:, In the multicenter, open-label Myriade study, renal transplant patients were randomized to early cyclosporine microemulsion (CsA-ME, day 0) or delayed CsA-ME (day 6) with enteric-coated mycophenolate sodium (EC-MPS), steroids and interleukin-2 receptor induction. One-yr results have been published previously. We now report the results of an extension study in which patients were followed up for a period of three yr post-transplant. Methods:, All patients completing the one-yr core study on-treatment were eligible to enter the extension study. Results:, Of the 203 patients, 153 completed the core trial on-treatment; 144 (94%) entered the extension study with a minimum follow-up of one yr (73 early CsA-ME, 71 delayed CsA-ME). In 75% of patients receiving EC-MPS during the extension, the recommended dose was administered (1440 mg/d). Median creatinine clearance remained constant (57 mL/min) at 12, 24 and 30 months post-transplant and was similar in the early and delayed CsA-ME groups as well as in subpopulations with or without delayed graft function. One patient in the early CsA-ME group died. No grafts were lost. The incidence of BPAR from time of transplant to the end of the extension study was 17% (24/139). Seven patients (5%) discontinued the extension study prematurely because of adverse events. Conclusion:, These results suggest that a regimen of CsA-ME, EC-MPS and steroids results in excellent survival rates with stable renal function over a mean follow-up of 30 months. Immediate introduction of CsA-ME has no deleterious effect on long-term renal function, even among patients with delayed graft function. [source]

Pharmacokinetics of enteric-coated mycophenolate sodium in stable liver transplant recipients

CLINICAL TRANSPLANTATION, Issue 3 2007
Theodore W. Perry
Abstract:, Introduction:, Mycophenolate mofetil (MMF) is one of the major immunosuppressive agents used in liver transplantation recipients. In an attempt to mitigate one of the most common side effects of MMF (gastrointestinal symptoms), enteric-coated mycophenolate sodium (EC-MPS) was developed. In this study, we report the pharmacokinetic profile of EC-MPS in stable liver transplantation recipients administered a single 720 mg dose. Methods:, Liver transplantation recipients more than one yr after transplantation were administered a single dose of 720 mg EC-MPS after which blood levels of MPA were measured at frequent intervals using a specific and validated LC-MS/MS assay. Results:, The characteristics of the 21 patients studied were: mean age was 55.9 yr, 13 were female, eight had hepatitis C, and 14 were on tacrolimus. The mean apparent half-life of MPA was 5.3 ± 4.3 h, (1.0,15.7). Mean tmax was 2.4 ± 1.1 h (1.0,5.0). The mean area-under-curve was 45.3 ± 23.1 ,g-h/mL (17.3,90.0). Trough level concentrations (C12 h) showed large inter-individual variability (0,9.2 ,g/mL). There was no difference in any of the pharmacokinetic parameters relative to: gender, HCV, administration of tacrolimus vs. cyclosporine or type of biliary anastomosis. Conclusions:, There is a wide variation in pharmacokinetic parameters in stable, long-term liver transplantation recipients receiving a single dose of EC-MPS. These data suggest that therapeutic drug monitoring with EC-MPS may have limited utility in liver transplantation recipients. [source]