38
Views
3
CrossRef citations to date
0
Altmetric
Drug Profile

Enteric-coated mycophenolate sodium - current and future use in transplant patients

Pages 203-211 | Published online: 10 Jan 2014

References

  • Allison AC, Eugui EM. Purine metabolism and immunosuppressive effects of mycophenolate mofetil (MMF). Clin. Transplant. 10, 77–84 (1996).
  • Barten MJ, Gummert JF, van Gelder T, Shorthouse R, Morris RE. Flow cytometric quantitation of calcium-dependent and -independent mitogen-stimulation of T-cell functions in whole blood: inhibition by immunosuppressive drugs in vitro. J. Immunol. Methods 253, 95–112 (2001).
  • Barten MJ, van Gelder T, Gummert JF, Shorthouse R, Morris RE. Novel assays of multiple lymphocyte functions in whole blood measure: new mechanisms of action of mycophenolate mofetil in vivo. Transpl. Immunol. 10, 1–14 (2002).
  • Budde K, Glander P, Diekmann F et al. Review of the immunosuppressant enteric-coated mycophenolate sodium. Expert Opin. Pharmacother. 5, 1333–1345 (2004).
  • Shaw LM, Holt DW, Oellerich M, Meiser B, van Gelder T. Current issues in therapeutic drug monitoring of mycophenolic acid: report of a roundtable discussion. Ther. Drug Monit. 23, 305–315 (2001).
  • Tedesco-Silva H, Bastien M-C, Choi L et al. Mycophenolic acid metabolite profile in renal transplant patients receiving enteric-coated mycophenolate sodium or mycophenolate mofetil. Transplant Proc. 37, 852–855 (2005).
  • Shipkova M, Armstrong VW, Wieland E et al. Identification of glucoside and carboxyl-linked glucuronide conjugates of mycophenolic acid in plasma of transplant recipients treated with mycophenolate mofetil. Br. J. Pharmacol. 126, 1075–1082 (1999).
  • Bailey MJ, Dickinson RG. Acyl glucuronide reactivity in perspective: biological consequences. Chem. Biol. Interact. 145, 117–137 (2003).
  • Bullingham R, Monroe S, Nicholls A, Hale M. Pharmacokinetics and bioavailability of mycophenolate mofetil in healthy subjects after single-dose oral and intravenous administration. J. Clin. Pharmacol. 36, 315–324 (1996).
  • European MycophenolateMofetil Co-operative Study Group. Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. Lancet 345, 1321–1325 (1995).
  • Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. US Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 60, 225–232 (1995).
  • The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. Transplantation 61, 1029–1037 (1996).
  • Meier-Kriesche HU, Ojo AO, Leichtman AB et al. Effect of mycophenolate mofetil on long-term outcomes in African American renal transplant recipients. J. Am. Soc. Nephrol. 11, 2366–2370 (2000).
  • Ojo AO, Meier-Kriesche HU, Hanson JA et al. Mycophenolate mofetil reduces late renal allograft loss independent of acute rejection. Transplantation 69, 2405–2409 (2000).
  • Meier-Kriesche HU, Steffen BJ, Hochberg AM et al. Mycophenolate mofetil versus azathioprine therapy is associated with a significant protection against long-term renal allograft function deterioration. Transplantation 75, 1341–1346 (2003).
  • Hale MD, Nicholls AJ, Bullingham RE et al. The pharmacokinetic– pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin. Pharmacol. Ther. 64, 672–683 (1998).
  • van Gelder T, Hilbrands LB, Vanrenterghem Y et al. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation 68, 261–266 (1999).
  • Knoll GA, MacDonald I, Khan A, van Walraven C. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J. Am. Soc. Nephrol. 14, 2381–2386 (2003).
  • Pelletier RP, Akin B, Henry ML et al. The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation. Clin. Transplant. 17, 200–205 (2003).
  • Ferguson RM, Porterfield-Baxa J, Tierce JC, Petrilla AA, Kilburg A. The cost of mycophenolate mofetil (MMF)-related adverse events and impact of MMF dose reductions/discontinuations on acute rejection in transplanted patients. 11th Congress of the European Society of Organ Transplantation. Venice, Italy (2003).
  • Hardinger KL, Brennan DC, Lowell J, Schnitzler MA. Long-term outcome of gastrointestinal complications in renal transplant patients treated with mycophenolate mofetil. Transpl. Int. 17, 609–616 (2004).
  • Schnitzler MA, Hardinger KL, Burroughs TE, Irish WD, Lentine KL, Brennan DC. Consequences of immunsuppression minimization following diagnosis of gastrointestinal complications in renal transplant. American Transplant Congress. WA, USA (2005).
  • Machnicki G, Schnitzler MA, Ricci J-F. Economic impact of MMF dose modification following gastrointestinal complications in renal transplantation. American Transplant Congress. WA, USA (2005).
  • Budde K, Glander P, Hahn U et al. Pharmacokinetic and pharmacodynamic comparison of mycophenolate mofetil and enteric-coated mycophenolate sodium in maintenance transplant patients. Am. J. Transplant. 2, 399 (2002).
  • Schuurman HJ, Pally C, Fringeli-Tanner M, Papageorgiou C. Comparative efficacy of mycophenolate sodium (MPS) and mycophenolate mofetil (MMF) with and without cyclosporin in rat transplantation models. Transplantation 72, 1776–1783 (2001).
  • Pally C, Tanner M, Rizvi H, Papageorgiou C, Schuurman HJ. Tolerability profile of sodium mycophenolate (ERL080) and mycophenolate mofetil with and without cyclosporin (Neoral) in the rat. Toxicology 157, 207–215 (2001).
  • Matsumoto Y, Hof A, Baumlin Y, Hof RP. Efficacy of mycophenolate sodium as monotherapy and in combination with FTY720 in a DA-to-Lewis-rat heart-transplantation model. Transplantation 74, 1372–1376 (2002).
  • Schmouder R, Arns W, Merkel F, Choudhury S, Russell D, Taccard G. Pharmacokinetics of ERL080A: a new, enteric-coated formulation of mycophenolic acid sodium. American Society of Transplantation 18th Annual Meeting. IL, USA (1999).
  • Ettenger R, Choi L, Al-Akash S, Zhu W, Starr J, Schmouder R. Myfortic® delivers therapeutic mycophenolic acid concentrations in pediatric renal transplant recipients. American Transplant Congress.WA, USA (2002).
  • Arns W, Choi L, Cooper P, Zhu W, Graf P, Schmouder R. Absorption of Myfortic® (enteric coated mycophenolate sodium) is proportional over a wide dose range. XXth International Congress of the Transplantation Society, Vienna, Austria (2004).
  • Granger DK. Enteric-coated mycophenolate sodium: results of two pivotal global multicenter trials. Transplant Proc. 33, 3241–3244 (2001).
  • Schmouder RL, Fachauld P, Arns W et al. Enteric-coated mycophenolate sodium delivers therapeutic mycophenolic acid exposure to more patients than mycophenolate mofetil. XIX International Congress of the Transplantation Society. FL, USA (2002).
  • Pou L, Brunet M, Cantarell C et al. Mycophenolic acid plasma concentrations: influence of comedication. Ther. Drug Monit. 23, 35–38 (2001).
  • Schmouder R, Arns W, Zhu W, Choi L, Carpenter P, Graf P. Decreased absolute bioavailability of mycophenolic acid is associated with cyclosporin. 2001 - A Transplant Odyssey: The Future is Here. Istanbul, Turkey (2001).
  • Shaw LM, Korecka M, Venkataramanan R, Goldberg L, Bloom R, Brayman KL. Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am. J. Transplant. 3, 534–542 (2003).
  • Kaplan B, Meier-Kriesche HU, Minnick P et al. Steady-state pharmacokinetics of enteric-coated mycophenolate sodium (myfortic®) in maintenance renal patients differ during concomitant treatment with Neoral® or tacrolimus. American Transplant Congress, MA, USA (2004).
  • Kaplan B, Meier-Kriesche HU, Minnick P et al. Pharmacokinetics of enteric-coated mycophenolate sodium (EC-MPS, Myfortic®) in stable renal transplant patients with Neoral® or tacrolimus. Presented at: the American Society of Nephrology, CA, USA (Abstract 631) (2003).
  • Salvadori M, Holzer H, de MA et al. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am. J. Transplant. 4, 231–236 (2004).
  • Budde K, Curtis J, Knoll G et al. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am. J. Transplant. 4, 237–243 (2004).
  • Salvadori M, on behalf of the ERL 301 Study Group. Long-term administration of Enteric-Coated Mycophenolate Sodium (EC-MPS, Myfortic®) is safe in kidney transplant patients. XXth International Congress of the Transplantation Society, Vienna, Austria (2004).
  • Budde K, Pelletier RP, on behalf of the ERL B302 Study Group. Long-term safety of enteric-coated mycophenolate sodium (EC-MPS) in renal transplant recipients. American Transplant Congress. WA, USA (2005).
  • Vitko S, Vogt B, Antoniadis A, Klinger M, Kircherr B, for the myPROMS study group. Efficacy and safety of enteric-coated mycophenolate sodium in de novo renal transplant recipients: results of a 12-month mulitcentre, open-label, prospective study. American Transplant Congress. WA, USA (2005).
  • Rostaing L, Mourad G, Legendre C. Sustainable tolerability effects of Myfortic® in combination with Neoral® and steroids at 12 months, in de novo kidney transplantation: a randomized, multicentre, open, prospective controlled study. American Transplant Congress. WA, USA (2005).
  • Budde K, Bosmans J-L, Zeier M et al. Safety and efficacy of reduced or full dose of cyclosporin (Neoral®) in combination with mycophenolate sodium (Myfortic®), basiliximab (Simulect®), and steroids in de novo kidney transplant recipients. XXth International Congress of the Transplantation Society. Vienna, Austria (2004).
  • Meier-Kriesche H-U, Cibrik D, Bresnahan B, Cohen D, Lieberman B for the Myfortic® US-01 Study. Optimized Neoral C2 monitoring in combination with enteric-coated mycophenolate acid, basiliximab, and steroids is effective, safe, and tolerable: 12-month results of a multi-center, randomized, prospective trial. American Society of Nephrology Meeting. MO, USA (2004).
  • Cibrik D, Jensik S, Bresnahan B, Whelchel J, Klintmalm G, the ERL2405-US01 Study Group. Safety and efficacy of EC-MPS in combination with simulect and neoral in de novo renal transplant high-risk recipients. American Transplant Congress, WA, USA (2005).
  • Nashan B, Ivens K, Suwelack B, Arns W, Abbud FM. Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in maintenance renal transplant patients: preliminary results from the myfortic prospective multicenter study. Transplant Proc. 36, S521–S523 (2004).
  • Abbud-Filho M, Girón F, Hernández E et al. Maintenance renal transplant recipients can be safely converted from MMF to enteric-coated mycophenolate sodium tablets: interim results of a multicenter Latin American study. Transplant Proc. 36, 1647–1649 (2004).
  • Massari P, Duro-Garcia V, Giron F et al. Safety assessment of the conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in stable renal transplant recipients. Transplant Proc. 36, 916–919 (2005).
  • Vathsala A on behalf of the Asia Pacific myPROMS Study Group. Safety of the conversion to enteric-coated mycophenolate sodium in stable renal transplant recipients. Results of a multicenter, Asia-Pacific study. TransplantAsia, Singapore (2004)
  • David-Neto E, Turconi A, Girón F, Adragna M, Otero A, Pereira ML. A study about the safety and tolerability of the conversion to enteric-coated mycophenolate sodium from mycophenolate mofetil in maintenance pediatric renal transplant recipients. American Transplant Congress, MA, USA (2004).
  • Sechaud R, Yeh C-M, Balez S et al. Enteric-coated mycophenolate sodium (EC-MPS) in de novo heart transplant patients: pharmacokinetic (PK) results. American Transplant Congress,WA, USA (2005).
  • Kobashigawa JA, Renlund DG, Gerosa G et al. Twelve months results of enteric-coated mycophenolate sodium (EC-MPS) in de novo heart transplant patients showed excellent efficacy and safety. International Society for Heart and Lung Transplantation 25th Anniversary Meeting, PA, USA (2005).
  • Revicki DA, Sorensen S, Maton PN, Orlando RC. Health-related quality of life outcomes of omeprazole versus ranitidine in poorly responsive symptomatic gastroesophageal reflux disease. Dig. Dis. 16, 284–291 (1998).
  • Eypasch E, Williams JI, Wood-Dauphinee S et al. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br. J. Surg. 82, 216–222 (1995).
  • Kleinman L, Faull R, Walker R, Prasad R, Ambuehl P, Bahner U. GI-specific patient-reported outcome instruments differentiate between renal transplant patients with or without GI complications. XXth International Congress of the Transplantation Society, Vienna, Austria (2004).
  • Hardinger KL, Koch MJ, Brennan DC. Current and future immunosuppressive strategies in renal transplantation. Pharmacotherapy 24, 1159–1176 (2004).
  • Tran HT, Acharya MK, McKay DB et al. Avoidance of cyclosporin in renal transplantation: effects of daclizumab, mycophenolate mofetil, and steroids. J. Am. Soc. Nephrol. 11, 1903–1909 (2000).
  • Vincenti F, Ramos E, Brattstrom C et al. Multicenter trial exploring calcineurin inhibitors avoidance in renal transplantation. Transplantation 71, 1282–1287 (2001).
  • Emparan C, Laukotter M, Wolters H, Dame C, Heidenreich S, Senninger N. Calcineurin-free protocols with basiliximab induction allow patients included in ‘old to old’ programs achieve standard kidney transplant function. Transplant Proc. 35, 1326–1327 (2003).
  • Pescovitz MD, Govani M. Sirolimus and mycophenolate mofetil for calcineurin-free immunosuppression in renal transplant recipients. Am. J. Kidney Dis. 38, S16–S21 (2001).
  • Flechner SM. Minimizing calcineurin inhibitor drugs in renal transplantation. Transplant Proc. 35, S118–S121 (2003).
  • Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am. J. Transplant. 4, 378–383 (2004).
  • Moreno JM, Rubio E, Gomez A et al. Effectiveness and safety of mycophenolate mofetil as monotherapy in liver transplantation. Transplant Proc. 35, 1874–1876 (2003).
  • Moreno Planas JM, Cuervas-Mons MV, Rubio GE et al. Mycophenolate mofetil can be used as monotherapy late after liver transplantation. Am. J. Transplant. 4, 1650–1655 (2004).
  • Cibrik DM, Jensik S, Meier-Kriesche H-U, Bresnahan B, Lieberman B for the Myfortic® -US01 Renal Transplant Group. Enteric-coated mycophenolate sodium in combination with optimized Neoral® dosing, basiliximab, and steroids results in good efficacy and renal function in renal transplant recipients in the first 6 months. American Transplant Congress, MA, USA (2004).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.