Randomized calcineurin inhibitor cross over study to measure the pharmacokinetics of co-administered enteric-coated mycophenolate sodium

Clinical Transplantation

Volumn 19, Issue 4, 2005, Pages 551-558

  Kaplan, Bruce ^a   Meier Kriesche, Herwig Ulf ^a   Minnick, Paula ^a   Bastien, Marie Claude ^b   Sechaud, Romain ^b   Yeh, Ching Ming ^b   Balez, Sebastien ^b   Picard, Franck ^b   Schmouder, Robert ^b  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Calcineurin inhibitors; Cyclosporine microemulsion; Enteric coated mycophenolate sodium; Myfortic ; Pharmacokinetics; Tacrolimus

Indexed keywords

CALCINEURIN INHIBITOR; CYCLOSPORIN A; DRUG METABOLITE; MYCOPHENOLIC ACID; MYCOPHENOLIC ACID 7 O GLUCURONIDE; MYCOPHENOLIC ACID ACYL GLUCURONIDE; TACROLIMUS; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CLINICAL OBSERVATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG RELEASE; DRUG SUBSTITUTION; ENTERIC COATED TABLET; FEMALE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; HUMAN; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; MALE; MAXIMUM ALLOWABLE CONCENTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SMALL INTESTINE; STEADY STATE;

ADULT; AGED; BLOOD GLUCOSE; CALCINEURIN; CROSS-OVER STUDIES; CYCLOSPORINE; EMULSIONS; ENZYME INHIBITORS; FEMALE; HUMANS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; SODIUM; TABLETS, ENTERIC-COATED; TACROLIMUS;

EID: 22244431879     PISSN: 09020063     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1399-0012.2005.00387.x     Document Type: Article

References (15)

1. Bjarnason I. Enteric coating of mycophenolate sodium: a rational approach to limit topical gastrointestinal lesions and extend the therapeutic index of mycophenolate. Transplant Proc 2001: 33: 3238.
2. Budde K, Glander P, Hahn U, Röblitz H, Mai I, Diekmann F. Pharmacokinetic and pharmacodynamic comparison of mycophenolate mofetil and enteric-coated mycophenolate sodium in maintenance transplant patients [abstract]. Am J Transplant 2002: 2(Suppl. 3): 399.
3. 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 2004: 4: 237.
4. Salvadori M, Holzer H, De Mattos A et al. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant 2004: 4: 231.
5. Zucker K, Rosen A, Tsaroucha A et al. Unexpected augmentation of mycophenolic acid pharmacokinetics in renal transplant patients receiving tacrolimus and mycophenolate mofetil in combination therapy, and analogous in vitro findings. Transplant Immunol 1997: 5: 225.
6. Hübner GI, Eismann R, Sziegloeit W. Drug interaction between mycophenolate mofetil and tacrolimus detectable within therapeutic mycophenolic acid monitoring in renal transplant patients. Ther Drug Monit 1999: 21: 536.
7. Filler G, Zimmering M, Mai I. Pharmacokinetics of mycophenolate mofetil are influenced by concomitant immunosuppression. Pediatr Nephrol 2000: 14: 100.
8. Hale MD, Nicholls AJ, Bullingham RE et al. The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther 1998: 64: 672.
9. Maes BD, VanWalleghem J, Kuypers D, Ghoos Y. Rutgeerts PJ, VanRenterghem YF. Differences in gastric motor activity in renal transplant recipients treated with FK-506 versus cyclosporine. Transplantation 1999: 68: 1482.
10. Jacqz-Aigrain E, Khan Shaghaghi E, Baudouin V et al. Pharmacokinetics and tolerance of mycophenolate mofetil in renal transplant children. Pediatr Nephrol 2000: 14: 95.
11. Glanemann M, Klupp J, Langrehr JM et al. Mycophenolate mofetil is superior in combination with tacrolimus compared to cyclosporine for immunosuppressive therapy after liver transplantation. Transplant Proc 2001: 33: 1069.
12. Groetzner J, Meiser B, Schirmer J et al. Tacrolimus/mycophenolate mofetil vs cyclosporine/mycophenolate mofetil: comparison of mycophenolate acid trough levels and coronary vasomotor function [abstract]. J Heart Lung Transplant 2001: 20: 191.
13. Bullingham RE, Nicholls AJ, Kamm BR. Clinical pharmacokinetics of mycophenolate mofetil. Clin Pharmacokinet 1998: 34: 429.
14. Filler G, Lepage N, Delisle B, Mai I. Effect of cyclosporine on mycophenolic acid area under the concentration-time curve in pediatric kidney transplant recipients. Ther Drug Monit 2001: 23: 514.
15. Zucker K, Tsaroucha A, Olson L, Esquenazi V, Tzakis A, Miller J. Evidence that tacrolimus augments the bioavailability of mycophenolate mofetil through the inhibition of mycophenolic acid glucuronidation. Ther Drug Monit 1999: 21: 35.