Potential clinical implications of substitution of generic cyclosporine formulations for cyclosporine microemulsion (Neoral) in transplant recipients

European Journal of Clinical Pharmacology

Volumn 60, Issue 6, 2004, Pages 389-395

  Johnston, Atholl ^a   Belitsky, Philip ^b   Frei, Ulrich ^c   Horvath, John ^d   Hoyer, Peter ^e   Helderman, J Harold ^f   Oellerich, Michael ^g   Pollard, Stephen ^h   Riad, Hany ⁱ   Rigotti, Paolo ^j   Keown, Paul ^k   Nashan, Björn ^l  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^e UNIVERSITY OF DUISBURG ESSEN   (Germany)

^f VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^g UNIVERSITY OF GÖTTINGEN   (Germany)

^h ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

ⁱ MANCHESTER ROYAL INFIRMARY   (United Kingdom)

^j UNIVERSITY OF PADOVA   (Italy)

^k VANCOUVER HOSPITAL AND HEALTH SCIENCES CENTRE   (Canada)

^l HANNOVER MEDICAL SCHOOL   (Germany)

more..

Author keywords

Bioequivalence; Cyclosporine; Generic

Indexed keywords

CREATININE; CYCLOSPORIN A; GENERIC DRUG; GENGRAFT; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; STEROID; UNCLASSIFIED DRUG;

ACUTE GRAFT REJECTION; AREA UNDER THE CURVE; BIOEQUIVALENCE; CLINICAL TRIAL; COMPARATIVE STUDY; CREATININE BLOOD LEVEL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CHOICE; DRUG CLEARANCE; DRUG EFFICACY; DRUG FORMULATION; DRUG LABELING; FOOD DRUG INTERACTION; HUMAN; KIDNEY GRAFT; META ANALYSIS; MICROEMULSION; NONHUMAN; ORGAN TRANSPLANTATION; PRIORITY JOURNAL; REVIEW; SYSTEMATIC REVIEW; TREATMENT OUTCOME;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS; CYCLOSPORINE; EMULSIONS; HUMANS; IMMUNOSUPPRESSIVE AGENTS; ORGAN TRANSPLANTATION; THERAPEUTIC EQUIVALENCY;

EID: 4544272183     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-004-0774-8     Document Type: Review

References (40)

1. Pollard S, Nashan B, Johnston A et al (2003) A pharmacokinetic and clinical review of the potential clinical impact of using different formulations of cyclosporin A. Clin Ther 25:1654-1669
2. Kovarik JM, Mueller EA, van Bree JB et al (1994) Cyclosporine pharmacokinetics and variability from a microemulsion formulation-a multicenter investigation in kidney transplant patients. Transplantation 58:658-663
3. Lindholm A, Kahan BD (1993) Influence of cyclosporine pharmacokinetics, trough concentrations, and AUC monitoring on outcome after kidney transplantation. Clin Pharmacol Ther 54:205-218
4. Kahan BD (1996) Variable oral absorption of cyclosporine. A biopharmaceutical risk factor for chronic renal allograft rejection. Transplantation 62:599-606
5. Humar A, Kerr S, Gillingham KJ, Matas AG (1999) Features of acute rejection that increase risk for chronic rejection. Transplantation 68:1200-1203
6. Basadonna GP, Matas AJ, Gillingham KJ et al (1993) Early versus later acute renal allograft rejection: impact on chronic rejection. Transplantation 55:993-995
7. Hariharan S, McBride MA, Cherikh SW et al (2002) Post-transplant renal function in the first year predicts long-term kidney transplant survival. Kidney Int 62:311-318
8. Kahan BD, Dunn J, Fitts C et al (1995) Reduced inter- and intrasubject variability in cyclosporine pharmacokinetics in renal transplant recipients treated with a microemulsion formulation in conjunction with fasting, low-fat meals, or high-fat meals. Transplantation 59:505-511
9. Holt DW, Mueller EA, Kovarik JM, van Bree JB, Richard F, Kutz K (1995) Sandimmun Neoral pharmacokinetics: impact of the new oral formulation. Transplant Proc 27:1434-1437
10. Committee for Proprietary Medicinal Products (CPMP) (2001) Notes for guidance on the investigation of bioavailability and bioequivalence. London,http://www.emea.eu.int/pdfs/human/ ewp/140198en.pdf Accessed 22 October 2003
11. Food and Drug Administration Center for Drug Evaluation and Research (2001) Approved drug products with therapeutic equivalence evaluations prescribing information.http:// www.fda.gov/cder/guidance/4964dft.pdf Accessed 22 October 2003
12. Johnston A, Keown PA, Holt DW (1997) Simple bioequivalence criteria: are they relevant to critical dose drugs? Experience gained from cyclosporine. Ther Drug Monit 19:375-378
13. Mueller EA, Kovarik JM, van Bree JB, Tetzloff W, Grevel J, Kutz K (1994) Improved dose linearity of cyclosporine pharmacokinetics from a microemulsion formulation. Pharm Res 11:301-304
14. Cooney GF, Jeevanandam V, Choudhury S, Feutren G, Mueller EA, Eisen H (1998) Comparative bioavailability of Neoral and Sandimmune in cardiac transplant recipients over 1 year. Transplantation 30:1892-1894
15. Freeman D, Grant D, Levy G et al (1995) Pharmacokinetics of a new oral formulation of cyclosporine in liver transplant recipients. Ther Drug Monit 17:213-216
16. Cooney GF, Habucky K, Hoppu K (1997) Cyclosporin pharmacokinetics in paediatric transplant recipients. Clin Pharmacokinet 32:481-495
17. Dunn S, Cooney G, Sommerauer J et al (1997) Pharmacokinetics of an oral solution of the microemulsion formulation of cyclosporine in maintenance pediatric liver transplant recipients. Transplantation 63:1762-1767
18. Schroeder TJ, Hariharan S, First MR (1995) Variations in bioavailability of cyclosporine and relationship to clinical outcome in renal transplant subpopulations. Transplant Proc 27:837-839
19. Lindholm A, Welsh M, Rutzky L et al (1993) The adverse impact of high cyclosporine: clearance rates on the incidences of acute rejection and graft loss. Transplantation 55:985-993
20. Cooney GF, Fiel SB, Shaw LM et al (1990) Cyclosporine bioavailability in heart-lung transplant candidates with cystic fibrosis. Transplantation 49:821-823
21. Tan KKC, Hue KL, Strickland SE et al (1990) Altered pharmacokinetics of cyclosporin in heart-lung transplant recipients with cystic fibrosis. Ther Drug Monit 12:520-524
22. Federal Register (2000) December 4, 2000; 65 (233). Available athttp://www.fda.gov/OHRMS/DOCKETS/98fr/120400a.htm Accessed 30 September 2003
23. Nashan B, Bleck J, Wonigeit K et al (1988) Effect of the application form of cyclosporine on blood levels: comparison of the oral solution and capsules. Transplant Proc 20:637-639
24. Curtis JJ, Barbeito R, Pirsch J, Lewis RM, Van Buren DH, Choudhury S (1999) Differences in bioavailability between oral cyclosporine formulations in maintenance renal transplant patients. Am J Kidney Dis 34:869-874
25. Koehler J, Kuehnel T, Kees F et al (2002) Comparison of bioavailability and metabolism with two commercial formulations of cyclosporine A in rats. Drug Metab Dispos 30:658-662
26. Wandel C, Kim RB, Stein CM (2003) "Inactive" excipients such as cremophor can affect in vivo drug disposition. Clin Pharmacol Ther 73:394-396
27. Based on Study Report number ANA-97-132 submitted by Eon Labs Manufacturing, Inc., Laurelton, NY (USA) Department of Public Health
28. Neoral Prescribing Information, Novartis Pharma AG, Basel, Switzerland
29. Based on Study Report number ANA-97-133 submitted by Eon Labs Manufacturing, Inc., Laurelton, NY (USA) to the Illinois (USA) Department of Public Health
30. Based on Biostudy Synopsis M97-686 submitted by Abbott Laboratories, Abbott Park, IL (USA) to the New Jersey (USA) Department of Health and Public Services, Drug Utilization Review Council
31. Kunz R, Hecker J, Lorenz R et al (2002) Analysis of the dose/ blood level ratio of ciclosporin (CyA) in stable kidney transplant patients with the administration of different CyA formulations [abstract], 11th Annual Conference of the German Transplantation Society, 24-26 October 2002, Hannover
32. Roza A, Tomlanovich S, Merion R et al (2002) Conversion of stable renal allograft recipients to a bioequivalent cyclosporine formulation. Transplantation 74:1013-1017
33. Qazi YA, Forrest A, Tornatore K et al (2002) The clinical and economic impact of 1:1 conversion from Neoral to Gengraf (abstract). ASN 2002, SA-P0505
34. Shah MB, Martin JE, Schroeder TJ et al (1999) The evaluation of the safety and tolerability of two formulations of cyclosporine: Neoral and Sandimmune. A meta-analysis. Transplantation 67:1411-1417
35. Meier-Kriesche H-U, Kaplan B (2002) Cyclosporine micro-emulsion and tacrolimus are associated with decreased chronic allograft failure and improved long-term graft survival as compared with Sandimmun. Am J Transplant 2:100-104
36. Taber DJ, Baillie GM, Ashcraft E et al (2003) Bioequivalence between Cyclosporine microemulsion formulations may not translate into equivalent clinical outcomes (abstract). American Transplant Congress 30 May-1 June 2003, Washington DC, Abstract 1211
37. British National Formulary Issue 46, September 2003,http://www.bnf.org Accessed 1 October 2003
38. Durlik M, Rauch C, Thyroff-Friesinger U, Streu H, Paczek L (2003) Comparison of peak and trough level monitoring of Cyclosporine treatment using two modern Cyclosporine preparations. Transplant Proc 35:1304-1307
39. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/2001-03-22_eac_ bb_e.pdf Accessed 24 November 2003
40. Levy G (1995) The clay feet of bioequivalence testing. J Pharm Pharmacol 47:975-977