Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: Comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial

Kidney International

Volumn 77, Issue SUPPL. 115, 2010, Pages

  Vítko, Štefan ^a   Ferkl, Marek ^b  

^a INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE   (Czech Republic)

^b Teva Pharmaceuticals Europe   (United Kingdom)

Author keywords

Ciclosporin; Generic drugs; Interchangeability; Renal transplantation

Indexed keywords

AZATHIOPRINE; CORTICOSTEROID; CYCLOSPORIN A; EQUORAL; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; UNCLASSIFIED DRUG; CYCLOSPORIN; GENERIC DRUG; IMMUNOSUPPRESSIVE AGENT;

ADULT; AGED; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DYSLIPIDEMIA; FEMALE; GASTROINTESTINAL DISEASE; GINGIVA HYPERPLASIA; GRAFT RECIPIENT; HUMAN; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; HYPERTENSION; HYPERTRIGLYCERIDEMIA; HYPERURICEMIA; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; INFESTATION; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; METABOLIC DISORDER; MULTICENTER STUDY; NUTRITIONAL DISORDER; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; THORAX DISEASE; URINARY TRACT INFECTION; VASCULAR DISEASE; DRUG TOXICITY; ECONOMICS; MIDDLE AGED;

ADULT; AGED; CYCLOSPORINE; DRUG TOXICITY; DRUGS, GENERIC; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED;

EID: 77951888511     PISSN: 00852538     EISSN: 15231755     Source Type: Journal    
DOI: 10.1038/ki.2009.506     Document Type: Article

References (14)

1. Frank RG. The ongoing regulation of generic drugs. N Engl J Med 2007; 357: 1993-1996.
2. Alloway RR. Generic immunosuppressant use in solid organ transplantation. Transplant Proc 1999; 31(3A Suppl): 2S-5S.
3. Srinivas TR, Meier-Kriesche HU. Minimizing immunosuppression, an alternative approach to reducing side effects: objectives and interim result. Clin J Am Soc Nephrol 2008; 3(Suppl 2): S101-S116.
4. Dunn CJ, Wagstaff AJ, Perry CM et al. Cyclosporin: an updated review of the pharmacokinetic properties, clinical efficacy and tolerability of a microemulsion-based formulation (neoral)1 in organ transplantation. Drugs 2001; 61: 1957-2016.
5. Kovarik JM, Mueller EA, van Bree JB et al. Reduced inter-and intraindividual variability in cyclosporine pharmacokinetics from a microemulsion formulation. J Pharm Sci 1994; 83: 444-446.
6. Mueller EA, Kovarik JM, van Bree JB et al. Improved dose linearity of cyclosporine pharmacokinetics from a microemulsion formulation. Pharm Res 1994; 11: 301-304.
7. Christians U. Generic immunosuppressants: the European perspective. Transplant Proc 1999; 31: 19S-22S.
8. Perlik F, Masri MA, Rost M et al. Pharmacokinetic conversion study of a new cyclosporine formulation in stable adult renal transplant recipients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 2005; 149: 309-313.
9. Andrysek T, Masri M, Jegorov A et al. Equoral, new cyclosporine drug delivery system, versus Neoral: a bioequivalence study in healthy volunteers. Transplant Proc 2003; 35: 207-209.
10. Masri MA, Haberal M, Rizvi A et al. The pharmacokinetics of Equoral versus Neoral in stable renal transplant patients: a multinational multicenter study. Transplant Proc 2004; 36: 80-83.
11. Masri MA, Haberal M, Rizvi A et al. Switchability of Neoral and Equoral according to Food and Drug Administration rules and regulations. Transplant Proc 2005; 37: 2988-2993.
12. Zadrazil J, Jabry SA, Bachleda P et al. Use of Equoral in de novo renal transplant recipients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 2004; 148: 171-173.
13. Pollard S, Nashan B, Johnston A et al. A pharmacokinetic and clinical review of the potential clinical impact of using different formulations of cyclosporin A. Berlin, Germany, November 19, 2001. Clin Ther 2003; 25: 1654-1669.
14. Alloway RR, Isaacs R, Lake K et al. Report of the American Society of Transplantation conference on immunosuppressive drugs and the use of generic immunosuppressants. Am J Transplant 2003; 3: 1211-1215.