Therapeutic equivalence and pharmacokinetics of generic tacrolimus formulation in de novo kidney transplant patients

Nephrology Dialysis Transplantation

Volumn 28, Issue 12, 2013, Pages 3110-3119

  Min, Sang Il ^a   Ha, Jongwon ^a   Kim, Yon Su ^a   Ahn, Sang Hyun ^a   Park, Taejin ^a   Park, Dae Do ^a   Kim, Suh Min ^a   Min, Seung Kee ^a   Hong, Hyejin ^a   Ahn, Curie ^a   Kim, Sang Joon ^a  

^a Seoul National University College of Medicine   (South Korea)

Author keywords

Generic tacrolimus formulation; Interchangeability; Renal transplantation; Therapeutic drug monitoring

Indexed keywords

GENERIC DRUG; TACROBELL; TACROLIMUS; UNCLASSIFIED DRUG;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DIABETES MELLITUS; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FEMALE; HAIR LOSS; HAND TREMOR; HEADACHE; HUMAN; INFECTION; KIDNEY DISEASE; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MENTAL DISEASE; MIDDLE AGED; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; THERAPEUTIC EQUIVALENCE; TREATMENT DURATION;

GENERIC TACROLIMUS FORMULATION; INTERCHANGEABILITY; RENAL TRANSPLANTATION; THERAPEUTIC DRUG MONITORING;

ADOLESCENT; ADULT; AGED; AREA UNDER CURVE; CROSS-OVER STUDIES; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY DISEASES; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TACROLIMUS; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 84890038313     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gft300     Document Type: Article

References (28)

1. Yu YD, Lee SG, Joh JW et al. Results of a phase 4 trial of tacrobell (R) in liver transplantation patients: a multicenter study in South Korea. Hepatogastroenterology 2012; 59: 357-363
2. McDevitt-Potter LM, Sadaka B, Tichy EM et al. A multicenter experience with generic tacrolimus conversion. Transplantation 2011; 92: 653-657
3. Momper JD, Ridenour TA, Schonder KS et al. The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. Am J Transplant 2011; 11: 1861-1867
4. Guleria S, Kamboj M, Chatterjee A et al. Generic tacrolimus (Pan Graf ) in renal transplantation: an experience of 155 recipients in India. Transplant Proc 2008; 40: 2237-2239
5. Sudhindran S, Aboobacker S, Menon RN et al. Cost and efficacy of immunosuppression using generic products following living donor liver transplantation in India. Indian J Gastroenterol 2012; 31: 20-23
6. Alloway RR, Sadaka B, Trofe-Clark J et al. A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients. Am J Transplant 2012; 12: 2825-2831
7. Spence MM, Nguyen LM, Hui RL et al. Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system. Pharmacotherapy 2012; 32: 981-987
8. Cutler C, Kesselheim A, Gabardi S et al. Generic immunosuppressants in hematopoietic cell transplantation. Biol Blood Marrow Transplant 2011; 17: 285-290
9. Park K, Kim YS, Kwon KI et al. A randomized, open-label, twoperiod, crossover bioavailability study of two oral formulations of tacrolimus in healthy Korean adults. Clin Ther 2007; 29: 154-162
10. Approval letter, ANDA 65-461. Available at [http://www. accessdata.fda.gov/drugsatfda-docs/appletter/2009/ 065461s000ltr.pdf]. (13 June 2012, date last accessed)
11. Drug approval information. Available at [http://ezdrug.kfda.go. kr/kfda2]. (12 April 2012, date last accessed)
12. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of mycophenolate in solid organ transplant recipients. Clin Pharmacokinet 2007; 46: 13-58
13. van Duijnhoven E, Christiaans M, Schafer A et al. Tacrolimus dosing requirements in diabetic and nondiabetic patients calculated from pretransplantation data. Transplant Proc 1998; 30: 1266-1267
14. Harrison JJ, Schiff JR, Coursol CJ et al. Generic immunosuppression in solid organ transplantation: a canadian perspective. Transplantation 2012; 93: 657-665
15. Scott LJ, McKeage K, Keam SJ et al. Tacrolimus: a further update of its use in the management of organ transplantation. Drugs 2003; 63: 1247-1297
16. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet 2004; 43: 623-653
17. Min SI, Kim SY, Ahn SH et al. CYP3A5 *1 allele: impacts on early acute rejection and graft function in tacrolimus-based renal transplant recipients. Transplantation 2010; 90: 1394-1400
18. Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999; 55: 713-723
19. Racusen LC, Colvin RB, Solez K et al. Antibody-mediated rejection criteria-an addition to the Banff 97 classification of renal allograft rejection. Am J Transplant 2003; 3: 708-714
20. Levey AS, Bosch JP, Lewis JB et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130: 461-470
21. Borra LC, Roodnat JI, Kal JA et al. High within-patient variability in the clearance of tacrolimus is a risk factor for poor long-term outcome after kidney transplantation. Nephrol Dial Transplant 2010; 25: 2757-2763
22. Guidance for Industry. Bioavailability and bioequivalence studies for orally administered drug products-general considerations. BP Revision. Rockville Md: US Dept of Health, Food and Drug Administration, Center for Drug Evaluation and Research, 2003
23. 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
24. Klintmalm GB. Immunosuppression, generic drugs and the FDA. Am J Transplant 2011; 11: 1765-1766
25. Kim SJ, Huh KH, Han DJ et al. A 6-month, multicenter, single-arm pilot study to evaluate the efficacy and safety of generic tacrolimus (TacroBell) after primary renal transplantation. Transplant Proc 2009; 41: 1671-1674
26. Muller H, Solari S, Zuniga C et al. Immunosuppression with generic tacrolimus andmycophenolate mofetil in renal transplant recipients: preliminary report in Chile. Transplant Proc 2008; 40: 705-707
27. Petan JA, Undre N, First MR et al. Physiochemical properties of generic formulations of tacrolimus in Mexico. Transplant Proc 2008; 40: 1439-1442
28. Alak AM, Moy S, Cook M et al. An HPLC/MS/MS assay for tacrolimus in patient blood samples. Correlation with results of an ELISA assay. J Pharm Biomed Anal 1997; 16: 7-13