Use of generic tacrolimus in elderly renal transplant recipients: Precaution is needed

Transplantation

Volumn 99, Issue 3, 2015, Pages 528-532

  Robertsen, Ida ^a   Åsberg, Anders ^a,b   Ingerø, Aleksander Olsen ^a   Vethe, Nils Tore ^b   Bremer, Sara ^b   Bergan, Stein ^a   Midtvedt, Karsten ^b  

^a UNIVERSITY OF OSLO   (Norway)

^b OSLO UNIVERSITY HOSPITAL   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

TACROLIMUS; GENERIC DRUG; IMMUNOSUPPRESSIVE AGENT;

ACUTE GRAFT REJECTION; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GRAFT RECIPIENT; HUMAN; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; MALE; MAXIMUM PLASMA CONCENTRATION; MINIMUM PLASMA CONCENTRATION; OPEN STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; GENETIC POLYMORPHISM; MIDDLE AGED; RENAL INSUFFICIENCY; THERAPEUTIC EQUIVALENCE;

AGED; AREA UNDER CURVE; CROSS-OVER STUDIES; DRUGS, GENERIC; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; POLYMORPHISM, GENETIC; PROSPECTIVE STUDIES; RENAL INSUFFICIENCY; TACROLIMUS; THERAPEUTIC EQUIVALENCY; TRANSPLANT RECIPIENTS;

EID: 84928194880     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0000000000000384     Document Type: Article

References (37)

1. Christians U, Klawitter J, Clavijo CF,. Bioequivalence testing of immunosuppressants: concepts and misconceptions. Kidney Int 2010; 77: S1
2. van Gelder T, Gabardi S,. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs. Transpl Int 2013; 26: 771
3. Trofe-Clark J, Gabardi S, McDevitt-Potter L, Immunosuppression, generic drugs and the FDA. Am J Transplant 2012; 12: 792
4. Klintmalm GB,. Immunosuppression, generic drugs and the FDA. Am J Transplant 2011; 11: 1765
5. Latran M.,. Response to Klintmalm on the use of generic immunosuppression. Am J Transplant 2012; 12: 791
6. Johnston A.,. Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation. Eur J Hosp Pharm 2013; 20: 302
7. Harrison JJ, Schiff JR, Coursol CJ, Generic immunosuppression in solid organ transplantation: a canadian perspective. Transplantation 2012; 93: 657
8. US Department of Health and Human Services. Guidance for Industry: bioequivalence recommendations for specific products. Silver Spring, MD: Food and Drug Administration; 2010
9. Committee for Medicinal Products for Human Use. Guideline on the Investigation of Bioequivalence. London: European Medicines Agency; 2010
10. Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients. Am J Transplant 2009; 9: S1
11. European Medicines Agency. Commitee for Human Medicinal Products. Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party. EMA/618604/2008 Rev 8. October 2013
12. Mendonza AE, Zahir H, Gohh RY, Tacrolimus in diabetic kidney transplant recipients: pharmacokinetics and application of a limited sampling strategy. Ther Drug Monit 2007; 29: 391
13. Anglicheau D, Flamant M, Schlageter MH, Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation. Nephrol Dial Transplant 2003; 18: 2409
14. van Gelder T.,. European Society for Organ Transplantation Advisory Committee Recommendations on generic substitution of immunosuppressive drugs. Transpl Int 2011; 24: 1135
15. Alloway RR, Isaacs R, Lake K, Report of the American Society of Transplantation Conference on immunosuppressive drugs and the use of generic immunosuppressants. Am J Transplant 2003; 3: 1211
16. Alloway RR, Sadaka B, Trofe-Clark J, A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients. Am J Transplant 2012; 12: 2825
17. Min S-I, Ha J, Kim YS, Therapeutic equivalence and pharmacokinetics of generic tacrolimus formulation in De novo kidney transplant patients. Nephrol Dial Transplant 2013; 28: 3110
18. Borra LCP, Roodnat JI, Kal JA, 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
19. Taber DJ, Baillie GM, Ashcraft EE, Does bioequivalence between modified cyclosporine formulations translate into equal outcomes? Transplantation 2005; 80: 1633
20. Momper JD, Ridenour TA, Schonder KS, 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
21. McDevitt-Potter LM, Sadaka B, Tichy EM, A multicenter experience with generic tacrolimus conversion. Transplantation 2011; 92: 653
22. Spence MM, Nguyen LM, Hui RL, 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
23. Connor A, Prowse A, MacPhee I, Generic tacrolimus in renal transplantation: trough blood concentration as a surrogate for drug exposure. Transplantation 2012; 93: e45
24. Bloom RD, Trofe-Clark J, Wiland A, A randomized, crossover pharmacokinetic study comparing generic tacrolimus vs. the reference formulation in subpopulations of kidney transplant patients. Clin Transplant 2013; 27: E685
25. Wallemacq P, Armstrong VW, Brunet M, Opportunities to optimize tacrolimus therapy in solid organ transplantation: report of the European Consensus Conference. Ther Drug Monit 2009; 31: 139
26. Scott LJ, McKeage K, Keam SJ, Tacrolimus: a further update of its use in the management of organ transplantation. Drugs 2003; 63: 1247
27. Naesens M, Kuypers DRJ, Sarwal M,. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol 2009; 4: 481
28. Bechstein WO,. Neurotoxicity of calcineurin inhibitors: impact and clinical management. Transpl Int 2000; 13: 313
29. Mange KC, Cizman B, Joffe M, Arterial hypertension and renal allograft survival. JAMA 2000; 283: 633
30. Riella LV, Gabardi S, Chandraker A,. Dyslipidemia and its therapeutic challenges in renal transplantation. Am J Transplant 2012; 12: 1975
31. Yates CJ, Fourlanos S, Hjelmesæth J, New-onset diabetes after kidney transplantation-changes and challenges. Am J Transplant 2012; 12: 820
32. Thervet E, Anglicheau D, King B, Impact of cytochrome p450 3A5 genetic polymorphism on tacrolimus doses and concentration-to-dose ratio in renal transplant recipients. Transplantation 2003; 76: 1233
33. Haufroid V, Wallemacq P, VanKerckhove V, CYP3A5 and ABCB1 polymorphisms and tacrolimus pharmacokinetics in renal transplant candidates: guidelines from an experimental study. Am J Transplant 2006; 6: 2706
34. Størset E, Holford N, Midtvedt K, Importance of hematocrit for a tacrolimus target concentration strategy. Eur J Clin Pharmacol. 2014; 70: 65
35. www.abbottdiagnostics.com 2014 [05.05.2014]
36. Levine DM, Maine GT, Armbruster DA, The need for standardization of tacrolimus assays. Clin Chem 2011; 57: 1739
37. Wallemacq P, Goffinet JS, O'Morchoe S, Multi-site analytical evaluation of the Abbott ARCHITECT tacrolimus assay. Ther Drug Monit. 2009; 31: 198