A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients

American Journal of Transplantation

Volumn 12, Issue 10, 2012, Pages 2825-2831

  Alloway, R R ^a   Sadaka, B ^a   Trofe Clark, J ^b,c   Wiland, A ^d   Bloom, R D ^b  

^a UNIVERSITY OF CINCINNATI   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^d NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Generic; Hecoria; kidney transplantation; pharmacokinetic; Sandoz; tacrolimus

Indexed keywords

GENERIC DRUG; TACROLIMUS;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; GRAFT RECIPIENT; HEADACHE; HUMAN; HYPERKALEMIA; HYPOKALEMIA; HYPONATREMIA; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; MAJOR CLINICAL STUDY; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; OROPHARYNX PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SINGLE BLIND PROCEDURE; SQUAMOUS CELL CARCINOMA; STEADY STATE; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING;

AREA UNDER CURVE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; PROSPECTIVE STUDIES; TACROLIMUS;

EID: 84867097632     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2012.04174.x     Document Type: Article

References (30)

1. Staatz CE, Tett SE,. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet 2004; 43: 623-653.
2. Haidar SH, Davit B, Chen ML, et al,. Bioequivalence approaches for highly variable drugs and drug products. Pharm Res 2008; 25: 237-241.
3. Tacrolimus (Prograf®): Prescribing Information. Astellas Pharma US, Inc., Deerfield, IL, USA. Revised September 2011. Available at: http://www.astellas.us/docs/prograf.pdf
4. Anglicheau D, Flamant M, Schlageter MH, et al,. Pharmacokinetic interaction between corticosteroids and tacrolimus after renal transplantation. Nephrol Dial Transplant 2003; 18: 2409-2414.
5. Klintmalm GB,. Immunosuppression, generic drugs and the FDA. Am J Transplant 2011; 11: 1765-1766.
6. Ensor CR, Trofe-Clark J, Gabardi S, McDevitt-Potter LM, Shullo MA,. Generic maintenance immunosuppression in solid organ transplant recipients. Pharmacotherapy 2011; 31: 1111-1129.
7. Alloway RA, 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.
8. van Gelder T, ESOT Advisory Committee on Generic Substitution. European society for organ transplantation advisory committee recommendations on generic substitution of immunosuppressive drugs. Transpl Int 2011; 24: 1135-1141.
9. Harrison JJ, Schiff JR, Coursol CJ, et al,. Generic immunosuppression in solid organ transplantation: A Canadian perspective. Transplantation 2012; 93: 657-665.
10. Sabatini S, Ferguson RM, Helderman JH, Hull AR, Kirkpatrick BS, Barr WH,. Drug substitution in transplantation: A National Kidney Foundation White Paper. Am J Kidney Dis 1999; 33: 389-397.
11. The 90% CI values for the ratios of the geometric means of AUC0-12h and Cmax were each within the stipulated range of 80-125% (2), thus meeting the FDA criteria for bioequivalence (11). Food and Drug Administration (FDA). Bioavailability and bioequivalence requirements. Fed Regist 1992; 57: 17997-18001.
12. Center for Drug Evaluation and Research, U.S. Department of Health and Human Services. Guidance for industry. Bioavailability and bioequivalence. Study for orally administered drug products. General considerations. March 2003. Retreived from http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf. Accessed June 6, 2012.
13. Schuirmann DJ,. A comparison of the two one-sided tests procedure and the power approach for assessing the bioequivalence of average bioavailability. J Pharmacokinet Biopharm 1987; 15: 657-680.
14. Health Canada. Bioequivalence requirements: critical dose drugs. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ bio/critical-dose-critique-eng.php. Accessed December 2011.
15. Wong KM, Shek CC, Chau KF, Li CS,. Abbreviated tacrolimus area-under-the-curve monitoring for renal transplant recipients. Am J Kidney Dis 2000; 35: 660-666.
16. Mathew BS, Fleming DH, Jeyaseelan V, et al,. A limited sampling strategy for tacrolimus in renal transplant patients. Br J Clin Pharmacol 2008; 66: 467-472.
17. Scholten EM, Cremers SC, Schoemaker RC, et al,. AUC-guided dosing of tacrolimus prevents progressive systemic overexposure in renal transplant recipients. Kidney Int 2005; 67: 2440-2447.
18. Kahan BD, Welsh M, Urbauer DL, et al,. Low intraindividual variability of cyclosporin A exposure reduces chronic rejection incidence and health care costs. J Am Soc Nephrol 2000; 11: 1122-1131.
19. Borra LC, Roodnat JI, Kal JA, Mathot RA, Weimar W, van Gelder T,. 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.
20. Ihara H, Shinkuma D, Ichikawa Y, Nojima M, Nagano S, Ikoma F,. Intra- and interindividual variation in the pharmacokinetics of tacrolimus (FK506) in kidney transplant recipients-importance of trough level as a practical indicator. Int J Urol 1995; 2: 151-155.
21. Kurnatowska I, Krawczyk J, Oleksik T, Nowicki M,. Tacrolimus dose and blood concentration variability in kidney transplant recipients undergoing conversion from twice daily to once daily modified release tacrolimus. Transplant Proc 2011; 43: 2954-2956.
22. Wu MJ, Cheng CY, Chen CH, et al,. Lower variability of tacrolimus trough concentration after conversion from Prograf to Advagraf in stable kidney transplant recipients. Transplantation 2011; 92: 648-652.
23. Center for Drug Evaluation and Research. Approval package for application number ANDA 65-461 Tacrolimus capsules, Sandoz. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/anda/2009/065461Orig1s000.pdf. Accessed January 2012.
24. Trofe-Clark J, Gabardi S, McDevitt-Potter L, Alloway RR,. Immunosuppression, generic drugs and the FDA. Am J Transplant 2012; 12: 792-793.
25. Bekersky I, Dressler D, Mekki QA,. Effect of low- and high-fat meals on tacrolimus absorption following 5 mg single oral doses to healthy human subjects. J Clin Pharmacol 2001; 41: 176-182.
26. McDevitt-Potter LM, Sadaka B, Tichy EM, Rogers CC, Gabardi S,. A multicenter experience with generic tacrolimus conversion. Transplantation 2011; 92: 653-657.
27. Momper JD, Ridenour TA, Schonder KS, Shapiro R, Humar A, Venkataramanan R,. 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.
28. Marfo K, Akalin E, Daniel G, et al,. Clinical outcomes of inadvertent conversion from brand to generic tacrolimus in renal transplant recipients. Am J Transplant 2011; 11 (Suppl 2): Abstract 1635.
29. Dick TB, Raines AA, Van der Werf W, Alonso D, Fujita S, Stinson J,. Comparison of dose requirements of Sandoz generic tacrolimus with brand Prograf in kidney transplant recipients. Am J Transplant 2011; 11 (Suppl 2): Abstract 1102.
30. Abdulnour HA, Araya CE, Dharnidharka VR,. Comparison of generic tacrolimus and Prograf drug levels in a pediatric kidney transplant program: Brief communication. Pediatr Transplant 2010; 14: 1007-1011.