Sensitive, specific quantitative analysis of tacrolimus (FK506) in blood by liquid chromatography-electrospray tandem mass spectrometry

Clinical Chemistry

Volumn 42, Issue 2, 1996, Pages 279-285

  Taylor, Paul J ^a,c   Jones, Alun ^a   Balderson, Glenda A ^b   Lynch, Steve V ^b   Norris, Ross L G ^a   Pond, Susan M ^a,b  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b PRINCESS ALEXANDRA HOSPITAL   (Australia)

^c Lions Clinical Research Building ^*  (Australia)

Author keywords

immunosuppressant drugs; liver transplantation; monitoring therapy

Indexed keywords

TACROLIMUS;

ADULT; ARTICLE; CHILD; CLINICAL ARTICLE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG METABOLISM; DRUG MONITORING; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; INFANT; LIQUID CHROMATOGRAPHY; LIVER TRANSPLANTATION; TANDEM MASS SPECTROMETRY;

EID: 0030063763     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1093/clinchem/42.2.279     Document Type: Article

References (41)

1. Taga T, Tanaka H, Goto T, Tada S. Structure of a new macrocyclic antibiotic. Acta Crystallogr 1987;C43:751-3.
2. Goto T, Kino T, Hatanaka H, Nishiyama M, Okuhara M, Kohsaka M, et al. Discovery of FK-506, a novel immunosuppressant isolated from Streptomyces tsukubaensis. Transplant Proc 1987;19(Suppl 6):4-8.
3. Kino T, Inamura F, Sakai K, Nakahara K, Goto T, Okuhara M, et al. Effect of FK-506 on human mixed lymphocyte reaction in vitro. Transplant Proc 1987;19(Suppl 6):36-9.
4. Fung J, Abu-Elmagd K, Jain A, Gordon R, Tzakis A, Todo S, et al. A randomized trial of primary liver transplantation under immunosuppression with FK 506 vs cyclosporine. Transplant Proc 1991;23: 2977-83.
5. Tzakis AG, Reyes J, Todo S, Green M, Ohya T, Jain A, et al. FK 506 versus cyclosporine in pediatric liver transplantation. Transplant Proc 1991;23:3010-5.
6. Egawa H, Esquivel CO, So SK, Cox K, Concepcion W, Lawrence L. FK506 conversion therapy in pediatric liver transplantation. Transplantation 1994;57:1169-73.
7. Peters DH, Fitton A, Plosker GL, Faulds D. Tacrolimus. A review of its pharmacology, and therapeutic potential in hepatic and renal transplantation. Drugs 1993;46:746-94.
8. Wallemacq PE, Reding R. FK506 (tacrolimus), a novel immunosuppressant in organ transplantation: clinical, biomedical and analytical aspects [Review]. Clin Chem 1993;39:2219-28.
9. Winkler M, Christians U. A risk-benefit assessment of tacrolimus in transplantation. Drug Saf 1995;12:348-57.
10. Jusko WJ, D'Ambrosio R. Monitoring FK-506 concentrations in plasma and whole blood. Transplant Proc 1991;23:2732-5.
11. Machida M, Takahara S, Ishibashi M, Hayashi M, Sekihara T, Yamanaka H. Effect of temperature and hematocrit on plasma concentration of FK-506. Transplant Proc 1991;23:2753-4.
12. Jusko WJ Kobayashi M. Therapeutic monitoring of tacrolimus (FK506) [Letter]. Ther Drug Monit 1993;15:349.
13. Wallemacq PE, Firdaous I, Hassoun A. Improvement and assessment of enzyme-linked immunosorbent assay to detect low FK506 concentrations in plasma or whole blood within 6 h. Clin Chem 1993;39:1045-9.
14. Winkler M, Ringe B, Baumann J, Loss M, Wongeit K, Pichlmayr R. Plasma vs whole blood for therapeutic drug monitoring of patients receiving FK 506 for immunosuppression. Clin Chem 1994;40: 2247-53.
15. Christians U, Braun F, Schmidt M, Kosian N, Scheibel HM, Ernst L, et al. Specific and sensitive measurement of FK506 and its metabolites in blood and urine of liver graft recipients. Clin Chem 1992;38:2025-32.
16. Tamura K, Kobayashi M, Hashimoto K, Kojima K, Nagase K, Iwasaki K, et al. A highly sensitive method to assay FK-506 levels in plasma. Transplant Proc 1987;5(Suppl 6):23-9.
17. Kobayashi M, Tamura K, Katayama N, Nakamura K, Nagase K, Hane K, et al. FK 506 assay past and present - characteristics of FK 506 ELISA. Transplant Proc 1991;23:2725-9.
18. D'Ambrosio R, Girzaitis N, Jusko WJ. Validation and quality assurance program for monitoring tacrolimus (FK 506) concentrations in plasma and whole blood. Ther Drug Monit 1993;15:414-26.
19. Bäckman L, Nicar M, Levy M, Distant K, Eisenstien C, Renard T, et al. FK506 trough levels in whole blood and plasma in liver transplant recipients. Transplantation 1994;57:519-25.
20. Jusko WJ, Piekoszewski W, Klintmalm GB, Shaefer MS, Hebert MF, Piergies AA, et al. Pharmacokinetics of tacrolimus in liver transplant patients. Clin Pharmacol Ther 1995;57:281-90.
21. Grenier FC, Luczkiw J, Bergmann M, Lunetta S, Morrison M, Blonski D, et al. A whole blood FK 506 assay for the IMx analyzer. Transplant Proc 1991;23:2748-9.
22. Iwasaki K, Shiraga T, Nagase Z, Tozuka Z, Noda K, Sakuma S, et al. Isolation, identification, and biological activities of oxidative metabolites of FK506, a potent immunosuppressive macrolide lactone. Drug Metab Dispos 1993;21:971-7.
23. Iwasaki K, Shiraga T, Matsuda H, Nagase K, Tokuma Y, Hata T, et al. Further metabolism of FK506 (tacrolimus). Identification and biological activities of the metabolites oxidised at multiple sites of FK506. Drug Metab Dispos 1995;23:28-34.
24. Venkataramanan R, Jain A, Warty VS, Abu-Elmagd K, Furakawa H, Imventarza O, et al. Pharmacokinetics of FK 506 following oral administration: a comparison of FK 506 and cyclosporine. Transplant Proc 1991;23:931-3.
25. Venkataramanan R, Jain A, Warty VS, Abu-Elmagd K, Alessiani M, Lever J, et al. Pharmacokinetics of FK 506 in transplant patients. Transplant Proc 1991;23:2736-40.
26. Christians U, Kruse C, Kownatzi R, Schiebel HM, Schwinzer R, Sattler M, et al. Measurement of FK 506 by HPLC and isolation and characterisation of its metabolites. Transplant Proc 1991;23: 940-1.
27. Shaw LM, Brayman KL. FK-506 therapeutic drug monitoring [Editorial]. Clin Chem 1994;40:2207-8.
28. Venkataramanan R, Warty VS, Zemaitis MA, Sanghvi AT, Burckart GJ, Seltman H, et al. Biopharmaceutical aspects of FK-506. Transplant Proc 1987;19(Suppl 6):30-5.
29. Friob MC, Hassoun A, Latinne D, Lnoëst G, Otte JB, Wallemacq PE. A combined HPLC-ELISA evaluation of FK 506 in transplant patients. Transplant Proc 1991;23:2750-2.
30. Warty V, Zuckerman S, Venkataramanan R, Lever J, FungJ, Starzl T. FK506 measurement: comparison of different analytical methods. Ther Drug Monit 1993;15:204-8.
31. Warty V, Zuckerman S, Venkataramanan R, Lever J, Chao J, Mckaveney T, et al. Tacrolimus analysis: a comparison of different methods and matrices. Ther Drug Monit 1995;17:159-67.
32. Takada K, Oh-Haski M, Yoshikawa H, Muranishi S. Determination of a novel potent immunosuppressant (FK-506) in rat serum and lymph by high-performance liquid chromatography with chemiluminescence detection. J Chromatogr 1990;530:212-8.
33. Gonschior AK, Christians U, Braun F, Winkler M, Linck A, Baumann J, Sewing KF. Measurement of blood concentrations of FK506 (tacrolimus) and its metabolites in seven liver graft patients after the first dose by h.p.l.c.-MS and microparticle enzyme immunoassay (MEIA). Br J Clin Pharmacol 1994;38:567-71.
34. D'Ambrosio R, Jusko WJ, Stabler T, Kobayashi M. Improved procedures for enzyme immunoassay of tacrolimus (FK506) in whole blood [Letter]. Clin Chem 1994;40:159-60.
35. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;i:307-10.
36. Krouwer JS, Rabinowitz R. How to improve estimates of precision. Clin Chem 1984;30:290-2.
37. Freeman DJ, Stawecki M, Howson B. Stability of FK 506 in whole blood samples. Ther Drug Monit 1995;17:265-7.
38. Siuzdak G. The emergence of mass spectrometry in biochemical research. Proc Natl Acad Sci U S A 1994;91:11290-7.
39. Burlingame AL, Boyd RK, Gaskell SJ. Mass spectrometry. Anal Chem 1994;66:634-83R.
40. Sandborn WJ, Lawson GM, Cody TJ, Porayko MK, Hay JE, Gores GJ, et al. Early cellular rejection after orthotopic liver transplantation correlates with low concentrations of FK506 in hepatic tissue. Hepatology 1995;21:70-6.
41. Taylor PJ, Salm P, Norris RLG, Ravenscroft PJ, Pond SM. Comparison of high performance liquid chromatography and monoclonal fluorescence polarization immunoassay for the determination of whole blood cyclosporin A in liver and heart transplant patients. Ther Drug Monit 1994;16:526-30.