Analysis of whole blood tacrolimus concentrations in liver transplant patients exhibiting impaired liver function

Therapeutic Drug Monitoring

Volumn 21, Issue 6, 1999, Pages 585-592

  MacFarlane, Gordon D ^a   Shaw, Leslie M ^b   Venkataramanan, Raman ^c   Mullins, Richard ^d   Scheller, Daniel G ^a   Ersfeld, Diana L ^a  

^a Diasorin SpA   (Italy)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITY OF PITTSBURGH   (United States)

^d EMORY UNIVERSITY   (United States)

Author keywords

Impaired liver function; PRO Trac II ELISA; Tacrolimus

Indexed keywords

TACROLIMUS;

ARTICLE; BLOOD SAMPLING; CHOLESTASIS; CROSS REACTION; DRUG BLOOD LEVEL; DRUG MONITORING; ENZYME LINKED IMMUNOSORBENT ASSAY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN CELL; LIVER FUNCTION; LIVER TRANSPLANTATION; PRIORITY JOURNAL; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY;

ADULT; BILIRUBIN; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LINEAR MODELS; LIVER FAILURE; LIVER TRANSPLANTATION; MALE; MASS SPECTROMETRY; PROSPECTIVE STUDIES; TACROLIMUS;

EID: 0032718602     PISSN: 01634356     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007691-199912000-00001     Document Type: Article

References (21)

1. Kino T, Hatanaka H, Hashimoto M, Nishiyama M, Goto T, Okuhara M, et al. FK506, a novel immunosuppressant isolated from a Streptomyces I. Fermentation, isolation, and physio-chemical and biological characteristics. J Antibiotics (Tokyo) 1987;40:1249-55.
2. Wallemacq PE, Reding R. FK506 (tacrolimus), a novel immunosuppressant in organ transplantation: Clinical biochemical, and analytical aspects. Clin Chem 1993;39:2219-28.
3. Venkataramanan R, Swaminathan A, Prasad T, Jain A, Zuckerman S, Warty V, et al. Clinical pharmacokinetics of tacrolimus. Clin Pharmacokinet 1995;29:404-30.
4. Jusko WJ, Thomson AW, Fung JJ, McMaster P, Wong SH, Zylber-Katz E, et al. Consensus Document: Therapeutic monitoring of tacrolimus (FK506). Ther Drug Monit 1995;17:606-14.
5. Alak, A. Measurement of tacrolimus (FK506) and its metabolites: A review of assay development and application in therapeutic drug monitoring and pharmacokinetic studies. Ther Drug Monit 1997; 19:338-51.
6. Grenier FC, Luczkiw J, Bergmann M, Lunetta S, Morrison M, Blonski D, et al. A whole blood FK506 assay for the IMx analyzer. Transplant Proc 1991;23:2745-7.
7. MacFarlane GD, Scheller D, Ersfeld D, Jensen T, Jevans A, Kobayashi M. A simplified whole blood ELISA [PRO-Trac II] for tacrolimus (FK506) using a proteolytic extraction in place of organic solvents. Ther Drug Monit 1996;18:698-705.
8. MacFarlane GD, Scheller DG, Ersfeld DL, Shaw LM, Venkatarmanan R, Sarkozi L, et al. Analytical Validalion of the PRO-Trac II ELISA for the Determination of Tacrolimus (FK506) in Whole Blood. Clin Chem 1999;45:1449-58.
9. Cao TZ, Jevans A, Brown G, Linder MW, Valdes Jr. R. Discrepancies between tacrolimus concentrations measured using the MEIA and ELISA methods are due to differences in drug recovery. [Abstract] Clin Chem 1998;44:A87.
10. 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 oxidized at multiple sites of FK506. Drug Metabolism and Disposition 1995;23:28-34.
11. Gonschior AK, Christians U, Winkler M, Linck A, Baumann J, Sewing KF. Tacrolimus (FK506) metabolite patterns in blood from liver and kidney transplant patients. Clin Chem, 196;42:1426-32.
12. Tokunaga Y, Alak AM. FK506 (tacrolimus) and its immunoreactive metabolites in whole blood of liver transplant patients and subjects with mild hepatic dysfunction. Pharm Res 1996;13:137-40.
13. Braun F, Schutz E, Christians U, Lorf T, Schiffmann JH, Armstrong VW, et al. Pitfalls in monitoring tacrolimus (FK506). Ther Drug Monit 1997;19:628-31.
14. Alak AM, Moy S, Cook M, Lizak P, Niggebiugge A, Menard S, 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.
15. Sattler M, Guengerich FP, Yun C, Christians U, Sewing KF. Cytochrome P-450 3A enzymes are responsible for biotransformation of FK506 and rapamycin in man and rat. Drug Metab Dispos Biol Fate Chem 1992;20:753-61.
16. Vincent SH, Karanam BV, Painter SK, Chiu S-HL. In vitro metabolism of FK506 in rat, rabbit, and human liver microsomes: Identification of a major metabolite and of cytochrome P450 3 A as the major enzymes responsible for its metabolism. Arch Biochem Biophys, 1992;294:454-60.
17. Taylor PJ, Jones A, Balderson GA, Lynch SV, Norris RLG, Pond SM. Sensitive, specific quantitative analysis of tacrolimus (FK506) in blood by liquid chromatography-electrospray tandem mass spectrometry. Clin Chem 1996;42:279-85.
18. Christians U, Braun F, Schmidt M, Kosian N, Schiebel HM, Ernst L, et al. Specific and sensitive measurement of FK506 and its metabolites in blood and urine of liver grafted patients. Clin Chem 1992;38:2025-32.
19. Salm P, Taylor PJ, Clark A, Balderson GA, Grygotis A, Norris RLG, et al. High-performance liquid chromatography-tandem mass spectrometry as a reference for analysis of tacrolimus to assess two immunoassays in patients with liver and renal transplants. Ther Drug Monit 1997;19:694-700.
20. Garg UC, Austin G, Barnes C, Hamilton M. Comparison of the Abbott IMx tacrolimus I and tacrolimus II assays. Clin Chem 1998; 44:1783-5.
21. Linnet, K. Necessary sample size for method comparison tudies based on regression analysis. Clin Chem 1999;45:882-94.