Consensus Document: Therapeutic Monitoring of Tacrolimus (FK-506)

Erratic tacrolimus exposure, assessed using the standard deviation of trough blood levels, predicts chronic lung allograft dysfunction and survival

“…The median number of tacrolimus measurements per patient for the 0-6, 6-12 and 12-24 month periods were 15 (IQR 8 -24), 11 (7-17, range 2-30 measurements) and 13 (7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20) respectively. There was a positive correlation between the number of tacrolimus measurements and trough level SD (r = 0.489 p<0.001, Figure 3) but not with the mean (p=0.698).…”

“…While the mean drug level required to prevent rejection has been well studied, little attention has been paid to the effect of erratic tacrolimus exposure, but with a satisfactory mean, in lung transplantation (15,(17)(18)(19)(20)(21)(22). There are good reasons to believe that erratic exposure may be just as deleterious as sub-therapeutic tacrolimus exposure, but this possibility has been little explored.…”

Evaluation of the Dade Behring Syva® EMIT 2000 tacrolimus assay on the Bayer Advia 1650

“…4 Trough levels are good indicators of systemic exposure, but correlation with drug dose is poor. 5 It is important, therefore, that patients receiving tacrolimus are monitored regularly. Methods available for measuring tacrolimus in whole blood include high-performance liquid chromatography (HPLC), enzyme-linked immunosorbent assay and microparticle enzyme immunoassay (MEIA).…”

Untitled

“…Large scale multi-centre, and, like cyclosporin, too much drug is associated with toxicity and too little with rejection. Again, like double-blind, randomised, controlled studies in renal transplant patients have shown the effectiveness of MMF cyclosporin, whole blood concentration measurements are used for the monitoring of tacrolimus therapy [55].…”