Abstract
P718 Objective: Tacrolimus (FK506) is a potent immunosuppressive agent that has been widely used in solid organ transplantation. However, its pharmacokinetic characteristics have not been well established in the ethnic Chinese patients. In this study, we examined the whole blood concentration of FK506 in the patients with the functioning kidney allografts. Materials and Methods: Sixty-four patients (46 men and 18 women) with the functioning kidney allografts were enrolled into this study. FK506 was given orally at 0.10-0.15 mg/kg bw for 30 days postoperatively and then 0.05-0.10mg/kg bw for the following 90 days in combination with mycophenolate mofetil and corticosteroids. Whole blood concentration was measured by using ELISA method. Multiple blood samples were collected just prior to and at 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 12 hours after oral administration of FK506. We examined the pharmacokinetic parameters, individual concentration-time profiles of whole blood samples after single dose of FK506 in 21 patients and during chronic therapy in 64 patients. Results: The whole blood concentration of FK506 was maintained in 10-15ng/ml during the 30 postoperative days and 5-10ng/ml during 90 days. Conclusions: In this study, the lower dosage of FK506 reaches an optimal blood concentration in the Chinese patients with the functioning kidney allografts. The different pharmacokinetic characteristics of FK506 may suggest that the bioavailability of FK506 in the Chinese patients differs from that in the western ones. The steady state of FK506 whole blood concentration is reached after single dosing period, suggesting that the pharmacokinetic characteristics measured in the early postoperative period can be used for the therapeutic drug monitoring during the chronic therapy of the patients with the functioning kidney allografts. The larger interindividual variation between patients is observed, indicating that individual therapeutic drug monitoring of FK506 is mandatory.
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