Background Enteric coated mycophenolate sodium (EC-MPS) is the sodium salt formulation of the active immunosuppressive compound mycophenolic acid (MPA). This drug was recently approved for use in renal transplantation. The pharmacokinetic profile for MPS has been well studied in renal transplant recipients but has not been described in the liver transplant population.
Methods This study is designed to determine the pharmacokinetic profile of MPS in liver transplant recipients. Patients enrolled in this study must be $ 12 months post-transplant and on a stable dose of tacrolimus or cyclosporine for 3 months. Exclusion criteria included ALT $ 235 IU/l, serum creatinine $ 2.5 mg/dL, current use of sirolimus, mycophenolate mofetil, or azathioprine, or acute cellular rejection within 3 months of enrolment. Each patient was orally administered one dose EC-MPS 720 mg followed by measurement of blood levels of MPA at the following intervals (hours) t = 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 8.0, and 12.0. Previous renal transplant studies have defined the MPA pharmacokinetics with EC-MPS as tmax mean (range) = 2 h (0.8-8), Cmax mean ± SD = 26.1 ± 12.0 μg/mL, AUC0-12 mean ± SD = 66.5 ± 22.6 μg-hr/mL.
Results From August to November 2005, eight patients were enrolled in this study. Demographics include 4 male/4 female, mean age = 53.4 years, mean weight = 81.2 kg. Etiology of underlying liver disease: four hepatitis C, two PBC, one hepatitis B, one hemangioma. Mean time post-transplant = 4.73 years. Results from this study showed the following pharmacokinetic parameters: tmax mean (range) = 2.9 h (1.5-5), Cmax mean ± SD = 33.9 ± 21.9 μg/mL, AUC0-12 mean ± SD = 52.9 ± 25.2 μg-hr/mL.
Conclusion (1) These preliminary findings show that in liver transplant recipients, the pharmacokinetic parameters of MPA appear similar to renal transplant patients. (2) Further study is required to better understand the pharmacokinetic profile of MPA in liver transplant patients and determine if any significant differences will be noted due to underlying liver disease or coadministered immunosuppressants.
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