Association between enteric coated mycophenolate sodium dose and exposure level in stable renal transplantation recipients

Abstract

Objective To observe the association between enteric coated mycophenolate sodium (EC-MPS) dose and its exposure level at 6th month after renal transplantation in the stable recipients.Method Sixty-eight recipients were treated with tacrolimus (Tac),EC-MPS and prednisone (Pred) triple immunosuppressive regimen.Peripheral venous blood was collected at 1st,2 nd,and 4 th h after EC-MPS oral administration,and the area under concentration and time curve of MPA in the recipients were calculate by LSS formula.According to the MPA AUC value,the recipients were divided into low MPA exposure (MPA AUC ＜30 mg· h· L-1) group,MPA target exposure (MPA AUC =30-60 mg·h·L-1) group and MPA high exposure group (MPA AUC ＞60 mg·h·L-1) group.Result In 68 recipients MPA AUC was (58.73 ± 20.14) mg· h· L-1,including 5 cases (7.35 ％) in MPA low exposure group,35 cases (51.47％) in MPA target exposure group,and 28 cases (41.18％) in MPA high exposure group,respectively.Tac doses in MPA low exposure group,MPA target exposure group,and MPA high exposure group were (4.21 ± 0.67),(3.82 ± 1.07),and (3.37 ± 0.62) mg/day respectively,and showed a decreasing trend.The dosage of Tac in MPA high exposure group was significantly lower than in MPA low exposure group (P＜0.05).Conclusion There were significant differences in MPA pharmacokinetics among individuals,so it is necessary to monitor EC-MPS pharmacokinetics for stable renal transplant recipients.Adequate exposure of MPA helps to reduce the dose of Tac,and does not influence the renal graft function. Key words: Kidney transplantation; Enteric-coated mycophenolate sodium; Mycophenolic acid; Dose-response relationship, drug