Pharmacokinetics of mycophenolate mofetil in juvenile patients with autoimmune diseases

Abstract

Objectives: This study aimed to determine the association between the dosage and pharmacokinetics of mycophenolate mofetil (MMF) in juvenile patients with autoimmune diseases.

Methods: Totally, 29 patients were administered oral MMF. The blood concentrations of mycophenolate acid (MPA) at seven points, the area under the time–concentration curve (MPA–AUC_0–12h), the peak concentration (C_max), and the time to peak concentration (T_max) were measured. To obtain a dose-normalized MPA–AUC_0–12h value, the actual measured MPA–AUC_0–12h value was divided by the dose value of the morning administration corrected for body weight (BW) or body surface area (BSA). The patients were classified into three age groups (group 1, ≤10 years; group 2, >10–≤15 years; and group 3, >15 years), and pharmacokinetic parameters were compared among the groups.

Results: In total, we obtained 37 measurements. The actual measured MPA–AUC_0–12h values and the MPA–AUC_0–12h values corrected for dose per BW and T_max were lower in young patients. The MPA–AUC_0–12h values corrected for dose per BSA and C_max were comparable among all the groups.

Conclusion: In patients with juvenile autoimmune diseases, determining MMF administration dosage according to BSA may facilitate MPA–AUC_0–12h value prediction.

Keywords:

• Area under the time–concentration curve (AUC)
• juvenile autoimmune disease
• mycophenolate mofetil
• pharmacokinetics

Conflict of interest

The Tokyo Medical and Dental University (TMDU) received unrestricted research grants for its Department of Lifetime Clinical Immunology from AbbVie GK; Ayumi Pharmaceutical Corporation; Chugai Pharmaceutical Co., Ltd.; CSL Behring K.K.; Japan Blood Products Organization; Mitsubishi Tanabe Pharma Corporation; Nippon Kayaku Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Towa Pharmaceutical Co., Ltd.; and UCB Japan Co. Ltd. and TMDU bore the salary expenses of Masaaki Mori. All other authors have declared no conflicts of interest.