title: Standard dose enteric-coated mycophenolate sodium (myfortic) delivers rapid therapeutic mycophenolic acid exposure in kidney transplant recipients.
abstract: Previous studies have shown poor absorption of enteric-coated mycophenolate sodium (E-MPS) during the initial post-kidney transplantation (KT) period. The percentage of patients with adequate therapeutic exposure (target AUC 30-60 microg.h/mL) of mycophenolic acid is 55%, 86%, and 100% at days 14, 90, and 180 postgrafting. To assess the adequacy of mycophenolic acid (MPA) delivery during the initial period, we prospectively studied the pharmacokinetics (AUC0-12 h of MPA (measured by high-performance liquid chromatography) in 12 patients after their first single dose of 720 mg of oral E-MPS and 3 to 8 months after 720 mg twice a day prescribed daily. Concomitant immunosuppression included CsA and prednisolone. Evaluation of the pharmacokinetic profiles was repeated at 2 weeks. The patients' mean +/- SD body weight was 48.1 +/- 8.8 kg; their mean (range) values of AUC0-12 h for MPA were 73.9 +/- 49.5 microg.h/ml (31.9-190) on day 1 and 74.3 +/- 44.3 (30.5-178) microg.h/ml on day 14. The mean nadir serum creatinine was 1.1 +/- 0.4 mg/dL. The patient and graft survival rates were 100%. Two patients (15%) developed significant diarrhea requiring E-MPS dose reduction. Other complications included urinary tract infections (n = 2), CMV syndrome (n = 1), borderline acute rejection (n = 1), and reversible CsA nephrotoxicity (n = 3). We conclude that the use of a standard dose of E-MPS results in immediate delivery of adequate therapeutic systemic MPA exposure in all patients. The absorption profile was better than that described previously.
authors.affiliation: Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok. ravsm@mahidol.ac.th
authors.forename: V
authors.initials: V
authors.lastname: Sumethkul
authors.forename: K
authors.initials: K
authors.lastname: Na-Bangchang
authors.forename: S
authors.initials: S
authors.lastname: Kantachuvesiri
authors.forename: S
authors.initials: S
authors.lastname: Jirasiritham
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001835:Body Weight; D016903:Drug Monitoring / Q000379:methods; D005965:Glucuronates / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D020719:Glucuronides; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology*; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D013608:Tablets, Enteric-Coated
chemical_list: D005965:Glucuronates; D020719:Glucuronides; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; C113145:mycophenolic acid glucuronide; D009173:Mycophenolic Acid