title: The use of mycophenolate mofetil suspension in pediatric renal allograft recipients.
abstract: Mycophenolate mofetil (MMF) is widely used to prevent acute rejection in adults after renal, cardiac, and liver transplantation. This study investigated the safety, tolerability, and pharmacokinetics of MMF suspension in pediatric renal allograft recipients. One hundred renal allograft recipients were enrolled into three age groups (33 patients, 3 months to <6 years; 34 patients, 6 to <12 years; 33 patients, 12 to 18 years). Patients received MMF 600 mg/m2 b.i.d. concomitantly with cyclosporine and corticosteroids with or without antilymphocyte antibody induction. One year after transplantation, patient and graft survival (including death) were 98% and 93%, respectively. Twenty-five patients (25%) experienced a biopsy-proven (Banff grade borderline or higher) or presumptive acute rejection within the first 6 months post-transplantation. Analysis of pharmacokinetic parameters for mycophenolic acid (MPA) and mycophenolic acid glucuronide showed no clinically significant differences among the age groups. The dosing regimen of MMF 600 mg/m2 b.i.d. achieved the targeted early post-transplantation MPA 12-h area under concentration-time curve (AUC0-12) of 27.2 microg h per ml. Adverse events had similar frequencies among the age groups (with the exception of diarrhea, leukopenia, sepsis, and anemia, which were more frequent in the <6 years age group) and led to withdrawal of MMF in about 10% of patients. Administration of MMF 600 mg/m2 b.i.d. is effective in prevention of acute rejection, provides predictable pharmacokinetics, and is associated with an acceptable safety profile in pediatric renal transplant recipients.
authors.affiliation: University of Alabama at Birmingham, 1600 7th Avenue South, Suite 735, Birmingham, Alabama 35233, USA. Tbunchman@peds.uab.edu
authors.forename: T
authors.initials: T
authors.lastname: Bunchman
authors.forename: M
authors.initials: M
authors.lastname: Navarro
authors.forename: M
authors.initials: M
authors.lastname: Broyer
authors.forename: J
authors.initials: J
authors.lastname: Sherbotie
authors.forename: B
authors.initials: B
authors.lastname: Chavers
authors.forename: B
authors.initials: B
authors.lastname: Tönshoff
authors.forename: P
authors.initials: P
authors.lastname: Birk
authors.forename: G
authors.initials: G
authors.lastname: Lerner
authors.forename: D
authors.initials: D
authors.lastname: Lirenman
authors.forename: L
authors.initials: L
authors.lastname: Greenbaum
authors.forename: R
authors.initials: R
authors.lastname: Walker
authors.forename: L B
authors.initials: LB
authors.lastname: Zimmerhackl
authors.forename: D
authors.initials: D
authors.lastname: Blowey
authors.forename: G
authors.initials: G
authors.lastname: Clark
authors.forename: R
authors.initials: R
authors.lastname: Ettenger
authors.forename: S
authors.initials: S
authors.lastname: Arterburn
authors.forename: K
authors.initials: K
authors.lastname: Klamerus
authors.forename: A
authors.initials: A
authors.lastname: Fong
authors.forename: H
authors.initials: H
authors.lastname: Tang
authors.forename: S
authors.initials: S
authors.lastname: Thomas
authors.forename: E
authors.initials: E
authors.lastname: Ramos
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D007223:Infant; D016030:Kidney Transplantation; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013535:Suspensions; D014184:Transplantation, Homologous; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D013535:Suspensions; D009173:Mycophenolic Acid