title: Pilot study on the efficacy and safety of generic mycophenolate mofetil (Mycept) compared with Cellcept among incident low-risk primary kidney transplant recipients.
abstract: OBJECTIVE
  The aim of this study was to establish the efficacy and safety of generic mycophenolate mofetil (Mycept) and determine the bioequivalence with Cellcept. This will provide patients an alternative cost-effective option that may improve compliance and long-term outcome.
  
  
  METHODS
  This was a comparative study between 2 nonconcurrent matched groups on Mycept and Cellcept. A total of 56 patients were included based on criteria (20 incidental patients on Mycept, matched to 20 historical patients on Cellcept, and 16 additional incidental patients on Cellcept). Patient and graft survival and safety parameters were reviewed at 6 months. Bioequivalence of Mycept with Cellcept was done by measuring area under the curve (AUC) of mycophenolic acid (MPA), maximum concentration, and time to maximum concentration for 16 patients in each group.
  
  
  RESULTS
  Twenty incidental Mycept patients completed 6 months of follow-up. No significant difference was observed in survival (P = 1.0), graft function (P = .2320), and rejection episodes (P = .6250) between groups. The most common side effect of Mycept was hematologic and infectious. The MPA AUC of Mycept (37.38 ng/mL) was within the recommended MPA of 30-60 ng/mL. The maximum concentration (6.06 ng/mL) and time to maximum concentration (1.19 hours) of the 10 Mycept patients were not significantly different from the 10 Cellcept patients.
  
  
  CONCLUSIONS
  There was no proven statistically significant difference between Mycept and Cellcept in efficacy and graft survival at 6 months after kidney transplantation. Hematologic side effects were noted more frequently among patients on Mycept and monitoring regularly is recommended.
authors.affiliation: Department of Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
authors.forename: R A
authors.initials: RA
authors.lastname: Danguilan
authors.affiliation: Department of Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
authors.forename: A B
authors.initials: AB
authors.lastname: Lamban
authors.affiliation: Department of Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines. Electronic address: cher_alaine@yahoo.com.
authors.forename: C A C
authors.initials: CA
authors.lastname: Luna
authors.affiliation: Department of Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
authors.forename: M
authors.initials: M
authors.lastname: Bacinillo
authors.affiliation: Department of Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.
authors.forename: M I C
authors.initials: MI
authors.lastname: Momongan
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D016568:Drugs, Generic; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D010865:Pilot Projects; D018570:Risk Assessment; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid