title: Conversion from Brand-Name Neoral to the Generic Ciqorin in Stable Renal Transplant Recipients.
abstract: OBJECTIVE
  Transplant physicians and patients are often reluctant to change to generic versions of immunosuppressive drugs with a narrow therapeutic index, such as ciclosporin (CsA). Thus, in routine follow-up for kidney transplant patients receiving CsA maintenance immunosuppressive therapy in our center, we evaluated the exchangeability of the brand name, Neoral, and the recently approved CsA generic formulation, Ciqorin.
  
  
  METHODS
  We assessed the complete 12-h CsA pharmacokinetic profile and direct measurement of glomerular filtration rate (mGFR) of 10 patients receiving stable doses of Neoral (138 ± 43 mg/day), at least 6 months after kidney transplantation (Neoral 1). The same evaluations were repeated 10 days after conversion to Ciqorin on a milligram-to-milligram basis and 10 days after reinstituting Neoral (Neoral 2).
  
  
  RESULTS
  The mean CsA area under the concentration-time curve increased slightly after switching from Neoral to Ciqorin (p = 0.03), but did not change significantly after Neoral was reintroduced (Neoral 1: 2,234 ± 783, Ciqorin: 2,452 ± 767, Neoral 2: 2,472 ± 784 ng × h/mL). There were no appreciable differences between the 2 CsA formulations in trough levels, maximum concentrations, or time to reach maximum concentrations. In all patients, renal function remained stable throughout the monitoring period (mGFR, Neoral 1: 52.0 ± 16.2; Ciqorin: 55.0 ± 19.0; Neoral 2: 55.8 ± 18.9 mL/min/1.73 m2), as did urinary and hematochemical parameters.
  
  
  CONCLUSIONS
  In stable kidney transplant recipients, switching from Neoral to Ciqorin resulted in similar pharmacokinetic parameters and did not change renal allograft function, reassuring physicians and patients regarding the exchangeability of reference and generic CsA formulations.
authors.affiliation: Clinical Research Center for Rare Diseases Aldo and Cele Daccò, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Bergamo, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Cortinovis
authors.forename: Eliana
authors.initials: E
authors.lastname: Gotti
authors.forename: Matias
authors.initials: M
authors.lastname: Trillini
authors.forename: Fabiola
authors.initials: F
authors.lastname: Carrara
authors.forename: Flavio
authors.initials: F
authors.lastname: Gaspari
authors.forename: Piero
authors.initials: P
authors.lastname: Ruggenenti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
authors.forename: Norberto
authors.initials: N
authors.lastname: Perico
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D016572:Cyclosporine / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004339:Drug Compounding; D016903:Drug Monitoring; D016568:Drugs, Generic / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D066027:Transplant Recipients
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016572:Cyclosporine