title: Therapeutic monitoring of pediatric transplant patients with conversion to generic tacrolimus.
abstract: OBJECTIVE
  Therapeutic monitoring during interchange of tacrolimus commercial formulations is essential to ensure similar exposure in transplant patients. However, there are limited data in the pediatric transplant population. This study aims to evaluate exposure, safety and efficacy in maintenance pediatric transplant patients under generic tacrolimus substitution.
  
  
  METHODS
  Pediatric patients who underwent interchange of tacrolimus formulations were detected by the Service of Pharmacy and included in this study. Tacrolimus trough levels (C0), laboratory parameters and clinical characteristics were recorded before and after the switch. Statistical analysis was performed using Wilcoxon matched pair t-test.
  
  
  RESULTS
  In total, 10 patients with kidney, liver, heart and hematopoietic stem cell transplantation received the innovator and switched to the generic product. The median (range) of the C0 normalized by the dose before and after switch was 74.8 [(ng/ml)/(mg/kg)] (13.8-518.4) and 65.1 [(ng/ml)/(mg/kg)] (13.5-723.5), respectively (p&gt;0.05). Tacrolimus dose was 0.070(mg/kg) (0.024-0.461) and 0.069(mg/kg) (0.017- 0.571) for the innovator and generic formulation, respectively, with no difference when comparing both values (p&gt;0.05). Laboratory parameters did not change after conversion (p&gt;0.05). Adverse events, acute rejection, death and graft loss were not observed.
  
  
  CONCLUSIONS
  In our study population, no significant differences in terms of laboratory parameters, drug exposure and dose were observed. We emphasize the need of close monitoring to ensure a safe interchange, especially in vulnerable populations such as the pediatric.
authors.affiliation: Clinical Pharmacokinetics Department, J.P. Garrahan Children's Hospital, Buenos Aires.. nataliarivahg@gmail.com.
authors.forename: Natalia
authors.initials: N
authors.lastname: Riva
authors.affiliation: 1Clinical Pharmacokinetics Department, J.P. Garrahan Children's Hospital, Buenos Aires.. caceresguido@gmail.com.
authors.forename: Paulo
authors.initials: P
authors.lastname: Cáceres Guido
authors.affiliation: Drug Monitoring Laboratory, J.P. Garrahan Children's Hospital, Buenos Aires.. licciardonenieves@yahoo.com.ar.
authors.forename: Nieves
authors.initials: N
authors.lastname: Licciardone
authors.affiliation: Liver Transplant Unit, J.P. Garrahan Children's Hospital, Buenos Aires.. imventarzaoscar@gmail.com.
authors.forename: Oscar
authors.initials: O
authors.lastname: Imventarza
authors.affiliation: Kidney Transplant Unit, J.P. Garrahan Children's Hospital, Buenos Aires.. martamonteverde@gmail.com.
authors.forename: Marta
authors.initials: M
authors.lastname: Monteverde
authors.affiliation: Hematopoietic Stem Cell Transplant Unit, J.P. Garrahan Children's Hospital, Buenos Aires.. rstaciuk@gmail.com.
authors.forename: Raquel
authors.initials: R
authors.lastname: Staciuk
authors.affiliation: Intensive Care Unit 35, J.P. Garrahan Children's Hospital, Buenos Aires.. acharro@hotmail.com.ar.
authors.forename: Alberto
authors.initials: A
authors.lastname: Charroqui
authors.affiliation: Clinical Pharmacokinetics Department, J.P. Garrahan Children's Hospital, Buenos Aires. National Scientific and Technological Research Council (CONICET).. paula.schaiquevich@gmail.com.
authors.forename: Paula
authors.initials: P
authors.lastname: Schaiquevich
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D016568:Drugs, Generic; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D008991:Monitoring, Physiologic / Q000379:methods*; D016377:Organ Transplantation / Q000379:methods*; D012189:Retrospective Studies; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus