title: Comparison of generic tacrolimus and Prograf drug levels in a pediatric kidney transplant program: brief communication.
abstract: A generic version of tacrolimus was approved for use in the USA in August 2009. These narrow therapeutic index generics are tested for bioequivalence only in adults. No data are available on generic tacrolimus levels in children with allografts. Four patients with stable renal allografts in our pediatric program were inadvertently switched to generic tacrolimus. We retrospectively analyzed pre- and post-switch trough tacrolimus and serum creatinine levels. Twelve-h trough tacrolimus levels (mean ± s.e.) were (i) patient 1 (12-yr-old girl): 7.0 ± 0.69 and 9.7 ± 3.5 (p =NS); (ii) patient 2 (eight-yr-old boy): 4.7 ± 0.68 and 3.4 ± 0.84 (p = 0.04); (iii) patient 3 (22-yr-old woman): 6.8 ± 0.17 and 6.6 ± 0.4 (p = NS); (iv) patient 4 (20-yr-old woman): 5.4 ± 0.25 and 4.9 ± 1.4 (p = NS). Creatinine levels were similar pre- and post-switch (eGFR > 75 mL/min/1.73 m²) in the first three. Patient 4 experienced a biopsy proven acute rejection immediately after switching. Mean creatinine rose from 1.15 ± 0.05 to 2.168 ± 0.07 after switch (p < 0.001). Given our mixed picture with the early data, we suggest careful monitoring of pediatric patients who get switched to generic tacrolimus.
authors.affiliation: Division of Pediatric Nephrology, Shands Children's Hospital and University of Florida College of Medicine, Gainesville, FL, USA.
authors.forename: Husam A
authors.initials: HA
authors.lastname: Abdulnour
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Araya
authors.forename: Vikas R
authors.initials: VR
authors.lastname: Dharnidharka
mesh_terms: D019540:Area Under Curve; D002648:Child; D003404:Creatinine / Q000097:blood; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood / Q000627:therapeutic use*; D016030:Kidney Transplantation; D008297:Male; D012189:Retrospective Studies; D016559:Tacrolimus / Q000097:blood / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D003404:Creatinine; D016559:Tacrolimus