Transition from brand to generic tacrolimus is associated with a decrease in trough blood concentration in pediatric heart transplant recipients.
There are limited data available on the bioequivalence of generic and brand-name tacrolimus in pediatric and heart transplant patients. We characterized changes in 12-hour trough concentrations and clinical outcomes after transition from brand to generic tacrolimus in pediatric thoracic organ transplant recipients. Patients with a pharmacy-confirmed date of switch between generic and brand tacrolimus were identified, as well as a matched control group that did not switch for comparison. We identified 18 patients with a confirmed date of switch, and in 12 patients that remained on the same dose, trough concentrations were 14% less than when they were on brand (p = 0.037). The average change was -1.15 ± 1.76 ng/mL (p = 0.045). The control group did not experience a change in trough concentration and was different than the switched group (p = 0.005). There were no differences in dosage changes or kidney or liver function. In the year after switch, 24% of patients who were switched to generic experienced a rejection event vs. 18% in the patients on brand. We suggest a strategy of monitoring around the time of transition, and education of the patient/family to notify the care team when changes from brand to generic or between generics occur.
Pediatric Cardiology, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.
Son Q
SQ
Duong
Pediatric Cardiology, Primary Children's Hospital, Salt Lake City, UT, USA.
Ashwin K
AK
Lal
Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA.
Rujuta
R
Joshi
Pediatric Cardiology, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA.|Clinical and Translational Science, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Brian
B
Feingold
Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA.|Department of Pathology, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.|Thomas Starzl Transplant Institute, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Raman
R
Venkataramanan
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D057915:Drug Substitution; D016568:Drugs, Generic / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D016014:Linear Models; D008297:Male; D012189:Retrospective Studies; D016559:Tacrolimus / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D055815:Young Adult
D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus
cardiac transplantation; heart-lung; immunosuppressive treatment; pediatrics; tacrolimus