1. Extended Comparison of Therapeutic Treatment Outcomes of de novo Liver and Kidney Transplant Recipients with Generic Tacrolimus (Sandoz™) or Brand Name (Prograf®)
Seth Heldenbrand, Pharm.D.1, Gavin D. Jones, Ph.D.2, Joshua Bornhorst, Ph.D.3, Nalin Payakachat, Ph.D.1
(1) Background and Importance
(4) Average Tacrolimus Levels and Doses for All Recipients
(7) Statistical Analysis
Tacrolimus (FK 506), a calcineurin inhibitor, is the cornerstone to most immunosuppressant regimens for solid organ transplant recipients. Multiple generic-FK formulations are now available in the U.S., but data regarding their therapeutic outcomes are lacking in de novo transplant recipients. Given its importance in immunosuppressive regimens, such data are needed to make comparisons between brand-FK and generic-FK formulations over prolonged periods following liver and kidney transplantation.
The purpose of this study was to compare the therapeutic equivalence of generic-FK (Sandoz™) to brand-FK (Prograf®) in de novo liver and kidney recipients. We hypothesize that patients initiated and maintained on generic-FK will have similar therapeutic outcomes as those who received brand-FK.
Data from 55 recipients were analyzed with 27 receiving generic-FK and 28 receiving brand-FK.
Biopsy proven rejection rates were not statistically different.
7.4% (n=2) generic-FK
7.1% (n=2) brand-FK
Week 2 after initiation of FK, the mean concentrations (p=0.014) and dosages (p=0.051) were significantly higher for generic-FK.
Month 1 after initiation of FK, the mean generic-FK dosages were significantly higher (p=0.002).
Month 2 after initiation of FK, mean concentrations (p=0.03) and dosages (p=0.03) were significantly higher for generic-FK.
Month 3 after initiation of FK, mean concentrations and dosages were statistically similar.
(8) Implications of Results
(2) Materials and Methods
Compared to brand-FK, in de novo liver and kidney recipients the 3- month clinical outcome (rejection episodes) and the ability to achieve and maintain therapeutic concentrations were similar with the use of generic-FK.
While further study is needed to assess longer-term outcomes, these data suggest generic-FK substitution appears to be an attractive initial therapeutic option for de novo liver and kidney transplant recipients.
Generic-FK is safe and effective alternative in both liver and kidney recipients.
(5) Average Tacrolimus Levels and Doses for Liver Recipients
Single-center historical control observational study
February July 2011 transplant recipients received brand-FK
June October 2010 transplant recipients received generic-FK
Tacrolimus levels (ng/mL) drawn and analyzed at UAMS
UAMS electronic medical records were utilized to assess FK dosages (mg/kg/day) and therapeutic levels (ng/mL) at time points: 2-3 days, 2 weeks, and 1-3 months
Logistic regression was used to determine if there was significant differences of rejection events between generic and brand name.
(3) Recipient Demographics
(9) Acknowledgements and Disclosure
Mean (± SD)
Range
Frequency (%)
Liver Recipients (n = 21)
Brand Name Cohort (n = 10)
48.0
Generic Cohort (n = 11)
52.0
Recipient age (years)
54 (9)
32 – 68
Recipient mass (kg)
92.8 (15.0)
67.7 – 123.1
Gender
Female (n = 5)
23.8
Male (n = 16)
76.2
Race
Caucasian (n = 21)
100
Days until discharge
7.4 (5.9)
3 – 30
Kidney Recipients (n = 34)
Brand Name Cohort (n = 18)
53.0
Generic Cohort (n = 16)
47.0
52 (14)
19 – 77
81.5 (15.3)
53.1 – 123.9
Female (n = 13)
38.2
Male (n = 21)
61.8
African American (n = 7)
20.6
Asian (n = 1)
2.9
Caucasian (n = 25)
73.6
Hispanic (n = 1)
6.0 (3.2)
3 – 16
Protocol approved through the Institutional Review Board (IRB) of UAMS (IRB ).
GDJ was funded by the 2011 UAMS College of Pharmacy Summer Research Fellowship.
The authors have no financial relationships to disclose within the past 12 months relevant to this poster presentation.
(6) Average Tacrolimus Levels and Doses for Kidney Recipients
(10) Author Information
Pharmacy Practice, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Pathology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States