PMID- 28660366
OWN - NLM
STAT- MEDLINE
DCOM- 20180612
LR  - 20180612
IS  - 1432-198X (Electronic)
IS  - 0931-041X (Linking)
VI  - 32
IP  - 11
DP  - 2017 Nov
TI  - Nationwide conversion to generic tacrolimus in pediatric kidney transplant
      recipients.
PG  - 2125-2131
LID - 10.1007/s00467-017-3707-3 [doi]
AB  - BACKGROUND: Bioequivalence between Tacrolimus Prograf(R) and generic tacrolimus
      formulations has been demonstrated in adult populations, however clinical
      experience and safety data regarding generic tacrolimus in pediatric transplant
      recipients is limited. This study aimed to evaluate conversion from Tacrolimus
      Prograf(R) to Sandoz(R) in pediatric renal transplant recipients nationwide. The 
      primary outcome was a change in mean trough tacrolimus concentration.
      Additionally, changes in tacrolimus intra-patient coefficient of variation (CoV),
      allograft function, requirement for dose adjustments, and episodes of
      biopsy-proven rejection were evaluated. METHODS: Retrospective cohort study in 37
      pediatric renal transplant recipients who switched to Tacrolimus Sandoz(R). Each 
      patient had three pre-conversion tacrolimus trough and creatinine concentrations 
      within the 4 months prior and three post-conversion concentrations on day 3, 10, 
      and the next subsequent level. Mean pre- and post-conversion tacrolimus trough
      concentrations and glomerular filtration rate (eGFR) were calculated. Tacrolimus 
      concentration, CoV, and creatinine differences were compared by paired t test.
      RESULTS: Thirty-seven patients (41% females, age 3-18 years) were included.
      Average intra-patient difference in trough tacrolimus concentration was 0.05mug/l
      (95% CI -0.37 to 0.47). Average intra-patient difference in eGFR was -1.20
      ml/min/1.73(2) (95% CI -3.53 to 1.13). Three patients had acute rejection during 
      12 months post-conversion compared to none during 12 months pre-conversion.
      CONCLUSIONS: Pediatric renal transplant recipients can be converted from
      Tacrolimus Prograf(R) to Sandoz(R) with negligible change in trough
      concentration, dose adjustments, or immediate allograft function. Of concern was 
      the number of acute rejection episodes, however non-adherence contributed to at
      least one episode and this difference was determined clinically and statistically
      not significant.
FAU - Naicker, Derisha
AU  - Naicker D
AUID- ORCID: http://orcid.org/0000-0003-0005-1337
AD  - Department of Pediatric Nephrology, Starship Children's Hospital, Park Road,
      Private Bag 92024, Auckland, 1142, New Zealand. n_derisha@hotmail.com.
FAU - Reed, Peter W
AU  - Reed PW
AD  - Children's Research Centre, Starship Children's Hospital, Auckland, New Zealand.
FAU - Ronaldson, Jane
AU  - Ronaldson J
AD  - Department of Pediatric Nephrology, Starship Children's Hospital, Park Road,
      Private Bag 92024, Auckland, 1142, New Zealand.
FAU - Kara, Tonya
AU  - Kara T
AD  - Department of Pediatric Nephrology, Starship Children's Hospital, Park Road,
      Private Bag 92024, Auckland, 1142, New Zealand.
FAU - Wong, William
AU  - Wong W
AD  - Department of Pediatric Nephrology, Starship Children's Hospital, Park Road,
      Private Bag 92024, Auckland, 1142, New Zealand.
FAU - Prestidge, Chanel
AU  - Prestidge C
AD  - Department of Pediatric Nephrology, Starship Children's Hospital, Park Road,
      Private Bag 92024, Auckland, 1142, New Zealand.
LA  - eng
PT  - Journal Article
DEP - 20170628
PL  - Germany
TA  - Pediatr Nephrol
JT  - Pediatric nephrology (Berlin, Germany)
JID - 8708728
RN  - 0 (Drugs, Generic)
RN  - 0 (Immunosuppressive Agents)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Cohort Studies
MH  - Drugs, Generic/*administration & dosage/adverse effects
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Graft Rejection/epidemiology
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects/blood
MH  - Kidney Transplantation/*adverse effects
MH  - Male
MH  - Retrospective Studies
MH  - Tacrolimus/*administration & dosage/adverse effects/blood
MH  - Transplant Recipients/*statistics & numerical data
OTO - NOTNLM
OT  - Calcineurin inhibitor
OT  - Generic
OT  - Immunosuppression
OT  - Renal
OT  - Tacrolimus
OT  - Transplantation
EDAT- 2017/07/01 06:00
MHDA- 2018/06/13 06:00
CRDT- 2017/06/30 06:00
PHST- 2016/12/24 00:00 [received]
PHST- 2017/05/15 00:00 [accepted]
PHST- 2017/05/13 00:00 [revised]
PHST- 2017/07/01 06:00 [pubmed]
PHST- 2018/06/13 06:00 [medline]
PHST- 2017/06/30 06:00 [entrez]
AID - 10.1007/s00467-017-3707-3 [doi]
AID - 10.1007/s00467-017-3707-3 [pii]
PST - ppublish
SO  - Pediatr Nephrol. 2017 Nov;32(11):2125-2131. doi: 10.1007/s00467-017-3707-3. Epub 
      2017 Jun 28.