Abstract
Pediatric liver transplant recipients constitute a population characterized by a particularly unpredictable and poor bioavailability of cyclosporin (CyA). Even though several adult studies show that the new oral formulation of CyA, Neoral (NEO), produces better bioavailability and blood level predictability, few data describe its pharmacokinetics in children. We performed a complete analysis of the pharmacokinetics of NEO in ten small children after primary liver transplantation. Three pharmacokinetic profiles were set up with data obtained from tests taken during i.v. administration of CyA, after the first oral NEO dose, and after the last NEO dose before discharge from the hospital. The mean half-lives obtained were 8.1, 7.7, and 6.9 h, respectively, and the bioavailabilities were 22% and 21% for the first and last NEO doses. A large interpatient variability was observed. This was due, in part, to episodes of diarrhea that interfered with the pharmacokinetic evaluation and, in part, to the variability of post-transplant hepatic function. There was a good correlation between CyA trough levels and their related AUCs for both NEO profiles (r = 0.93 and r = 0.74, respectively). We conclude that, even though the pediatric OLT population remains more unpredictable than that of adults, NEO has a relatively rapid half-life and a remarkably improved bioavailability.
| Original language | English |
|---|---|
| Pages (from-to) | 466-470 |
| Number of pages | 5 |
| Journal | Transplant International |
| Volume | 10 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Nov 1997 |
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Keywords
- Liver transplantation, pediatric, Neoral
- Neoral, liver transplantation, pediatric
- Pediatric liver transplantation, Neoral, pharmacokinetics
- Pharmacokinetics, Neoral, pediatric liver transplantation
ASJC Scopus subject areas
- Transplantation
Cite this
Clinical pharmacokinetics of Neoral in pediatric recipients of primary liver transplants. / Wallemacq, Pierre E.; Reding, Raymond; Sokal, Etienne M.; De Goyet, Jean Ville De; De Clety, Stéphane Clement; Van Leeuw, Véronique; De Backer, Marc; Otte, Jean Bernard.
In: Transplant International, Vol. 10, No. 6, 11.1997, p. 466-470.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical pharmacokinetics of Neoral in pediatric recipients of primary liver transplants
AU - Wallemacq, Pierre E.
AU - Reding, Raymond
AU - Sokal, Etienne M.
AU - De Goyet, Jean Ville De
AU - De Clety, Stéphane Clement
AU - Van Leeuw, Véronique
AU - De Backer, Marc
AU - Otte, Jean Bernard
PY - 1997/11
Y1 - 1997/11
N2 - Pediatric liver transplant recipients constitute a population characterized by a particularly unpredictable and poor bioavailability of cyclosporin (CyA). Even though several adult studies show that the new oral formulation of CyA, Neoral (NEO), produces better bioavailability and blood level predictability, few data describe its pharmacokinetics in children. We performed a complete analysis of the pharmacokinetics of NEO in ten small children after primary liver transplantation. Three pharmacokinetic profiles were set up with data obtained from tests taken during i.v. administration of CyA, after the first oral NEO dose, and after the last NEO dose before discharge from the hospital. The mean half-lives obtained were 8.1, 7.7, and 6.9 h, respectively, and the bioavailabilities were 22% and 21% for the first and last NEO doses. A large interpatient variability was observed. This was due, in part, to episodes of diarrhea that interfered with the pharmacokinetic evaluation and, in part, to the variability of post-transplant hepatic function. There was a good correlation between CyA trough levels and their related AUCs for both NEO profiles (r = 0.93 and r = 0.74, respectively). We conclude that, even though the pediatric OLT population remains more unpredictable than that of adults, NEO has a relatively rapid half-life and a remarkably improved bioavailability.
AB - Pediatric liver transplant recipients constitute a population characterized by a particularly unpredictable and poor bioavailability of cyclosporin (CyA). Even though several adult studies show that the new oral formulation of CyA, Neoral (NEO), produces better bioavailability and blood level predictability, few data describe its pharmacokinetics in children. We performed a complete analysis of the pharmacokinetics of NEO in ten small children after primary liver transplantation. Three pharmacokinetic profiles were set up with data obtained from tests taken during i.v. administration of CyA, after the first oral NEO dose, and after the last NEO dose before discharge from the hospital. The mean half-lives obtained were 8.1, 7.7, and 6.9 h, respectively, and the bioavailabilities were 22% and 21% for the first and last NEO doses. A large interpatient variability was observed. This was due, in part, to episodes of diarrhea that interfered with the pharmacokinetic evaluation and, in part, to the variability of post-transplant hepatic function. There was a good correlation between CyA trough levels and their related AUCs for both NEO profiles (r = 0.93 and r = 0.74, respectively). We conclude that, even though the pediatric OLT population remains more unpredictable than that of adults, NEO has a relatively rapid half-life and a remarkably improved bioavailability.
KW - Liver transplantation, pediatric, Neoral
KW - Neoral, liver transplantation, pediatric
KW - Pediatric liver transplantation, Neoral, pharmacokinetics
KW - Pharmacokinetics, Neoral, pediatric liver transplantation
UR - http://www.scopus.com/inward/record.url?scp=0030844126&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0030844126&partnerID=8YFLogxK
U2 - 10.1007/s001470050088
DO - 10.1007/s001470050088
M3 - Article
VL - 10
SP - 466
EP - 470
JO - Transplant International
JF - Transplant International
SN - 0934-0874
IS - 6
ER -