Efficacy and pharmacokinetics of tacrolimus oral suspension in pediatric liver transplant recipients.
The use of tacrolimus in small pediatric graft recipients may require the availability of a suspension formulation for appropriate dose titration and easier administration. The pharmacokinetics (Pk) of an extemporaneously prepared oral suspension of tacrolimus (OST) was investigated in 15 pediatric liver transplant recipients, and was compared with the corresponding data with tacrolimus capsules (TC). Graft and patient survival rates were 100%. Acute rejection and steroid-resistant rejection were encountered in 9/15 and 3/15 patients, respectively. Comparison of Pk data showed a lower oral absorption of OST when compared with TC. No significant correlation could be made between the Pk parameters and rejection. Despite the lower bioavailability of OST when compared with TC, the rejection incidence was similar with both formulations (60% vs. 55%, respectively). Accordingly, the use of OST may constitute an alternative option for tacrolimus administration in low body weight organ recipients, to allow dosage titration in the early post-transplant weeks.
Reding
Raymond
R
Pediatric Liver Transplant Program andHospital Pharmacy, Saint-Luc University Clinics, Université Catholique de Louvain, Brussels, Belgium. reding@chex.ucl.ac.be
Sokal
Etienne
E
Paul
Killick
K
Janssen
Magda
M
Evrard
Veerle
V
Wilmotte
Léon
L
Chardot
Christophe
C
Otte
Jean-Bernard
JB
Wallemacq
Pierre
P
D000284:Administration, Oral; D002214:Capsules / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D016031:Liver Transplantation / Q000276:immunology*; D008297:Male; D010372:Pediatrics / Q000379:methods; D013535:Suspensions / Q000008:administration & dosage; D016559:Tacrolimus / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D014181:Transplantation Immunology / Q000187:drug effects*; D016896:Treatment Outcome
D002214:Capsules; D007166:Immunosuppressive Agents; D013535:Suspensions; D016559:Tacrolimus