Ciclosporin and tacrolimus therapeutic drug monitoring in pediatric renal transplant : A retrospective study of the tunisian National Centre of Pharmacovigilance

[Speaker] Mehdi Bouhlel:1
[Co-author] Emna Gaies:1, Rim Charfi:1, Mouna Ben Sassi:1, Issam Salouage:1, Sameh Trabelsi:1, Riadh Daghfous:1
1:Clinical Pharmacology department, National Centre of Pharmacovigilance, Tunisia

Ciclosporin (CsA) and Tacrolimus (TAC) are an immunosuppressant widely prescribed in kidney transplantation characterized by inter and intra-individual variability in its pharmacokinetics. Therapeutic drug monitoring is often performed by measuring trough concentrations (C0) to individually adjust the dosage.
The aim of this work is to study the evolution of C0 and its relationship with CsA and TAC doses over time in renal transplant patients under 16 years of age.
This is a retrospective study of kidney transplant recipients under 16 years old.
For CsA, we collected 37 samples from 17 patients. Therapeutic Interval (TI): Acute Phase [150-300 ng / mL], Chronic Phase [100-200 ng / mL]
We have two groups, group 1 (from D0 to D42 days post transplant) and group 2 (> J42 days post transplant).
For TAC, we collected 117 samples from 42 patients. TI: acute phase [10-15 ng / mL], chronic phase [5-10 ng / mL]
We have three groups, group 1 (from D0 to D42 days post transplant), group 2 (D42 to 6 months (M) post transplant) and group 3 (> 6 M).
The C0 measurement of CsA and TAC was made by an enzyme immunoassay technique
The age of our patients ranges from 3 days to 15 years with a median of 12 years for CsA and from 5 months to 15 years with a median of 12 years for TAC. The average dose of CsA is 155 mg / day in the 1st group and 163 mg / day in the 2nd group and for the TAC it is 5.65 mg / day for group 1, 5.47 mg / day for group 2 and 3.90 mg / day for group 3.
Our results showed that there is no correlation between CsA C0 and dose in both groups and no correlation between TAC C0 and dose in the 3 groups with a considerable proportion of C0 that is out of the therapeutic interval in all the groups.
The lack of correlation between doses and concentrations and the presence of concentrations outside the therapeutic range justify the benefit of individual dosage adjustment.

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