Background:

Tacrolimus in infants has been administered as an extemporaneously compounded oral liquid made by hospital pharmacy. Modigraf ® is a new tacrolimus formulation available as sachets containing granules (0.2 mg and 1 mg), that are made up with water, prepared by parents or caregivers. Modigraf ® is considered at least as safe and practical than the compounded oral tacrolimus liquid. Furthermore, it is easier to be stored and ready to use, and promotes patient´s autonomy, preventing potential medication errors.

Purpose:

9 kidney transplanted infants, 3 “de-novo” and 6 converted from oral liquid to Modigraf® were evaluated to assess its safety and adequate dose.

Patients and methods:

After induction with Basiliximab or ATG, “de novo” 3 patients were treated with Modigraf® associated with MMF and with tapered steroids. 6 infants with similar immunosuppression regimen were converted from oral tacrolimus to Modigraf®. Target tacrolimus through level was 8-10 ng/ml. Mean patients’ age at transplantation was 2.2 years old, and mean follow-up period with Modigraf® was 10±8 months.

Results:

In the “de-novo” group the stable Modigraf® dose needed to reach target levels was 0.28± 0.12 mg/kg/day. In the converted group, the initial oral tacrolimus liquid dose was 0.20± 0.12 mg/kg/day, whereas Modigraf® stable required dose was higher: 0.30± 0.10 mg/kg/day (p =0.0003). Target levels of tacrolimus were reached after 7±2 Modigraf® administration days in the converted group. In the whole series, mean creatinine level was 0.7±0.5 mg/dl throughout the observational period, and no rejection episodes were detected. Blood pressure was well controlled and no proteinuria was seen. The equivalent dose ratio between Modigraf® and liquid tacrolimus was 1.28.

Comment:

Modigraf® appears to be a safe and sustainable way to administer tacrolimus in kidney transplanted infants. In our experience required Modigraf® dose was 1.28 times the oral liquid tacrolimus one, and therapeutic levels were attained in one week.

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