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.
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.
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.
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.
To cite this abstract in AMA style:Vilalta R, Lara E, Madrid A, Muñoz M, Chocron S, Ariceta G, Vilalta R. Tacrolimus Granules Use in Kidney Transplanted Infants. Dose and Safety [abstract]. Am J Transplant. 2013; 13 (suppl 5). http://atcmeetingabstracts.com/abstract/tacrolimus-granules-use-in-kidney-transplanted-infants-dose-and-safety/. Accessed January 17, 2018.
« Back to 2013 American Transplant Congress