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14 May 2019 : Original article  

Pharmacokinetic Profile of Prolonged-Release Tacrolimus When Administered via Nasogastric Tube in De Novo Liver Transplantation: A Sub-Study of the DIAMOND Trial

Nasrullah Undre1ADE*, Umberto Baccarani2ABDE, Russel Britz3ABDE, Irinel Popescu4ABDE

DOI: 10.12659/AOT.909693

Ann Transplant 2019; 24:268-272

Abstract

BACKGROUND: For patients unable to swallow during the immediate post-transplant period, immunosuppressant therapy may be initiated by administering prolonged-release tacrolimus as a suspension via a nasogastric tube.

MATERIAL AND METHODS: In this sub-study of the DIAMOND randomized controlled trial of prolonged-release tacrolimus in de novo liver transplant recipients, we investigated the pharmacokinetic (PK) profile of prolonged-release tacrolimus when administered via nasogastric tube immediately post-transplant. PK analyses were performed on whole-blood samples collected on Day 1 of tacrolimus administration and on Day 3 post-transplantation. Endpoints included AUC0–24, Cmax, Tmax, and Cmin.

RESULTS: In total, 10 patients were included in the PK sub-study. The overall mean daily dose of prolonged-release tacrolimus administered via nasogastric tube was higher on Day 1 (0.179 mg/kg) vs. Day 3 (0.140 mg/kg). Mean AUC0–24 was higher and less variable on Day 3 vs. Day 1 (AUC0–24 (coefficient of variation; CV): 301 (50.8) vs. 193 (94.5) ng·h/mL). Mean Cmax was lower and median Tmax was shorter on Day 1 vs. Day 3 (Cmax (CV): 15.1 (73.9) vs. 19.1 (47.9) ng/mL; Tmax (range): 2.0 (2.0–24.0) vs. 4.5 (0.5–24.0) h). A similar pattern was also observed when data were normalized for dose and body weight.

CONCLUSIONS: In contrast to previously reported findings in healthy volunteers, nasogastric administration of prolonged-­release tacrolimus suspension in liver transplant patients did not substantially affect the PK profile of tacrolimus vs. intact capsules. Nasogastric administration is thus a feasible option to ensure appropriate early tacrolimus exposure in de novo liver transplant recipients.

Keywords: Delayed-Action Preparations, Immunosuppression, Liver Transplantation, Pharmacokinetics, Tacrolimus, Drug Administration Schedule, Immunosuppressive Agents, Intubation, Gastrointestinal

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Annals of Transplantation eISSN: 2329-0358
Annals of Transplantation eISSN: 2329-0358