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 Popescu4ABDEDOI: 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
In Press
Original article
Effect of Dexmedetomidine Combined with Remifentanil on Emergence Agitation During Awakening from Sevoflura...Ann Transplant In Press; DOI: 10.12659/AOT.943281
Review article
Alternative Therapies in Transplantology as a Promising Perspective in MedicineAnn Transplant In Press; DOI: 10.12659/AOT.943387
Original article
Physical Activity Levels in Transplant RecipientsAnn Transplant In Press; DOI: 10.12659/AOT.944101
Original article
Implementation and Evaluation of Discharge Planning for Patients Undergoing Umbilical Cord Blood Transplant...Ann Transplant In Press; DOI: 10.12659/AOT.943770
Most Viewed Current Articles
05 Apr 2022 : Original article
Impact of Statins on Hepatocellular Carcinoma Recurrence After Living-Donor Liver TransplantationDOI :10.12659/AOT.935604
Ann Transplant 2022; 27:e935604
12 Jan 2022 : Original article
Risk Factors for Developing BK Virus-Associated Nephropathy: A Single-Center Retrospective Cohort Study of ...DOI :10.12659/AOT.934738
Ann Transplant 2022; 27:e934738
22 Nov 2022 : Original article
Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipient...DOI :10.12659/AOT.937988
Ann Transplant 2022; 27:e937988
15 Mar 2022 : Case report
Combined Liver, Pancreas-Duodenum, and Kidney Transplantation for Patients with Hepatitis B Cirrhosis, Urem...DOI :10.12659/AOT.935860
Ann Transplant 2022; 27:e935860