Real-world utilization and acceptance of tacrolimus-based immunosuppression in solid organ transplant recipients in India


  • Lav Patel Medical Affairs, Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
  • Shreekant Sharma Medical Affairs, Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India
  • Deepak Bunger Medical Affairs, Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India



Tacrolimus, Immunosuppression, Transplant, KT, LT


Background: The objectives of the study were to describe the demographics and utilization pattern of tacrolimus (TAC)-based immunosuppressive regimens in recipients with solid organ transplant in India.

Methods: This real-world, multicenter (134 centers), retrospective analysis included data of solid organ transplant recipients between 2010 and 2022 who had received TAC-based immunosuppressive therapy. The study data was collected between April 2021 and March 2022.

Results: Data of a total of 1022 recipients with kidney transplant (KT, n=899) or liver transplant (LT, n=123) who received TAC-based immunosuppression was analyzed. The mean age of recipients among KT and LT was 41.04±10.62 and 42.88±11.32 years, respectively. The most common diseases leading to end stage organ failure were diabetes (24.7%), hypertension (15.8%), concomitant diabetes and hypertension (14.9%), chronic kidney disease (9.2%), nephrotic syndrome (5%), and end stage renal disease (ESRD, 4.4%) in KT recipients, whereas for LT, the common indications were liver cirrhosis (32.5%), hepatitis B viral infection (11.4%), alcoholic liver disease (10.6%), fatty liver disease (12, 9.8%) and non-alcoholic steatohepatitis (NASH, 5.7%). The source of transplant was living donor in majority of both KT (91.2%) and LT (77.2%) recipients. The most common induction regimen in KT was anti-thymocyte globulin (ATG), TAC, mycophenolate mofetil (MMF), and steroid (ATG+TAC+MMF+steroid, 42.3%) whereas in LT, it was TAC+MMF+steroid (67.5%); TAC+MMF+steroid was most common maintenance regimen (KT: 91.1%, LT: 78%).

Conclusions: Tacrolimus-based immunosuppression is widely used in the recipients of solid organ transplantation, including KT or LT in real‑world clinical practice in India.


Ramesh V, Pal C. Organ Donation and Transplantation in India in 2019. Exp Clini Transplantation. 2021;19:1313-21.

Grinyó JM. Why is organ transplantation clinically important? Cold Spring Harbor perspectives Med. 2013;3.

Health Resources and Service Administration, USA. Organ Donation Statistics. Available at: Accessed on 25 September, 2022.

Enderby C, Keller CA. An overview of immunosuppression in solid organ transplantation. Am J Managed car. 2015;21:s12-23.

Prograf (tacrolimus). Northbrook, IL: Astellas Pharma US. 2013.

Mathew P, Mandal J, Patel K, Soni K, Tangudu G, Patel R et al. Bioequivalence of two tacrolimus formulations under fasting conditions in healthy male subjects. Clin Therap. 2011;33:1105-19.

Shroff S. Current trends in kidney transplantation in India. Ind J Urol. 2016;32:173-4.

Directorate General of Health Services. National Organ Transplant Programme. Available at: Accessed on 25 September, 2022.

Narasimhan G, Kota V, Rela M. Liver transplantation in India. Liver Transplantation. 2016;22:1019-24.

Jha VK, Mahapatra D, Jairam A, Singh V. Demographic Characteristics, Outcome and Complications of Renal Transplantations at a Tertiary Care Center in South India. J Asso Physicians Ind. 2021;69:28-31.

Kelly D, Sibal A. Current status of liver transplantation. Ind J Pediatr. 2003;70:731-6.

Finotti M, Auricchio P, Vitale A, Gringeri E, Cillo U. Liver transplantation for rare liver diseases and rare indications for liver transplant. Translational Gastroenterol Hepatol. 2021;6:27.

Adam R, Karam V, Cailliez V, JG OG, Mirza D, Cherqui D et al. 2018 Annual Report of the European Liver Transplant Registry (ELTR) - 50-year evolution of liver transplantation. Transplant Int. 2018;31:1293-317.

Hellemans R, Bosmans JL, Abramowicz D. Induction Therapy for Kidney Transplant Recipients: Do We Still Need Anti-IL2 Receptor Monoclonal Antibodies? Am J Transplantation. 2017;17:22-7.

Adam R, Karam V, Delvart V, Trunečka P, Samuel D, Bechstein WO et al. Improved Survival in Liver Transplant Recipients Receiving Prolonged-Release Tacrolimus in the European Liver Transplant Registry. Am J Transplantation. 2015;15:1267-82.

Wiseman AC. Induction Therapy in Renal Transplantation: Why? What Agent? What Dose? We May Never Know. Clin J Am Society Nephrol. 2015;10:923-5.






Original Research Articles