Tacrolimus for the prevention and treatment of rejection of solid organ transplants

References

• Matas AJ, Smith JM, Skeans MA, et al. OPTN/SRTR 2012 Annual Data Report: kidney. Am J Transplant. 2014;14(Suppl 1):11–44.
   PubMed Web of Science ®Google Scholar
• Murray JE, Merrill JP, Harrison JH, et al. Prolonged survival of human-kidney homografts by immunosuppressive drug therapy. N Engl J Med. 1963;268:1315–1323.
   PubMed Web of Science ®Google Scholar
• Hariharan S, Johnson CP, Bresnahan BA, et al. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000;342(9):605–612.
   PubMed Web of Science ®Google Scholar
• Sykes M. Mechanisms of transplantation tolerance in animals and humans. Transplantation. 2009;87(9 Suppl):S67S69.
   Web of Science ®Google Scholar
• Kurtz J, Raval F, Vallot C, et al. CTLA-4 on alloreactive CD4 T cells interacts with recipient CD80/86 to promote tolerance. Blood. 2009;113(15):3475–3484.
   PubMed Web of Science ®Google Scholar
• Kawai T, Cosimi AB, Spitzer TR, et al. HLA-mismatched renal transplantation without maintenance immunosuppression. N Engl J Med. 2008;358(4):353–361.
   PubMed Web of Science ®Google Scholar
• Kawai T, Leventhal J, Madsen JC, et al. Tolerance: one transplant for life. Transplantation. 2014;98(2):117–121.
   PubMed Web of Science ®Google Scholar
• Wertheim JA, Leventhal JR. Clinical implications of basic science discoveries: induced pluripotent stem cell therapy in transplantation–a potential role for immunologic tolerance. Am J Transplant. 2015;15(4):887–890.
   PubMed Web of Science ®Google Scholar
• Leventhal JR, Mathew JM, Salomon DR, et al. Nonchimeric HLA-Identical Renal Transplant Tolerance: Regulatory Immunophenotypic/Genomic Biomarkers. Am J Transplant. 2015. [Epub ahead of print]
   Web of Science ®Google Scholar
• Calne RY, Wheeler JR, Hurn BA. Combined Immunosuppressive Action of Phytohaemagglutinin and Azathioprine (Imuran) on Dogs with Renal Homotransplants. Br Med J. 1965;2(5454):154–155.
   PubMed Web of Science ®Google Scholar
• Merion RM, White DJ, Thiru S, et al. Cyclosporine: five years’ experience in cadaveric renal transplantation. N Engl J Med. 1984;310(3):148–154.
   PubMed Web of Science ®Google Scholar
• Scalea JR, Butler CC, Munivenkatappa RB, et al. Pancreas transplant alone as an independent risk factor for the development of renal failure: a retrospective study. Transplantation. 2008;86(12):1789–1794.
   PubMed Web of Science ®Google Scholar
• Diekmann F. Immunosuppressive minimization with mTOR inhibitors and belatacept. Transpl Int. 2015;28(8):921–927.
   PubMed Web of Science ®Google Scholar
• Kesiraju S, Paritala P, Rao Ch UM, et al. New onset of diabetes after transplantation - an overview of epidemiology, mechanism of development and diagnosis. Transpl Immunol. 2014;30(1):52–58.
   PubMed Web of Science ®Google Scholar
• Balla A, Chobanian M. New-onset diabetes after transplantation: a review of recent literature. Curr Opin Organ Transplant. 2009;14(4):375–379.
   PubMed Web of Science ®Google Scholar
• Ojo AO, Held PJ, Port FK, et al. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003;349(10):931–940.
   PubMed Web of Science ®Google Scholar
• Prescott TA, Panaretou B, Veitch NC, et al. A yeast chemical genetics approach identifies the compound 3,4,5-trimethoxybenzyl isothiocyanate as a calcineurin inhibitor. FEBS Lett. 2014;588(3):455–458.
   PubMed Web of Science ®Google Scholar
• Prescott TA, Arino J, Kite GC, et al. Inhibition of human calcineurin and yeast calcineurin-dependent gene expression by Jasminum humile leaf and root extracts. J Ethnopharmacol. 2012;140(2):293–297.
   PubMed Web of Science ®Google Scholar
• Huang X, Xu B. Efficacy and Safety of Tacrolimus versus Pimecrolimus for the Treatment of Atopic Dermatitis in Children: A Network Meta-Analysis. Dermatology. 2015;231(1):41–49.
   PubMed Web of Science ®Google Scholar
• McAlister VC, Gao Z, Peltekian K, et al. Sirolimus-tacrolimus combination immunosuppression. Lancet. 2000;355(9201):376–377.
   PubMed Web of Science ®Google Scholar
• Martins L, Ventura A, Branco A, et al. Cyclosporine versus tacrolimus in kidney transplantation: are there differences in nephrotoxicity?. Transplant Proc. 2004;36(4):877–879.
   PubMed Web of Science ®Google Scholar
• Adamczak M, Gazda M, Gojowy D, et al. 3a.03: Hypertension in Patients after Liver Transplantation. J Hypertens. 2015;33(Suppl 1):e32.
   PubMedGoogle Scholar
• Nagib AM, Abbas MH, Abu-Elmagd MM, et al. Long-term study of steroid avoidance in renal transplant patients: a single-center experience. Transplant Proc. 2015;47(4):1099–1104.
   PubMed Web of Science ®Google Scholar
• Rostaing L, Vincenti F, Grinyo J, et al. Long-term belatacept exposure maintains efficacy and safety at 5 years: results from the long-term extension of the BENEFIT study. Am J Transplant. 2013;13(11):2875–2883.
   PubMed Web of Science ®Google Scholar
• Vincenti F, Larsen CP, Alberu J, et al. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant. 2012;12(1):210–217.
   PubMed Web of Science ®Google Scholar
• Masson P, Henderson L, Chapman JR, et al. Belatacept for kidney transplant recipients. Cochrane Database Syst Rev. 2014;11:CD010699.
   PubMed Web of Science ®Google Scholar
• Larsen CP, Grinyo J, Medina-Pestana J, et al. Belatacept-based regimens versus a cyclosporine A-based regimen in kidney transplant recipients: 2-year results from the BENEFIT and BENEFIT-EXT studies. Transplantation. 2010;90(12):1528–1535.
   PubMed Web of Science ®Google Scholar
• Grinyo J, Charpentier B, Pestana JM, et al. An integrated safety profile analysis of belatacept in kidney transplant recipients. Transplantation. 2010;90(12):1521–1527.
   PubMed Web of Science ®Google Scholar
• Goto T, Kino T, Hatanaka H, et al. Discovery of FK-506, a novel immunosuppressant isolated from Streptomyces tsukubaensis. Transplant Proc. 1987;19(5 Suppl 6):4–8.
   PubMed Web of Science ®Google Scholar
• Fung JJ. Tacrolimus and transplantation: a decade in review. Transplantation. 2004;77(9 Suppl):S41S43.
   Web of Science ®Google Scholar
• Kramer BK, Charpentier B, Backman L, et al. Tacrolimus once daily (ADVAGRAF) versus twice daily (PROGRAF) in de novo renal transplantation: a randomized phase III study. Am J Transplant. 2010;10(12):2632–2643.
   PubMed Web of Science ®Google Scholar
• Silva HT Jr., Yang HC, Abouljoud M, et al. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant. 2007;7(3):595–608.
   PubMed Web of Science ®Google Scholar
• Gaber AO, Alloway RR, Bodziak K, et al. Conversion from twice-daily tacrolimus capsules to once-daily extended-release tacrolimus (LCPT): a phase 2 trial of stable renal transplant recipients. Transplantation. 2013;96(2):191–197.
   PubMed Web of Science ®Google Scholar
• Alloway RR, Eckhoff DE, Washburn WK, et al. Conversion from twice daily tacrolimus capsules to once daily extended-release tacrolimus (LCP-Tacro): phase 2 trial of stable liver transplant recipients. Liver Transplant. 2014;20(5):564–575.
   PubMed Web of Science ®Google Scholar
• Beckebaum S, Iacob S, Sweid D, et al. Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice-daily tacrolimus-based regimen to once-daily tacrolimus extended-release formulation. Transpl Int. 2011;24(7):666–675.
   PubMed Web of Science ®Google Scholar
• Kino T, Hatanaka H, Hashimoto M, et al. FK-506, a novel immunosuppressant isolated from a Streptomyces. I. Fermentation, isolation, and physico-chemical and biological characteristics. J Antibiot (Tokyo). 1987;40(9):1249–1255.
   PubMed Web of Science ®Google Scholar
• Reynolds NJ, Al-Daraji WI. Calcineurin inhibitors and sirolimus: mechanisms of action and applications in dermatology. Clin Exp Dermatol. 2002;27(7):555–561.
   PubMed Web of Science ®Google Scholar
• Barbarino JM, Staatz CE, Venkataramanan R, et al. PharmGKB summary: cyclosporine and tacrolimus pathways. Pharmacogenet Genomics. 2013;23(10):563–585.
   PubMed Web of Science ®Google Scholar
• Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2004;43(10):623–653.
   PubMed Web of Science ®Google Scholar
• Christians U, Jacobsen W, Benet LZ, et al. Mechanisms of clinically relevant drug interactions associated with tacrolimus. Clin Pharmacokinet. 2002;41(11):813–851.
   PubMed Web of Science ®Google Scholar
• Paterson DL, Singh N. Interactions between tacrolimus and antimicrobial agents. Clin Infect Dis. 1997;25(6):1430–1440.
   PubMed Web of Science ®Google Scholar
• Fitzsimmons WE, Bekersky I, Dressler D, et al. Demographic considerations in tacrolimus pharmacokinetics. Transplant Proc. 1998;30(4):1359–1364.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Benet LZ. The gut as a barrier to drug absorption: combined role of cytochrome P450 3A and P-glycoprotein. Clin Pharmacokinet. 2001;40(3):159–168.
   PubMed Web of Science ®Google Scholar
• Macphee IA, Fredericks S, Tai T, et al. Tacrolimus pharmacogenetics: polymorphisms associated with expression of cytochrome p4503A5 and P-glycoprotein correlate with dose requirement. Transplantation. 2002;74(11):1486–1489.
   PubMed Web of Science ®Google Scholar
• Murase N, Todo S, Lee PH, et al. Heterotopic Heart Transplantation in the Rat Receiving FK-506 Alone or With Cyclosporine. Transplant Proc. 1987;19(5 Suppl 6):71–75.
   PubMed Web of Science ®Google Scholar
• Thiru S, Collier DS, Calne R. Pathological studies in canine and baboon renal allograft recipients immunosuppressed with FK-506. Transplant Proc. 1987;19(5 Suppl 6):98–99.
   PubMed Web of Science ®Google Scholar
• Todo S, Ueda Y, Demetris JA, et al. Immunosuppression of canine, monkey, and baboon allografts by FK 506: with special reference to synergism with other drugs and to tolerance induction. Surgery. 1988;104(2):239–249.
   PubMed Web of Science ®Google Scholar
• Todo S, Demetris A, Ueda Y, et al. Renal transplantation in baboons under FK 506. Surgery. 1989;106(2):444–450. discussion 450-441.
   PubMed Web of Science ®Google Scholar
• Starzl TE, Todo S, Fung J, et al. FK 506 for liver, kidney, and pancreas transplantation. Lancet. 1989;2(8670):1000–1004.
   PubMed Web of Science ®Google Scholar
• Todo S, Fung JJ, Demetris AJ, et al. Early Trials With FK 506 as Primary Treatment in Liver Transplantation. Transplant Proc. 1990;22(1):13–16.
   PubMed Web of Science ®Google Scholar
• Todo S, Fung JJ, Starzl TE, et al. Liver, kidney, and thoracic organ transplantation under FK 506. Ann Surg. 1990;212(3):295–305. discussion 306-297.
   PubMed Web of Science ®Google Scholar
• Starzl TE, Fung J, Jordan M, et al. Kidney Transplantation Under FK 506. Jama. 1990;264(1):63–67.
   PubMed Web of Science ®Google Scholar
• Japanese study of FK 506 on kidney transplantation: results of an early phase II study. Japanese FK 506 Study Group. Transplant Proc. 1991;23(6):3071–3074.
   PubMed Web of Science ®Google Scholar
• Japanese study of FK 506 on kidney transplantation: results of late phase II study. Transplant Proc. 1993;25(1 Pt 1):649–654.
   PubMed Web of Science ®Google Scholar
• Armitage JM, Kormos RL, Morita S, et al. Clinical Trial of FK 506 Immunosuppression in Adult Cardiac Transplantation. Ann Thorac Surg. 1992;54(2):205–211.
   PubMed Web of Science ®Google Scholar
• Shapiro R, Jordan M, Scantlebury V, et al. FK 506 in Clinical Kidney Transplantation. Transplant Proc. 1991;23(6):3065–3067.
   PubMed Web of Science ®Google Scholar
• Tzakis AG, Reyes J, Todo S, et al. FK 506 Versus Cyclosporine in Pediatric Liver Transplantation. Transplant Proc. 1991;23(6):3010–3015.
   PubMed Web of Science ®Google Scholar
• Fung J, Abu-Elmagd K, Jain A, et al. A Randomized Trial of Primary Liver Transplantation Under Immunosuppression With FK 506 vs Cyclosporine. Transplant Proc. 1991;23(6):2977–2983.
   PubMed Web of Science ®Google Scholar
• A comparison of tacrolimus (FK 506) and cyclosporine for immunosuppression in liver transplantation. The U.S. Multicenter FK506 Liver Study Group. N Engl J Med. 1994;331(17):1110–1115.
   PubMed Web of Science ®Google Scholar
• Randomised trial comparing tacrolimus (FK506) and cyclosporin in prevention of liver allograft rejection. European FK506 Multicentre Liver Study Group. Lancet. 1994;344(8920):423–428.
   PubMed Web of Science ®Google Scholar
• Naesens M, Kuypers DR, Sarwal M. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol. 2009;4(2):481–508.
   PubMed Web of Science ®Google Scholar
• Ramirez C, Olmo A, O’Valle F, et al. Role of intrarenal endothelin 1, endothelin 3, and angiotensin II expression in chronic cyclosporin A nephrotoxicity in rats. Exp Nephrol. 2000;8(3):161–172.
   PubMedGoogle Scholar
• Randhawa PS, Shapiro R, Jordan ML, et al. The histopathological changes associated with allograft rejection and drug toxicity in renal transplant recipients maintained on FK506. Clinical significance and comparison with cyclosporine. Am J Surg Pathol. 1993;17(1):60–68.
   PubMed Web of Science ®Google Scholar
• Evenepoel P, Van Den Bergh B, Naesens M, et al. Calcium metabolism in the early posttransplantation period. Clin J Am Soc Nephrol. 2009;4(3):665–672.
   PubMed Web of Science ®Google Scholar
• Palepu S, Prasad GV. New-onset diabetes mellitus after kidney transplantation: current status and future directions. World J Diabetes. 2015;6(3):445–455.
   PubMed Web of Science ®Google Scholar
• Kasiske BL, Snyder JJ, Gilbertson D, et al. Diabetes mellitus after kidney transplantation in the United States. Am J Transplant. 2003;3(2):178–185.
   PubMed Web of Science ®Google Scholar
• Woodward RS, Schnitzler MA, Baty J, et al. Incidence and cost of new onset diabetes mellitus among U.S. wait-listed and transplanted renal allograft recipients. Am J Transplant. 2003;3(5):590–598.
   PubMed Web of Science ®Google Scholar
• Vanrenterghem Y, Bresnahan B, Campistol J, et al. Belatacept-based regimens are associated with improved cardiovascular and metabolic risk factors compared with cyclosporine in kidney transplant recipients (BENEFIT and BENEFIT-EXT studies). Transplantation. 2011;91(9):976–983.
   PubMed Web of Science ®Google Scholar
• Hinchey J, Chaves C, Appignani B, et al. A reversible posterior leukoencephalopathy syndrome. N Engl J Med. 1996;334(8):494–500.
   PubMed Web of Science ®Google Scholar
• Wu G, Weng FL, Balaraman V. Tacrolimus-induced encephalopathy and polyneuropathy in a renal transplant recipient. BMJ Case Rep. 2013;2013. doi:10.1136/bcr-2013-201099.
   PubMedGoogle Scholar
• Krishna N, Chiappelli J, Fischer BA, et al. Tacrolimus-induced paranoid delusions and fugue-like state. Gen Hosp Psychiatry. 2013;35(3):e327 e325e327 e326.
   Web of Science ®Google Scholar