Tacrolimus Prolonged Release (Envarsus®): A Review of Its Use in Kidney and Liver Transplant Recipients

Drugs

Volumn 75, Issue 3, 2015, Pages 309-320

  Garnock Jones, Karly P ^a  

^a Springer   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; CHOLESTEROL; CREATININE; CYTOCHROME P450 3A4; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TACROLIMUS; TRIACYLGLYCEROL; CALCINEURIN INHIBITOR; DELAYED RELEASE FORMULATION; IMMUNOSUPPRESSIVE AGENT;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BK VIRUS INFECTION; CELLULAR IMMUNITY; CHOLESTEROL BLOOD LEVEL; CONSTIPATION; CREATININE BLOOD LEVEL; CYTOMEGALOVIRUS INFECTION; DELAYED GRAFT FUNCTION; DIARRHEA; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG RELEASE; DRUG TOLERABILITY; FOLLOW UP; GLOMERULUS FILTRATION RATE; HUMAN; HUMORAL IMMUNITY; HYPERKALEMIA; HYPERTENSION; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LETHARGY; LIVER TRANSPLANTATION; LYMPHOPROLIFERATIVE DISEASE; NAUSEA; NEUROLOGIC DISEASE; OPPORTUNISTIC INFECTION; PHASE 3 CLINICAL TRIAL (TOPIC); PLASMA PROTEIN BINDING; PREMATURE LABOR; PROLONGED RELEASE; RHINOPHARYNGITIS; SPONTANEOUS ABORTION; TREMOR; TRIACYLGLYCEROL BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL; URINARY TRACT INFECTION; URTICARIA; VOLUME OF DISTRIBUTION AT STEADY-STATE; VOMITING; CLINICAL TRIAL (TOPIC); DELAYED RELEASE FORMULATION; DRUG INTERACTION; GRAFT REJECTION; IMMUNOLOGY; TREATMENT OUTCOME;

CALCINEURIN INHIBITORS; CLINICAL TRIALS AS TOPIC; DELAYED-ACTION PREPARATIONS; DRUG INTERACTIONS; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; TACROLIMUS; TREATMENT OUTCOME;

EID: 84925463247     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-015-0349-2     Document Type: Article

References (36)

1. Baker R, Jardine A, Andrews P. Renal Association Clinical Practice Guideline on post-operative care of the kidney transplant recipient. Nephron Clin Pract. 2011;118(Suppl 1):c311-47.
2. Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009;9(Suppl. 3):S1-157.
3. Barraclough KA, Isbel NM, Johnson DW, et al. Once- versus twice-daily tacrolimus: are the formulations truly equivalent? Drugs. 2011;71(12):1561-77.
4. Butler JA, Roderick P, Mullee M, et al. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004;77(5):769-76.
5. Weng FL, Israni AK, Joffe MM, et al. Race and electronically measured adherence to immunosuppressive medications after deceased donor renal transplantation. J Am Soc Nephrol. 2005;16(6):1839-48.
6. Kuypers DR, Peeters PC, Sennesael JJ, et al. Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring. Transplantation. 2013;95(2):333-40.
7. Hardinger KL, Brennan DC. Novel immunosuppressive agents in kidney transplantation. World J Transplant. 2013;3(4):68-77.
8. Ho ETL, Wong G, Craig JC, et al. Once-daily extended-release versus twice-daily standard-release tacrolimus in kidney transplant recipients: a systematic review. Transplantation. 2013;95(9):1120-8.
9. 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):191-7.
10. Budde K, Bunnapradist S, Grinyo JM, et al. Novel once-daily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: one-year results of phase III, double-blind, randomized trial. Am J Transplant. 2014;14(12):2796-806.
11. Cross SA, Perry CM. Tacrolimus once-daily formulation: in the prophylaxis of transplant rejection in renal or liver allograft recipients. Drugs. 2007;67(13):1931-43.
12. Scott LJ, McKeage K, Keam SJ, et al. Tacrolimus: a further update of its use in the management of organ transplantation. Drugs. 2003;63(12):1247-97.
13. Plosker GL, Foster RH. Tacrolimus: a further update of its pharmacology and therapeutic use in the management of organ transplantation. Drugs. 2000;59(2):323-89.
14. Spencer CM, Goa KL, Gillis JC. Tacrolimus. An update of its pharmacology and clinical efficacy in the management of organ transplantation. Drugs. 1997;54(6):925-75.
15. Peters DH, Fitton A, Plosker GL, et al. Tacrolimus. A review of its pharmacology, and therapeutic potential in hepatic and renal transplantation. Drugs. 1993;46(4):746-94.
16. European Medicines Agency. Envarsus® (tacrolimus extended-release tablets): EU summary of product characteristics. 2014. http://www.ema.europa.eu/. Accessed 17 Sept 2014.
17. European Medicines Agency. Envarsus® (tacrolimus extended-release tablets): CHMP assessment report. 2014. http://www.ema.europa.eu/. Accessed 19 Dec 2014.
18. Nigro V, Glicklich A, Weinberg J. Improved bioavailability of MELTDOSE once-daily formulation of tacrolimus (LCP-Tacro) with controlled agglomeration allows for consistent absorption over 24 hrs: a scintigraphic and pharmacokinetic evaluation [abstract no. B1034]. In: American Transplant Congress; 2013.
19. Nigro V, Glicklich A, Weinberg J. Flexible dosing of once-daily LCP-Tacro tablets: morning vs. evening randomized crossover chronopharmacokinetic study [abstract plus poster]. In: European Society for Organ Transplantation/American Society of Transplantation 2012 joint meeting; 2012.
20. Alloway RR, Eckhoff DE, Washburn KW, 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 Transpl. 2014;20(5):564-75.
21. Feng S, Chapman WC, DuBay D. A phase 2 randomized study of the pharmacokinetics, safety and efficacy of LCP-Tacro™ tablets once-a-day vs. Prograf® capsules twice-a-day in de novo liver transplants [abstract no. 709]. Am J Transplant. 2012;12(Suppl. s3):239.
22. Alloway R, Mulgaonkar S, Ueda K, et al. A phase 2 randomized study of the pharmacokinetics, safety and efficacy of LCP-Tacro tablets once-a-day vs Prograf capsules twice-a-day in de novo kidney transplants [abstract no. 1106]. Am J Transplant. 2011;11(Suppl. 2):355.
23. Nigro V, Glicklich A, Weinberg J. Improved bioavailability and pharmacokinetics of tacrolimus with novel once-daily Lcp-Tacro™ meltdose formulation versus once-daily Advagraf® capsules [abstract plus poster]. In: European Society for Organ Transplantation/American Society of Transplantation 2012 joint meeting; 2012.
24. Bunnapradist S, Ciechanowski K, West-Thielke P, et al. Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial. Am J Transplant. 2013;13(3):760-9.
25. Mulgaonkar S. LCP-Tacro demonstrated significantly fewer dose adjustments: results of a phase 2 randomized study of LCP-Tacro (MeltDose once-daily prolonged release tacrolimus tablets) vs. Prograf® capsules twice-a-day in de novo kidney transplant patients [abstract no. PP IS-C22]. In: European Society for Organ Transplantation + American Society of Transplantation meeting; 2014.
26. Rostaing L, Ciechanowski K, Bunnapradist S, et al. Two-year results of Envarsus (once-daily MeltDose tacrolimus tablets) vs Prograf (twice-daily tacrolimus capsules): a phase 3, double-blind, double-dummy, multi-center, prospective, randomized study. [abstract no. A2978 plus poster]. Am J Transplant. 2014;14(Suppl. 3):661-2.
27. Bunnapradist S, Alloway R, West-Thielke P, et al. Lower treatment failures in Blacks and older de novo and stable kidney transplant recipients treated with Envarsus once-daily MeltDose tablets vs. twice-daily Prograf capsules: a pooled subgroup analysis of two phase 3 trials [abstract no. A211 plus poster]. Am J Transplant. 2014;14(Supp(3)):459-60.
28. Budde K, Silva H, Steinberg S, et al. Higher initial exposure of Envarsus immediately post transplantation is not associated with increased risk of delayed graft function in kidney transplant patients treated with novel once-daily MeltDose tacrolimus (Envarsus) vs. twice-daily tacrolimus (Prograf): results from a phase 3, double-blind, double-dummy, multi-center, randomized trial [abstract no. A212]. Am J Transplant. 2014;14(Suppl. 3):460.
29. Silva TH Jr, Bunnapradist S, Steinberg S. Higher starting dose and rapid attainment of tacrolimus blood levels with Envarsus vs. Prograf is not associated with increased toxicity: exploratory analysis of a phase 3, double-blind, double-dummy, multi-center, randomized, prospective study of Envarsus (once-daily MeltDose tacrolimus tablets) vs. Prograf (twice-daily tacrolimus capsules). [abstract no. A207]. Am J Transplant. 2014;14(Suppl. 3):458.
30. Morgan J, Langone A, Nigro V, et al. Tacrolimus-induced tremor: switching from immediate-release (IR-TAC) to LCP-Tacro extended-release tacrolimus (LCPT) reduces tremor and improves quality of life [abstract no. P4.072]. Neurology. 2014;82(10 Suppl. 1).
31. Gedaly R, Steinberg SM, Langone A, et al. LCP-Tacro-associated improvement in tacrolimus-induced tremors is also associated with improvement in quality of life: results of a switching study of kidney transplant patients with tremor (Strato) [abstract no. P508]. In: 16th Congress of the European Society for Organ Transplantation; 2013.
32. van Rossum HH, de Fijter JW, van Pelt J. Pharmacodynamic monitoring of calcineurin inhibition therapy: principles, performance, and perspectives. Ther Drug Monit. 2010;32(1):3-10.
33. Wallemacq P, Armstrong VW, Brunet M, et al. Opportunities to optimize tacrolimus therapy in solid organ transplantation: report of the European consensus conference. Ther Drug Monit. 2009;31(2):139-52.
34. de Jonge H, Naesens M, Kuypers DR. New insights into the pharmacokinetics and pharmacodynamics of the calcineurin inhibitors and mycophenolic acid: possible consequences for therapeutic drug monitoring in solid organ transplantation. Ther Drug Monit. 2009;31(4):416-35.
35. Provenzani A, Santeusanio A, Mathis E, et al. Pharmacogenetic considerations for optimizing tacrolimus dosing in liver and kidney transplant patients. World J Gastroenterol. 2013;19(48):9156-73.
36. Veloxis Pharmaceuticals. Envarsus® development strategy and status. 2014. http://www.veloxis.com/devStrategy.cfm. Accessed 13 Oct 2014.