De-novo Use Comparison Between Extended-release Once-daily Tacrolimus (Envarsus Xr®) and Immediate-release Twice-daily Tacrolimus (Prograf®) – A Single Center’s Experience
1Transplant, John C. McDonald Regional Transplant Center - Willis Knighton Medical Center, Shreveport, LA, 2Advanced Surgery, John C. McDonald Regional Transplant Center - Willis Knighton Medical Center, Shreveport, LA
Meeting: 2021 American Transplant Congress
Abstract number: 157
Keywords: Dosage, FK506, Kidney transplantation, Pharmacokinetics
Topic: Clinical Science » Pharmacy » Non-Organ Specific: Pharmacogenomics / Pharmacokinetics
Session Information
Session Name: The Metabolism Milleu: Updates in Pharmacokinetics and Pharmacogenomics
Session Type: Rapid Fire Oral Abstract
Date: Sunday, June 6, 2021
Session Time: 6:00pm-7:00pm
Presentation Time: 6:35pm-6:40pm
Location: Virtual
*Purpose: Envarsus XR® is approved for de-novo use post-kidney transplantation at a higher starting dose (0.14mg/kg/day) as compared with Prograf® (0.1 mg/kg/day) despite better bioavailability. The goal of this study was to compare the initial dosing and pharmacokinetic profile of these two formulations at our center early post-transplantation.
*Methods: We evaluated 106 Envarsus XR® patients (Aug 2016 to Jun 2020) and 109 Prograf® patients (Jun 2008 to Nov 2016). We compared the two formulations for patient demographics, initial dose, therapeutic dose, maintenance dose, and time taken for drug level to become detectable and therapeutic.
*Results: Compared with Prograf®, Envarsus XR® patients received a higher initial starting dose (0.09 ± 0.03 vs. 0.06 ± 0.03 mg/kg/day, p < 0.01), but required lower doses to reach target level ≥ 6 ng/ml (0.12 ± 0.05 vs. 0.16 ± 0.06 mg/kg/day, p < 0.01) and target level ≥ 10 ng/ml (0.14 ± 0.06 vs. 0.17 ± 0.07 mg/kg/day, p < 0.01). Time taken for drug level to first become detectable and achieve therapeutic levels were also significantly lower in Envarsus XR® patients (Table 1). The rejection episodes, graft survival, patient survival, delayed function, and adverse events is currently being compared between the two groups.
| Envarsus (n=106) | Prograf (n=109) | P-Value | |
| Time (d) for drug level to be first detectable, mean ± SD | 2.77 ± 1.60 | 4.45 ± 2.12 | <0.01 |
| Time (d) to reach drug level ≥6 ng/ml, mean ± SD | 4.12 ± 2.37 | 7.12 ± 4.82 | <0.01 |
| Time (d) to reach drug level ≥10 ng/ml, mean ± SD | 6.67 ± 6.23 | 12.00 ± 8.72 | <0.01 |
| Initial starting dose (mg/kg), mean ± SD | 0.09 ± 0.03 | 0.06 ± 0.03 | <0.01 |
| Therapeutic dose (mg/kg) for target level ≥6 ng/ml, mean ± SD | 0.12 ± 0.05 | 0.16 ± 0.06 | <0.01 |
| Therapeutic dose (mg/kg) for target level ≥10 ng/ml, mean ± SD | 0.14 ± 0.06 | 0.17 ± 0.07 | <0.01 |
| Maintenance dose (mg/kg) at Day-30, mean ± SD | 0.13 ± 0.08 | 0.16 ± 0.07 | >0.05 |
*Conclusions: Envarsus XR® provides the advantage of reaching a therapeutic level earlier with a lower dose as compared with Prograf®.
To cite this abstract in AMA style:
Singh N, Le T, Naseer MS, Asmil S, Palermini A, Qamar A, Chand R, Tandukar S, Aultman D, Shokouh-Amiri H, Zibari G. De-novo Use Comparison Between Extended-release Once-daily Tacrolimus (Envarsus Xr®) and Immediate-release Twice-daily Tacrolimus (Prograf®) – A Single Center’s Experience [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/de-novo-use-comparison-between-extended-release-once-daily-tacrolimus-envarsus-xr-and-immediate-release-twice-daily-tacrolimus-prograf-a-single-centers-experience/. Accessed May 18, 2025.« Back to 2021 American Transplant Congress