12 March 2024: Original Paper
Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians
Alexander Wiseman 1ADEF* , Tarek Alhamad 2DE , Rita R. Alloway 3DEF , Beatrice P. Concepcion 4DE , Matthew Cooper 5DE , Richard Formica 6DE , Christina L. Klein 7DE , Vineeta Kumar 8DEF , Nicolae Leca 9DE , Fuad Shihab 10DE , David J. Taber 11DE , Sarah Mulnick 12ABCDE , Donald M. Bushnell 12BCDE , Monica Hadi 13ABCDE , Suphamai Bunnapradist 14ADEFDOI: 10.12659/AOT.943498
Ann Transplant 2024; 29:e943498
Table 5 Final recommendations on the use of LCPT (Envarsus XR®) in kidney transplantation.
| Final recommendation/statement | Consensus |
|---|---|
| In the de novo setting, Envarsus XR can be used as first-line therapy considering its efficacy and safety are equivalent to BID tacrolimus A. Envarsus XR has a similar efficacy profile as tacrolimus IRB. Envarsus XR has a similar safety profile as tacrolimus IR | 92% |
| When considering safety and efficacy, Envarsus XR is preferred as first-line therapy for African American patient population in the de novo setting | 83% |
| When considering safety and efficacy, Envarsus XR is preferred as first-line therapy in known rapid metabolizers in the de novo setting | 83% |
| In the de novo setting, the first assessment of trough levels of Envarsus XR can be after the third dose although steady state is not expected until after 7 days on a stable dose | 92% |
| In the de novo setting, the Envarsus XR dosing should begin with 0.14 mg/kg/day and should be calculated for ideal body weight in the setting of obesity, except in the following scenarios: A. The initial dosing of Envarsus XR may be reduced in the setting of depleting antibody therapy when using induction therapy B. The dose may be increased in known rapid metabolizers C. The dose may be adjusted in the presence of known drug interactions that influence tacrolimus metabolism | 92% |
| In the de novo setting, ideal body weight should be used as the preferred initial dosing weight for Envarsus XR in obese recipients | 100% |
| In the de novo setting, Envarsus XR should be initiated on the morning of POD1 for all kidney transplant recipients, regardless of initial kidney function | 83% |
| In the de novo setting, initial dosing of Envarsus XR can be reduced in the setting of depleting antibody therapy when using induction therapy | 83% |
| In the de novo setting, initial dosing of Envarsus XR can be adjusted in patients for whom the risk of supratherapeutic levels outweighs the benefit of rapid achievement of therapeutic levels | 100% |
| During the first week post-transplant the dose of Envarsus XR should only be adjusted in circumstances of a supratherapeutic level or circumstances of a significantly subtherapeutic trough level suggestive of rapid metabolism (e.g., tacrolimus trough | 75% |
| Conversion to Envarsus XR is recommended to address neurological side-effects related to BID Tacrolimus | 100% |
| Steady state is achieved after Envarsus XR dose 7 and therefore, on a stable dose, dose adjustments can be made per clinical practice protocols following the seventh dose | 75% |
| Further evidence of clinical long-term outcomes (graft survival, renal function) would help support the use of Envarsus XR in current clinical practice, in both the de novo setting and conversion setting | 92% |
| Patients should consistently take Envarsus XR on an empty stomach, rather than consistently with or without food | 92% |
| Trough level assessment of Envarsus XR should take into account the time to achieve steady state (approximately 7 days) | 100% |
| When available, pharmacogenomic screening is recommended for initial dosing considerations for Envarsus XR | 83% |
| Additional cost and formulary considerations pose barriers to the use of Envarsus XR as first line therapy in the de novo setting | 75% |
| Additional costs and staff time required pose barriers to conversion to Envarsus XR | 92% |
| Intrapatient variability has been shown with tacrolimus preparations. There are no specific recommendations for utilization of Envarsus XR related to intrapatient variability | 83% |
| Further evidence of clinical long-term outcomes (graft survival, renal function) would help support the use of Envarsus XR in current clinical practice, in both the de novo setting and conversion setting | 92% |
| BID – twice a day; GI – gastrointestinal; IR – immediate release; POD1 – post-operative day 1. | |