4. LCP-tacrolimus in daily practice: tolerability and intrapatient variability

K.L.W. Bunthof, A.D. van Zuilen, J.W. van der Heijden, L.B. Hilbrands

Wednesday 4 march 2020

0:00 - 0:00h at Toon Hermans Foyer

Parallel session: Postersessie 1 – Klinische abstracts

Background: Tacrolimus is one of the most widely used immunosuppressive drugs in kidney transplantation. LifeCyclePharma (LCP)-tacrolimus is an extended-release, MeltDose formulation of tacrolimus (Envarsus), which is registered for clinical use. Studies demonstrate greater bioavailability and flatter concentration-time curves with similar efficacy compared to other tacrolimus formulations. We aimed to evaluate the differences in side effects and variability in trough levels in patients who have been converted to Envarsus on clinical indication.

Methods: We initiated a non-interventional prospective registry. Patients from three Dutch university medical centers are followed for 2 years after conversion. Collected data include side effects, doses and trough levels of Envarsus, and serum creatinine during follow up. Intrapatient variability of tacrolimus trough levels is expressed as the coefficient of variation.

Results: 27 patients (15 male, 12 female) were included for analysis. Former formulations of tacrolimus were advagraf (n=22), prograft (n=4) or other (n=1). The interval between kidney transplantation and start of Envarsus was 19.1 months (SD 24.3 months) and 23/27 patients were converted to Envarsus because of side effects. Most common side effects were tremors (n=15), psychological complaints (n=8) and headache (n=3), which disappeared in 11, 6 and 1 patients, respectively. New side effects appeared in 9 patients. 2 patients were converted because of unstable trough levels and had stable levels of tacrolimus when using Envarsus. Tacrolimus intrapatient variability (IPV) in the study cohort ranged from 16.4 to 55%, with a mean IPV of 31.5% (SD 8.9%).

Conclusions: Most tacrolimus-associated side effects disappeared after conversion from other tacrolimus formulations to Envarsus. Intrapatient variability in this registry was high compared to the intrapatient variability of tacrolimus levels reported in previous studies.