Comparison of the long-term efficacy and safety of generic tacrolimus, Tacrobell, with Prograf in liver transplant recipients

Abstract

IntroductionThe purpose of this study was to compare the safety and efficacy of generic tacrolimus (Tacrobell [TCB]) and a reference tacrolimus (Prograf [PGF]) in liver transplant recipients.Patients and methodsWe retrospectively analyzed 167 patients who used TCB or PGF between January 2009 and March 2016 for >1 year (TCB group, n=86; PGF group, n=81). To assess the efficacy and safety of TCB, we evaluated the relationship between drug dose and trough level, survival, rejection, infection, kidney function, and side effects.ResultsThere was no difference in the preoperative demographics between the two groups. Moreover, there was no difference in the drug dose and trough level between the groups at 1 week after surgery. Coefficient of variation (CV) values were obtained at the drug trough level for each patient and no differences in CV values were identified within 1 year (p=0.587) and up to 5 years (p=0.824) in both groups. Rehospitalization (p=0.1) and total rejection (p=0.915) did not differ between the two groups, but the rejection severity, recorded as the rejection activity index value, was worse in the PGF group (p=0.039). No difference was found in the infection rate (p=0.818), and with regard to nephrotoxicity, there was no difference in the rate of patients with chronic kidney disease stage 3 and above during the follow-up period. No differences were found between the two groups in terms of drug side effects and adverse events.ConclusionThe generic tacrolimus, TCB, is a comparable alternative to the original tacrolimus, PGF, as a main immunosuppressive drug for liver transplantation.

Immunosuppression with generic tacrolimus in liver and kidney transplantation—systematic review and meta‐analysis on biopsy‐proven acute rejection and bioequivalence

“…A total of 390 publications were excluded during abstract screening. After the elimination of preliminary reports (2), case reports (3), reviews (25), and studies without a control group (16), 17 studies met the inclusion criteria (Fig. ).…”

“…A few studies on generic Tac have been performed on BPAR rates , whereas five studies found risk ratios favoring innovator Tac and eight studies favoring generic Tac, CIs were often wide due to the low sample sizes. Only one study each found a significant benefit of innovator and generic Tac.…”

Evaluating the conversion to extended-release tacrolimus from immediate-release tacrolimus in liver transplant recipients

“…However, in this study, we did not find a difference in CV-IPV between IR-tac and LCP-tac. While some studies have suggested that high-IPV may be a predictor for adverse outcomes related to liver transplants, other studies have similarly shown no differences in CV-IPV from twice daily and once-daily formulations [11][12][13][14]. It is possible that this study did not have a sufficient number of patients to account for the difference and due to the limited length of follow-up time, further analysis with longer follow-up time may be warranted to assess for potential differences in CV-IPV in IR-tac and LCP-tac.…”

“…CV-IPV was calculated by the following method: CV-IPV (%) = (SD/mean) × 100% [11][12][13][14]. Tacrolimus levels were obtained 3 months prior to conversion as well as 3 months postconversion.…”