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Effectiveness and safety of the conversion to MeltDose ® extended‐release tacrolimus from other formulations of tacrolimus in stable kidney transplant patients: A retrospective study

2019; Wiley; Volume: 34; Issue: 1 Linguagem: Inglês

10.1111/ctr.13767

1399-0012

Ana Sánchez‐Fructuoso, Juan Carlos Ruiz, Antonio Franco, Fritz Diekmann, Dolores Redondo‐Pachón, Jesús Calviño, Núria Serra, María José Aladrén, Secundino Cigarrán, Ana Manonelles, Ana Ramos, Gonzalo Gómez, José Manuel González Posada, Amado Andrés, Isabel Beneyto, Andrés López Muñíz, Manel Perelló, Ricardo Lauzurica,

Pregnancy and Medication Impact

Abstract Tacrolimus is the cornerstone of immunosuppressive therapy after kidney transplantation. Its narrow therapeutic window mandates serum level strict monitoring and dose adjustments to ensure the optimal risk‐benefit balance. This observational retrospective study analyzed the effectiveness and safety of conversion from twice‐daily immediate‐release tacrolimus (IR‐Tac) or once‐daily prolonged‐release tacrolimus (PR‐Tac) to the recent formulation once‐daily MeltDose ® extended‐release tacrolimus (LCP‐Tac) in 365 stable kidney transplant recipients. We compared kidney function three months before and three months after the conversion. Three months after conversion, the total daily dose was reduced ~35% ( P < .0001), and improved bioavailability and stable serum LCP‐Tac concentrations were observed. There was no increase in the number of patients requiring tacrolimus dose adjustments after conversion. Renal function was unaltered, and no cases of BPAR were reported. Reports of tremors, as collected in the clinical histories for each patient, decreased from pre‐conversion (20.8%) to post‐conversion (11.8%, P < .0001). LCP‐Tac generated a cost reduction of 63% compared with PR‐Tac. In conclusion, the conversion strategy to LCP‐Tac from other tacrolimus formulations in stable kidney transplant patients showed safety and effectiveness in a real‐world setting, confirming the data from RCTs. The specific pharmacokinetic properties of LCP‐Tac could be potentially advantageous in patients with tacrolimus‐related adverse events.