M Baraldo1. 1. Department of Experimental and Clinical Medicine, Medical School, University of Udine; SOC Institute of Clinical Pharmacology, University-Hospital S. Maria della Misercordia, Udine, Italy. Electronic address: massimo.baraldo@uniud.it.
Abstract
BACKGROUND: Nonadherence to immunosuppressive therapy contributes to the loss of grafts. One of the problem is the fractioning of immunosuppressive dose. In fact, it was demonstrated that a single daily dose (QD) is associated with an increased adherence to therapy compared with twice daily dosing (BID). Tacrolimus (TAC), calcineurin inhibitor, is one of immunosuppression pillar in organ transplantation and its action is strongly correlated with blood concentration and therefore the therapeutic drug monitoring is recommended in the guidelines. However, one of the critical points of TAC is the poor and variable bioavailability that influences immunosuppression, and is also responsible for adverse effects. METHODS: MeltDose® Technology is a new technology to improve efficacy and/or reduce side effects. This new technology applied to TAC (Envarsus® or LCP-TAC) has achieved 4 main objectives: (1) improved bioavailability, (2) reduced dose fractioning to one tablet per day, (3) limited variability concentrations of TAC, and (4) lower doses of TAC will be administered. RESULTS: We analyzed the pharmacokinetic profile, efficacy, and security of Envarsus®.
BACKGROUND: Nonadherence to immunosuppressive therapy contributes to the loss of grafts. One of the problem is the fractioning of immunosuppressive dose. In fact, it was demonstrated that a single daily dose (QD) is associated with an increased adherence to therapy compared with twice daily dosing (BID). Tacrolimus (TAC), calcineurin inhibitor, is one of immunosuppression pillar in organ transplantation and its action is strongly correlated with blood concentration and therefore the therapeutic drug monitoring is recommended in the guidelines. However, one of the critical points of TAC is the poor and variable bioavailability that influences immunosuppression, and is also responsible for adverse effects. METHODS: MeltDose® Technology is a new technology to improve efficacy and/or reduce side effects. This new technology applied to TAC (Envarsus® or LCP-TAC) has achieved 4 main objectives: (1) improved bioavailability, (2) reduced dose fractioning to one tablet per day, (3) limited variability concentrations of TAC, and (4) lower doses of TAC will be administered. RESULTS: We analyzed the pharmacokinetic profile, efficacy, and security of Envarsus®.
Authors: Ana Sánchez Fructuoso; Juan Carlos Ruiz; Antonio Franco; Fritz Diekmann; Dolores Redondo; Jesús Calviño; Nuria Serra; María José Aladrén; Secundino Cigarrán; Ana Manonelles; Ana Ramos; Gonzalo Gómez; José Manuel González Posada; Amado Andrés; Isabel Beneyto; Andrés López Muñiz; Manel Perelló; Ricardo Lauzurica Journal: Clin Transplant Date: 2019-12-31 Impact factor: 2.863
Authors: Max M Maurer; Marius Ibach; Julius Plewe; Axel Winter; Paul Ritschl; Brigitta Globke; Robert Öllinger; Georg Lurje; Wenzel Schöning; Johann Pratschke; Dennis Eurich Journal: Biomedicines Date: 2022-01-26