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Tacrolimus pharmacokinetics

Paula Schaiquevich, Paula Taich, Natalia Riva, Francisco Leone, Nora Paternoster, Gabriel Mato, Paulo Cáceres Guido
Objective Determine the status of analytical laboratories that quantify immunosuppressants in transplant patients who are under therapeutic drug monitoring (TDM) for these drugs in Argentina in order to identify potential perfectible areas for action. Methods A survey of the clinical and analytical TDM centers in Argentina was conducted between September 2013 and November 2014 under the direction of the Garrahan Hospital Clinical Pharmacokinetics Unit and the National Unified Central Institute for Ablation and Implant Coordination...
March 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Jiang-Tao Tang, Brenda C de Winter, Dennis A Hesselink, Ferdi Sombogaard, Lan-Lan Wang, Teun van Gelder
AIM: Elderly transplant recipients have a lower incidence of acute rejection, and a higher risk to die from infectious complications. Potentially this may be caused by differences in the pharmacokinetics (PK) or pharmacodynamics (PD) of the immunosuppressive drugs they are taking. This study was designed to comprehensively evaluate the influence of age on the PK and PD of mycophenolic acid (MPA). METHODS: In this study the PK and PD of MPA was studied in 26 elderly and 54 younger renal transplant recipients treated with mycophenolate mofetil and tacrolimus...
October 18, 2016: British Journal of Clinical Pharmacology
Lucy Chen, Lisa Liberatore, Tom Chin, Scott Walker, Helen Fanous, Michelle M Nash, Lindita Rapi, Jennie Huckle, Jeffrey S Zaltzman, G V Ramesh Prasad
BACKGROUND: Ensuring reliable gastrointestinal drug absorption of orally-administered immunosuppressive medications posttransplant is critical to ensuring graft survival. METHODS: A 66 year old man of East Asian origin with a previous total gastrectomy was evaluated for living donor kidney transplantation. Pretransplant pharmacokinetic testing was performed to determine the most appropriate posttransplant medication strategy. The Gastrointestinal Quality of Life Index and Gastrointestinal Rating Scale questionnaires were administered to gauge immunosuppressive medication-related side effects in the absence of a stomach...
September 29, 2016: Transplantation
S Dashti-Khavidaki, S Ghaffari, M Gohari, M R Khatami, Z Zahiri
BACKGROUND: Tacrolimus is the main immunosuppressive agent in many kidney transplant protocols with an initial recommended daily dose of 0.2 mg/kg of ideal body weight (IBW). However, due to the high inter- and intra-patient variability in its pharmacokinetics, the required tacrolimus doses may differ markedly from patient to patient. OBJECTIVE: To assess the required tacrolimus dose to achieve the desired whole blood concentration within the first three weeks after kidney transplantation among Iranian patients...
2016: International Journal of Organ Transplantation Medicine
Ayumi Asada, Shigeki Bamba, Yukihiro Morita, Kenichiro Takahashi, Hirotsugu Imaeda, Atsushi Nishida, Osamu Inatomi, Mitsushige Sugimoto, Masaya Sasaki, Akira Andoh
BACKGROUND: Tacrolimus is an immunosuppressive agent, used in the remission induction therapy of ulcerative colitis (UC). AIMS: We investigated the correlation between CYP3A5 genetic polymorphisms and the adverse events in patients with UC. The pharmacokinetics of tacrolimus after oral administration were also analyzed. METHODS: We enrolled 29 hospitalized patients with UC received oral tacrolimus. Genotyping for CYP3A5 A6986G (rs776746) was performed using Custom TaqMan(®) SNP genotyping assays...
September 21, 2016: Digestive and Liver Disease
Jaleh Varshosaz, Mohsen Minayian, Shila Yazdekhasti
Tacrolimus, an immunosuppressive drug has a variable pharmacokinetic and poor oral bioavailability due to poor solubility. The aim of the present study was enhancing the solubility and oral bioavailability of this drug. Tacrolimus nanoparticles were prepared by precipitation anti-solvent evaporation method. The effect of different parameters including: surfactant type, solvent to nonsolvent ratio and drug to surfactant ratio were studied on the particle size, saturated solubility and dissolution rate of the drug...
October 3, 2016: Current Drug Delivery
J Ge, J Wang, H Zhao, K Li, Y Jing, G Li
INTRODUCTION: Tacrolimus is an immunosuppressive medication for organ transplantation. FOXP3(+) T regulatory cells (Tregs) play roles in suppression of rejection and induction of graft tolerance. This study aimed to evaluate the correlation between the polymorphism of FOXP3 and the blood level of tacrolimus in renal transplant recipients. METHODS: This retrospective study included 100 renal transplant recipients receiving tacrolimus treatment and 100 healthy control subjects...
July 2016: Transplantation Proceedings
Yasuyoshi Ishiwata, Masashi Nagata, Takafumi Arai, Misato Makiishi, Maho Yoshikawa, Hiromitsu Takahashi, Hitoshi Kohsaka, Masato Yasuhara
BACKGROUND: Although azole antifungal agents have been shown to affect the pharmacokinetics of calcineurin inhibitors such as tacrolimus and cyclosporine by inhibiting drug metabolism, there are few clinical reports on drug interactions between miconazole oral gel and calcineurin inhibitors. In the present study, the effects of miconazole oral gel on the blood concentrations of tacrolimus and cyclosporine were investigated. METHODS: In this retrospective study, 18 patients concomitantly administered miconazole oral gel and tacrolimus (9 for dermatomyositis, 3 for myasthenia gravis, 2 for systemic lupus erythematosus, 2 for rheumatoid arthritis, 1 for polymyositis, 1 for prevention of graft-versus-host disease post bone marrow transplantation), and 15 patients concomitantly administered miconazole oral gel and cyclosporine (11 for interstitial pneumonia, 2 for pemphigus, 1 for eosinophilic granulomatosis with polyangiitis, 1 for systemic lupus erythematosus) were evaluated...
August 23, 2016: Therapeutic Drug Monitoring
Xue-Feng Lu, Jian Zhan, Yang Zhou, Kai-Shun Bi, Xiao-Hui Chen
1. The aim of this study was to investigate the influence of itraconazole (ITCZ) on tacrolimus absorption, distribution and metabolism by developing a semi-physiological pharmacokinetic model of tacrolimus in mice. 2. Mice were randomly divided into four groups, namely control group (CG, taking 3 mg·kg(-1) tacrolimus only), low-dose group (LDG, taking tacrolimus with 12.5 mg·kg(-1) ITCZ), medium-dose group (MDG, taking tacrolimus with 25 mg·kg(-1) ITCZ) and high-dose group (HDG, taking tacrolimus with 50 mg·kg(-1) ITCZ)...
August 17, 2016: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
S W Chan, Y Xiao, M Hu, O Q P Yin, T T W Chu, B S P Fok, V H L Lee, B Tomlinson
WHAT IS KNOWN AND OBJECTIVE: The oral plasma clearance of midazolam and the ratio of 6β-hydroxycortisol (6β-OHF) to cortisol (F) in urine are two potential markers for evaluating CYP3A activity in vivo. We assessed the influence of two common CYP3A polymorphisms on the pharmacokinetics of oral midazolam and urinary ratio of 6β-OHF/F in healthy Chinese. METHODS: Single oral 15 mg doses of midazolam were given to 20 healthy male Chinese subjects who were genotyped for the CYP3A5*3 and CYP3A4*1G polymorphisms...
October 2016: Journal of Clinical Pharmacy and Therapeutics
Nadia Ben Fredj, Jean Baptiste Woillard, Jean Debord, Amel Chaabane, Naceur Boughattas, Pierre Marquet, Franck Saint-Marcoux, Karim Aouam
OBJECTIVES: The aim of this study was to develop a pharmacokinetics model allowing the description of the evolution of tacrolimus exposure in kidney transplant patients over the first months after transplant, using trough concentrations of routinely collected blood. MATERIALS AND METHODS: The authors performed a retrospective analysis of trough concentration data collected from adult kidney transplant recipients (from 2008 to 2013). The total data set was divided into a building data set, used to build the structural model, and a validation data set, used to validate the structural model...
August 2016: Experimental and Clinical Transplantation
Yoichi Miyata, Nobuhisa Akamatsu, Yasuhiko Sugawara, Junichi Kaneko, Takehito Yamamoto, Hiroshi Suzuki, Junichi Arita, Yoshihiro Sakamoto, Kiyoshi Hasegawa, Sumihito Tamura, Norihiro Kokudo
BACKGROUND The aim of the present study was to investigate the pharmacokinetics of the once-daily tacrolimus formulation (QD form) in relation to polymorphisms of the donor cytochrome P450 family 3 sub-family A polypeptide 5 (CYP3A5) gene and recipient adenosine triphosphate-binding cassette sub-family B member 1 (ABCB1) gene. MATERIAL AND METHODS A total of 80 consecutive living-donor liver transplant (LDLT) recipients were started on the QD form of tacrolimus (day 1), and 60 patients were completely followed for 7 days early after liver transplantation in order to evaluate the pharmacokinetics...
2016: Annals of Transplantation: Quarterly of the Polish Transplantation Society
C R Early, J M Park, M P Dorsch, K T Pogue, S M Hanigan
BACKGROUND: Two case reports suggest that metronidazole treatment for Clostridium difficile infections (CDI) increases tacrolimus (TAC) trough levels. The primary objective of this study was to determine the clinical significance of this potential interaction in transplant patients receiving CDI treatment. Currently, no robust literature exists to estimate a magnitude of pharmacokinetic interaction between metronidazole and TAC. METHODS: In this retrospective study, the effects of CDI and metronidazole treatment on TAC levels in 52 adult solid organ transplant patients were investigated...
October 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
Pooja Khandelwal, Tsuyoshi Fukuda, Kana Mizuno, Ashley Teusink-Cross, Parinda A Mehta, Rebecca A Marsh, Angela D M Kashuba, Alexander A Vinks, Stella M Davies
Maraviroc is an allosteric small molecule antagonist of chemokine receptor type 5 (CCR5) and has been used in adult allogeneic hematopoietic stem cell transplant (HSCT) recipients to prevent acute graft-versus-host disease (GVHD) of the gastrointestinal (GI) tract and liver. The goal of this study was to establish feasibility and pharmacokinetic and pharmacodynamic profiles of maraviroc in pediatric HSCT recipients. Children ages 2 to 12 years were enrolled and maraviroc was added to standard GVHD prophylaxis, which included a calcineurin inhibitor and either steroids or mycophenolate mofetil...
October 2016: Biology of Blood and Marrow Transplantation
A Capron, V Haufroid, P Wallemacq
Immunosuppressive drugs (IS) used in solid organ transplantation are critical dose drugs with high intra- and inter-subject variability. Therefore, IS therapeutic drug monitoring (TDM), mainly as trough levels analysis, is a major support to patient management, mandatory to optimize clinical outcome. Even though transplant patients undoubtedly benefited by this pre-dose (C0) monitoring, the relationship between these C0 concentrations and the incidence of graft rejections remains hardly predictable. Identification and validation of additional biomarkers of efficacy are therefore very much needed...
September 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Xiao-Xue Liu, Bei-Ming Xu, Hao Chen, Yan-Yan Song, Wan-Hua Yang, Bing Chen
OBJECTIVES: Limited sampling strategies (LSS) have been proposed as an alternative method for estimating area under concentration-time curve (AUC) of immunosuppressive agent tacrolimus (TAC). In this study, we aimed to develop the LSS models for predicting AUC of TAC in Chinese liver transplant patients. METHODS: Twenty-eight adult liver transplant patients receiving immunosuppressive regimen including TAC were enrolled. A total of 47 pharmacokinetic profiles were obtained after 1 or 3 weeks therapy...
July 23, 2016: Pharmacology
Chi Chiu Mok
INTRODUCTION: Despite the emergence of newer immunomodulating agents for systemic lupus erythematosus (SLE), a substantial proportion of patients still do not respond optimally. While the mechanisms for the differential responses to drug therapy are unclear, variation in drug exposure with the same dosing protocol related to pharmacogenetic and pharmacokinetic factors may contribute. This article discusses the use of therapeutic drug monitoring (TDM) to optimize therapies in SLE patients...
July 22, 2016: Expert Review of Clinical Immunology
Simon Tremblay, Vincenza Nigro, John Weinberg, E Steve Woodle, Rita R Alloway
This two-sequence, three-period crossover study is the first pharmacokinetic (PK) study to compare all three innovator formulations of tacrolimus (twice-daily immediate release tacrolimus capsules [IR-Tac]; once-daily extended release tacrolimus capsules [ER-Tac]; novel once-daily tacrolimus tablets [LCPT]). Stable renal transplant patients were dosed with each drug for seven days and blood samples were obtained over 24 hours. Thirty subjects were included in the PK analysis set. A conversion factor of 1:1:0...
June 24, 2016: American Journal of Transplantation
H Kato, M Usui, Y Muraki, A Tanemura, Y Murata, N Kuriyama, Y Azumi, M Kishiwada, S Mizuno, H Sakurai, M Okuda, K Nakatani, S Isaji
BACKGROUND: We investigated a long-term association between donor/recipient CYP3A5 polymorphisms, pharmacokinetics of tacrolimus, and recipient outcomes in settings of living donor liver transplantation (LDLT). METHODS: From February 2002 to November 2009, 67 couples of donor/recipients with tacrolimus administration, who could be genotyped for CYP3A5*3 and *1, were eligible in this study. We compared the dose-adjusted trough levels (C/D ratio) and dose/weight ratio of tacrolimus at 1 to 36 months postoperatively and recipient prognosis according to donor/recipient CYP3A5 polymorphisms; *1*1 in 7, *1*3 in 15, and *3*3 in 45, based on recipient genotype, and *1*1 in 1, *1*3 in 28, and *3*3 in 38, based on donor genotype...
May 2016: Transplantation Proceedings
Kimberly M Deininger, Anh Vu, Robert L Page, Amrut V Ambardekar, JoAnn Lindenfeld, Christina L Aquilante
BACKGROUND: Cytochrome P450 (CYP) 3A polymorphisms are associated with variable CYP3A metabolizing enzyme activity and tacrolimus pharmacokinetics. We sought to determine the singular and combined impact of CYP3A4*22 and CYP3A5*3 variants on tacrolimus drug disposition in adult heart transplant recipients. METHODS: The retrospective study included 76 patients greater than one year post-heart transplant and receiving tacrolimus. Patients were genotyped for CYP3A4*22 and CYP3A5*3, and combined genotypes were classified as follows: extensive metabolizers (EM, CYP3A4*1/*1+CYP3A5*1 carriers), intermediate metabolizers (IM, CYP3A4*1/*1+CYP3A5*3/*3, or CYP3A4*22 carriers+CYP3A5*1 carriers), and poor metabolizers (PM, CYP3A4*22 carriers+CYP3A5*3/*3)...
September 2016: Clinical Transplantation
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