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Tacrolimus pharmacokinetics

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https://www.readbyqxmd.com/read/28094348/weight-of-abcb1-and-por-genes-on-oral-tacrolimus-exposure-in-cyp3a5-nonexpressor-pediatric-patients-with-stable-kidney-transplant
#1
G N Almeida-Paulo, I Dapía García, R Lubomirov, A M Borobia, N L Alonso-Sánchez, L Espinosa, A J Carcas-Sansuán
Tacrolimus (TAC) is highly effective for the prevention of acute organ rejection. However, its clinical use may be challenging due to its large interindividual pharmacokinetic variability, which can be partially explained by genetic variations in TAC-metabolizing enzymes and transporters. The aim of this study was to evaluate the influence of genetic and clinical factors on TAC pharmacokinetic variability in 21 stable pediatric renal transplant patients. This study was nested in a previous Prograf to Advagraf conversion clinical trial...
January 17, 2017: Pharmacogenomics Journal
https://www.readbyqxmd.com/read/28081041/a-systematic-literature-review-approach-to-estimate-the-therapeutic-index-of-selected-immunosuppressant-drugs-after-renal-transplantation
#2
Jessica E Ericson, Kanecia O Zimmerman, Daniel Gonzalez, Chiara Melloni, Jeffrey T Guptill, Kevin D Hill, Huali Wu, Michael Cohen-Wolkowiez
BACKGROUND: Drugs that exhibit close margins between therapeutic and toxic blood concentrations are considered to have a narrow therapeutic index (NTI). The Food and Drug Administration has proposed that NTI drugs should have more stringent bioequivalence standards for approval of generic formulations. However, many immunosuppressant drugs do not have a well-defined therapeutic index (TI). METHODS: We sought to determine whether safety, efficacy, and pharmacokinetic data obtained from the medical literature through a comprehensive literature search could be used to estimate the TI of cyclosporine, tacrolimus, and sirolimus...
February 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28079558/once-daily-tacrolimus-in-liver-transplantation-a-me-too-drug-or-a-therapeutic-advantage
#3
Pavel Trunečka
PURPOSE OF REVIEW: To provide latest information on differences between standard tacrolimus (TAC BID) and slow-released formulation of tacrolimus (Advagraf) in liver transplantation (LTx), and to discuss the latter's therapeutic value as a distinct entity. RECENT FINDINGS: Two articles on de-novo studies, several on conversion and one on survival analysis from the European Liver Transplant Registry published recently showed that low-dose Advagraf immediately after transplantation provided same protection to the kidney as standard dose delayed until day 5, and was associated with lower rejection rate; to maintain the same trough level after late conversion to Advagraf, an approximately 1...
January 11, 2017: Current Opinion in Organ Transplantation
https://www.readbyqxmd.com/read/28070711/immune-suppression-during-preclinical-drug-development-mitigates-immunogenicity-mediated-impact-on-therapeutic-exposure
#4
Jonathan Herskovitz, Josiah Ryman, Theingi Thway, Stephanie Lee, Lei Zhou, Narendra Chirmule, Bernd Meibohm, Vibha Jawa
In the clinical setting, anti-drug antibodies (ADA) against biotherapeutics can influence patient safety and interfere with product efficacy. High immunogenicity has been addressed in clinic by concomitant immune suppression, such as co-administration of methotrexate with enzyme replacement therapy (ERT) and combination tacrolimus/sirolimus treatment for prophylaxis against organ transplant rejection. This study investigates the use of such immune suppressants in mitigating ADA responses to a fully human monoclonal antibody (mAb1) in preclinical animal studies...
January 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28050888/a-new-cyp3a5-3-and-cyp3a4-22-cluster-influencing-tacrolimus-target-concentrations-a-population-approach
#5
Franc Andreu, Helena Colom, Laure Elens, Teun van Gelder, Ronald H N van Schaik, Dennis A Hesselink, Oriol Bestard, Joan Torras, Josep M Cruzado, Josep M Grinyó, Nuria Lloberas
BACKGROUND: Single nucleotide polymorphisms (SNPs) in the CYP3A5 and CYP3A4 genes have been reported to be an important cause of variability in the pharmacokinetics of tacrolimus in renal transplant patients. The aim of this study was to merge all of the new genetic information available with tacrolimus pharmacokinetics to generate a more robust population model with data from renal transplant recipients. METHODS: Tacrolimus exposure data from 304 renal transplant recipients were collected throughout the first year after transplantation and were simultaneously analyzed with a population pharmacokinetic approach using NONMEM(®) version 7...
January 3, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28030534/single-nucleotide-polymorphism-of-cyp3a5-impacts-the-exposure-to-tacrolimus-in-pediatric-renal-transplant-recipients-a-pharmacogenetic-substudy-of-the-twist-trial
#6
Heiko Billing, Britta Höcker, Alexander Fichtner, Rita van Damme-Lombaerts, Styrbjorn Friman, Jenö Jaray, Karel Vondrak, Eniko Sarvary, Luca Dello Strologo, Michael Oellerich, Nicolas von Ahsen, Burkhard Tönshoff
BACKGROUND: The pharmacokinetics (PK) of tacrolimus (TAC) and mycophenolic acid (MPA) are highly variable. An impact of single-nucleotide polymorphisms (SNPs) of the genes coding for enzymes and transporters involved in the PK of TAC and/or MPA is intuitively conceivable. Accordingly, we sought to analyze the influence of different SNPs on TAC and MPA exposure in pediatric renal transplant recipients. METHODS: A subpopulation of 37 patients (median age: 12.8 years, range 2...
November 24, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28025957/correlation-between-pharmacokinetics-of-tacrolimus-and-pharmacodynamics-on-nfat-regulated-gene-expression-in-stable-kidney-transplant-recipients%C3%A2
#7
Frieder Keller, Claudia Sommerer, Thomas Giese, Martin Zeier, Bernd Schröppel
Gene expression regulated by the transcription factor NFAT (nuclear factor of activated T-cells) has been proposed for monitoring the pharmacodynamic effect of calcineurin inhibitors. We aimed to correlate the pharmacokinetics of tacrolimus with the suppression of NFAT-regulated gene expression. Tacrolimus trough (C<sub>trough</sub>) and peak concentrations (C<sub>peak</sub>) were measured by LC-MS. The effect on NFAT-regulated gene expression at trough (E<sub>trough</sub>) and at peak levels (E<sub>peak</sub>) were determined by qRT-PCR...
February 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/27966227/tacrolimus-dose-requirements-in-paediatric-renal-allograft-recipients-are-characterized-by-a-biphasic-course-determined-by-age-and-bone-maturation
#8
Noël Knops, Jean Herman, Maria van Dyck, Yasaman Ramazani, Edward Debbaut, Rita van Damme-Lombaerts, Elena Levtchenko, Lambertus P van den Heuvel, Steffen Fieuws, Dirk Kuypers
AIMS: Despite longstanding recognition of significant age-dependent differences in drug disposition during childhood, the exact course and the underlying mechanisms are not known. Our aim was to determine the course and determinants of individual relative dose requirements, during long-term follow-up in children on tacrolimus. METHODS: This was a cohort study in a tertiary hospital with standardized annual pharmacokinetic (PK) follow-up (AUC0-12hr ) in recipients of a renal allograft (≤19 years), between 1998 and 2015...
November 2, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27958377/a-pharmacogenomic-study-on-the-pharmacokinetics-of-tacrolimus-in-healthy-subjects-using-the-dmettm-plus-platform
#9
Y Choi, F Jiang, H An, H J Park, J H Choi, H Lee
No abstract text is available yet for this article.
December 13, 2016: Pharmacogenomics Journal
https://www.readbyqxmd.com/read/27943166/use-of-mycophenolate-mofetil-and-a-calcineurin-inhibitor-in-allogeneic-hematopoietic-stem-cell-transplantation-from-hla-matched-siblings-or-unrelated-volunteer-donors-japanese-multicenter-phase-ii-trials
#10
Takahiko Nakane, Hirohisa Nakamae, Takuhiro Yamaguchi, Saiko Kurosawa, Atsuo Okamura, Michihiro Hidaka, Shigeo Fuji, Akio Kohno, Takeshi Saito, Yasutaka Aoyama, Kazuo Hatanaka, Yoshio Katayama, Kimikazu Yakushijin, Toshimitsu Matsui, Motohiro Yamamori, Akiyoshi Takami, Masayuki Hino, Takahiro Fukuda
To test the feasibility of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis in Japanese patients, we conducted two multicenter prospective phase II trials of allogeneic hematopoietic stem-cell transplantation (HSCT) from HLA-matched related donors (MRD group) with MMF and cyclosporine or HLA 7-8/8 allele-matched unrelated bone-marrow donors (URD group) with MMF and tacrolimus. The cumulative incidences of grade II-IV acute GVHD on day 100, which was the primary endpoint in these trials, were 45...
December 9, 2016: International Journal of Hematology
https://www.readbyqxmd.com/read/27898598/pharmacokinetics-of-mycophenolic-acid-and-dose-optimization-in-children-after-intestinal-transplantation
#11
Caroline Barau, Antonio Mellos, Stéphanie Chhun, Florence Lacaille, Valérie Furlan
BACKGROUND: Mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (MPS) are now commonly used in pediatric intestinal transplantation (Tx), but to date, no clear recommendations regarding the dosing regimen have been made in this population. The aim of this study was to determine the MMF/MPS dosage required to achieve an area under the plasma concentration-time curve from 0 to 12 hours (AUC0-12) for mycophenolic acid (MPA) greater than 30 mg.h/L in children after intestinal transplantation...
November 28, 2016: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/27885697/dynamic-effects-of-cyp3a5-polymorphism-on-dose-requirement-and-trough-concentration-of-tacrolimus-in-renal-transplant-recipients
#12
P Chen, J Li, J Li, R Deng, Q Fu, J Chen, M Huang, X Chen, C Wang
WHAT IS KNOWN AND OBJECTIVE: Tacrolimus is a widely used immunosuppressive drug with marked pharmacokinetic variability partly due to CYP3A5 polymorphism. Our study aimed to investigate the dynamic effects of CYP3A5 genotypes on dose requirement and trough concentration (C0 ) of tacrolimus in renal transplant recipients. METHODS: A total of 194 Chinese renal transplant recipients received oral tacrolimus twice daily. Whole-blood C0 of tacrolimus were measured on the 3rd day, 7th day, 14th day, 1st month, 3rd month and 6th month post-transplantation...
February 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/27855589/twice-daily-telaprevir-for-posttransplant-genotype-1-hepatitis-c-virus-a-prospective-safety-efficacy-and-pharmacokinetics-study
#13
Raymond A Rubin, Mark W Russo, Kimberly A Brown, Robert J Fontana, Josh Levitsky, Hugo Vargas, Eric M Yoshida, Robert S Brown
OBJECTIVES: Our objective was to determine the safety, efficacy, and pharmacokinetics of telaprevir plus pegylated interferon alfa 2a and ribavirin for chronic, posttransplant genotype 1 hepatitis C virus infection. MATERIALS AND METHODS: A prospective, single-arm, multicenter, open-label, phase 2b study was conducted at 22 North American sites to assess the safety, efficacy, and pharmacokinetics of pegylated interferon alfa 2a, ribavirin, and twice daily telaprevir in liver transplant recipients with recurrent, chronic hepatitis C without cirrhosis...
November 18, 2016: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/27798513/longitudinal-pharmacokinetics-of-everolimus-when-combined-with-low-level-of-tacrolimus-in-elderly-renal-transplant-recipients
#14
Elias David-Neto, Fabiana Agena, Fernanda Ramos, Ana Heloisa Triboni, Paschoalina Romano, Persio de Almeida Rezende Ebner, Venceslau Coelho, Nelson Zocoler Galante, Francine Carvalinho Lemos
BACKGROUND: Although the proportion of elderly patients among renal transplant recipients has increased, pharmacokinetic (PK) studies of immunosuppressants rarely include older patients. METHODS: We studied 12-hours everolimus (EVL) PK in 16 elderly renal transplant recipients (all caucasians; 10 males; mean age, 64±2 years, (61-71y), in 4 separate time-points (at 7, 30, 60 and 150 days) after EVL introduction, corresponding to a mean post renal-transplantation day: PK1 (43±4days), PK2 (65±7 days), PK3 (106±17 days) and PK4 (206±40 days)...
October 28, 2016: Transplantation
https://www.readbyqxmd.com/read/27793753/tacrolimus-loaded-nanostructured-lipid-carriers-for-oral-delivery-in-vivo-bioavailability-enhancement
#15
Saba Khan, M Shaharyar, Mohammad Fazil, Md Quamrul Hassan, Sanjula Baboota, Javed Ali
The aim of the present study was to assess the Tacrolimus (TL) loaded nanostructured lipid carrier for enhancement in solubilisation potential, pharmacokinetic parameters and lymphatic distribution profile. The solubilisation potential of TL-NLC was determined via application of dynamic lipolysis models, which simulate the GIT environment and the intestinal conditions. The in vitro lipolysis studies revealed significantly high solubilisation (***p<0.001) of TL-NLCs in aqueous phase (69.3%) in contrast to TL suspension (1...
December 2016: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/27771258/development-and-validation-of-a-sensitive-and-selective-lc-ms-ms-method-for-determination-of-tacrolimus-in-oral-fluids
#16
Mwlod Ghareeb, Fatemeh Akhlaghi
Tacrolimus is a commonly used immunosuppressive agent in organ transplant recipients. Therapeutic drug monitoring (TDM) of tacrolimus is essential to adjust the dose and achieve optimal immunosuppression level. Routine TDM is practiced using whole blood samples obtained through venipuncture. However, tacrolimus concentration that is present in oral fluid (OF) can theoretically represent the free or pharmacologically active form of tacrolimus. In this study, we report the development and validation of a rapid, sensitive and selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantification of tacrolimus in OF...
December 1, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/27754526/-current-status-and-regulation-of-bioanalytical-laboratories-engaged-in-quantifying-immunosuppressants-for-transplant-patients-in-argentina
#17
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
https://www.readbyqxmd.com/read/27753146/the-pharmacokinetics-and-pharmacodynamics-of-mycophenolate-mofetil-in-younger-and-elderly-renal-transplant-recipients
#18
Jiang-Tao Tang, Brenda C de Winter, Dennis A Hesselink, Ferdi Sombogaard, Lan-Lan Wang, Teun van Gelder
AIMS: Elderly transplant recipients have a lower incidence of acute rejection, and a higher risk to die from infectious complications. A potential cause may be 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
https://www.readbyqxmd.com/read/27748705/the-impact-of-total-gastrectomy-on-pharmacokinetics-in-kidney-transplant-immunosuppressive-drug-regimes-a-case-study
#19
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
https://www.readbyqxmd.com/read/27721963/tacrolimus-dose-requirement-in-iranian-kidney-transplant-recipients-within-the-first-three-weeks-after-transplantation
#20
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
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