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Tacrolimus pharmacokinetics

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https://www.readbyqxmd.com/read/28214069/-pharmacokinetic-drug-interaction-between-miconazole-mucoadhesive-tablet-and-tacrolimus-about-3%C3%A2-case-reports-in-transplant-patients
#1
Marion Lepelley, Sophie Logerot, Xavier Fonrose, Céline Villier
Loramyc(®) is a mucoadhesive tablet of miconazole, indicated for the treatment of oropharyngeal candidiasis in immunocompromised patients. Miconazole, as others azole antifungals, is known for its potent inhibitory properties of cytochromes P450 enzymes and P-glycoprotein (P-gp). Inhibition of cytochromes P450 enzymes and P-gp can produce pharmacokinetic drug interaction. Immunosuppressive agents, such as calcineurin inhibitors (tacrolimus, cyclosporine) are substrates of cytochromes P450 3A4 and P-gp. Nevertheless, the impact of systemic absorption of miconazole mucoadhesive tablet has not been investigated by the laboratory before regulatory approval...
January 12, 2017: Thérapie
https://www.readbyqxmd.com/read/28185946/decreased-tacrolimus-plasma-concentrations-during-hcv-therapy-a-drug-drug-interaction-or-is-there-an-alternative-explanation
#2
E J Smolders, S Pape, C T M M de Kanter, A P van den Berg, J P H Drenth, D M Burger
Chronic hepatitis C virus (HCV) infection can cause severe liver cirrhosis, for which liver transplantation is the only therapy. To prevent organ rejection, transplanted patients are treated with immunosuppressive agents. We describe two transplanted patients treated with tacrolimus who were simultaneously treated with direct-acting antivirals (DAAs) for their chronic HCV infection. No pharmacokinetic drug-drug interactions (DDIs) were expected between tacrolimus and the selected DAAs. However, in both patients, tacrolimus plasma concentrations decreased during HCV treatment...
February 6, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28164520/the-effect-of-abcb1-polymorphisms-on-serial-tacrolimus-concentrations-in-stable-austrian-long-term-kidney-transplant-recipients
#3
Markus Riegersperger, Max Plischke, Corinna Steinhauser, Anita Jallitsch-Halper, Guerkan Sengoelge, Wolfgang C Winkelmayer, Gere Sunder-Plassmann, Manuela F Ouml Dinger
BACKGROUND: The multidrug resistance 1 gene (ABCB1) encodes P-glycoprotein (PGP), mainly expressed in the liver and engaged in metabolism of drugs including the immunosuppressant tacrolimus (TAC). ABCB1 single nucleotide polymorphisms (SNP) may significantly alter pharmacokinetics and influence TAC concentrations of kidney transplant recipients (KTR). METHODS: The genotype distribution of ABCB1 1236C>T, 2677G>T/A and 3435C>T was investigated among 96 Austrian KTR who were converted from cyclosporin to TAC...
October 1, 2016: Clinical Laboratory
https://www.readbyqxmd.com/read/28146606/the-cyp3a-biomarker-4%C3%AE-hydroxycholesterol-does-not-improve-tacrolimus-dose-predictions-early-after-kidney-transplantation
#4
Elisabet Størset, Kristine Hole, Karsten Midtvedt, Stein Bergan, Espen Molden, Anders Åsberg
AIMS: Tacrolimus is a cornerstone in modern immunosuppressive therapy after kidney transplantation. Tacrolimus dosing is challenged by considerable pharmacokinetic variability, both between patients and over time after transplantation, partly due to variability in cytochrome P450 3A (CYP3A) activity. The aim of this study was to assess the value of the endogenous CYP3A marker 4β-hydroxycholesterol (4βOHC) for tacrolimus dose individualization early after kidney transplantation. METHODS: Data were obtained from 79 adult kidney transplant recipients who contributed a total of 625 4βOHC measurements and 1999 tacrolimus whole blood concentrations during the first two months after transplantation...
February 1, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28112181/il-3-and-ctla4-gene-polymorphisms-may-influence-the-tacrolimus-dose-requirement-in-chinese-kidney-transplant-recipients
#5
Mou-Ze Liu, Hai-Yan He, Yue-Li Zhang, Yong-Fang Hu, Fa-Zhong He, Jian-Quan Luo, Zhi-Ying Luo, Xiao-Ping Chen, Zhao-Qian Liu, Hong-Hao Zhou, Ming-Jie Shao, Ying-Zi Ming, Hua-Wen Xin, Wei Zhang
The highly variable pharmacokinetics and narrow therapeutic window of tacrolimus (TAC) has hampered its clinical use. Genetic polymorphisms may contribute to the variable response, but the evidence is not compelling, and the explanation is unclear. In this study we attempted to find previously unknown genetic factors that may influence the TAC dose requirements. The association of 105 pathway-related single nucleotide polymorphisms (SNPs) with TAC dose-adjusted concentrations (C0/D) was examined at 7, 30 and 90 d post-operation in 382 Chinese kidney transplant recipients...
January 23, 2017: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/28104153/pharmacokinetic-profile-of-twice-and-once-daily-tacrolimus-in-pediatric-kidney-transplant-recipients
#6
Y Takahashi, S Shishido, Y Hyodo, T Yonekura, H Nihei, Y Itabashi, M Muramatsu, Y Hamasaki, T Kawamura, A Aikawa
BACKGROUND: The aim of this study was to assess the differences in pharmacokinetic (PK) profiles after the 1:1 ratio-based conversion from a twice-daily to a once-daily tacrolimus formulation (TD-TAC and OD-TAC, respectively) in pediatric recipients of kidney transplants. METHODS: TD-TAC was initially administered to 29 pediatric patients who underwent kidney transplantations between April 2010 and September 2015 and were then subsequently switched to OD-TAC. The switch dose ratio was 1:1, and the 24-hour complete PK parameter assessment was performed before and after the regimen was changed from TD-TAC to OD-TAC...
January 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28104136/acute-calcineurin-inhibitor-nephrotoxicity-secondary-to-turmeric-intake-a-case-report
#7
A Nayeri, S Wu, E Adams, C Tanner, J Meshman, I Saini, W Reid
Tacrolimus, also known as FK-506, is a potent immunosuppressant agent with a host of drug-drug and food-drug interactions. We present the first case of a probable food-drug interaction between the herb turmeric and tacrolimus leading to acute calcineurin inhibitor nephrotoxicity. A 56-year-old man with a history of orthotopic liver transplantation presented to the emergency department from the clinic with worsening edema in the setting of an elevated creatinine level of 4.2 mg/dL. Before the current presentation, the patient had been recently discharged on a previously tolerated low-dose regimen of tacrolimus with a whole-blood tacrolimus level within the desired range...
January 2017: Transplantation Proceedings
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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 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 pharmacokinetics 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...
February 2017: 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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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