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tacrolimus and sirolimus review

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
Aiman Obed, Abdalla Bashir, Anwar Jarrad
BACKGROUND Hepatitis C virus (HCV) genotype 4 (GT-4) is widespread in the Middle East, where it is responsible for the majority of HCV infections. It shows moderate treatment response rates when compared to other genotypes in the current era of interferon-based regimens. However, in the era of direct acting antiviral (DAA) drugs, its response is at least as good as observed for HCV genotypes 1-3. CASE REPORT We present a case of a 44-year-old patient with HCV cirrhosis. Since 2007, he has been treated for HCV infection with multiple ineffective regimens of interferon (INF) and ribavirin...
September 20, 2016: American Journal of Case Reports
Tracey Jones-Hughes, Tristan Snowsill, Marcela Haasova, Helen Coelho, Louise Crathorne, Chris Cooper, Ruben Mujica-Mota, Jaime Peters, Jo Varley-Campbell, Nicola Huxley, Jason Moore, Matt Allwood, Jenny Lowe, Chris Hyde, Martin Hoyle, Mary Bond, Rob Anderson
BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring renal replacement therapy: kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation, followed by immunosuppressive therapy (induction and maintenance therapy) to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect(®), Novartis Pharmaceuticals UK Ltd) and rabbit anti-human thymocyte immunoglobulin (rATG) (Thymoglobulin(®), Sanofi) as induction therapy, and immediate-release tacrolimus (TAC) (Adoport(®), Sandoz; Capexion(®), Mylan; Modigraf(®), Astellas Pharma; Perixis(®), Accord Healthcare; Prograf(®), Astellas Pharma; Tacni(®), Teva; Vivadex(®), Dexcel Pharma), prolonged-release tacrolimus (Advagraf(®) Astellas Pharma), belatacept (BEL) (Nulojix(®), Bristol-Myers Squibb), mycophenolate mofetil (MMF) (Arzip(®), Zentiva; CellCept(®), Roche Products; Myfenax(®), Teva), mycophenolate sodium (MPS) (Myfortic(®), Novartis Pharmaceuticals UK Ltd), sirolimus (SRL) (Rapamune(®), Pfizer) and everolimus (EVL) (Certican(®), Novartis) as maintenance therapy in adult renal transplantation...
August 2016: Health Technology Assessment: HTA
Marcela Haasova, Tristan Snowsill, Tracey Jones-Hughes, Louise Crathorne, Chris Cooper, Jo Varley-Campbell, Ruben Mujica-Mota, Helen Coelho, Nicola Huxley, Jenny Lowe, Jan Dudley, Stephen Marks, Chris Hyde, Mary Bond, Rob Anderson
BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation followed by induction and maintenance immunosuppressive therapy to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To systematically review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect,(®) Novartis Pharmaceuticals) and rabbit antihuman thymocyte immunoglobulin (Thymoglobuline,(®) Sanofi) as induction therapy and immediate-release tacrolimus [Adoport(®) (Sandoz); Capexion(®) (Mylan); Modigraf(®) (Astellas Pharma); Perixis(®) (Accord Healthcare); Prograf(®) (Astellas Pharma); Tacni(®) (Teva); Vivadex(®) (Dexcel Pharma)], prolonged-release tacrolimus (Advagraf,(®) Astellas Pharma); belatacept (BEL) (Nulojix,(®) Bristol-Myers Squibb), mycophenolate mofetil (MMF) [Arzip(®) (Zentiva), CellCept(®) (Roche Products), Myfenax(®) (Teva), generic MMF is manufactured by Accord Healthcare, Actavis, Arrow Pharmaceuticals, Dr Reddy's Laboratories, Mylan, Sandoz and Wockhardt], mycophenolate sodium, sirolimus (Rapamune,(®) Pfizer) and everolimus (Certican,(®) Novartis Pharmaceuticals) as maintenance therapy in children and adolescents undergoing renal transplantation...
August 2016: Health Technology Assessment: HTA
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
Helio Tedesco Silva, Claudia Rosso Felipe, Jose Osmar Medina Pestana
Here, we review 15 years of clinical use of sirolimus in our transplant center, in context with the developing immunosuppressive strategies use worldwide. The majority of studies were conducted in de novo kidney transplant recipients, using sirolimus (SRL) in combination with calcineurin inhibitors (CNIs). We also explored steroid (ST) or CNI-sparing therapies, including CNI minimization, elimination, or conversion strategies in combination with mycophenolate (MMF/MPS). Pooled long-term outcomes were comparable with those obtained with CNI and antimetabolite combination...
2015: Transplantation Research
Nuria Montero, María José Pérez-Sáez, Julio Pascual, Daniel Abramowicz, Klemens Budde, Chris Dudley, Mark Hazzan, Marian Klinger, Umberto Maggiore, Rainer Oberbauer, Julio Pascual, Soren S Sorensen, Ondrej Viklicky
BACKGROUND: The Elderly are the fastest growing part of kidney transplant recipients. The best immunosuppressive strategy is unknown. METHODS: We performed a systematic search of randomized controlled trials and observational studies focused on safety and efficacy of different immunosuppression strategies in elderly kidney recipients. Data extraction and risk of bias evaluation were systematically performed. RESULTS: Ten studies were included: 2 randomized clinical trials and 8 observational...
July 2016: Transplantation Reviews
Rakesh K Singh, Timothy Humlicek, Aamir Jeewa, Keith Fester
OBJECTIVE: In this Consensus Statement, we review the etiology and pathophysiology of inflammatory processes seen in critically ill children with cardiac disease. Immunomodulatory therapies aimed at improving outcomes in patients with myocarditis, heart failure, and transplantation are extensively reviewed. DATA SOURCES: The author team experience and along with an extensive review of the medical literature were used as data sources. DATA SYNTHESIS: The authors synthesized the data in the literature to present current immumodulatory therapies...
March 2016: Pediatric Critical Care Medicine
D Q Zhao, S W Li, Q Q Sun
Sirolimus (SRL)-based immunosuppressive regimens have been used for preventing rejection after kidney transplantation. This review analyzes their merits and demerits compared with other conventional regimes from the aspects of acute rejection rate, graft function, as well as patient/graft survival rates. In general, SRL is mostly recommended to be used as conversion therapy from calcineurin inhibitor (CNI) after kidney transplantation in most studies. Minimization or withdrawal of cyclosporine A (CsA) could also be considered when it was combined with SRL...
January 2016: Transplantation Proceedings
Adriana Mika, Piotr Stepnowski
More than 100000 solid organ transplantations are performed every year worldwide. Calcineurin (cyclosporine A, tacrolimus), serine/threonine kinase (sirolimus, everolimus) and inosine monophosphate dehydrogenase inhibitor (mycophenolate mofetil), are the most common drugs used as immunosuppressive agents after solid organ transplantation. Immunosuppressive therapy, although necessary after transplantation, is associated with many adverse consequences, including the formation of secondary metabolites of drugs and the induction of their side effects...
August 5, 2016: Journal of Pharmaceutical and Biomedical Analysis
Adam J McShane, Dustin R Bunch, Sihe Wang
Immunosuppressant medications allow the transplantation of tens of thousands of allografts per year and consequently have great potential to decrease patient morbidity and mortality. However, some medications have great risk associated with over- and under-dosing leading to adverse effects or allograft rejection, respectively. This necessitates immunosuppressant therapeutic drug monitoring accomplished by immunoassay or liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The former's accuracy can be hindered by metabolites of immunosuppressant medications, antibodies against these medications and heterophilic antibodies...
February 15, 2016: Clinica Chimica Acta; International Journal of Clinical Chemistry
Heungman Jun, Myung Gyu Kim, Cheol Woong Jung
PURPOSE: For the past decades, the long-term results of renal allograft unchanged despite the development of immunology and drugs. The long-term use of a calcineurin-inhibitor (CNI) and medication nonadherence have become important issues affecting long-term results. The combination of the once-daily advagraf and sirolimus was proposed as a good alternative with such reasons. The purpose of this study was the analysis of the clinical advantages of oncedaily advagraf and sirolimus combination by decreasing the use of CNI and improving medication adherence in stable kidney recipients...
February 2016: International Journal of Clinical Pharmacology and Therapeutics
Bojana Golubovic, Milica Prostran, Branislava Miljkovic, Katarina Vucicevic, Dragana Radivojevic, Iztok Grabnar
Immunosuppressive therapy is the cornerstone of successful kidney transplantation. Frequently used immunosuppressives are cyclosporine, tacrolimus, sirolimus and mycophenolic acid. These drugs have narrow therapeutic index and show high pharmacokinetic variability. In order to maintain the balance between efficacy and safety, dosing is based on measured drug concentrations. Proper identification, quantification and understanding the sources of variability in measured concentrations facilitate routine dose adjustment in clinical practice...
2016: Current Medicinal Chemistry
Jeannine S McCune, Meagan J Bemer
Although immunosuppressive treatments and target concentration intervention (TCI) have significantly contributed to the success of allogeneic haematopoietic cell transplantation (alloHCT), there is currently no consensus on the best immunosuppressive strategies. Compared with solid organ transplantation, alloHCT is unique because of the potential for bidirectional reactions (i.e. host-versus-graft and graft-versus-host). Postgraft immunosuppression typically includes a calcineurin inhibitor (cyclosporine or tacrolimus) and a short course of methotrexate after high-dose myeloablative conditioning, or a calcineurin inhibitor and mycophenolate mofetil after reduced-intensity conditioning...
May 2016: Clinical Pharmacokinetics
Ashesh P Shah, Jeanne M Chen, Jonathan A Fridell
Cytomegalovirus (CMV) is a common opportunistic infection encountered after pancreas transplantation. The records of 407 pancreas transplant recipients (226 simultaneous pancreas and kidney transplant (SPK), 101 pancreas transplant after kidney (PAK), and 97 pancreas transplants alone [PTA]) performed at a single center with at least 1-yr follow-up were reviewed. Immunosuppression included rabbit antithymocyte globulin induction, steroid withdrawal, and maintenance therapy of tacrolimus and sirolimus (± mycophenolate)...
December 2015: Clinical Transplantation
Reza Karbasi-Afshar, Morteza Izadi, Mozhgan Fazel, Hossein Khedmat
Influenza vaccination is widely used in transplant recipients, but there is little known about the significance and correlating factors of its effectiveness. In the current study, we reviewed the existing literature on clinical trials performed in transplant recipients on the effectiveness of influenza vaccination and to evaluate the relevance of the type of immunosuppression employed in these patients on the humoral reaction to the vaccine. A comprehensive search of the literature was performed through Pubmed and Google Scholar to find reports indicating immunogenicity of influenza vaccination in transplant patients...
September 2015: Saudi Journal of Kidney Diseases and Transplantation
Sung-Hwa Kang, Shin Hwang, Tae-Yong Ha, Gi-Won Song, Dong-Hwan Jung, Ki-Hun Kim, Chul-Soo Ahn, Deok-Bog Moon, Gil-Chun Park, Bo-Hyun Jung, Young-In Yoon, Sung-Gyu Lee
BACKGROUNDS/AIMS: There are few guidelines for tailored immunosuppressive regimens for liver transplantation (LT) recipients with hepatocellular carcinoma (HCC). To establish long-term immunosuppressive regimens suitable for Korean adult LT recipients, we analyzed those that were currently in use at a single high-volume institution. METHODS: This cross-sectional study comprises three parts including review of the immunosuppressive regimens used to manage 2,147 adult LT outpatients, review of LT recipients who were diagnosed of HCC at LT, and review of LT recipients who suffered from HCC recurrence...
May 2014: Korean Journal of Hepato-biliary-pancreatic Surgery
Juhan Lee, Jung Jun Lee, Beom Seok Kim, Jae Geun Lee, Kyu Ha Huh, Yongjung Park, Yu Seun Kim
The optimal immunosuppressive strategy for renal transplant recipients at high immunologic risk remains a topic of investigation. This prospective single arm pilot study was undertaken to evaluate the safety and efficacy of a combined tacrolimus and sirolimus regimen in recipients at immunological high risk and to compare outcomes with a contemporaneous control group received tacrolimus and mycophenolate mofetil. Patients that received a renal allograft between 2010 and 2011 at high risk (defined as panel reactive antibodies > 50%, 4 or more human leukocyte antigen mismatches, or retransplantation) were enrolled...
June 2015: Journal of Korean Medical Science
Ian B Hollis, Brent N Reed, Michael P Moranville
Cardiac allograft vasculopathy (CAV) is a common complication following heart transplantation (HT), resulting in diminished graft survival. The preferred strategy for preventing CAV is optimal medical management; however, for patients who develop CAV, delaying disease progression through effective medication management is equally important. A review of the literature regarding medication management of CAV was conducted via a search of the MEDLINE database. Studies were included if they were published in English, conducted in humans ≥ 18 years of age or older, and used noninvestigational medications...
May 2015: Pharmacotherapy
Paul Y Kwo, Maaz B Badshah
PURPOSE OF REVIEW: This article will review the new direct acting antiviral agent (DAA) drug classes for the treatment of hepatitis C, how they are combined and the relevant drug-drug interactions in the postliver transplant setting. Treatment options for chronic hepatitis C in patients with decompensated cirrhosis and end-stage renal disease will also be discussed. RECENT FINDINGS: The availability of new drug classes has increased the treatment options in patients with hepatitis C in the post-transplant settings...
June 2015: Current Opinion in Organ Transplantation
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