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Isavuconazol

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https://www.readbyqxmd.com/read/29112717/isavuconazole-susceptibility-of-clinical-aspergillus-fumigatus-isolates-and-feasibility-of-isavuconazole-dose-escalation-to-treat-isolates-with-elevated-mics
#1
Jochem B Buil, Roger J M Brüggemann, Roeland E Wasmann, Jan Zoll, Jacques F Meis, Willem J G Melchers, Johan W Mouton, Paul E Verweij
No abstract text is available yet for this article.
November 3, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29112326/real-world-challenges-and-unmet-needs-in-the-diagnosis-and-treatment-of-suspected-invasive-pulmonary-aspergillosis-in-patients-with-hematological-diseases-an-illustrative-case-study
#2
Martin Hoenigl, Juergen Prattes, Peter Neumeister, Albert Wölfler, Robert Krause
Recent years have seen important advances in the diagnosis of invasive pulmonary aspergillosis (IPA), complemented by the introduction of new therapies. Despite this, IPA remains a major cause of infection-related mortality in patients with hematological diseases. There are two main reasons for this. First, diagnosis of IPA remains a challenge, since risk factors and the clinical, radiological and mycological presentations vary not only by fungal disease stage, but also by patient group (e.g. neutropenic versus non-neutropenic patients)...
November 7, 2017: Mycoses
https://www.readbyqxmd.com/read/29101732/a-review-of-the-clinical-pharmacokinetics-and-pharmacodynamics-of-isavuconazole
#3
Kyle John Wilby
Invasive fungal infections are a major cause of morbidity and mortality, especially for immunocompromised patients. Treatment options are few and most are limited by safety and formulation concerns. Isavuconazole is a new triazole antifungal agent with official indications for the treatment of invasive fungal infections caused by Aspergillus and Mucormycosis. Its clinical efficacy has been proven in two landmark trials, SECURE and VITAL. This review aims to summarize and evaluate the published literature reporting clinical pharmacokinetic and pharmacodynamic outcome data of isavuconazole in humans...
November 4, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/29048485/isavuconazole-susceptibility-of-clinical-aspergillus-fumigatus-isolates-and-feasibility-of-isavuconazole-dose-escalation-to-treat-isolates-with-elevated-mics
#4
Jochem B Buil, Roger J M Brüggemann, Roeland E Wasmann, Jan Zoll, Jacques F Meis, Willem J G Melchers, Johan W Mouton, Paul E Verweij
Introduction: Isavuconazole is a new triazole approved for the treatment of invasive aspergillosis. We investigated isavuconazole MIC distributions, isavuconazole MIC correlations with those of other azoles and pharmacodynamics of isavuconazole in low-level resistant Aspergillus fumigatus isolates. Methods: Isavuconazole, voriconazole, itraconazole and posaconazole susceptibility of 487 clinical A. fumigatus isolates was determined by EUCAST broth microdilution methodology...
October 18, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29038263/in-vitro-combination-of-isavuconazole-with-echinocandins-against-azole-susceptible-and-resistant-aspergillus-spp
#5
A Raffetin, V Courbin, V Jullien, E Dannaoui
The in vitro combinations of isavuconazole with echinocandins were evaluated against 30 Aspergillus spp. by a two-dimensional checkerboard microdilution method and an agar-based diffusion method. With the checkerboard method, the three combinations showed indifferent interactions for all the strains. With the agar-based method, indifferent interactions were found for all the strains for isavuconazole-micafungin and isavuconazole-anidulafungin. For the isavuconazole-caspofungin combination, indifference was found in 24/30 strains, synergy in 4/30 strains, and antagonism in 2/30 strains...
October 16, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29022838/pharmacogenomics-of-triazole-antifungal-agents-implications-for-safety-tolerability-and-efficacy
#6
REVIEW
Jarrett R Amsden, Paul O Gubbins
Triazole antifungal agents are prescribed to treat invasive fungal infections in neutropenic and non-neutropenic patients. These antifungal agents are substrates and inhibitors of cytochrome P450 (CYP). Genetic polymorphisms in CYP2C9, CYP2C19 and CYP3A5 can lead to large population-specific variations in drug efficacy and safety, optimal dosing, or contribute to drug interactions associated with this class. Areas covered: This manuscript reviews the pharmacogenomics (i.e. the influence of genetics on drug disposition) of triazole antifungal agents related to their CYP-mediated metabolism and summarizes their implications on triazole efficacy, safety, and tolerability...
November 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28971866/tissue-distribution-and-elimination-of-isavuconazole-following-single-and-repeat-oral-dose-administration-of-isavuconazonium-sulfate-to-rats
#7
Anne-Hortense Schmitt-Hoffmann, Kota Kato, Robert Townsend, Michael J Potchoiba, William W Hope, David Andes, Jochen Spickermann, Marlowe J Schneidkraut
Quantitative whole-body autoradiography was used to assess the distribution and tissue penetration of isavuconazole in rats following single and repeated oral-dose administration of radiolabeled isavuconazonium sulfate, the prodrug of isavuconazole. Following a single-dose administration of radiolabeled isavuconazonium sulfate (labelled on active moiety), radioactivity was detectable within 1 h post dose in 56 of 65 tissues/fluids. The highest maximum concentrations (Cmax) were observed in bile and liver (66...
October 2, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28923872/exposure-response-relationships-for-isavuconazole-in-patients-with-invasive-aspergillosis-and-other-filamentous-fungi
#8
Amit V Desai, Laura L Kovanda, William W Hope, David Andes, Johan W Mouton, Donna L Kowalski, Robert W Townsend, Salim Mujais, Peter L Bonate
Isavuconazole, the active moiety of the water-soluble prodrug isavuconazonium sulfate, is a triazole antifungal agent for the treatment of invasive fungal infections. The purpose of this analysis was to characterize the isavuconazole exposure-response relationship for measures of efficacy and safety in patients with invasive aspergillosis and other filamentous fungi from the SECURE trial. Two hundred and thirty one patients who received the clinical dosing regimen and had exposure parameters were included in this analysis...
September 18, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28864232/development-and-validation-of-a-liquid-chromatography-tandem-mass-spectrometry-assay-for-the-simultaneous-quantitation-of-5-azole-antifungals-and-1-active-metabolite
#9
Adam J McShane, Sihe Wang
BACKGROUND: Azole antifungal medications are often administered to prevent or treat invasive fungal infections. These infections are deadly in the immunocompromised population. Therapeutic drug monitoring of the azole antifungal medications may potentially decrease morbidity and mortality in patients undergoing azole treatment. METHODS: To assist with azole therapeutic drug monitoring, a liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed and validated for 6 azole analytes: fluconazole, voriconazole, posaconazole, isavuconazole, itraconazole, and its active metabolite hydroxyitraconazole...
November 2017: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/28830945/pharmacodynamics-of-the-orotomides-against-aspergillus-fumigatus-new-opportunities-for-treatment-of-multidrug-resistant-fungal-disease
#10
William W Hope, Laura McEntee, Joanne Livermore, Sarah Whalley, Adam Johnson, Nicola Farrington, Ruwanthi Kolamunnage-Dona, Julie Schwartz, Anthony Kennedy, Derek Law, Michael Birch, John H Rex
F901318 is an antifungal agent with a novel mechanism of action and potent activity against Aspergillus spp. An understanding of the pharmacodynamics (PD) of F901318 is required for selection of effective regimens for study in phase II and III clinical trials. Neutropenic murine and rabbit models of invasive pulmonary aspergillosis were used. The primary PD endpoint was serum galactomannan. The relationships between drug exposure and the impacts of dose fractionation on galactomannan, survival, and histopathology were determined...
August 22, 2017: MBio
https://www.readbyqxmd.com/read/28806568/a-simple-high-performance-liquid-chromatography-mass-spectrometry-method-for-therapeutic-drug-monitoring-of-isavuconazole-and-four-other-antifungal-drugs-in-human-plasma-samples
#11
Giovanna Fatiguso, Fabio Favata, Ilaria Zedda, Amedeo De Nicolò, Jessica Cusato, Valeria Avataneo, Giovanni Di Perri, Antonio D'Avolio
Triazoles chanced the prevention and treatment of invasive fungal infections, but their pharmacokinetic properties are still unclear. In particular, isavuconazole (ISC) is a new broad-spectrum antifungal triazole approved in 2015 as first-line treatment for intravenous and oral use against invasive aspergillosis and for mucormycosis. Nowadays, the optimal management of the treatments with triazoles requires the use of Therapeutic Drug Monitoring (TDM), in order to prevent sub-therapeutic or toxic concentrations...
October 25, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28802855/antifungal-resistance-in-mucorales
#12
E Dannaoui
The order Mucorales, which includes the agents of mucormycosis, comprises a large number of species. These fungi are characterised by high-level resistance to most currently available antifungal drugs. Standardised antifungal susceptibility testing methods are now available, allowing a better understanding of the in vitro activity of antifungal drugs against members of Mucorales. Such tests have made apparent that antifungal susceptibility within this group may be species-specific. Experimental animal models of mucormycosis have also been developed and are of great importance in bridging the gap between in vitro results and clinical trials...
August 9, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28750160/two-phase-1-open-label-mass-balance-studies-to-determine-the-pharmacokinetics-of-14-c-labeled-isavuconazonium-sulfate-in-healthy-male-volunteers
#13
Robert Townsend, Kota Kato, Christine Hale, Donna Kowalski, Christopher Lademacher, Takao Yamazaki, Shahzad Akhtar, Amit Desai
Isavuconazonium sulfate is the water-soluble prodrug of the active triazole isavuconazole. Two phase 1 studies were conducted to identify the metabolic profile and mass balance of isavuconazole and BAL8728 (inactive cleavage product). Seven subjects in study 1 (isavuconazole mass balance) received a single oral dose of [cyano-(14) C]isavuconazonium sulfate corresponding to 200 mg isavuconazole. Six subjects in study 2 (BAL8728 mass balance) received a single intravenous dose of [pyridinylmethyl-(14) C]isavuconazonium sulfate corresponding to 75 mg BAL8728...
July 27, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28742650/reliable-and-easy-to-use-liquid-chromatography-tandem-mass-spectrometry-method-for-simultaneous-analysis-of-fluconazole-isavuconazole-itraconazole-hydroxy-itraconazole-posaconazole-and-voriconazole-in-human-plasma-and-serum
#14
Carsten Müller, David Gehlen, Cornelia Blaich, Domenik Prozeller, Blasius Liss, Thomas Streichert, Martin H J Wiesen
BACKGROUND: A fast and easy-to-use liquid chromatography-tandem mass spectrometry method for the determination and quantification of 6 triazoles [fluconazole (FLZ), isavuconazole (ISZ), itraconazole (ITZ), hydroxy-itraconazole (OH-ITZ), posaconazole (PSZ), and voriconazole (VRZ)] in human plasma and serum was developed and validated for therapeutic drug monitoring. METHODS: Sample preparation was based on protein precipitation with acetonitrile and subsequent centrifugation...
October 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28722255/drug-drug-interactions-between-triazole-antifungal-agents-used-to-treat-invasive-aspergillosis-and-immunosuppressants-metabolized-by-cytochrome-p450-3a4
#15
REVIEW
Andreas H Groll, Robert Townsend, Amit Desai, Nkechi Azie, Mark Jones, Marc Engelhardt, Anne-Hortense Schmitt-Hoffman, Roger J M Brüggemann
Patients undergoing treatment with immunosuppressant drugs following solid organ or hematopoietic stem cell transplantation are at particular risk for development of serious infections such as invasive aspergillosis. Four triazole antifungal drugs, voriconazole, posaconazole, itraconazole, and isavuconazole, are approved to treat invasive aspergillosis either as first- or second-line therapy. All of these agents are inhibitors of cytochrome P450 3A4, which plays a key role in metabolizing immunosuppressant drugs such as cyclosporine, tacrolimus, and sirolimus...
July 19, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28702763/pharmacokinetics-of-antifungal-drugs-practical-implications-for-optimized-treatment-of-patients
#16
REVIEW
Romuald Bellmann, Piotr Smuszkiewicz
INTRODUCTION: Because of the high mortality of invasive fungal infections (IFIs), appropriate exposure to antifungals appears to be crucial for therapeutic efficacy and safety. MATERIALS AND METHODS: This review summarises published pharmacokinetic data on systemically administered antifungals focusing on co-morbidities, target-site penetration, and combination antifungal therapy. CONCLUSIONS AND DISCUSSION: Amphotericin B is eliminated unchanged via urine and faeces...
July 12, 2017: Infection
https://www.readbyqxmd.com/read/28696236/combination-therapy-with-isavuconazole-and-micafungin-for-treatment-of-experimental-invasive-pulmonary-aspergillosis
#17
Vidmantas Petraitis, Ruta Petraitiene, Matthew W McCarthy, Laura L Kovanda, Myo H Zaw, Kaiser Hussain, Naima Shaikh, Bo Bo W Maung, Navjot K Sekhon, William W Hope, Thomas J Walsh
Invasive pulmonary aspergillosis (IPA) is an important cause of morbidity and mortality in immunocompromised patients. We hypothesized that simultaneous inhibition of biosynthesis of ergosterol in the fungal cell membrane and (1→3)-β-d-glucan in the cell wall, respectively, by the antifungal triazole isavuconazole (ISA) and the echinocandin micafungin (MFG) may result in improved outcomes in experimental IPA in persistently neutropenic rabbits. Treatments included ISA at 20 mg/kg of body weight/day (ISA20), 40 mg/kg/day (ISA40), and 60 mg/kg/day (ISA60); MFG at 2 mg/kg/day (MFG2); combinations of ISA20 and MFG2, ISA40 and MFG2, and ISA60 and MFG2; and no treatment (untreated controls [UC])...
September 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28674051/effects-of-isavuconazole-on-the-plasma-concentrations-of-tacrolimus-among-solid-organ-transplant-patients
#18
Ryan M Rivosecchi, Cornelius J Clancy, Ryan K Shields, Christopher R Ensor, Michael A Shullo, Bonnie A Falcione, Raman Venkataramanan, M Hong Nguyen
We evaluated the interaction between isavuconazole and tacrolimus among 55 organ transplant recipients. After isavuconazole discontinuation, the tacrolimus concentration/dose ratio normalized by weight (C/D) was reduced by 16%. Liver transplant recipients experienced the largest C/D reduction. A 1.3-fold decrease in tacrolimus daily dose was required to maintain desired tacrolimus levels. There was considerable interpatient variability in the magnitude of the drug interaction. Tacrolimus doses should not be adjusted uniformly but, rather, be guided by therapeutic drug monitoring...
September 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28636889/complications-of-hematopoietic-stem-transplantation-fungal-infections
#19
REVIEW
Ali S Omrani, Reem S Almaghrabi
Patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at increased risk of invasive fungal infections, especially during the early neutropenic phase and severe graft-versus-host disease. Mold-active prophylaxis should be limited to the highest risk groups. Empiric antifungal therapy for HSCT with persistent febrile neutropenia is associated with unacceptable response rates, unnecessary antifungal therapy, increased risk of toxicity, and inflated costs. Empiric therapy should not be a substitute for detailed work up to identify the cause of fever in such patients...
June 13, 2017: Hematology/oncology and Stem Cell Therapy
https://www.readbyqxmd.com/read/28605488/in-vitro-activity-of-the-novel-antifungal-compound-f901318-against-difficult-to-treat-aspergillus-isolates
#20
J B Buil, A J M M Rijs, J F Meis, M Birch, D Law, W J G Melchers, P E Verweij
Background: F901318 is a new antifungal agent with a novel mechanism of action with activity against Aspergillus species. We investigated the in vitro activity of F901318 against a collection of Aspergillus isolates. Methods: A total of 213 Aspergillus isolates were used in this study. A total of 143 Aspergillus fumigatus sensu stricto isolates were used, of which 133 were azole resistant [25 TR34/L98H; 25 TR46/Y121F/T289A; 33 A. fumigatus with cyp51A-associated point mutations (25 G54, 1 G432 and 7 M220); and 50 azole-resistant A...
September 1, 2017: Journal of Antimicrobial Chemotherapy
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