Adverse Effects of Voriconazole: Analysis of the French Pharmacovigilance Database

Eiden, Céline; Peyrière, Hélène; Cociglio, M.; Djezzar, Samira; Hansel, Sylvie; Blayac, Jean-Pierre; Hillaire‐Buys, Dominique

doi:10.1345/aph.1h671

Cited by 96 publications

(62 citation statements)

References 24 publications

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“…Serious adverse events were consistent with the recognized toxicities of azoles 18 but for voriconazole, less frequent than post-marketing reports. 19,20 The emergence of resistant fungi is a potential drawback of broad-spectrum antifungal prophylaxis. Intrinsically resistant organisms including A. niger, Scedosporium prolificans and Rhizopus spp.…”

Section: Discussionmentioning

confidence: 99%

Comparative clinical effectiveness of prophylactic voriconazole/posaconazole to fluconazole/itraconazole in patients with acute myeloid leukemia/myelodysplastic syndrome undergoing cytotoxic chemotherapy over a 12-year period

et al. 2011

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Post-induction aplasia for acute myeloid leukemia/myelodysplastic syndrome is a high-risk period for invasive fungal diseases. The effectiveness of fluconazole, itraconazole solution, voriconazole and posaconazole prophylaxis used consecutively from December 1998 to January 2010 in patients with acute myeloid leukemia/ myelodysplastic syndrome undergoing remission-induction chemotherapy was retrospectively evaluated. A total of 216 consecutive patients received 573 prophylaxis courses. Breakthrough-invasive fungal disease incidence in fluconazole, itraconazole, voriconazole, posaconazole recipients was 25%, 16%, 14% and 3%, respectively. Voriconazole/posconazole versus fluconazole/itraconazole combined was associated with significant reductions in breakthrough-invasive fungal disease incidence (20% vs

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Section: Discussionmentioning

confidence: 99%

Comparative clinical effectiveness of prophylactic voriconazole/posaconazole to fluconazole/itraconazole in patients with acute myeloid leukemia/myelodysplastic syndrome undergoing cytotoxic chemotherapy over a 12-year period

et al. 2011

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“…Studies have demonstrated that itraconazole (7 ) and metronidazole (8 ) can alter the AUC for busulfan. In addition, Eiden et al (9 ) have suggested that because of the extensive metabolism of voriconazole by cytochrome P450 isoenzymes, …”

Section: Discussionmentioning

confidence: 99%

Which Dose of Busulfan Is Best?

et al. 2010

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CASEA 24-year-old woman with advanced Hodgkin disease received the standard dosing protocol for busulfan/cyclophosphamide before allogeneic hematopoietic stem cell transplantation (HSCT) 4 from a matched unrelated donor. The target area under the plasma concentration vs time curve (AUC) for busulfan was set at 950 mol ⅐ L Ϫ1 ⅐ min Ϫ1 , near the low end of the therapeutic interval of 900 -1350 mol ⅐ L Ϫ1 ⅐ min Ϫ1 . The patient's body mass index (BMI) was 45.5 kg/m 2 (height, 170.2 cm; weight, 132.0 kg), so the dose was based on the patient's ideal body weight. The patient received 2-hour intravenous infusions of busulfan every 6 h for 4 days (16 doses total). The patient was concurrently prescribed multiple medications, including an immunosuppressant, an antiviral, an antifungal, an antidepressant, an anxiolytic, a ␤-blocker, and a muscle relaxant, as well as antibiotics, warfarin, opioids, and antiepileptic drugs.After the first dose (51 mg Busulfex; Otsuka Pharmaceutical), timed plasma samples were collected after infusion to determine the AUC. Pharmacokinetics (PK) analysis was performed, and the AUC was determined to be 642 mol ⅐ L Ϫ1 ⅐ min Ϫ1 . According to these results, the predicted busulfan dosage required to achieve the target AUC was 75 mg per dose for the remaining 14 scheduled doses. Because of the large change in dosage, additional PK monitoring of busulfan was performed after the fifth dose (day 2). The fifth dose was selected to allow time to reach a steady-state concentration (Css) after the dosage adjustment and to avoid challenges in interpretation due to possible circadian variation in busulfan concentrations (1 ). Samples for monitoring were collected at the same time of day as the first monitoring dose. The AUC after the fifth dose was 1342 mol ⅐ L Ϫ1 ⅐ min Ϫ1. On the basis of the PK data from the fifth dose, dose 7 was changed from 75 mg to 53 mg, close to the original calculated dose of 51 mg. Of note is that the patient was started on an oral antifungal agent (fluconazole, 400 mg/day) after dose 6. Additional monitoring of busulfan was performed immediately after the ninth dose because of another change in dose and potential reduced clearance through busulfan interaction with fluconazole. The AUC after dose 9 was 1306 mol ⅐ L Ϫ1 ⅐ min Ϫ1 . The busulfan dose was decreased to 39 mg for the remaining doses because the AUC was near the high end of the therapeutic range and because clearance was reduced between the fifth and ninth doses. Monitoring was performed after the 14th dose to verify the adjustment; an AUC of 871 mol ⅐ L Ϫ1 ⅐ min Ϫ1 was observed. No further dose adjustments were made. The busulfan half-life and elimination constant were relatively stable throughout the dosing regimen (Table 1). DISCUSSIONBusulfan is a cytotoxic compound commonly used in preparing patients for standard myeloablative preparative regimens before hematopoietic stem cell transplantation. Busulfan PK studies have demonstrated wide intra-and interpatient variation in drug disposition, metabolism, and cleara...

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“…Identifying the problem focus using pareto diagram The Pareto diagram is a powerful graphical tool or a special bar chart Johnson, Miller & Freund (2000), Frakes & Fox (1996) that presents clear information Sokovic, Pavletic & Fakin (2005) and helps to determine the element of major contributor in a process (Eiden et al, 2007). Sokovic et al (2005), posited that Pareto diagram can provide domains of the process for possible improvement.…”

Section: Analyze Phase: Pareto Diagram and Ishikawa Diagram (Fishbonementioning

confidence: 99%

A frontier in organizational and business process innovation in service management through lean six sigma Kaizen project implementation

2017

J. adm. bus. stud.

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Abstract. The rudiments and repercussions of the transformative global economy have reshaped the ServiceManagement industry and other developed economies. Business process innovation using Lean Six Sigma (LSS) methodology has long been considered to improve service quality, process ef iciency, and organizational performance by deploying Kaizen projects. This paper presents the business process innovation using De ine, Measure, Analyze, Improve and Control (DMAIC) methodology. The results show that the Kaizen Project positively impacted the company's productivity and support ef iciency and exceeded Service Level Agreement (SLA). The researcher recommends that the organization should continuously embark on process improvement, document lessons learned, share best practices, and champion LSS projects in larger scale and support operational units in institutionalizing the same innovation. Further studies could be done on the basis of how one-time scheme process better the quality of the service or product by using other framework and process improvement methodology.

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Adverse Effects of Voriconazole: Analysis of the French Pharmacovigilance Database

Cited by 96 publications

References 24 publications

Comparative clinical effectiveness of prophylactic voriconazole/posaconazole to fluconazole/itraconazole in patients with acute myeloid leukemia/myelodysplastic syndrome undergoing cytotoxic chemotherapy over a 12-year period

Comparative clinical effectiveness of prophylactic voriconazole/posaconazole to fluconazole/itraconazole in patients with acute myeloid leukemia/myelodysplastic syndrome undergoing cytotoxic chemotherapy over a 12-year period

Which Dose of Busulfan Is Best?

A frontier in organizational and business process innovation in service management through lean six sigma Kaizen project implementation

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