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      Pharmacokinetic/pharmacodynamic study of posaconazole delayed-release tablet in a patient with coexisting invasive aspergillosis and mucormycosis

      case-report

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          Abstract

          Limited information exists regarding the optimal dose of posaconazole delayed-release tablet for the treatment of invasive mold infection. Here, we report the case of a previously healthy 44-year-old Thai man who developed coexisting invasive pulmonary aspergillosis and mucormycosis following a car accident. He was treated with posaconazole delayed-release tablet. This report describes the pharmacokinetic/pharmacodynamic study, safety profile, and determination of the appropriate dosage of posaconazole delayed-release tablet in a patient with coexisting invasive aspergillosis and mucormycosis. Posaconazole exposure was analyzed by noncompartmental model. Ratio of area under the plasma concentration-time curve over the minimum inhibitory concentration (AUC/MIC) was applied to maximize the efficacy of posaconazole. The loading dose of 300 mg q 12 hrs was found to be potentially insufficient for achieving the AUC/MIC target for treatment of invasive mold infection with minimum inhibitory concentrations >0.01 mg/L. Early therapeutic drug monitoring to detect the drug concentration of posaconazole delayed-release tablet is necessary so that dosing adjustments can be made, as needed. In addition, a maintenance dose of either 400 or 300 mg once daily could achieve the AUC/MIC targets. These maintenance dosing regimens effectuated a successful clinical outcome with minimal adverse events.

          Most cited references18

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          Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology.

          H Ashbee, Rosemary A. Barnes, Elizabeth Johnson … (2014)
          The burden of human disease related to medically important fungal pathogens is substantial. An improved understanding of antifungal pharmacology and antifungal pharmacokinetics-pharmacodynamics has resulted in therapeutic drug monitoring (TDM) becoming a valuable adjunct to the routine administration of some antifungal agents. TDM may increase the probability of a successful outcome, prevent drug-related toxicity and potentially prevent the emergence of antifungal drug resistance. Much of the evidence that supports TDM is circumstantial. This document reviews the available literature and provides a series of recommendations for TDM of antifungal agents.
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            Pharmacokinetics and absorption of posaconazole oral suspension under various gastric conditions in healthy volunteers.

            Gopal Krishna Sarepaka, Lei Ma, Megan J Osmond-McLeod … (2009)
            A four-part, randomized, crossover study with healthy subjects evaluated the effects of gastric pH, the dosing frequency and prandial state, food consumption timing, and gastric motility on the absorption of posaconazole. In part 1, a single dose (SD) of posaconazole (400 mg) was administered alone or with an acidic beverage or a proton pump inhibitor (PPI), or both. In part 2, posaconazole (400 mg twice daily and 200 mg four times daily) was administered for 7 days with and without a nutritional supplement (Boost). In part 3, an SD of posaconazole (400 mg) was administered while the subjects were fasting and before, during, and after a high-fat meal. In part 4, an SD of posaconazole (400 mg) and the nutritional supplement were administered alone, with metoclopramide, and with loperamide. Compared to the results obtained with posaconazole alone, administration with an acidic beverage increased the posaconazole maximum concentration in plasma (C(max)) and the area under the concentration-time curve (AUC) by 92% and 70%, respectively, whereas a higher gastric pH decreased the posaconazole C(max) and AUC by 46% and 32%, respectively. Compared to the results obtained with posaconazole alone, posaconazole at 400 mg or at 200 mg plus the nutritional supplement increased the posaconazole C(max) and AUC by 65% and 66%, respectively, and by up to 137% and 161%, respectively. Administration before a high-fat meal increased the C(max) and the AUC by 96% and 111%, respectively, while administration during and after the meal increased the C(max) and the AUC by up to 339% and 387%, respectively. Increased gastric motility decreased the C(max) and the AUC by 21% and 19%, respectively. Strategies to maximize posaconazole exposure in patients with absorption difficulties include administration with or after a high-fat meal, with any meal or nutritional supplement, with an acidic beverage, or in divided doses and the avoidance of proton pump inhibitors.
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              Exposure–Response of Posaconazole Used for Prophylaxis Against Invasive Fungal Infections: Evaluating the Need to Adjust Doses Based on Drug Concentrations in Plasma

              S H Jang, P Colangelo, J V S Gobburu (2010)
              The purpose of this article is to report the exposure-response (E-R) relationship of posaconazole oral suspension (POS) for prophylaxis against invasive fungal infections (IFIs), on the basis of the US Food and Drug Administration (FDA) clinical pharmacology review of two randomized, active-controlled clinical studies. Posaconazole average steady state plasma concentrations (C(avg)) ranged from 22 to 3,650 ng/ml after administration of POS 200 mg three times daily (t.i.d.). In a double-blind, randomized clinical trial, the quartile ranges of C(avg) with midpoint values of 289, 736, 1,239, and 2,607 ng/ml had clinical failure rates of 44, 21, 18, and 18%, respectively, indicating an inverse association between C(avg) and clinical failure rate. There were no significant relationships between C(avg) and posaconazole-related major adverse events. Determining posaconazole concentrations in plasma will aid in assessing the need for either POS dose adjustment (e.g., increasing the POS dose) or switching to another systemic antifungal drug, thereby improving the effectiveness of prophylaxis against IFIs.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Ther Clin Risk Manag
                Journal ID (iso-abbrev): Ther Clin Risk Manag
                Journal ID (publisher-id): TCRM
                Journal ID (pmc): tcriskman
                Title: Therapeutics and Clinical Risk Management
                Publisher: Dove
                ISSN (Print): 1176-6336
                ISSN (Electronic): 1178-203X
                Publication date (Electronic): 24 April 2019
                Publication date Collection: 2019
                Volume: 15
                Pages: 589-595
                Affiliations
                [1 ]Division of Clinical Pharmacy, Department of Pharmacy, Faculty of Pharmacy, Mahidol University , Bangkok, Thailand
                [2 ]Department of Pharmacy, Faculty of Medicine Vajira Hospital, Navamindradhiraj University , Bangkok, Thailand
                [3 ]Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok, Thailand
                Author notes
                Correspondence: Methee Chayakulkeeree Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University , 2 Wanglang Road, Bangkokoi, Bangkok10700, ThailandTel +662 419 9462Fax +662 419 7783Email methee.cha@ 123456mahidol.ac.th
                Article
                Publisher ID: 203625
                DOI: 10.2147/TCRM.S203625
                PMC ID: 6497849
                SO-VID: 87f75801-534f-4b9e-8d00-a4a6bf6a60b1
                Copyright © © 2019 Leelawattanachai et al.
                License:

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                Date received : 31 January 2019
                Date accepted : 30 March 2019
                Page count
                Figures: 2, Tables: 2, References: 23, Pages: 7
                Categories
                Subject: Case Report

                ScienceOpen disciplines: Medicine
                Keywords: antifungal,treatment,therapeutic drug monitoring,auc/mic,invasive fungal infection,mixed infection
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: antifungal, treatment, therapeutic drug monitoring, auc/mic, invasive fungal infection, mixed infection

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