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Safety, clinical effectiveness and trough plasma concentrations of intravenous posaconazole in patients with haematological malignancies and/or undergoing allogeneic haematopoietic stem cell transplantation: off-trial experience.
- Source :
-
The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2016 Dec; Vol. 71 (12), pp. 3540-3547. Date of Electronic Publication: 2016 Aug 11. - Publication Year :
- 2016
-
Abstract
- Objectives: This study describes the safety, clinical effectiveness and trough plasma concentration (C <subscript>min</subscript> ) of intravenous (iv) posaconazole, provided as part of Merck Sharp and Dohme Australia's Named Patient Programme (NPP) in non-clinical trial settings.<br />Methods: A multicentre, retrospective study on the NPP use of iv posaconazole between July 2014 and March 2015 across seven Australian hospitals.<br />Results: Seventy courses of iv posaconazole were prescribed and evaluated in 61 patients receiving treatment for haematological malignancy. Sixty-one courses were prescribed for prophylaxis against invasive fungal disease (IFD), the majority of which (59) were initiated in patients with gastrointestinal disturbances and/or intolerance to previous antifungals. The median (IQR) duration for prophylaxis was 10 (6-15) days. No breakthrough IFD was observed during or at cessation of iv posaconazole. Nine courses of iv posaconazole were prescribed for treatment of IFD with a median (IQR) duration of 19 (7-30) days. Improvement in signs and symptoms of IFD was observed in five cases at cessation of, and six cases at 30 days post-iv posaconazole. C <subscript>min</subscript> was measured in 39 courses of iv posaconazole, with the initial level taken [median (IQR)] 4 (3-7) days after commencing iv posaconazole. The median (IQR) of initial C <subscript>min</subscript> was 1.16 (0.69-2.06) mg/L. No severe adverse events specifically attributed to iv posaconazole were documented, although six courses were curtailed due to potential toxicity.<br />Conclusions: This non-clinical trial experience suggests that iv posaconazole appeared to be safe and clinically effective for prophylaxis or treatment of IFD in patients receiving treatment for haematological malignancies.<br /> (© The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)
- Subjects :
- Administration, Intravenous
Adult
Antifungal Agents administration & dosage
Australia
Chemoprevention adverse effects
Drug-Related Side Effects and Adverse Reactions epidemiology
Drug-Related Side Effects and Adverse Reactions pathology
Female
Hematologic Neoplasms complications
Hematologic Neoplasms therapy
Hematopoietic Stem Cell Transplantation
Humans
Male
Middle Aged
Plasma chemistry
Retrospective Studies
Transplantation, Homologous
Treatment Outcome
Triazoles administration & dosage
Antifungal Agents adverse effects
Antifungal Agents pharmacokinetics
Chemoprevention methods
Mycoses drug therapy
Mycoses prevention & control
Triazoles adverse effects
Triazoles pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 1460-2091
- Volume :
- 71
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- The Journal of antimicrobial chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 27521358
- Full Text :
- https://doi.org/10.1093/jac/dkw322