Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/16208
Title: 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
Austin Authors: Jeong, Wirawan;Haywood, Peter;Shanmuganathan, Naranie;Lindsay, Julian;Urbancic, Karen;Ananda-Rajah, Michelle R;Chen, Sharon CA;Bajel, Ashish;Ritchie, David;Grigg, Andrew P ;Seymour, John F;Peleg, Anton Y;Kong, David CM;Slavin, Monica A
Affiliation: Centre for Medicine Use and Safety, Monash University, Parkville, Victoria, Australia
Department of Clinical Haematology and Bone Marrow Transplant Service, Royal Melbourne Hospital, Parkville, Victoria, Australia
Department of Haematology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
Pharmacy Department, Royal North Shore Hospital, Sydney, NSW, Australia
Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia
General Medical Unit, Alfred Health and Central & Eastern Clinical School, Monash University, Victoria, Australia
Centre for Infectious Diseases and Microbiology Laboratory Services, Westmead Hospital, The University of Sydney, Sydney, NSW, Australia
Department of Clinical Haematology and Bone Marrow Transplant Service, Royal Melbourne Hospital and The University of Melbourne, Parkville, Victoria, Australia
Department of Clinical Haematology, Austin Health and The University of Melbourne, Heidelberg, Victoria, Australia
Department of Haematology, Peter MacCallum Cancer Centre and The University of Melbourne, Victoria, Australia
Department of Infectious Diseases, Alfred Health and Central Clinical School, Monash University, Victoria, Australia
Pharmacy Department, Ballarat Health Services, Ballarat, Victoria, Australia
Department of Infectious Diseases, Peter MacCallum Cancer Centre, Victoria, Australia
Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, Victoria, Australia
Issue Date: Dec-2016
metadata.dc.date: 2016-08-11
Publication information: Journal of Antimicrobial Chemotherapy 2016; 71(12): 3540-3547
Abstract: Objectives: This study describes the safety, clinical effectiveness and trough plasma concentration (Cmin) of intravenous (iv) posaconazole, provided as part of Merck Sharp and Dohme Australia's Named Patient Programme (NPP) in non-clinical trial settings. Methods: A multicentre, retrospective study on the NPP use of iv posaconazole between July 2014 and March 2015 across seven Australian hospitals. 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. Cmin 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 Cmin 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. 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.
URI: http://ahro.austin.org.au/austinjspui/handle/1/16208
DOI: 10.1093/jac/dkw322
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/27521358
Type: Journal Article
Appears in Collections:Journal articles

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