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

Wirawan Jeong, Peter Haywood, Naranie Shanmuganathan, Julian Lindsay, Karen Urbancic, Michelle Ananda-Rajah, Sharon C A Chen, Ashish Bajel, David Ritchie, Andrew Grigg, John F. Seymour, Anton Y. Peleg, David C. M. Kong, Monica Slavin

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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.
Original languageEnglish
Pages (from-to)3540-3547
Number of pages8
JournalJournal of Antimicrobial Chemotherapy
Volume71
Issue number12
DOIs
Publication statusPublished - 11 Aug 2016

Cite this

Jeong, Wirawan ; Haywood, Peter ; Shanmuganathan, Naranie ; Lindsay, Julian ; Urbancic, Karen ; Ananda-Rajah, Michelle ; Chen, Sharon C A ; Bajel, Ashish ; Ritchie, David ; Grigg, Andrew ; Seymour, John F. ; Peleg, Anton Y. ; Kong, David C. M. ; Slavin, Monica. / 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. In: Journal of Antimicrobial Chemotherapy. 2016 ; Vol. 71, No. 12. pp. 3540-3547.
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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",
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.",
author = "Wirawan Jeong and Peter Haywood and Naranie Shanmuganathan and Julian Lindsay and Karen Urbancic and Michelle Ananda-Rajah and Chen, {Sharon C A} and Ashish Bajel and David Ritchie and Andrew Grigg and Seymour, {John F.} and Peleg, {Anton Y.} and Kong, {David C. M.} and Monica Slavin",
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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. / Jeong, Wirawan; Haywood, Peter; Shanmuganathan, Naranie; Lindsay, Julian; Urbancic, Karen; Ananda-Rajah, Michelle; Chen, Sharon C A; Bajel, Ashish; Ritchie, David; Grigg, Andrew; Seymour, John F.; Peleg, Anton Y.; Kong, David C. M.; Slavin, Monica.

In: Journal of Antimicrobial Chemotherapy, Vol. 71, No. 12, 11.08.2016, p. 3540-3547.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Safety, clinical effectiveness and trough plasma concentrations of intravenous posaconazole in patients with haematological malignancies and/or undergoing allogeneic haematopoietic stem cell transplantation

T2 - off-trial experience

AU - Jeong, Wirawan

AU - Haywood, Peter

AU - Shanmuganathan, Naranie

AU - Lindsay, Julian

AU - Urbancic, Karen

AU - Ananda-Rajah, Michelle

AU - Chen, Sharon C A

AU - Bajel, Ashish

AU - Ritchie, David

AU - Grigg, Andrew

AU - Seymour, John F.

AU - Peleg, Anton Y.

AU - Kong, David C. M.

AU - Slavin, Monica

PY - 2016/8/11

Y1 - 2016/8/11

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85018568739&partnerID=8YFLogxK

U2 - 10.1093/jac/dkw322

DO - 10.1093/jac/dkw322

M3 - Article

C2 - 27521358

AN - SCOPUS:85018568739

VL - 71

SP - 3540

EP - 3547

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

SN - 0305-7453

IS - 12

ER -