Real‐world use—Isavuconazole at a large academic medical center

Hassouna, Habiba; Athans, Vasilios; Brizendine, Kyle

doi:10.1111/myc.12910

Cited by 17 publications

(28 citation statements)

References 28 publications

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“…Adverse events to ISZ in the present study were mostly gastroenteric and hepatic, reported by the treating physician and also reported by others [ 12 , 14 , 25 , 29 , 30 , 31 ]. Adverse events were not closely related to high median TDMs.…”

Section: Discussionsupporting

confidence: 89%

Therapeutic Drug Monitoring of Isavuconazole: Serum Concentration Variability and Success Rates for Reaching Target in Comparison with Voriconazole

et al. 2021

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Isavuconazole (ISZ) is used in the treatment of aspergillosis and mucormycosis. The purpose of this study was to evaluate the therapeutic drug monitoring (TDM) of ISZ samples from a clinical setting performed at Statens Serum Institut. Materials/methods: Isavuconazole serum concentrations were determined by fluorescent detection on a UHPLC. Serum-ISZ (s-ISZ) results were included and compared to those of serum-voriconazole (s-VRZ) in a 33 month period from March 2017. Clinical data were obtained for patients receiving ISZ. The therapeutic range was initially 2–10 mg/L, but was adjusted to 2–5 mg/L during the study period except for selected patients with Mucorales infections who received off-label doses of ISZ. Results: A total of 273 s-ISZ and 1242 s-VRZ measurements from 35 and 283 patients, respectively, were included. Seventeen patients had received both ISZ and VRZ with TDM within the study period. The median s-ISZ was 4.3 mg/L (0.5–15.4 mg/L) with 83% of measurements within the therapeutic index. The median s-VRZ was 2.6 mg/L (0.2–21.9 mg/L) with 67% of measurements within the therapeutic index. The median intra-/interindividual coefficient of variation (CV) was 43.4%/54.8% for ISZ compared to 53.2%/83.3% for VRZ. For patients receiving ISZ, the adverse events were mostly gastroenteric and few drug–drug interactions were observed. Furthermore, immediate change from ISZ to VRZ treatment seemed to lead to prolonged metabolism of ISZ with detection up to 35 days after discontinuation. Conclusions: The majority of patients achieved s-ISZ levels well within the therapeutic range with less intra/interindividual CV than patients receiving VRZ.

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Section: Discussionsupporting

confidence: 89%

Therapeutic Drug Monitoring of Isavuconazole: Serum Concentration Variability and Success Rates for Reaching Target in Comparison with Voriconazole

et al. 2021

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“…Another study evaluated isavuconazole prophylaxis in lung transplant recipients and identified a 3.5% bIFD rate among 144 patients 6 . So far, the highest reported bIFD incidence is 13.0% in 100 leukemia patients 13 and the lowest is 0% in 11 solid organ transplants, 15 HSCT, and 58 acute leukemia patients receiving isavuconazole for either prophylaxis or treatment 7,13 . Our overall 8.5% breakthrough rate is most similar to a study by Fontana et al, who reported an 8.3% bIFI rate among 145 allogeneic HSCT patients receiving isavuconazole for primary prophylaxis 5 .…”

Section: Discussionsupporting

confidence: 85%

“…Our results show that the most common reasons for switching to isavuconazole was better tolerability compared to first‐line agents. Similar to a study published by Hassouna et al, a majority of our patients were switched to isavuconazole for its beneficial effect on QTc, broad spectrum of activity, high oral bioavailability, lower incidence of hepatotoxicity, and to avoid drug‐drug interactions 7 . Owing to isavuconazole's unique ability to inhibit L‐type calcium channels, all patients who switched for prolonged QTc experienced shortening effects 10 .…”

Section: Discussionsupporting

confidence: 51%

“…To date, there have only been two studies comparing breakthrough rates between different triazoles within the same institution. Fontana et al showed higher bIFD rates among AML patients on isavuconazole (10.2%) compared to posaconazole (4.1%) and voriconazole (1.1%) and Samanta et al demonstrated similar bIFD rates among lung transplant recipients on isavuconazole (3.5%) compared to voriconazole (3.2%) 5,6 . Combining these findings, it remains unclear whether or not isavuconazole is similar or worse than other broad‐spectrum triazoles for breakthrough infections.…”

Section: Discussionmentioning

confidence: 99%

“…Over the last few years, isavuconazole has gained popularity for its broad spectrum of activity, favorable pharmacokinetics, and safety profile. Despite limited evidence, many institutions have begun using isavuconazole for off‐label indications, such as antifungal prophylaxis in high‐risk patient populations 4‐8 . In this study, we aimed to describe our single‐center experience with isavuconazole over a 18‐month time period.…”

Section: Introductionmentioning

confidence: 99%

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Isavuconazole for the prophylaxis and treatment of invasive fungal disease: A single‐center experience

Rana

Jacobs

et al. 2020

Transplant Infectious Dis

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Background Invasive fungal disease (IFD) is a serious complication among the immunocompromised population. Isavuconazole is a newer broad‐spectrum antifungal agent with promising efficacy and safety. However, there remains limited data to favor its use over current first‐line agents. Objectives We aimed to evaluate isavuconazole use and describe rates of associated breakthrough invasive fungal disease (bIFD). Methods A single‐center, retrospective study was conducted to evaluate patients receiving isavuconazole for prophylaxis or treatment of IFD between July 1, 2017 and December 31, 2018. Patient‐related and outcomes data were extracted from electronic medical records. Descriptive statistics were used to analyze our findings. Results A total of 54 patients received 61 isavuconazole courses. Isavuconazole was most commonly prescribed for primary prophylaxis in the acute myeloid leukemia (AML) and allogeneic hematopoietic stem cell transplant (HSCT) population along with treatment for possible invasive fungal disease. The primary reasons for choosing isavuconazole included QTc shortening effects, decreased risk of acute kidney injury, broader spectrum of activity, and concern for breakthrough invasive fungal disease on a different prophylactic agent. We found a breakthrough rate of 8.5% for patients and 7.8% for courses. Conclusions Isavuconazole appears to be a promising alternative for prophylaxis and treatment of invasive fungal disease. We observed similar bIFD rates and improved tolerability when compared to historical data for posaconazole and voriconazole.

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Clinical Considerations of Isavuconazole Administration in High-Risk Hematological Patients: A Single-Center 5-Year Experience

et al. 2021

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Background There are limited real-life data on isavuconazole prophylaxis and treatment of invasive mold infections (IMI) in hematological patients and allogeneic hematopoietic cell transplant (HCT) recipients. Objectives Primary objective was to describe the indications of real-life isavuconazole administration at a university hospital. Secondary objectives included the description of liver function tests and QTc interval between baseline and end of treatment (EOT), clinical outcomes and breakthrough IMI by the EOT. Patients/Methods This was a 5-year single-center retrospective study of all adult patients with acute myeloid leukemia and/or allogeneic HCT recipients who received isavuconazole as prophylaxis and/or treatment between June 1, 2016, and July 31, 2020. Results Among 30 identified patients, the indications for isavuconazole administration were adverse events associated with prior antifungal treatment (N: 18, 60%: hepatotoxicity, renal insufficiency, long QTc interval, neurotoxicity, and potential drug–drug interactions in 6, 4, 3, 1 and 4 patients, respectively), clinical efficacy (N: 5, 16.6%), and other reasons (N: 10, 33.3%; 5/10 patients treated with isavuconazole to facilitate hospital discharge with orally administered appropriate treatment). Alanine aminotransferase significantly decreased from baseline (mean: 129 IU/L, range: 73, 202) to a mean of 48 IU/L (range: 20, 80) by day 14 (P-value: 0.02), 23.5 IU/L (range: 20, 27) by day 28 (P-value: 0.03) and 16.5 IU/L (range: 16, 17) by day 42 (P-value: 0.009). The QTc interval decreased from baseline (mean: 456.8 ms, range: 390, 533) to EOT (mean: 433.8 ms, range: 400, 472; P-value: 0.03). The mean isavuconazole plasma concentration was 2.9 mg/L (range: 0.9, 6.7). There was no breakthrough IMI observed. Conclusion Isavuconazole is a safe and reliable antifungal agent in complex hematological patients, with relatively low hepatotoxicity and QTc interval shortening properties.

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Real‐world use—Isavuconazole at a large academic medical center

Cited by 17 publications

References 28 publications

Therapeutic Drug Monitoring of Isavuconazole: Serum Concentration Variability and Success Rates for Reaching Target in Comparison with Voriconazole

Therapeutic Drug Monitoring of Isavuconazole: Serum Concentration Variability and Success Rates for Reaching Target in Comparison with Voriconazole

Isavuconazole for the prophylaxis and treatment of invasive fungal disease: A single‐center experience

Clinical Considerations of Isavuconazole Administration in High-Risk Hematological Patients: A Single-Center 5-Year Experience

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