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9. A Simple HPLC-UV Method for Ivosidenib Determination in Human Plasma.

Author

Gando, Yoshito and Yasu, Takeo

Subjects
*DRUG monitoring, *ACUTE myeloid leukemia, *ISOCITRATE dehydrogenase, *ACETONITRILE, *PATIENT monitoring, *ALPHA fetoproteins
Abstract

Ivosidenib is used for the treatment of acute myeloid leukemia (AML) with isocitrate dehydrogenase 1 (IDH1) mutations. However, increased blood concentrations of ivosidenib are associated with a risk of a prolonged QT interval in patients with AML. Therapeutic drug monitoring in patients with AML with IDH1 mutation offers the potential to improve treatment efficacy while minimizing toxicity. In this study, we developed an efficient high-performance liquid chromatography–ultraviolet (HPLC-UV) method for the quantification of ivosidenib in plasma. Human plasma samples (50 μL) were processed by protein precipitation using acetonitrile, followed by chromatographic separation on a reversed-phase column with an isocratic mobile phase of 0.5% KH₂PO₄ (pH 4.5) and acetonitrile (45:55, v/v) at a flow rate of 1.0 mL/min, with ultraviolet detection at 245 nm. Calibration curves were linear over the range of 0.25–20 μg/mL with a coefficient of determination (r 2) of 0.99999. Intra-day and inter-day precision were 1.20–8.04% and 0.69–4.20%, respectively. The assay accuracy was −2.00% to 1.93% and recovery was >91.2%. These findings support the effectiveness of the newly developed HPLC-UV method for the quantification of ivosidenib in human plasma. This simple and cost-effective method is expected to expand ivosidenib monitoring in laboratories lacking LC–MS/MS instruments. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Association between plasma venetoclax trough levels and serum C-reactive protein levels in patients with acute myeloid leukemia treated with venetoclax plus azacitidine.

Author

Yasu, Takeo, Gando, Yoshito, Shirota, Mikio, Kosugi, Nobuharu, and Kobayashi, Masayuki

Subjects
*BLOOD proteins, *ACUTE myeloid leukemia, *VORICONAZOLE, *VENETOCLAX, *AZACITIDINE, *TUMOR necrosis factors
Abstract

This document discusses the association between plasma venetoclax (VEN) trough levels and serum C-reactive protein (CRP) levels in patients with acute myeloid leukemia (AML) who are treated with VEN plus azacitidine (AZA). The study found that inflammation, indicated by elevated CRP levels, is frequently observed in AML patients during induction therapy and can affect VEN levels. The VEN trough levels were significantly higher in patients with moderate and severe inflammation compared to those with no or mild inflammation. The study suggests that monitoring plasma trough VEN levels may be useful for ensuring the safety of AML patients undergoing VEN + AZA treatment. However, further research is needed to determine the optimal therapeutic range of VEN and its relationship with adverse events. [Extracted from the article]

Published
2024
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31. A Survey of Near-Miss Dispensing Errors in Hospital Pharmacies in Japan: DEPP-J Study—Multi-Center Prospective Observational Study—

Author

Momo, Kenji, primary, Yasu, Takeo, additional, Kuroda, Seiichiro, additional, Higashino, Sonoe, additional, Mitsugi, Eiko, additional, Ishimaru, Hiromasa, additional, Goto, Kazumi, additional, Eguchi, Atsuko, additional, Sato, Kuniyoshi, additional, Matsumoto, Masahiro, additional, Shiga, Takashi, additional, Kobayashi, Hideki, additional, Seki, Reisuke, additional, Nakano, Mikako, additional, Yashiro, Yoshiki, additional, Nagata, Takuya, additional, Yamazaki, Hiroshi, additional, Ishida, Shou, additional, Watanabe, Naoki, additional, Tagomori, Mihoko, additional, Sotoishi, Noboru, additional, Sato, Daisuke, additional, Kuroda, Kengo, additional, Harada, Dai, additional, Nagasawa, Hitoshi, additional, Kawakubo, Takashi, additional, Miyazawa, Yuta, additional, Aoyagi, Kyoko, additional, Kanauchi, Sachiko, additional, Okuyama, Kiyoshi, additional, Kohsaka, Satoshi, additional, Ono, Kohtaro, additional, Terayama, Yoshiyasu, additional, Matsuzawa, Hiroshi, additional, and Shirota, Mikio, additional

Published
2022
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37. Determination of Venetoclax Concentration in Plasma Using High-Performance Liquid Chromatography.

Author

Yasu, Takeo, Gando, Yoshito, Nomura, Yuka, Kosugi, Nobuharu, and Kobayashi, Masayuki

Subjects
*HIGH performance liquid chromatography, *BCL-2 proteins, *VENETOCLAX, *LYMPHOBLASTIC leukemia, *DRUG monitoring
Abstract

Venetoclax is an oral B-cell lymphoma-2 protein inhibitor. It is a key drug for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia. However, venetoclax is administered at a fixed dose, irrespective of body surface area or weight. Furthermore, the plasma concentration of venetoclax varies widely between individuals and is influenced by diet. Therefore, individualized dosing using therapeutic drug monitoring (TDM) may help to optimize treatment in clinical practice. In this study, we aimed to develop a simple method to determine venetoclax concentrations in plasma. The analysis required the extraction of a 50-μL plasma sample and precipitation of proteins using acetonitrile extraction. Venetoclax and the internal standard (12.5-μg/mL ibrutinib) were separated by high-performance liquid chromatography (HPLC). The calibration curve was linear over the plasma venetoclax concentration range 0.25–10 μg/mL with a coefficient of determination (r 2) of 0.9999. The coefficients of intra-day and inter-day validation were 0.8–4.1% and 1.3–3.3%, respectively. The assay accuracy was −2.8 to 1.6%, and the recovery was >97.2%. These results demonstrate a very simple, novel and sensitive HPLC-UV-based method for determining the concentration of plasma venetoclax, and confirm its applicability to the TDM of venetoclax in a clinical setting. [ABSTRACT FROM AUTHOR]

Published
2023
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38. Oral azole antifungal prophylaxis in Japanese patients with chronic lymphocytic leukemia receiving ibrutinib: a nationwide cohort study.

Author

Yasu, Takeo, Sakurai, Kotono, Hoshino, Makoto, and Akazawa, Manabu

Subjects
*CHRONIC lymphocytic leukemia, *JAPANESE people, *BRUTON tyrosine kinase, *PREVENTIVE medicine, *CANDIDEMIA, *CHRONIC leukemia
Abstract

There was no difference in the number of cases with >=3 prior treatment regimens between the azole prophylaxis and control groups, suggesting that antifungal prophylaxis is not a confounding variable for such treatment regimens. Ibrutinib, a first-generation inhibitor of Bruton's tyrosine kinase, is an important treatment option in chronic lymphocytic leukemia (CLL) [[1]]. For both the prophylaxis and control groups, data on ibrutinib treatment duration, prior CLL treatment regimens, oral azole prophylaxis, and corticosteroid treatments were collected at all relevant times during ibrutinib treatment. [Extracted from the article]

Published
2023
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