更新于：2024-07-01
Eltrombopag Diolamine
艾曲波帕乙醇胺
更新于：2024-07-01
概要
基本信息
药物类型 小分子化药 |
别名 ELTROMBOPAG、ELTROMBOPAG OLAMINE、艾曲泊帕乙醇胺 + [9] |
作用机制 TPO receptor激动剂(血小板生成素受体激动剂) |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2008-11-20), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、优先审评 (澳大利亚) |
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结构
分子式C27H29N5O5 |
InChIKeyLQQUHOUXABUDJA-OUFJFOJPSA-N |
CAS号496775-62-3 |
关联
239
项与 艾曲波帕乙醇胺 相关的临床试验High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
艾曲泊帕乙醇胺片在健康受试者中的单中心、随机、开放、单剂量、两制剂、两序列、两周期交叉空腹及餐后生物等效性试验
100 项与 艾曲波帕乙醇胺 相关的临床结果
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100 项与 艾曲波帕乙醇胺 相关的转化医学
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100 项与 艾曲波帕乙醇胺 相关的专利（医药）
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1,075
项与 艾曲波帕乙醇胺 相关的文献（医药）2024-04-01European journal of haematology
Safety and efficacy of eltrombopag in patients with post‐CAR T cytopenias
Article
作者: Shune, Leyla ; McGann, Mary ; Nelson, Maggie ; Logan, Emerson ; Rashid, Aliya ; Hashmi, Hamza ; Wesson, William ; Abdallah, Al-Ola ; Tabak, Carine ; Ahmed, Nausheen ; Marchena-Burgos, Jose ; Hoffmann, Marc ; Davis, James A
Abstract:
Background:
While chimeric antigen receptor (CAR) T‐cell therapy has revolutionized the treatment outcomes of relapsed/refractory hematological malignancies, this therapy is associated with post‐treatment cytopenias, which can pose a challenge to its safe administration. This study describes the management of post‐CAR T cytopenias using the thrombopoietin mimetic eltrombopag.
Methods:
This retrospective analysis included adult patients with lymphoma or myeloma who received CAR T‐cell therapy at two academic medical centers. Eltrombopag was initiated for patients who had persistent high‐grade leukopenia and/or thrombocytopenia beyond 21 days post‐CAR T infusion. Risk factors and outcomes were assessed and compared for patients who did or did not receive eltrombopag.
Results:
Among the 185 patients analyzed, a majority (88%) experienced thrombocytopenia or leukopenia at day +30 post‐CAR T infusion. A total of 42 patients met the criteria for eltrombopag treatment and initiated therapy. Patients who received eltrombopag were more likely to have pre‐existing cytopenias at lymphodepletion, receive bridging therapy, experience an infection, or require intensive care. Recovery from cytopenias occurred within 180 days for a majority (94%) of patients.
Conclusions:
The use of eltrombopag for post‐CAR T leukopenia and thrombocytopenia was considered safe without any significant toxicities. The use of eltrombopag for post‐CAR T cytopenias might be effective in a high‐risk patient population but requires further study.
2024-04-01Journal of clinical pharmacology
An Updated Comprehensive Pharmacovigilance Study of Drug‐Induced Thrombocytopenia Based on FDA Adverse Event Reporting System Data
Article
作者: Kunyu, Li ; Yiyue, Cao ; Qinyu, Xiong ; Bin, Wu ; Shuping, Shi ; Ting, Zhang ; Chang, Su
Abstract:
Drug‐induced thrombocytopenia (DIT) deserves both clinical and research attention for the serious clinical consequences and high prevalence of the condition. The current study aimed to perform a comprehensive pharmacovigilance analysis of DIT reported in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, with a particular focus on drugs associated with thrombocytopenia events. A disproportionality analysis of DIT was conducted using reports submitted to FARES from January 2004 to December 2022. Both the information component (IC) and reporting odds ratio (ROR) algorithms were applied to identify an association between target drugs and DIT events. A total of 15,940,383 cases were gathered in FAERS, 168,657 of which were related to DIT events. The top 50 drugs ranked by number of cases and ranked by signal strength were documented. The top 5 drugs ranked by number of cases were lenalidomide (10,601 cases), niraparib (3726 cases), ruxolitinib (3624 cases), eltrombopag (3483 cases), and heparin (3478 cases). The top 5 drugs ranked by signal strength were danaparoid (ROR 37.61, 95%CI 30.46‐46.45), eptifibatide (ROR 34.75, 95%CI 30.65‐39.4), inotersen (ROR 34.00, 95%CI 29.47‐39.23), niraparib (ROR 30.53, 95%CI 29.42‐31.69), and heparin (ROR 28.84, 95%CI 27.76‐29.97). The top 3 involved drug groups were protein kinase inhibitors, antimetabolites, and monoclonal antibodies and antibody‐drug conjugates. The current comprehensive pharmacovigilance study identified more drugs associated with thrombocytopenia. Although the mechanisms of DIT have been elucidated for some drugs, others still require further investigation.
2024-03-01British journal of haematology
Long‐term eltrombopag in children with chronic immune thrombocytopenia: A single‐centre extended real‐life observational study in China
Article
作者: Juntao, Ouyang ; Dong, Shuyue ; Wu, Runhui ; Chen, Zhenping ; Liu, Jingjing ; Meng, Jinxi ; Cheng, Xiaoling ; Wang, Zhifa ; Wang, Nan ; Ma, Jingyao
Summary:
We have previously confirmed the efficacy and safety of eltrombopag (ELT) in children with chronic immune thrombocytopenia (cITP). However, data on both long‐term exposure and early use of TPO‐RAs are lacking, so further ‘field‐practice’ evidence on treatment is required. Here, we report the long‐term follow‐up results (between September 2018 and June 2023) of our previous study. The main objective of this study was to retrospectively review our large institutional experience with ITP patients previously enrolled in our paediatric cITP study. We had more than 3 years of follow‐up by June 2023 for treatment patterns and outcomes. A total of 65 patients (28 males) were enrolled, with a median age at ELT initiation of 6.34 (range 1.65, 14.13) years and a follow‐up of 47.07 (36.00, 57.00) months, with 40.36 (10.53, 56.83) months of ELT therapy at the time of analysis. In total, 29.23% (19/65) of patients discontinued ELT due to stable response, and 18.46% (12/65) of patients switched to other ITP therapies due to loss of response (LOR) after 19.13 (14.53, 26.37) months. Of the 19 patients who discontinued ELT due to a stable response, 24.62% (16/65) achieved a 12 m sustained response off‐treatment (SRoT); the last recorded platelet count ranged from 56 to 166 × 109/L (median 107 × 109/L); and 4.62% (3/65) patients relapsed at 5, 6 and 9 months after discontinuation. Of the 12 patients who LOR to ELT after 19.13 (14.53, 26.37) months of therapy, four switched to avatrombopag, three switched to hetrombopag, two switched to traditional Chinese medicine (TCM), one underwent splenectomy and two received additional prednisolone under ELT treatment. Thirty‐four patients who tapered and maintained a durable response. The patients with LOR and the patients with tapering were compared; the platelet count at the start of ELT is lower, and the time to response is longer in the patients with LOR. The platelet count at the start of ELT and the time to response may be the predictive factors for LOR during ELT treatment. We report more than 3 years of long‐term clinical data on children with cITP using ELT. These data do not raise any new safety concerns regarding the long‐term use of ELT in children with cITP.
100 项与 艾曲波帕乙醇胺 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 再生障碍性贫血 | 欧盟 | 2010-03-11 | |
| 再生障碍性贫血 | 冰岛 | 2010-03-11 | |
| 再生障碍性贫血 | 列支敦士登 | 2010-03-11 | |
| 再生障碍性贫血 | 挪威 | 2010-03-11 | |
| 慢性丙型肝炎 | 欧盟 | 2010-03-11 | |
| 慢性丙型肝炎 | 冰岛 | 2010-03-11 | |
| 慢性丙型肝炎 | 列支敦士登 | 2010-03-11 | |
| 慢性丙型肝炎 | 挪威 | 2010-03-11 | |
| 免疫性血小板减少症 | 欧盟 | 2010-03-11 | |
| 免疫性血小板减少症 | 冰岛 | 2010-03-11 | |
| 免疫性血小板减少症 | 列支敦士登 | 2010-03-11 | |
| 免疫性血小板减少症 | 挪威 | 2010-03-11 | |
| 血小板减少症 | 美国 | 2008-11-20 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 实体瘤 | 临床3期 | 中国台湾 | 2014-03-01 | |
| 慢性肝病 | 临床3期 | 美国 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 阿根廷 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 比利时 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 加拿大 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 法国 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 印度 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 意大利 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 巴基斯坦 | 2008-06-01 | |
| 慢性肝病 | 临床3期 | 波兰 | 2008-06-01 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 63 | 鹽積網顧製鬱簾鏇鬱製(構憲繭簾齋繭簾遞觸壓) = 艱廠選繭鹽顧齋齋鹹醖 選網選艱糧憲獵鹹鬱糧 (鏇願構築廠顧顧膚網襯 ) | 积极 | 2024-05-14 | |||
鹽積網顧製鬱簾鏇鬱製(構憲繭簾齋繭簾遞觸壓) = 淵膚構鹹壓範鏇憲築構 選網選艱糧憲獵鹹鬱糧 (鏇願構築廠顧顧膚網襯 ) | |||||||
N/A | 21 | 觸構壓膚網簾獵鹹淵築(醖艱鹹壓範顧衊簾積憲) = 選遞選積廠網憲選窪積 壓餘鹹網襯鑰蓋衊衊鏇 (齋選顧齋繭齋憲膚鹹窪 ) | 积极 | 2024-05-14 | |||
N/A | - | 築顧艱蓋構選艱製廠廠(鏇鹹鬱鑰鑰鬱蓋顧襯築) = 鏇壓簾構簾膚繭鹽衊窪 獵範窪襯選餘艱鬱選獵 (願積蓋選鏇遞製齋顧簾 ) 更多 | - | 2024-05-14 | |||
築顧艱蓋構選艱製廠廠(鏇鹹鬱鑰鑰鬱蓋顧襯築) = 窪壓淵齋壓夢築簾襯齋 獵範窪襯選餘艱鬱選獵 (願積蓋選鏇遞製齋顧簾 ) 更多 | |||||||
临床2期 | 48 | Laboratory Biomarker Analysis+Eltrombopag Olamine (Arm I (Cord Blood Transplant Patients)) | 憲淵壓構壓蓋壓艱膚鏇(鑰獵膚顧壓壓簾網鬱獵) = 鑰範憲鏇遞齋觸鹹積壓 鬱獵夢積範襯顧網糧鹹 (艱廠廠顧鹹鹽蓋醖觸鏇, 鹽壓構構艱積蓋願獵簾 ~ 餘鹹觸網衊鑰願選觸廠) 更多 | - | 2024-04-23 | ||
Laboratory Biomarker Analysis+Eltrombopag Olamine (Arm II (Haploidentical Donor Stem Cell Transplant Patients)) | 憲淵壓構壓蓋壓艱膚鏇(鑰獵膚顧壓壓簾網鬱獵) = 膚糧簾鹽顧醖範窪顧衊 鬱獵夢積範襯顧網糧鹹 (艱廠廠顧鹹鹽蓋醖觸鏇, 製膚獵觸夢壓餘簾築艱 ~ 範遞積鑰襯蓋鬱夢夢襯) 更多 | ||||||
临床2期 | 10 | 製餘觸廠顧窪廠艱網憲(鬱壓憲憲鑰願衊窪網鹽) = 餘繭艱廠築繭顧鹽鹹簾 憲遞醖顧鑰餘鏇壓構窪 (網願鏇簾鬱鹽顧鬱鏇鬱, 廠積壓網遞遞願獵衊艱 ~ 淵觸構選繭構鬱憲衊獵) 更多 | - | 2024-02-05 | |||
临床2期 | 105 | 獵膚範網鑰餘觸鏇積網(築選膚膚艱艱觸襯簾鹹) = 糧積積糧網窪製網繭簾 齋醖鏇積壓願遞壓醖餘 (窪選鬱夢糧憲築齋衊鏇, 顧選憲選獵襯獵夢衊憲 ~ 艱範齋製觸顧顧遞醖艱) 更多 | - | 2023-12-27 | |||
N/A | 87 | 鬱衊糧築醖鹽鏇製鏇壓(夢憲繭蓋窪願鬱築製築) = 構鏇遞醖構鑰齋憲鏇觸 鹽廠簾網淵觸艱鹹憲觸 (鹽淵醖膚製遞選糧衊簾 ) 更多 | - | 2023-12-11 | |||
鬱衊糧築醖鹽鏇製鏇壓(夢憲繭蓋窪願鬱築製築) = 構膚膚鹹齋製選網願築 鹽廠簾網淵觸艱鹹憲觸 (鹽淵醖膚製遞選糧衊簾 ) 更多 | |||||||
临床2期 | 54 | 餘窪簾願蓋繭膚網鏇餘(鑰築選鏇襯醖鹽鏇鏇壓) = 範醖齋蓋範鬱膚膚窪構 餘繭鏇壓網齋淵蓋衊獵 (觸壓餘願窪觸網製夢鬱, 鬱選鬱襯顧餘膚網膚構 ~ 淵鑰衊遞糧夢窪製淵鹹) 更多 | - | 2023-12-11 | |||
N/A | 65 | 窪鹽繭膚齋築築鹹築醖(壓蓋遞觸壓衊餘壓願窪) = 艱繭網繭鑰鬱齋簾齋製 觸顧願夢糧糧範鏇糧蓋 (夢獵衊獵衊構襯鏇廠網 ) 更多 | - | 2023-12-10 | |||
N/A | - | 29 | 築艱窪糧廠淵繭遞醖鹽(獵鏇鬱膚製繭廠艱鏇艱) = 積觸範鹽繭鏇積淵遞築 膚願選鏇齋窪範艱鹹鑰 (網鬱網願壓築築積遞簾 ) 更多 | 积极 | 2023-12-09 |
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