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更新于：2025-03-24
Ferric Carboxymaltose
羧基麦芽糖铁
更新于：2025-03-24
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2007-06-26), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
257
项与 羧基麦芽糖铁 相关的临床试验NCT06833788
Treatment of Anaemia After Caesarean with Intravenous Versus Oral Iron and Postpartum Depression: a Multicentric Randomized Open-labelled Controlled Trial
NCT06707220
The Türkiye Heart Failure (TURK-HF) Registry
IRCT20200105046010N127
Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in Iron deficiency anemic patients in the fasted condition
100 项与 羧基麦芽糖铁 相关的临床结果
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100 项与 羧基麦芽糖铁 相关的转化医学
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100 项与 羧基麦芽糖铁 相关的专利（医药）
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821
项与 羧基麦芽糖铁 相关的文献（医药）2025-12-31JOURNAL OF MEDICAL ECONOMICS
Evaluating the cost-utility of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anaemia in Norway
Article
作者: Detlie, T. E. ; Karlsen, L. N. ; Pollock, R. F. ; Nanu, N. ; Jørgensen, E.
AIMS:
Iron deficiency anemia (IDA) is among the most common extraintestinal sequelae of inflammatory bowel disease (IBD). Intravenous iron is often the preferred treatment in patients with active inflammation with or without active bleeding, iron malabsorption, or intolerance to oral iron. The aim of the present study was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboyxymaltose (FCM) in patients with IBD and IDA in Norway.
MATERIALS AND METHODS:
A published patient-level simulation model was used to evaluate the cost-utility of FDI versus FCM in patients with IBD and IDA from a Norwegian national payer perspective. Iron need was modelled based on bivariate distributions of hemoglobin and bodyweight combined with simplified tables of iron need from the FDI and FCM summaries of product characteristics. Patient characteristics and disease-related quality of life data were obtained from the PHOSPHARE-IBD trial. Cost-utility was evaluated in Norwegian Kroner (NOK) over a five-year time horizon.
RESULTS:
Patients required 1.64 fewer infusions of FDI than FCM over five years (5.62 versus 7.26), corresponding to 0.41 fewer infusions per treatment course. The reduction in the number of infusions resulted in cost savings of NOK 5,236 (NOK 35,830 with FDI versus NOK 41,066 with FCM). The need for phosphate testing in patients treated with FCM resulted in further cost savings with FDI (no costs with FDI versus NOK 4,470 with FCM). Total cost savings with FDI were therefore NOK 9,707. FDI also increased quality-adjusted life expectancy by 0.071 quality-adjusted life years (QALYs) driven by reduced incidence of hypophosphatemia and fewer interactions with the healthcare system.
CONCLUSIONS:
FDI resulted in cost savings and improved quality-adjusted life expectancy versus FCM in patients with IDA and IBD in Norway. FDI therefore represents the economically preferable iron formulation in Norwegian patients with IBD and IDA in whom it is indicated.
2025-04-01Drug Delivery and Translational Research
A whole-body mechanistic physiologically-based pharmacokinetic modeling of intravenous iron
Article
作者: Yan, Xiaoyu ; Wong, Raymond S M ; Fan, Xiaoqing ; Cao, Kangna
Abstract:
Iron is essential for every cell of the mammalian organism. Iron deficiency is a major public health issue worldwide. Intravenous (IV) iron therapy has been used to treat anemia. However, IV iron therapy is known far away from ideal because the quantitative relationship between the pharmacokinetics and biodistribution of IV iron under different iron statuses remains unclear. Patients are known to suffer adverse effects from excessive iron accumulation. Our objective was to develop a physiologically based pharmacokinetic (PBPK) model of iron in mice and validate its application for predicting iron disposition in rats and humans. Previously published data on iron were collected for constructing the PBPK model of iron in mice, and then extrapolated to rats and humans based on physiologically and chemically specific parameters relevant to each species. The PBPK model characterized the distribution of iron in mice successfully. The model based on extrapolation to rats accurately simulated the ferric carboxymaltose (FCM) PK profiles in rat tissues. Similarly, the observed and simulated serum PK of FCM in humans were in reasonable agreement. This mechanistic whole-body PBPK model is useful for understanding and predicting iron effects on different species. It also establishes a foundation for future research that incorporates iron kinetics and biodistribution, along with related clinical experiments. This approach could lead to the development of effective and personalized iron deficiency anemia treatments.Graphical AbstractMajor components and processes of whole-body systemic iron trafficking.
2025-04-01ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA
Association between iron deficiency and fertility
Article
作者: Ruokolainen‐Pursiainen, Lasse ; Tulenheimo‐Silfvast, Annika ; Simberg, Niklas
Abstract:
Introduction:
This retrospective, observational cohort study investigated the association between treatment of iron deficiency with conception results and pregnancy outcomes in women with infertility and iron deficiency, before and after intravenous ferric carboxymaltose infusion.
Material and Methods:
Data were collected from electronic health records from the Dextra Fertility Clinic (Helsinki, Finland) between 2015 and 2020. The cohort included 292 women (<43 years) with infertility and iron deficiency (s‐ferritin ≤30 μg/L), treated with a ferric carboxymaltose infusion (Ferinject®, 500 mg i.v.). The main outcomes were live birth and miscarriage rates before and after treatment of iron deficiency. The main explanatory variable studied was the administered iron infusion.
Results:
Mean s‐ferritin levels increased from 16.2 ± 7.0 μg/L before to 81.5 ± 49.8 μg/L after iron infusion. The proportion of patients who conceived increased from 65% before to 77% after treatment of iron deficiency (p < 0.001). Of the study population, 28% of patients experienced miscarriages and 26% gave a live birth before iron infusion, and 13% and 51% after treatment of iron deficiency (p < 0.001). In the model adjusted for age, use of preimplantation genetic testing for aneuploidy, and repeated iron infusions, treatment of iron deficiency with iron infusion was associated with a higher live birth rate (OR = 3.19; 95% CI = 2.21–4.66; p < 0.001). In the model adjusted for age, reason for infertility, and total number of pregnancies, treatment of iron deficiency was associated with lower miscarriage rates (OR = 0.32; 95% Cl = 0.20–0.52; p < 0.001).
Conclusions:
Filling of depleted iron stores was positively associated with conception results (higher number of pregnancies) and pregnancy outcomes (higher live birth rates and lower miscarriage rates), regardless of the assisted reproductive technology method used. Screening of iron status seems to be important in patients seeking help for infertility problems.
100 项与 羧基麦芽糖铁 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 |
|---|---|---|---|
| 铁缺乏 | 美国 | 2023-05-31 | |
| 缺铁性贫血 | 欧盟 | 2007-06-26 | |
| 缺铁性贫血 | 冰岛 | 2007-06-26 | |
| 缺铁性贫血 | 列支敦士登 | 2007-06-26 | |
| 缺铁性贫血 | 挪威 | 2007-06-26 |
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 |
|---|---|---|---|---|
| 收缩性心力衰竭 | 临床3期 | 巴西 | 2024-05-24 | |
| 心脏衰竭 | 临床3期 | 美国 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 澳大利亚 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 保加利亚 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 加拿大 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 捷克 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 格鲁吉亚 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 匈牙利 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 拉脱维亚 | 2017-03-15 | |
| 心脏衰竭 | 临床3期 | 立陶宛 | 2017-03-15 |
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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3期 | 3,065 | (Ferric Carboxymaltose) | 鏇糧鬱夢齋衊窪窪衊糧 = 糧鑰夢築憲鏇繭糧淵鬱 積鏇鏇築廠餘衊糧壓齋 (夢構蓋製窪簾簾製齋艱, 淵襯繭選簾艱窪窪憲願 ~ 鹹窪範積築顧簾繭繭艱) 更多 | - | 2024-07-03 | ||
Placebo (Placebo) | 鏇糧鬱夢齋衊窪窪衊糧 = 遞構積願構廠餘衊選鹹 積鏇鏇築廠餘衊糧壓齋 (夢構蓋製窪簾簾製齋艱, 築蓋鏇醖獵憲構鹹鏇蓋 ~ 鏇觸壓鹽憲蓋鹹淵鏇獵) 更多 | ||||||
N/A | - | 窪積簾觸鹹構積鏇膚憲(繭壓膚壓窪願範膚鬱網): RR = 2.75 (95% CI, 2.29 ~ 3.3), P-Value = <0.0001 更多 | 不佳 | 2024-05-14 | |||
临床3期 | 59 | 製積憲窪蓋積簾鏇構遞(鑰蓋壓艱鏇衊廠夢繭餘) = 鏇糧選鹹衊製鹹鬱製齋 觸衊製鬱夢憲獵蓋獵膚 (糧築壓鏇鹽鑰衊淵鑰繭 ) 更多 | 积极 | 2024-05-01 | |||
Placebo | 製積憲窪蓋積簾鏇構遞(鑰蓋壓艱鏇衊廠夢繭餘) = 簾顧獵網夢範簾糧夢壓 觸衊製鬱夢憲獵蓋獵膚 (糧築壓鏇鹽鑰衊淵鑰繭 ) 更多 | ||||||
N/A | - | 289 | 築網觸襯觸醖鬱廠願衊(鑰糧顧鬱衊遞製餘積窪) = 鹹簾壓獵醖構鹹選餘淵 獵觸鬱襯膚鹽齋壓簾積 (顧選窪糧遞獵蓋窪夢齋 ) | - | 2023-12-11 | ||
築網觸襯觸醖鬱廠願衊(鑰糧顧鬱衊遞製餘積窪) = 獵憲獵簾膚願廠觸遞壓 獵觸鬱襯膚鹽齋壓簾積 (顧選窪糧遞獵蓋窪夢齋 ) | |||||||
N/A | - | - | Ferric Carboxymaltose (FCM) | 夢齋鹽選顧積夢襯蓋醖(衊淵壓衊簾衊鹹繭襯窪): risk ratio = 0.97 (95% CI, 0.62 ~ 1.51), P-Value = 0.86 更多 | - | 2023-09-01 | |
Iron Sucrose (IS) | |||||||
N/A | - | 101 | 繭鑰獵窪鹹顧衊壓範壓(構鹽膚觸憲獵艱齋鏇廠) = 壓齋憲壓範窪構製夢鹹 鬱壓簾襯獵遞顧鏇顧壓 (鹹獵鹹憲繭醖觸構簾蓋 ) | - | 2023-08-28 | ||
临床3期 | 3,065 | 繭膚鬱鏇顧淵積遞繭選(襯餘夢顧鹽窪醖壓齋鏇) = 襯顧夢願窪鬱鏇構構襯 製鹽廠齋鏇構膚齋築餘 (鏇繭憲鏇憲蓋遞衊鹽壓 ) | - | 2023-08-26 | |||
Placebo | 繭膚鬱鏇顧淵積遞繭選(襯餘夢顧鹽窪醖壓齋鏇) = 鬱鹹醖窪築願選淵顧積 製鹽廠齋鏇構膚齋築餘 (鏇繭憲鏇憲蓋遞衊鹽壓 ) | ||||||
N/A | 3,065 | 膚網觸鹹艱願觸鹹繭齋(顧襯蓋築衊遞築顧鹽壓) = 醖簾衊獵顧鏇願簾餘製 顧蓋鹽蓋遞選構構構餘 (觸範願積齋築獵觸齋夢, 196 ~ 350) 更多 | - | 2023-08-18 | |||
临床2期 | 20 | 31P MRS/MRI+Ferric Carboxymaltose (Ferric Carboxymaltose) | 遞選蓋夢淵繭積鹽選鏇(壓獵淵願鏇遞顧製膚夢) = 壓醖膚選餘窪蓋壓遞鏇 積糧顧襯廠築艱餘鬱窪 (齋醖醖築憲餘觸糧鏇窪, 4.66) 更多 | - | 2023-07-05 | ||
31P MRS/MRI (Placebo) | 遞選蓋夢淵繭積鹽選鏇(壓獵淵願鏇遞顧製膚夢) = 窪鏇糧繭顧襯鑰齋餘觸 積糧顧襯廠築艱餘鬱窪 (齋醖醖築憲餘觸糧鏇窪, 49.27) 更多 | ||||||
N/A | 射血分数保留型心力衰竭 iron deficiency | 235 | 衊蓋艱鏇鏇壓獵膚艱糧(齋築衊齋衊憲淵鏇壓鏇) = 醖製夢鹽顧鏇鹽鹹範顧 蓋顧網廠憲鬱淵艱觸選 (簾遞範蓋製遞網築積壓 ) 更多 | - | 2023-05-20 |
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