卡西瑞單抗/伊德單抗
 | |
| 组成 | |
|---|---|
| Casirivimab | 與嚴重急性呼吸綜合症冠狀病毒2型上的冠状病毒刺突蛋白結合的单克隆抗体 |
| Imdevimab | 與嚴重急性呼吸綜合症冠狀病毒2型上的冠状病毒刺突蛋白結合的单克隆抗体 |
| 臨床資料 | |
| 商品名 | REGEN-COV, Ronapreve |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a620063 |
| 核准狀況 | |
| 懷孕分級 | |
| 给药途径 | 靜脈注射, 皮下注射 |
| ATC碼 | |
| 法律規範狀態 | |
| 法律規範 |
|
| 识别信息 | |
| DrugBank | |
| KEGG | |
| 单克隆抗体 | |
|---|---|
| 种类 | 完整抗体 |
| 目標 | 嚴重急性呼吸綜合症冠狀病毒2型上的冠状病毒刺突蛋白 |
| 臨床資料 | |
| 其他名稱 | REGN10933 |
| ATC碼 |
|
| 识别信息 | |
| CAS号 | 2415933-42-3 |
| DrugBank | |
| UNII | |
| KEGG | |
| 单克隆抗体 | |
|---|---|
| 种类 | 完整抗体 |
| 目標 | 嚴重急性呼吸綜合症冠狀病毒2型的冠状病毒刺突蛋白 |
| 臨床資料 | |
| 其他名稱 | REGN10987 |
| ATC碼 |
|
| 识别信息 | |
| CAS号 | 2415933-40-1 |
| DrugBank | |
| UNII | |
| KEGG | |
卡西瑞單抗/伊德單抗（INN：Casirivimab/imdevimab）是治疗和预防2019冠状病毒病药物[13]。用于治疗高風險族群的轻度至中度疾病[13]。对嚴重急性呼吸道症候群冠狀病毒2型Omicron變異株感染的患者療效較差[14] [15]。药物是由皮下或静脉注射[13]。
常见副作用包括输液反应和注射部位发红[13]。其他副作用包括可能过敏反应、发热和呼吸问题[13]。虽然可在孕期使用，但安全性尚不清楚[13]。两种单克隆抗体，卡西瑞單抗（Casirivimab，REGN10933）和伊德單抗（Imdevimab, REGN10987）都會与病毒结合[16] [17]。
卡西瑞單抗/伊德單抗在2021年於美国取得緊急使用授權[13]。目前已在澳大利亚、英国和日本取得医疗使用許可[18] [19] [20]。
参考文獻
[编辑]- ^ 1.0 1.1 Ronapreve. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. （原始内容存档于23 October 2021）.
- ^ 2.0 2.1 AusPAR: Casirivimab/imdevimab. Therapeutic Goods Administration (TGA). 2 November 2021 [23 March 2022]. （原始内容存档于21 November 2021）.
- ^ Updates to the Prescribing Medicines in Pregnancy database. Therapeutic Goods Administration (TGA). 12 May 2022 [13 May 2022]. （原始内容存档于3 April 2022）.
- ^ COVID-19 treatment: Roche Products Pty Ltd, casirivimab + imdevimab (Ronapreve). Therapeutic Goods Administration (TGA). 15 October 2021 [22 October 2021]. （原始内容存档于24 October 2021）.
- ^ Casirivimab (casirivimab) and imdevimab (imdevimab). Health Canada. 9 June 2021 [20 December 2021]. （原始内容存档于3 December 2021）.
- ^ Summary Basis of Decision (SBD) for Casirivimab and Imdevimab. Health Canada. 23 October 2014 [29 May 2022]. （原始内容存档于29 May 2022）.
- ^ Summary of Product Characteristics for Ronapreve. Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021 [29 August 2021]. （原始内容存档于30 August 2021）.
- ^ Casirivimab injection, solution, concentrate Imdevimab injection, solution, concentrate REGEN-COV – casirivimab and imdevimab kit. DailyMed. [18 March 2021]. （原始内容存档于4 January 2021）.
- ^ Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19. U.S. Food and Drug Administration (FDA) (新闻稿). 21 November 2020 [21 November 2020]. （原始内容存档于25 January 2021）.
本文含有此來源中屬於公有领域的内容。
- ^ Ronapreve EPAR. European Medicines Agency. 10 November 2021 [12 November 2021]. （原始内容存档于13 November 2021）. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ COVID-19 medicines. European Medicines Agency (EMA). 14 October 2024 [14 October 2024].
- ^ Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19. Roche (新闻稿). 20 July 2021 [29 August 2021]. （原始内容存档于24 July 2021）.
- ^ 13.0 13.1 13.2 13.3 13.4 13.5 13.6 Casirivimab and Imdevimab Monograph for Professionals. Drugs.com. [6 November 2021]. （原始内容存档于21 October 2021） （英语）.
- ^ Kozlov, Max. Omicron overpowers key COVID antibody treatments in early tests. Nature. 21 December 2021 [23 December 2021]. doi:10.1038/d41586-021-03829-0. （原始内容存档于22 December 2021） （英语）.
- ^ Statement on Therapies for High-Risk, Nonhospitalized Patients. COVID-19 Treatment Guidelines. [6 January 2022]. （原始内容存档于7 January 2022） （英语）.
- ^ Casirivimab injection, solution, concentrate Imdevimab injection, solution, concentrate REGEN-COV – casirivimab and imdevimab kit. DailyMed. [18 March 2021]. （原始内容存档于4 January 2021）.
- ^ Casirivimab + imdevimab. SPS - Specialist Pharmacy Service. 26 December 2020 [6 November 2021]. （原始内容存档于6 November 2021）.
- ^ Regulatory approval of Ronapreve. Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021 [29 August 2021]. （原始内容存档于30 August 2021）.
- ^ Tsukimori, Osamu. Japan OKs use of 'antibody cocktail' to prevent COVID-19. The Japan Times. 5 November 2021 [6 November 2021]. （原始内容存档于6 November 2021）.
- ^ Ronapreve. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. （原始内容存档于23 October 2021）.
延伸閱讀
[编辑]- O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N, Bar KJ, Barnabas RV, Barouch DH, Cohen MS, Hurt CB, Burwen DR, Marovich MA, Hou P, Heirman I, Davis JD, Turner KC, Ramesh D, Mahmood A, Hooper AT, Hamilton JD, Kim Y, Purcell LA, Baum A, Kyratsous CA, Krainson J, Perez-Perez R, Mohseni R, Kowal B, DiCioccio AT, Stahl N, Lipsich L, Braunstein N, Herman G, Yancopoulos GD, Weinreich DM. Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. N Engl J Med //www.ncbi.nlm.nih.gov/pmc/articles/PMC8362593
|PMC=缺少标题 (帮助). September 2021, 385 (13): 1184–1195. PMC 8362593
. PMID 34347950. doi:10.1056/NEJMoa2109682 .
外部連結
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维基共享资源上的相关多媒体资源：卡西瑞單抗/伊德單抗
- Casirivimab and Imdevimab EUA Letter of Authorization (PDF). U.S. Food and Drug Administration (FDA).
- Frequently Asked Questions on the Emergency Use Authorization of Casirivimab + Imdevimab (PDF). U.S. Food and Drug Administration (FDA).
- Clinical trial number NCT04426695 for "Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19" at ClinicalTrials.gov
- Clinical trial number NCT04425629 for "Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19" at ClinicalTrials.gov
- Clinical trial number NCT04452318 for "COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay" at ClinicalTrials.gov
