卡西瑞單抗/伊德單抗
 | |
| 組成 | |
|---|---|
| Casirivimab | 與嚴重急性呼吸道症候群冠狀病毒2型上的冠狀病毒刺突蛋白結合的單株抗體 |
| Imdevimab | 與嚴重急性呼吸道症候群冠狀病毒2型上的冠狀病毒刺突蛋白結合的單株抗體 |
| 臨床資料 | |
| 商品名 | REGEN-COV, Ronapreve |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a620063 |
| 核准狀況 | |
| 懷孕分級 | |
| 給藥途徑 | 靜脈注射, 皮下注射 |
| ATC碼 | |
| 法律規範狀態 | |
| 法律規範 |
|
| 識別資訊 | |
| DrugBank | |
| KEGG | |
| 單株抗體 | |
|---|---|
| 種類 | 完整抗體 |
| 目標 | 嚴重急性呼吸道症候群冠狀病毒2型上的冠狀病毒刺突蛋白 |
| 臨床資料 | |
| 其他名稱 | REGN10933 |
| ATC碼 |
|
| 識別資訊 | |
| CAS號 | 2415933-42-3 |
| DrugBank | |
| UNII | |
| KEGG | |
| 單株抗體 | |
|---|---|
| 種類 | 完整抗體 |
| 目標 | 嚴重急性呼吸道症候群冠狀病毒2型的冠狀病毒刺突蛋白 |
| 臨床資料 | |
| 其他名稱 | REGN10987 |
| ATC碼 |
|
| 識別資訊 | |
| CAS號 | 2415933-40-1 |
| DrugBank | |
| UNII | |
| KEGG | |
卡西瑞單抗/伊德單抗（INN：Casirivimab/imdevimab）是治療和預防2019冠狀病毒病藥物[13]。用於治療高風險族群的輕度至中度疾病[13]。對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]。藥物是由皮下或靜脈注射[13]。
常見副作用包括輸液反應和注射部位發紅[13]。其他副作用包括可能過敏反應、發熱和呼吸問題[13]。雖然可在孕期使用，但安全性尚不清楚[13]。兩種單株抗體，卡西瑞單抗（Casirivimab，REGN10933）和伊德單抗（Imdevimab, REGN10987）都會與病毒結合[16] [17]。
卡西瑞單抗/伊德單抗在2021年於美國取得緊急使用授權[13]。目前已在澳大利亞、英國和日本取得醫療使用許可[18] [19] [20]。
參考文獻
[編輯]- ^ 1.0 1.1 Ronapreve. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. （原始內容存檔於23 October 2021）.
- ^ 2.0 2.1 AusPAR: Casirivimab/imdevimab. Therapeutic Goods Administration (TGA). 2 November 2021 [23 March 2022]. （原始內容存檔於21 November 2021）.
- ^ Updates to the Prescribing Medicines in Pregnancy database. Therapeutic Goods Administration (TGA). 12 May 2022 [13 May 2022]. （原始內容存檔於3 April 2022）.
- ^ COVID-19 treatment: Roche Products Pty Ltd, casirivimab + imdevimab (Ronapreve). Therapeutic Goods Administration (TGA). 15 October 2021 [22 October 2021]. （原始內容存檔於24 October 2021）.
- ^ Casirivimab (casirivimab) and imdevimab (imdevimab). Health Canada. 9 June 2021 [20 December 2021]. （原始內容存檔於3 December 2021）.
- ^ Summary Basis of Decision (SBD) for Casirivimab and Imdevimab. Health Canada. 23 October 2014 [29 May 2022]. （原始內容存檔於29 May 2022）.
- ^ Summary of Product Characteristics for Ronapreve. Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021 [29 August 2021]. （原始內容存檔於30 August 2021）.
- ^ Casirivimab injection, solution, concentrate Imdevimab injection, solution, concentrate REGEN-COV – casirivimab and imdevimab kit. DailyMed. [18 March 2021]. （原始內容存檔於4 January 2021）.
- ^ Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19. U.S. Food and Drug Administration (FDA) (新聞稿). 21 November 2020 [21 November 2020]. （原始內容存檔於25 January 2021）.
本文含有此來源中屬於公有領域的內容。
- ^ Ronapreve EPAR. European Medicines Agency. 10 November 2021 [12 November 2021]. （原始內容存檔於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 (新聞稿). 20 July 2021 [29 August 2021]. （原始內容存檔於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]. （原始內容存檔於21 October 2021） （英語）.
- ^ 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. （原始內容存檔於22 December 2021） （英語）.
- ^ Statement on Therapies for High-Risk, Nonhospitalized Patients. COVID-19 Treatment Guidelines. [6 January 2022]. （原始內容存檔於7 January 2022） （英語）.
- ^ Casirivimab injection, solution, concentrate Imdevimab injection, solution, concentrate REGEN-COV – casirivimab and imdevimab kit. DailyMed. [18 March 2021]. （原始內容存檔於4 January 2021）.
- ^ Casirivimab + imdevimab. SPS - Specialist Pharmacy Service. 26 December 2020 [6 November 2021]. （原始內容存檔於6 November 2021）.
- ^ Regulatory approval of Ronapreve. Medicines and Healthcare products Regulatory Agency (MHRA). 20 August 2021 [29 August 2021]. （原始內容存檔於30 August 2021）.
- ^ Tsukimori, Osamu. Japan OKs use of 'antibody cocktail' to prevent COVID-19. The Japan Times. 5 November 2021 [6 November 2021]. （原始內容存檔於6 November 2021）.
- ^ Ronapreve. Therapeutic Goods Administration (TGA). 18 October 2021 [22 October 2021]. （原始內容存檔於23 October 2021）.
延伸閱讀
[編輯]- 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=缺少標題 (幫助). September 2021, 385 (13): 1184–1195. PMC 8362593
. PMID 34347950. doi:10.1056/NEJMoa2109682 .
外部連結
[編輯]
維基共享資源上的相關多媒體資源：卡西瑞單抗/伊德單抗
- Casirivimab and Imdevimab EUA Letter of Authorization (PDF). U.S. Food and Drug Administration (FDA). [2025-01-14]. （原始內容存檔於2021-01-17）.
- Frequently Asked Questions on the Emergency Use Authorization of Casirivimab + Imdevimab (PDF). U.S. Food and Drug Administration (FDA). [2025-01-14]. （原始內容存檔於2021-03-01）.
- 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
