奧法妥木單抗
 | |
| 單株抗體 | |
|---|---|
| 種類 | 完整抗體 |
| 目標 | CD20 |
| 臨床資料 | |
| 商品名 | Arzerra, Kesimpta |
| 其他名稱 | HuMax-CD20, OMB157 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a621050 |
| 核准狀況 | |
| 懷孕分級 | |
| 給藥途徑 | 靜脈注射 (Arzerra), 皮下注射 (Kesimpta) |
| ATC碼 | |
| 法律規範狀態 | |
| 法律規範 |
|
| 藥物動力學數據 | |
| 生物半衰期 | 14天 |
| 識別資訊 | |
| CAS號 | 679818-59-8  |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| 化學資訊 | |
| 化學式 | C6480H10022N1742O2020S44 |
| 摩爾質量 | 146,062.27 g·mol−1 |
奧法妥木單抗（INN：ofatumumab）用於治療慢性淋巴細胞白血病和多發性硬化症[12] [13]。是慢性淋巴細胞白血病的二線治療，用於氟達拉濱和阿侖單抗治療失敗後[12]。可以皮下或靜脈注射給藥[12] [13]。
常見副作用包括上呼吸道感染、泌尿道感染、注射部位疼痛、頭痛、發燒和疲倦[14]。其他副作用可能包括B型肝炎復發和進行性多灶性白質腦病[12]。一般認為母乳餵育期使用的的風險低[15]。它是一種單株抗體，與B細胞上的CD20結合 ，因此減少它的活性[14]。
奧法妥木單抗於 2009 年在美國取得醫療使用許可[13]。儘管它於 2010 年在歐洲曾取得治療慢性淋巴細胞白血病的使用許可，但之後被撤銷[16]。 2021 年，歐洲核准它用於治療多發性硬化症[14]。
參考文獻
[編輯]- ^ Ofatumumab (Arzerra) Use During Pregnancy. Drugs.com. 29 January 2020 [22 August 2020]. （原始內容存檔於29 November 2020）.
- ^ 2.0 2.1 AusPAR: Ofatumumab. Therapeutic Goods Administration (TGA). 19 August 2021 [10 September 2021]. （原始內容存檔於11 September 2021）.
- ^ Summary for ARTG Entry:196945 Arzerra ofatumumab (rmc) 100mg/5mL injection concentrate vial. Therapeutic Goods Administration (TGA). [23 August 2020]. （原始內容存檔於28 August 2021）.
- ^ Health product highlights 2021: Annexes of products approved in 2021. Health Canada. 3 August 2022 [25 March 2024]. （原始內容存檔於25 March 2024）.
- ^ Arzerra (acetate formulation) -Summary of Product Characteristics (SPC). electronic Medicines Compendium. GlaxoSmithKline UK. 27 November 2013 [24 January 2014]. （原始內容存檔於4 March 2016）.
- ^ Kesimpta 20 mg solution for injection in pre-filled pen - Patient Information Leaflet (PIL). (emc). 14 April 2021 [16 April 2021]. （原始內容存檔於16 April 2021）.
- ^ Arzerra- ofatumumab injection, solution. DailyMed. 22 June 2020 [21 August 2020]. （原始內容存檔於14 February 2021）.
- ^ Kesimpta- ofatumumab injection, solution. DailyMed. 20 August 2020 [23 August 2020]. （原始內容存檔於14 February 2021）.
- ^ Arzerra EPAR. European Medicines Agency (EMA). 17 September 2018 [21 August 2020]. （原始內容存檔於8 August 2020）. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Kesimpta EPAR. European Medicines Agency (EMA). 25 January 2021 [16 April 2021]. （原始內容存檔於16 April 2021）.
- ^ Kesimpta Product information. Union Register of medicinal products. [3 March 2023]. （原始內容存檔於5 March 2023）.
- ^ 12.0 12.1 12.2 12.3 Ofatumumab (Systemic) Monograph for Professionals. Drugs.com. [7 November 2021]. （原始內容存檔於21 January 2021） （英語）.
- ^ 13.0 13.1 13.2 Ofatumumab Monograph for Professionals. Drugs.com. [7 November 2021]. （原始內容存檔於23 May 2020） （英語）.
- ^ 14.0 14.1 14.2 Kesimpta. [7 November 2021]. （原始內容存檔於16 April 2021）.
- ^ Ofatumumab. SPS - Specialist Pharmacy Service. 3 February 2016 [7 November 2021]. （原始內容存檔於8 November 2021）.
- ^ Arzerra. [7 November 2021]. （原始內容存檔於8 August 2020）.
延伸閱讀
[編輯]- Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Flensburg M, Petersen J, Robak T. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study. Blood. February 2008, 111 (3): 1094–1100. PMID 18003886. S2CID 22333805. doi:10.1182/blood-2007-09-111781.
- Zhang B. Ofatumumab. mAbs. July 2009, 1 (4): 326–331. PMC 2726602
. PMID 20068404. doi:10.4161/mabs.1.4.8895 .
外部連結
[編輯]- Clinical trial number NCT01848145 for "Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia" at ClinicalTrials.gov
