奧法妥木單抗
 | |
| 单克隆抗体 | |
|---|---|
| 种类 | 完整抗体 |
| 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 | |
| 给药途径 | 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 |
| 识别信息 | |
| CAS号 | 679818-59-8  |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| 化学信息 | |
| 化学式 | C6480H10022N1742O2020S44 |
| 摩尔质量 | 146,062.27 g·mol−1 |
奧法妥木單抗（INN：ofatumumab）用于治疗慢性淋巴细胞白血病和多发性硬化症[12] [13]。是慢性淋巴细胞白血病的二線治療，用於氟达拉滨和阿侖單抗治疗失败後[12]。可以皮下或静脉注射给药[12] [13]。
常见副作用包括上呼吸道感染、泌尿道感染、注射部位疼痛、头痛、发烧和疲倦[14]。其他副作用可能包括乙型肝炎复发和进行性多灶性白质脑病[12]。一般认为母乳喂育期使用的的风险低[15]。它是一种单克隆抗体，與B细胞上的CD20結合 ，因此減少它的活性[14]。
奧法妥木單抗于 2009 年在美国取得医疗使用許可[13]。尽管它于 2010 年在欧洲曾取得治疗慢性淋巴细胞白血病的使用許可，但之后被撤销[16]。 2021 年，欧洲核准它用于治疗多发性硬化症[14]。
参考文獻
- ^ Ofatumumab (Arzerra) Use During Pregnancy. Drugs.com. 29 January 2020 [22 August 2020]. （原始内容存档于29 November 2020）.
- ^ 2.0 2.1 AusPAR: Ofatumumab. Therapeutic Goods Administration (TGA). 19 August 2021 [10 September 2021]. （原始内容存档于11 September 2021）.
- ^ Summary for ARTG Entry:196945 Arzerra ofatumumab (rmc) 100mg/5mL injection concentrate vial. Therapeutic Goods Administration (TGA). [23 August 2020]. （原始内容存档于28 August 2021）.
- ^ Health product highlights 2021: Annexes of products approved in 2021. Health Canada. 3 August 2022 [25 March 2024]. （原始内容存档于25 March 2024）.
- ^ Arzerra (acetate formulation) -Summary of Product Characteristics (SPC). electronic Medicines Compendium. GlaxoSmithKline UK. 27 November 2013 [24 January 2014]. （原始内容存档于4 March 2016）.
- ^ Kesimpta 20 mg solution for injection in pre-filled pen - Patient Information Leaflet (PIL). (emc). 14 April 2021 [16 April 2021]. （原始内容存档于16 April 2021）.
- ^ Arzerra- ofatumumab injection, solution. DailyMed. 22 June 2020 [21 August 2020]. （原始内容存档于14 February 2021）.
- ^ Kesimpta- ofatumumab injection, solution. DailyMed. 20 August 2020 [23 August 2020]. （原始内容存档于14 February 2021）.
- ^ Arzerra EPAR. European Medicines Agency (EMA). 17 September 2018 [21 August 2020]. （原始内容存档于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]. （原始内容存档于16 April 2021）.
- ^ Kesimpta Product information. Union Register of medicinal products. [3 March 2023]. （原始内容存档于5 March 2023）.
- ^ 12.0 12.1 12.2 12.3 Ofatumumab (Systemic) Monograph for Professionals. Drugs.com. [7 November 2021]. （原始内容存档于21 January 2021） （英语）.
- ^ 13.0 13.1 13.2 Ofatumumab Monograph for Professionals. Drugs.com. [7 November 2021]. （原始内容存档于23 May 2020） （英语）.
- ^ 14.0 14.1 14.2 Kesimpta. [7 November 2021]. （原始内容存档于16 April 2021）.
- ^ Ofatumumab. SPS - Specialist Pharmacy Service. 3 February 2016 [7 November 2021]. （原始内容存档于8 November 2021）.
- ^ Arzerra. [7 November 2021]. （原始内容存档于8 August 2020）.
延伸閱讀
- 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
- Clinical trial number NCT01848145 for "Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia" at ClinicalTrials.gov
