奧法妥木單抗

奧法妥木單抗
奧法妥木單抗的抗原結合片段英语Fragment antigen-binding (PDB 3GIZ)
单克隆抗体
种类完整抗体
目標CD20英语CD20
臨床資料
商品名英语Drug nomenclatureArzerra, Kesimpta
其他名稱HuMax-CD20, OMB157
AHFS/Drugs.comMonograph
MedlinePlusa621050
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  ☒N
DrugBank
ChemSpider
  • none
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英语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

  1. ^ Ofatumumab (Arzerra) Use During Pregnancy. Drugs.com. 29 January 2020 [22 August 2020]. (原始内容存档于29 November 2020). 
  2. ^ 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). 
  3. ^ Summary for ARTG Entry:196945 Arzerra ofatumumab (rmc) 100mg/5mL injection concentrate vial. Therapeutic Goods Administration英语Therapeutic Goods Administration (TGA). [23 August 2020]. (原始内容存档于28 August 2021). 
  4. ^ 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). 
  5. ^ 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). 
  6. ^ 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). 
  7. ^ Arzerra- ofatumumab injection, solution. DailyMed. 22 June 2020 [21 August 2020]. (原始内容存档于14 February 2021). 
  8. ^ Kesimpta- ofatumumab injection, solution. DailyMed. 20 August 2020 [23 August 2020]. (原始内容存档于14 February 2021). 
  9. ^ 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.
  10. ^ Kesimpta EPAR. European Medicines Agency (EMA). 25 January 2021 [16 April 2021]. (原始内容存档于16 April 2021). 
  11. ^ Kesimpta Product information. Union Register of medicinal products. [3 March 2023]. (原始内容存档于5 March 2023). 
  12. ^ 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. ^ 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. ^ 14.0 14.1 14.2 Kesimpta. [7 November 2021]. (原始内容存档于16 April 2021). 
  15. ^ Ofatumumab. SPS - Specialist Pharmacy Service. 3 February 2016 [7 November 2021]. (原始内容存档于8 November 2021). 
  16. ^ Arzerra. [7 November 2021]. (原始内容存档于8 August 2020). 

延伸閱讀

外部連結

  • Clinical trial number NCT01848145 for "Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia" at ClinicalTrials.gov


 

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