Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Human |
Target | CD20 |
Clinical data | |
Trade names | Arzerra, Kesimpta |
Other names | HuMax-CD20, OMB157 |
AHFS/Drugs.com | General: Monograph Systemic: Monograph |
MedlinePlus | a610009 |
License data |
|
Pregnancy category |
|
Routes of administration | Intravenous, subcutaneous |
Drug class | Monoclonal antibody |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Elimination half-life | 14 days |
Chemical and physical data | |
Formula | C6480H10022N1742O2020S44 |
Molar mass | 146062.27 g·mol−1 |
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Ofatumumab, sold under the brand name Arzerra among others, is a medication used to treat chronic lymphocytic leukemia (CLL) and multiple sclerosis.[9][10] For CLL it is used for cases when fludarabine and alemtuzumab have failed.[9] It is given by injection under the skin or into a vein.[9][10]
Common side effects include upper respiratory tract infection, urinary tract infections, pain at the site of injection, headache, fever, and tiredness.[11] Other side effects may include reactivation of hepatitis B and progressive multifocal leukoencephalopathy.[9] Risk with breastfeeding is believed to be low.[12] It is a monoclonal antibody that attaches to CD20 on B cells thus decreasing their activity.[11]
Ofatumumab was approved for medical use in the United States in 2009.[10] While it was approved for CLL in Europe in 2010, this approval was subsequently withdrawn.[13] In 2021 Europe approved its use for MS.[11] In the United Kingdom 20 mg of medication costs the NHS about £1,500.[12] In the United States this amount costs about 7,500 USD.[14]
References
edit- ^ "Ofatumumab (Arzerra) Use During Pregnancy". Drugs.com. 29 January 2020. Archived from the original on 29 November 2020. Retrieved 22 August 2020.
- ^ "Summary for ARTG Entry:196945 Arzerra ofatumumab (rmc) 100mg/5mL injection concentrate vial". Therapeutic Goods Administration (TGA). Archived from the original on 28 August 2021. Retrieved 23 August 2020.
- ^ "Arzerra (acetate formulation) -Summary of Product Characteristics (SPC)". electronic Medicines Compendium. GlaxoSmithKline UK. 27 November 2013. Archived from the original on 4 March 2016. Retrieved 24 January 2014.
- ^ "Kesimpta 20 mg solution for injection in pre-filled pen - Patient Information Leaflet (PIL)". (emc). 14 April 2021. Archived from the original on 16 April 2021. Retrieved 16 April 2021.
- ^ "Arzerra- ofatumumab injection, solution". DailyMed. 22 June 2020. Archived from the original on 14 February 2021. Retrieved 21 August 2020.
- ^ "Kesimpta- ofatumumab injection, solution". DailyMed. 20 August 2020. Archived from the original on 14 February 2021. Retrieved 23 August 2020.
- ^ "Arzerra EPAR". European Medicines Agency (EMA). Archived from the original on 8 August 2020. Retrieved 21 August 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Kesimpta EPAR". European Medicines Agency (EMA). 25 January 2021. Archived from the original on 16 April 2021. Retrieved 16 April 2021.
- ^ a b c d e "Ofatumumab (Systemic) Monograph for Professionals". Drugs.com. Archived from the original on 21 January 2021. Retrieved 7 November 2021.
- ^ a b c d "Ofatumumab Monograph for Professionals". Drugs.com. Archived from the original on 23 May 2020. Retrieved 7 November 2021.
- ^ a b c d "Kesimpta". Archived from the original on 16 April 2021. Retrieved 7 November 2021.
- ^ a b "Ofatumumab". SPS - Specialist Pharmacy Service. 3 February 2016. Archived from the original on 8 November 2021. Retrieved 7 November 2021.
- ^ "Arzerra". Archived from the original on 8 August 2020. Retrieved 7 November 2021.
- ^ "Kesimpta Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 7 November 2021.