Fragment antigen-binding of ofatumumab (PDB: 3GIZ)
Monoclonal antibody
Type
Whole antibody
Source
Human
Target
CD20
Clinical data
Trade names
Arzerra, Kesimpta
Other names
HuMax-CD20, OMB157
AHFS/Drugs.com
Monograph
MedlinePlus
a621050
License data
US DailyMed: Ofatumumab
Pregnancy category
AU: C[1][2]
Routes of administration
Intravenous (Arzerra), subcutaneous (Kesimpta)
ATC code
L01FA02 (WHO) (Arzerra), L04AG12 (WHO) (Kesimpta)
Legal status
Legal status
AU: S4 (Prescription only)[4][2]
CA: ℞-only /Schedule D[5]
UK: POM (Prescription only)[6][7]
US: WARNING[3]Rx-only[8][9]
EU: Rx-only[10][11][12]
In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life
14 days
Identifiers
CAS Number
679818-59-8N
DrugBank
DB06650N
ChemSpider
none
UNII
M95KG522R0
KEGG
D09314
ChEMBL
ChEMBL1201836N
Chemical and physical data
Formula
C6480H10022N1742O2020S44
Molar mass
146062.27 g·mol−1
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Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion.[13] Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions.[9][11] Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States.[14] It is sold by Novartis under license from Genmab.[15]
The most common side effects for ofatumumab (Kesimpta) include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.[9] The most common side effects for ofatumumab (Arzerra) include infusion reactions and neutropenia.[14]
^"Ofatumumab (Arzerra) Use During Pregnancy". Drugs.com. 29 January 2020. Retrieved 22 August 2020.
^ ab"AusPAR: Ofatumumab". Therapeutic Goods Administration (TGA). 19 August 2021. Retrieved 10 September 2021.
^"FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
^"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.
^"Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
^Cite error: The named reference EMC was invoked but never defined (see the help page).
^"Kesimpta 20 mg solution for injection in pre-filled pen - Patient Information Leaflet (PIL)". (emc). 14 April 2021. Retrieved 16 April 2021.
^Cite error: The named reference Arzerra FDA label was invoked but never defined (see the help page).
^ abc"Kesimpta- ofatumumab injection, solution". DailyMed. 20 August 2020. Retrieved 23 August 2020.
^ ab"Kesimpta EPAR". European Medicines Agency (EMA). 25 January 2021. Retrieved 16 April 2021.
^"Kesimpta Product information". Union Register of medicinal products. Retrieved 3 March 2023.
^Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, et al. (August 2020). "Ofatumumab versus Teriflunomide in Multiple Sclerosis". The New England Journal of Medicine. 383 (6): 546–557. doi:10.1056/nejmoa1917246. hdl:11573/1473907. PMID 32757523. S2CID 221015936.
^ ab"Arzerra : EPAR - Product Information" (PDF). European Medicines Agency. 7 March 2013. Archived from the original (PDF) on 4 February 2014. Retrieved 24 January 2014.
^Cite error: The named reference Genmab was invoked but never defined (see the help page).
Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved...
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ibrutinib down-modulates the expression of CD20 (target of rituximab/ofatumumab) by targeting the CXCR4/SDF1 axis. Together, these data are consistent...
in the clinic including Aimovig (erenumab) for migraine and Kesimpta (ofatumumab) for multiple sclerosis.[citation needed] Dolmetsch was also involved...
monoclonal antibody, has been approved for some indications. Ocrelizumab, ofatumumab, and "third-generation" anti-CD20 monoclonals are in development.[citation...
those diseases, as antibodies against CD20 exist: e.g. Rituximab and Ofatumumab, with several more in development. Similarly, anti-CD20 monoclonal antibody...
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in trade names. Examples include: HuMax-CD4 (zanolimumab) HuMax-CD20 (ofatumumab) HuMax-EGFr (zalutumumab) This article includes a list of related items...
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