Ofatumumab

Ofatumumab
Fragment antigen-binding of ofatumumab (PDB: 3GIZ​)
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetCD20
Clinical data
Trade namesArzerra, Kesimpta
Other namesHuMax-CD20, OMB157
AHFS/Drugs.comMonograph
MedlinePlusa621050
License data
Pregnancy
category
Routes of
administration		Intravenous (Arzerra), subcutaneous (Kesimpta)
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life14 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6480H10022N1742O2020S44
Molar mass146062.27 g·mol−1
 NY (what is this?)  (verify)

Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion.[12] 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.[8][10] Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States.[13] It is sold by Novartis under license from Genmab.[14]

The most common side effects for ofatumumab (Kesimpta) include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.[8] The most common side effects for ofatumumab (Arzerra) include infusion reactions and neutropenia.[13]

  1. ^ "Ofatumumab (Arzerra) Use During Pregnancy". Drugs.com. 29 January 2020. Archived from the original on 29 November 2020. Retrieved 22 August 2020.
  2. ^ a b "AusPAR: Ofatumumab". Therapeutic Goods Administration (TGA). 19 August 2021. Archived from the original on 11 September 2021. Retrieved 10 September 2021.
  3. ^ "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.
  4. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
  5. ^ Cite error: The named reference EMC was invoked but never defined (see the help page).
  6. ^ "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.
  7. ^ Cite error: The named reference Arzerra FDA label was invoked but never defined (see the help page).
  8. ^ a b c "Kesimpta- ofatumumab injection, solution". DailyMed. 20 August 2020. Archived from the original on 14 February 2021. Retrieved 23 August 2020.
  9. ^ "Arzerra EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 8 August 2020. Retrieved 21 August 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. ^ a b "Kesimpta EPAR". European Medicines Agency (EMA). 25 January 2021. Archived from the original on 16 April 2021. Retrieved 16 April 2021.
  11. ^ "Kesimpta Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  12. ^ 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.
  13. ^ a b "Arzerra : EPAR – Product Information" (PDF). European Medicines Agency. 7 March 2013. Archived from the original (PDF) on 4 February 2014. Retrieved 24 January 2014.
  14. ^ Cite error: The named reference Genmab was invoked but never defined (see the help page).
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