 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 |
|
| Pregnancy category | |
| Routes of administration | Intravenous (Arzerra), subcutaneous (Kesimpta) |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 14 days |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C6480H10022N1742O2020S44 |
| Molar mass | 146062.27 g·mol−1 |
  (what is this?) (verify) | |
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. Archived from the original on 29 November 2020. Retrieved 22 August 2020.
- ^ a b "AusPAR: Ofatumumab". Therapeutic Goods Administration (TGA). 19 August 2021. Archived from the original on 11 September 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. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
- ^ Cite error: The named reference
EMCwas 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. Archived from the original on 16 April 2021. Retrieved 16 April 2021.
- ^ Cite error: The named reference
Arzerra FDA labelwas invoked but never defined (see the help page). - ^ a b c "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). 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.
- ^ a b "Kesimpta EPAR". European Medicines Agency (EMA). 25 January 2021. Archived from the original on 16 April 2021. Retrieved 16 April 2021.
- ^ "Kesimpta Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. 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.
- ^ 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.
- ^ Cite error: The named reference
Genmabwas invoked but never defined (see the help page).