Eculizumab

Not to be confused with ocrelizumab.

Eculizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetComplement protein C5
Clinical data
Trade namesSoliris
BiosimilarsBekemv,[1] Elizaria,[2] Bkemv,[3] eculizumab-aagh, eculizumab-aeeb,[3] Epysqli[4]
AHFS/Drugs.comMonograph
MedlinePlusa612024
License data
Pregnancy
category
  • AU: B2
Routes of
administration		Intravenous
Drug classComplement inhibitor
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life8 to 15 days (mean 11 days)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
Molar mass148 kg/mol
 ☒NcheckY (what is this?)  (verify)

Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica.[8][9] In people with paroxysmal nocturnal hemoglobinuria, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death.[11] Eculizumab was the first medication approved for each of its uses, and its approval was granted based on small trials.[12][13][14][15] It is given by intravenous infusion.[8] It is a humanized monoclonal antibody functioning as a terminal complement inhibitor.[13] It binds to the complement C5 protein and inhibits activation of the complement system, a part of the body's immune system.[16] This binding prevents the breakdown of red blood cells in the bloodstream (intravascular hemolysis) in people with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.[16]

The most frequently reported adverse reactions for people with paroxysmal nocturnal hemoglobinuria include headache, nasopharyngitis (common cold), back pain and nausea[16] The most frequently reported adverse reactions for people with atypical hemolytic uremic syndrome include headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, swelling of lower legs or hands, nausea, urinary tract infections and fever[16]

Eculizumab (Soliris) is developed, manufactured, and marketed by Alexion Pharmaceuticals.[17]: 6 

  1. ^ a b "Bekemv". European Medicines Agency (EMA). 15 May 2023. Archived from the original on 16 May 2023. Retrieved 15 May 2023.
  2. ^ Cite error: The named reference Generium was invoked but never defined (see the help page).
  3. ^ a b "Bkemv (eculizumab-aeeb) injection, for intravenous use" (PDF). Archived (PDF) from the original on 29 May 2024. Retrieved 31 May 2024.
  4. ^ a b "Epysqli EPAR". European Medicines Agency (EMA). 31 May 2023. Archived from the original on 31 May 2023. Retrieved 31 May 2023.
  5. ^ "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.
  6. ^ "Soliris - Summary of Product Characteristics (SmPC)". (emc). 16 July 2021. Archived from the original on 21 May 2022. Retrieved 9 April 2022.
  7. ^ "Soliris - Summary of Product Characteristics". UK Electronic Medicines Compendium. 23 March 2017. Archived from the original on 19 February 2018. Retrieved 18 July 2017.
  8. ^ a b c "Soliris- eculizumab injection, solution, concentrate". DailyMed. 20 April 2021. Archived from the original on 9 April 2022. Retrieved 9 April 2022.
  9. ^ a b "Soliris EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 19 October 2019. Retrieved 9 April 2022.
  10. ^ "Epysqli". Union Register of medicinal products. 31 May 2023. Archived from the original on 6 June 2023. Retrieved 6 June 2023.
  11. ^ Martí-Carvajal AJ, Anand V, Cardona AF, Solà I (October 2014). "Eculizumab for treating patients with paroxysmal nocturnal hemoglobinuria". The Cochrane Database of Systematic Reviews. 10 (10): CD010340. doi:10.1002/14651858.CD010340.pub2. PMID 25356860.
  12. ^ "FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system" (Press release). U.S. Food and Drug Administration (FDA). 27 June 2019. Archived from the original on 14 September 2019. Retrieved 28 June 2019.
  13. ^ a b Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L (November 2007). "Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria". Nature Biotechnology. 25 (11): 1256–1264. doi:10.1038/nbt1344. PMID 17989688. S2CID 22732675.
  14. ^ Dmytrijuk A, Robie-Suh K, Cohen MH, Rieves D, Weiss K, Pazdur R (September 2008). "FDA report: eculizumab (Soliris) for the treatment of patients with paroxysmal nocturnal hemoglobinuria". The Oncologist. 13 (9): 993–1000. doi:10.1634/theoncologist.2008-0086. PMID 18784156. S2CID 21972428.
  15. ^ Keating GM (December 2013). "Eculizumab: a review of its use in atypical haemolytic uraemic syndrome". Drugs. 73 (18): 2053–2066. doi:10.1007/s40265-013-0147-7. PMID 24249647. S2CID 36682579.
  16. ^ a b c d "FDA Approves First Interchangeable Biosimilar for Two Rare Diseases". U.S. Food and Drug Administration. 28 May 2024. Archived from the original on 30 May 2024. Retrieved 31 May 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  17. ^ Cite error: The named reference Biosimilar_2013 was invoked but never defined (see the help page).