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Eculizumab information


Eculizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetComplement protein C5
Clinical data
Trade namesSoliris
BiosimilarsBekemv,[1] Elizaria,[2] Epysqli[3]
AHFS/Drugs.comMonograph
MedlinePlusa612024
License data
  • US DailyMed: Eculizumab
Pregnancy
category
  • AU: B2
Routes of
administration
Intravenous
Drug classComplement inhibitor
ATC code
  • L04AJ01 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)[5]
  • US: WARNING[4]Rx-only[6]
  • EU: Rx-only[7][1][3][8]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life8 to 15 days (mean 11 days)
Identifiers
CAS Number
  • 219685-50-4 checkY
DrugBank
  • DB01257 checkY
ChemSpider
  • none
UNII
  • A3ULP0F556
KEGG
  • D03940
ChEMBL
  • ChEMBL1201828 ☒N
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 (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis, and neuromyelitis optica.[6][7] In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death.[9] Eculizumab was the first drug approved for each of its uses, and its approval was granted based on small trials.[10][11][12][13] It is given by intravenous infusion.[6]

Side effects include a risk for meningococcal infections and it is only prescribed to those who have enrolled in and follow a risk evaluation and mitigation strategy, which involves counseling people and ensuring that they are vaccinated.[6][14] It is a humanized monoclonal antibody functioning as a terminal complement inhibitor.[11]

It is developed, manufactured, and marketed by Alexion Pharmaceuticals.[15]: 6 

  1. ^ a b "Bekemv". European Medicines Agency (EMA). 15 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 "Epysqli EPAR". European Medicines Agency (EMA). 31 May 2023. Retrieved 31 May 2023.
  4. ^ "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.
  5. ^ "Soliris - Summary of Product Characteristics (SmPC)". (emc). 16 July 2021. Archived from the original on 21 May 2022. Retrieved 9 April 2022.
  6. ^ a b c d "Soliris- eculizumab injection, solution, concentrate". DailyMed. 20 April 2021. Archived from the original on 9 April 2022. Retrieved 9 April 2022.
  7. ^ a b "Soliris EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 19 October 2019. Retrieved 9 April 2022.
  8. ^ "Epysqli". Union Register of medicinal products. 31 May 2023. Retrieved 6 June 2023.
  9. ^ 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.
  10. ^ Cite error: The named reference FDA eculiz was invoked but never defined (see the help page).
  11. ^ a b Cite error: The named reference Rother2007 was invoked but never defined (see the help page).
  12. ^ Cite error: The named reference Dmytrijuk2008 was invoked but never defined (see the help page).
  13. ^ 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.
  14. ^ "Soliris - Summary of Product Characteristics". UK Electronic Medicines Compendium. 23 March 2017. Archived from the original on 19 February 2018. Retrieved 18 July 2017.
  15. ^ Cite error: The named reference Biosimilar_2013 was invoked but never defined (see the help page).

and 28 Related for: Eculizumab information

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Eculizumab

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Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria...

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Paroxysmal nocturnal hemoglobinuria

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monoclonal antibody eculizumab reduces the need for blood transfusions and improves quality of life for those affected by PNH. Eculizumab dramatically alters...

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Degos disease

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symptoms with the use of eculizumab and treprostinil. Discovered by dermatopathologist, Cynthia Magro, response to eculizumab is often immediate and dramatic...

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Crovalimab

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patients switching from eculizumab. The study showed that crovalimab maintained disease control in PNH patients switching from eculizumab. COMMODORE 2 is a...

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Ravulizumab

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activity in people who are clinically stable after having been treated with eculizumab for at least the past six months. The most common side effects are upper...

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Danicopan

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March 2024. Danicopan is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis in adults with paroxysmal...

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Atypical hemolytic uremic syndrome

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for example anti–factor H antibodies.: 1933  Prior to availability of eculizumab (Soliris) and ravulizumab (Ultomiris), an estimated 33–40% of patients...

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Alexion Pharmaceuticals

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specializes in orphan drugs to treat rare diseases. Its products include eculizumab (Soliris) and ravulizumab (Ultomiris), both used to treat the rare disorders...

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Nephrology

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also used in these conditions and include rituximab, basiliximab and eculizumab. Blood products including intravenous immunoglobulin and a process known...

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Pegcetacoplan

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who had not received a complement inhibitor or had previously received eculizumab. These trials demonstrated that 1–2 years of pegcetacoplan treatment effectively...

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CD55 deficiency

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clinical condition. Kurolap and colleagues treated patients with off-label eculizumab, a humanized anti-C5 monoclonal antibody and complement inhibitor, and...

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Pascal Soriot

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

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Rosuvastatin

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Propofol

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

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Quetiapine

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

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Meningococcal vaccine

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warned of an increased risk of anemia or hemolysis in people treated with eculizumab (Soliris). The highest risk was when individuals "received a dose of Soliris...

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AstraZeneca

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

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Neuromyelitis optica spectrum disorder

Last Update:

of AQP4-IgG binding), sivelestat (neutrophil elastase inhibitor), and eculizumab (complement inhibitor). There is little research into the primary causes...

Word Count : 7255

Omeprazole

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Astra AB

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

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Vancomycin

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"Unusual Neisseria species as a cause of infection in patients taking eculizumab". J Infect. 78 (2): 113–118. doi:10.1016/j.jinf.2018.10.015. PMC 7224403...

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Brompheniramine

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

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Dapagliflozin

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ATC code L04

Last Update:

L04AG16 Rozanolixizumab L04AH01 Sirolimus L04AH02 Everolimus L04AJ01 Eculizumab L04AJ02 Ravulizumab L04AJ03 Pegcetacoplan L04AJ04 Sutimlimab L04AJ05 Avacopan...

Word Count : 367

Metoprolol

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

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Candesartan

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Nirsevimab

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Atenolol

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bromide/formoterol Candesartan Dapagliflozin Disufenton sodium Durvalumab Eculizumab Esomeprazole Exenatide FluMist Fulvestrant Gefitinib Glycopyrronium bromide/formoterol...

Word Count : 2008

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