Infliximab

Infliximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetTumor necrosis factors (TNF)
Clinical data
Trade namesRemicade
Biosimilarsinfliximab-abda,[1] infliximab-axxq,[2] infliximab-dyyb,[3] infliximab-qbtx,[4] Avsola,[2] Flixabi,[5] Inflectra,[3][6] Ixifi,[4] Remsima,[6] Renflexis,[1][7][8] Zessly, Zymfentra[9]
AHFS/Drugs.comMonograph
MedlinePlusa604023
License data
Pregnancy
category
Routes of
administration		Intravenous, subcutaneous
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability92% (IV, if 8% left in the syringe)
Metabolismreticuloendothelial system
Elimination half-life9.5 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC6428H9912N1694O1987S46
Molar mass144190.64 g·mol−1
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Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease.[23] It is given by slow injection into a vein, typically at six- to eight-week intervals.[23]

Common side effects include infections, acute infusion reactions, and abdominal pain.[23] Infliximab is a chimeric monoclonal antibody biologic. It seems to work by binding to and neutralizing TNF-α, preventing it from interacting with its receptors on the cell.[23] TNF-α is a chemical messenger (cytokine) and a key part of the autoimmune reaction.

Infliximab was originally developed in mice as a mouse antibody. Because humans have immune reactions to mouse proteins, the mouse common domains were replaced with similar human antibody domains. They are monoclonal antibodies and have identical structures and affinities to the target. Because they are a combination of mouse and human antibody amino acid sequences, they are called a "chimeric monoclonal antibody".[24][medical citation needed]

Infliximab was approved for medical use in the United States in 1998,[23] and in the European Union in August 1999.[19] Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United States (2016, 2017, 2019).[1][4][2] It is on the World Health Organization's List of Essential Medicines.[25]

  1. ^ a b c Cite error: The named reference Renflexis FDA approval was invoked but never defined (see the help page).
  2. ^ a b c Cite error: The named reference Avsola FDA approval was invoked but never defined (see the help page).
  3. ^ a b Cite error: The named reference Inflectra FDA approval was invoked but never defined (see the help page).
  4. ^ a b c Cite error: The named reference Ixifi FDA approval was invoked but never defined (see the help page).
  5. ^ a b Cite error: The named reference Flixabi EPAR was invoked but never defined (see the help page).
  6. ^ a b c "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Archived from the original on 7 April 2024. Retrieved 7 April 2024.
  7. ^ "Arthritis". Health Canada. 8 May 2018. Retrieved 13 April 2024.
  8. ^ "Regulatory Decision Summary for Renflexis". Drug and Health Products Portal. 1 December 2017. Retrieved 13 April 2024.
  9. ^ Cite error: The named reference Zymfentra PR was invoked but never defined (see the help page).
  10. ^ "Infliximab Use During Pregnancy". Drugs.com. 2 July 2019. Archived from the original on 30 November 2020. Retrieved 13 August 2020.
  11. ^ "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.
  12. ^ "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.
  13. ^ "Regulatory Decision Summary for Remsima SC". Drug and Health Products Portal. 15 February 2024. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
  14. ^ "Remicade- infliximab injection, powder, lyophilized, for solution". DailyMed. 8 April 2022. Retrieved 22 May 2024.
  15. ^ "Avsola- infliximab-axxq injection, powder, lyophilized, for solution". DailyMed. 7 April 2023. Retrieved 22 May 2024.
  16. ^ "Inflectra- infliximab-dyyb injection, powder, lyophilized, for solution". DailyMed. 5 April 2024. Retrieved 22 May 2024.
  17. ^ "Renflexis- infliximab injection, powder, lyophilized, for solution". DailyMed. 26 January 2023. Retrieved 22 May 2024.
  18. ^ "Zymfentra- infliximab-dyyb injection". DailyMed. 2 May 2024. Retrieved 22 May 2024.
  19. ^ a b "Remicade EPAR". European Medicines Agency (EMA). Archived from the original on 22 October 2020. Retrieved 2 April 2020.
  20. ^ Cite error: The named reference Remsima EPAR was invoked but never defined (see the help page).
  21. ^ Cite error: The named reference Inflectra EPAR was invoked but never defined (see the help page).
  22. ^ Cite error: The named reference Zessly EPAR was invoked but never defined (see the help page).
  23. ^ a b c d e "Infliximab, Infliximab-dyyb Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 15 July 2019. Retrieved 15 July 2019.
  24. ^ Mouser JF, Hyams JS (June 1999). "Infliximab: a novel chimeric monoclonal antibody for the treatment of Crohn's disease". Clinical Therapeutics. 21 (6): 932–42, discussion 931. doi:10.1016/s0149-2918(99)80015-0. PMID 10440618.
  25. ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.