Editing Infliximab (section)

{{Short description|Biopharmaceutical drug for autoimmune disorders}}
{{Use dmy dates|date=May 2024}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{infobox drug
| Verifiedfields    = changed
| verifiedrevid     = 458271995
| type = mab
| image             = Infliximab_structure2.jpg
| width             = 
| alt               = 
| caption           =

<!-- Monoclonal antibody data -->
| mab_type = mab
| source = xi/o
| target = [[Tumor necrosis factors]] (TNF)

<!-- Clinical data -->
| pronounce         = 
| tradename         = Remicade
| Drugs.com         = {{drugs.com|monograph|infliximab}}
| MedlinePlus       = a604023
| DailyMedID        = Infliximab
| pregnancy_AU      = C
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Infliximab Use During Pregnancy | website=Drugs.com | date=2 July 2019 | url=https://www.drugs.com/pregnancy/infliximab.html | access-date=13 August 2020 | archive-date=30 November 2020 | archive-url=https://web.archive.org/web/20201130151454/https://www.drugs.com/pregnancy/infliximab.html | url-status=live }}</ref>
| pregnancy_category= 
| routes_of_administration = [[Intravenous]], [[Subcutaneous administration|subcutaneous]]
| class             = 
| ATC_prefix        = L04
| ATC_suffix        = AB02
| ATC_supplemental  = 
| biosimilars = infliximab-abda,<ref name="Renflexis FDA approval" /> infliximab-axxq,<ref name="Avsola FDA approval" /> infliximab-dyyb,<ref name="Inflectra FDA approval" /> infliximab-qbtx,<ref name="Ixifi FDA approval" /> Avsola,<ref name="Avsola FDA approval" /> Flixabi,<ref name="Flixabi EPAR" /> Inflectra,<ref name="Inflectra FDA approval" /><ref name="CA 2016 Highlights" /> Ixifi,<ref name="Ixifi FDA approval" /> Remsima,<ref name="CA 2016 Highlights" /> Renflexis,<ref name="Renflexis FDA approval" /><ref>{{cite web | title=Arthritis | website=[[Health Canada]] | date=8 May 2018 | url=https://www.canada.ca/en/services/health/drug-health-products/drug-medical-device-highlights-2017/approved-drugs/arthritis.html | access-date=13 April 2024}}</ref><ref>{{cite web | title=Regulatory Decision Summary for Renflexis | website=Drug and Health Products Portal | date=1 December 2017 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00305 | access-date=13 April 2024}}</ref> Zessly, Zymfentra<ref name="Zymfentra PR" />

<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = 
| legal_BR =  <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| legal_BR_comment = 
| legal_CA = Rx-only
| legal_CA_comment = /&nbsp;Schedule D<ref>{{cite web | title=Health product highlights 2021: Annexes of products approved in 2021 | website=[[Health Canada]] | date=3 August 2022 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html | access-date=25 March 2024 | archive-date=25 March 2024 | archive-url=https://web.archive.org/web/20240325234307/https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html | url-status=live }}</ref><ref>{{cite web | title=Regulatory Decision Summary for Remsima SC | website=Drug and Health Products Portal | date=15 February 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708630999500 | access-date=2 April 2024 | archive-date=2 April 2024 | archive-url=https://web.archive.org/web/20240402033003/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708630999500 | url-status=live }}</ref><ref name="CA 2016 Highlights">{{cite web | title=Health Canada New Drug Authorizations: 2016 Highlights | website=[[Health Canada]] | date=14 March 2017 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2016-highlights.html | access-date=7 April 2024 | archive-date=7 April 2024 | archive-url=https://web.archive.org/web/20240407045431/https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2016-highlights.html | url-status=live }}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment = 
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment = 
| legal_UK = POM
| legal_UK_comment = 
| legal_US = Rx-only
| legal_US_comment = <ref name="Remicade FDA label">{{cite web | title=Remicade- infliximab injection, powder, lyophilized, for solution | website=DailyMed | date=8 April 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257 | access-date=22 May 2024}}</ref><ref>{{cite web | title=Avsola- infliximab-axxq injection, powder, lyophilized, for solution | website=DailyMed | date=7 April 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de34bcb7-b524-45c8-9181-61c6f48d540e | access-date=22 May 2024}}</ref><ref>{{cite web | title=Inflectra- infliximab-dyyb injection, powder, lyophilized, for solution | website=DailyMed | date=5 April 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37eaca10-d812-48bc-8b8e-b836bfa9968f | access-date=22 May 2024}}</ref><ref>{{cite web | title=Renflexis- infliximab injection, powder, lyophilized, for solution | website=DailyMed | date=26 January 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3827e1be-f328-45f7-b113-311b57039f8c | access-date=22 May 2024}}</ref><ref>{{cite web | title=Zymfentra- infliximab-dyyb injection | website=DailyMed | date=2 May 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=93a193ab-9f96-4da6-aa7c-31212e81879a | access-date=22 May 2024}}</ref>
| legal_EU          = Rx-only
| legal_EU_comment  = <ref name="Remicade EPAR" /><ref name="Flixabi EPAR" /><ref name="Remsima EPAR" /><ref name="Inflectra EPAR" /><ref name="Zessly EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment = 
| legal_status      = <!--For countries not listed above-->

<!-- Pharmacokinetic data -->
| bioavailability   = 92% (IV, if 8% left in the syringe)
| protein_bound     = 
| metabolism        = [[reticuloendothelial]] system
| metabolites       = 
| onset             = 
| elimination_half-life = 9.5 days
| duration_of_action = 
| excretion         =

<!-- Identifiers -->
| CAS_number_Ref    = {{cascite|correct|??}}
| CAS_number        = 170277-31-3
| CAS_supplemental  = 
| PubChem           = 
| IUPHAR_ligand     = 
| DrugBank_Ref      = {{drugbankcite|correct|drugbank}}
| DrugBank          = DB00065
| ChemSpiderID_Ref  = {{chemspidercite|changed|chemspider}}
| ChemSpiderID      = none
| UNII_Ref          = {{fdacite|correct|FDA}}
| UNII              = B72HH48FLU
| KEGG_Ref          = {{keggcite|correct|kegg}}
| KEGG              = D02598
| ChEBI_Ref         = 
| ChEBI             = 
| ChEMBL_Ref        = {{ebicite|changed|EBI}}
| ChEMBL            = 1201581
| NIAID_ChemDB      = 
| PDB_ligand        = 
| synonyms          =

<!-- Chemical and physical data -->
| IUPAC_name        = 
| C=6428 | H=9912 | N=1694 | O=1987 | S=46
| SMILES            = 
| StdInChI          = 
| StdInChI_comment  = 
| StdInChIKey       = 
| density           = 
| density_notes     = 
| melting_point     = 
| melting_high      = 
| melting_notes     = 
| boiling_point     = 
| boiling_notes     = 
| solubility        = 
| sol_units         = 
| specific_rotation = 
}}

<!-- Definition and medical uses -->
'''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]].<ref name=AHFS2019/> It is given by [[intravenous therapy|slow injection into a vein]], typically at six- to eight-week intervals.<ref name=AHFS2019/>

<!-- Side effects and mechanism -->
Common side effects include infections, [[acute infusion reaction]]s, and abdominal pain.<ref name=AHFS2019/> Infliximab is a [[chimeric protein|chimeric]] [[monoclonal antibody]] [[Biopharmaceutical|biologic]]. It seems to work by binding to and neutralizing [[TNF alpha|TNF-α]], preventing it from interacting with its [[receptor (biochemistry)|receptors]] on the cell.<ref name=AHFS2019/> TNF-α is a chemical messenger ([[cytokine]]) and a key part of the autoimmune reaction.

<!-- History and culture -->
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 antibody|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".<ref>{{cite journal | vauthors = Mouser JF, Hyams JS | title = Infliximab: a novel chimeric monoclonal antibody for the treatment of Crohn's disease | journal = Clinical Therapeutics | volume = 21 | issue = 6 | pages = 932–42; discussion 931 | date = June 1999 | pmid = 10440618 | doi = 10.1016/s0149-2918(99)80015-0 }}</ref>{{medical citation needed|date=August 2020}}

Infliximab was approved for medical use in the United States in 1998,<ref name=AHFS2019>{{cite web |title=Infliximab, Infliximab-dyyb Monograph for Professionals |url=https://www.drugs.com/monograph/infliximab-infliximab-dyyb.html |website=Drugs.com |publisher=American Society of Health-System Pharmacists |access-date=15 July 2019 |archive-date=15 July 2019 |archive-url=https://web.archive.org/web/20190715045122/https://www.drugs.com/monograph/infliximab-infliximab-dyyb.html |url-status=live }}</ref> and in the European Union in August 1999.<ref name="Remicade EPAR">{{cite web | title=Remicade EPAR | website=[[European Medicines Agency]] (EMA) | date=10 August 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/remicade | access-date=2 April 2020 | archive-date=22 October 2020 | archive-url=https://web.archive.org/web/20201022094956/https://www.ema.europa.eu/en/medicines/human/EPAR/remicade | url-status=live }}</ref> Infliximab [[biosimilar]]s have been approved in the EU (2013), in Japan (2014), and in the United States (2016, 2017, 2019).<ref name="Renflexis FDA approval" /><ref name="Ixifi FDA approval" /><ref name="Avsola FDA approval" /> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO22nd">{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 22nd list (2021) | year = 2021 | hdl = 10665/345533 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2021.02 | hdl-access=free }}</ref>
{{TOC limit}}