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Revision as of 19:41, 16 February 2012 editBeetstra (talk | contribs)Edit filter managers, Administrators172,084 edits Saving copy of the {{drugbox}} taken from revid 472863863 of page Abatacept for the Chem/Drugbox validation project (updated: 'ChEMBL', 'KEGG', 'CAS_number').  Latest revision as of 06:54, 5 November 2024 edit Citation bot (talk | contribs)Bots5,459,746 edits Added date. | Use this bot. Report bugs. | Suggested by Dominic3203 | #UCB_webform 14/166 
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{{Short description|Immunomodulating pharmaceutical drug}}
{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}}
{{cs1 config|name-list-style=vanc}}
{{Use dmy dates|date=March 2022}}
{{Drugbox {{Drugbox
| Verifiedfields = changed | Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 456662913
| verifiedrevid = 477237032


<!--Clinical data--> <!-- Clinical data -->
| tradename = Orencia | tradename = Orencia
| Drugs.com = {{drugs.com|monograph|abatacept}} | Drugs.com = {{drugs.com|monograph|abatacept}}
| MedlinePlus = a606016 | MedlinePlus = a606016
| licence_EU = yes
| pregnancy_category = C <small>(])</small>
| DailyMedID = Abatacept
| legal_status = POM <small>(])</small>, ℞-only <small>(U.S.)</small>
| pregnancy_AU = C
| routes_of_administration = ]
| routes_of_administration = ], ]
| ATC_prefix = L04
| ATC_suffix = AA24


| legal_UK = POM
<!--Pharmacokinetic data-->
| legal_US = Rx-only
| legal_US_comment = <ref name="Orencia FDA label">{{cite web | title=Orencia- abatacept injection, powder, lyophilized, for solution Orencia- abatacept injection, solution | website=DailyMed | date=15 December 2021 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0836c6ac-ee37-5640-2fed-a3185a0b16eb | access-date=16 March 2022}}</ref><ref>{{cite web | title=FDA approves abatacept for prophylaxis of acute graft | website=U.S. ] (FDA) | date=15 December 2021 | url=http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abatacept-prophylaxis-acute-graft-versus-host-disease | archive-url=https://web.archive.org/web/20220124140010/http://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abatacept-prophylaxis-acute-graft-versus-host-disease | archive-date=24 January 2022 | url-status=live | access-date=16 March 2022}}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Orencia EPAR">{{cite web | title=Orencia EPAR | website=] (EMA) | date=5 June 2007 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/orencia | access-date=6 October 2020}}</ref>
| legal_status =

<!-- Pharmacokinetic data -->
| elimination_half-life = 13.1 days | elimination_half-life = 13.1 days


<!--Identifiers--> <!-- Identifiers -->
| CAS_number_Ref = {{cascite|changed|??}}
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| CAS_number = 332348-12-6
| ChemSpiderID = NA
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| CAS_number_Ref = {{cascite|changed|??}}
| DrugBank = DB01281
| CAS_number = <!-- blanked - oldvalue: 213252-14-3 -->
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ATC_prefix = L04
| ChemSpiderID = none
| ATC_suffix = AA24
| DrugBank_Ref = {{drugbankcite|correct|drugbank}} | UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 7D0YB67S97
| DrugBank = DB01281
| UNII_Ref = {{fdacite|correct|FDA}} | KEGG_Ref = {{keggcite|changed|kegg}}
| KEGG = D03203
| UNII = 7D0YB67S97
| KEGG_Ref = {{keggcite|changed|kegg}} | ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201823
| KEGG = <!-- blanked - oldvalue: D03203 -->

| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = <!-- blanked - oldvalue: 1201823 --> <!-- Chemical data -->
| C = 3498
| H = 5458
| N = 922
| O = 1090
| S = 32
}} }}

'''Abatacept''', sold under the brand name '''Orencia''', is a medication used to treat autoimmune diseases like ], by interfering with the immune activity of ]s.<ref name="Orencia FDA label" /><ref name="Orencia EPAR" /> It is a modified antibody.<ref name="Orencia FDA label" /><ref name="Orencia EPAR" />

Abatacept is a ] composed of the Fc region of the ] IgG1 fused to the extracellular domain of ]. In order for a ] to be activated and produce an immune response, an ] must present two signals to the T cell. One of those signals is the ] (MHC), combined with the antigen, and the other signal is the ] or ] molecule (also known as B7-1 and B7-2). Abatacept binds to the CD80 and CD86 molecule, and prevents the second signal. Without the second signal, the T cell can't be activated.

Abatacept was developed by ] and is licensed in the United States for the treatment of rheumatoid arthritis in the case of inadequate response to anti-] therapy. Abatacept received approval from the FDA in 2005.<ref>{{cite web|title=Drug Approval Package: Orencia (Abatacept) NDA #125118|url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125118_s0000_OrenciaTOC.cfm |access-date=29 December 2020|website=U.S. ] (FDA) }}</ref>

==Medical uses==
Abatacept is used to treat adults with moderate to severe ] (RA) as a second-line agent, and as a first-line agent for people whose RA is severe and rapidly progressing. It also used to treat ] and ].<ref name="Orencia FDA label" /><ref name=UKlabelPen>{{cite web|title=UK label prefilled pen|url=https://www.medicines.org.uk/emc/medicine/30346|publisher=UK Electronic Medicines Compendium|date=25 July 2017}}</ref><ref name=UKlabelPowder>{{cite web|title=UK label powder|url=https://www.medicines.org.uk/emc/medicine/19714|publisher=UK Electronic Medicines Compendium|date=25 July 2017}}</ref><ref name="Orencia EPAR" />

==Contraindications==
Abatacept has not been tested in pregnant women and it is not known if it is secreted in breast milk; it causes birth defects in rodents when given in very high doses, and is transmitted in rodent breast milk.<ref name=UKlabelPen/>

Abatacept will likely interfere with any vaccine given while people are taking it.<ref name=UKlabelPen/>

It should not be used in combination with ] or ]s.<ref name=Moreland>{{cite journal | vauthors= Moreland L, Bate G, Kirkpatrick P | title=Abatacept | journal= Nature Reviews Drug Discovery | year= 2006 | volume= 5 | pages= 185–186 | pmid= 16557658 | doi=10.1038/nrd1989 | issue= 3| s2cid=266176720 }}</ref> Because abatacept, anakinra, and TNF antagonists suppress the immune system, using them in combination may significantly increase the risk for severe infections.<ref name="Orencia FDA label"/>

==Adverse effects==
People have experienced serious infections due to abatacept's suppression of the immune system; some of these infections have been fatal. People with ] are likely to get lung infections more often than usual. Some people have had ] reactions to the drug. Abatacept may cause otherwise slow-growing ] to proliferate and ], due to suppression of the immune system.<ref name=UKlabelPen/>

Very common adverse effects (occurring in more than 10% of people) include upper respiratory tract infections. Common adverse effects (occurring in between 1% and 10% of people) include lower respiratory tract infections, urinary tract infections, herpes infections, pneumonia, flu, cough, high blood pressure, stomach pain, diarrhea, nausea, vomiting, upset stomach, mouth sores, ], rashes, fatigue, weakness, local injection site reactions, and systemic injection reactions.<ref name=UKlabelPen/>

==Chemistry==
Abatacept is a ] composed of the extracellular domain of ] with the hinge, CH2, and CH3 domains of ].<ref name="Moreland" />

==Mechanism of action==
Abatacept is a soluble CTLA-4 analog that prevents ] (APCs) from delivering the co-stimulatory signal. This prevents the T cells from being ], and even downregulates them. Simple signaling without co-stimulation allows the cell to recognize the primary signal as "self" and not ramp-up responses for future responses as well.

In order for T cells to be activated and attack an antigen, that antigen must be presented to the T cell by an APC.

That activation requires two signals (one of which is called co-stimulatory signal or signal 2):

For signal 1, the APC must bind the antigen to a ] (MHC) molecule, bring that complex to its surface, and present it to the T cell receptor on the surface of the T cell.

For signal 2, the APC must present a B7 protein (] or ]) on its cell surface to a ] protein on the surface of the T cell. These two signals activate the T cell. Without signal 2, the T cell will not be activated, and will become ].

Abatacept, which consists of a fusion protein of the extracellular domain of CTLA-4 and human IgG1, binds to the B7 protein on the APC and prevents it from delivering the co-stimulatory signal to the T cell.<ref>{{cite web | url = http://www.healthvalue.net/ctlaigenglish.html | title = ABATACEPT & BELATACEPT: the CTLA-4-Igs | publisher = Healthvalue.net | access-date = 25 May 2007 | archive-date = 5 December 2008 | archive-url = https://web.archive.org/web/20081205034856/http://www.healthvalue.net/ctlaigenglish.html | url-status = dead }}</ref><ref>{{cite journal | vauthors= Dall'Era M, Davis J| title=CTLA4Ig: a novel inhibitor of co-stimulation | journal= Lupus | year= 2004 | volume= 13 | issue=5 | pages= 372–376 | pmid= 15230295| doi=10.1191/0961203303lu1029oa| s2cid=32235606 }}</ref>

==References==
{{Reflist}}

== External links ==
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/abatacept | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Abatacept }}

{{Immunosuppressants}}
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Misplaced Pages:WikiProject Chemicals/Chembox validation/VerifiedDataSandbox and Abatacept: Difference between pages Add topic