Editing Basiliximab

{{Short description|Pharmaceutical drug}}
{{Use dmy dates|date=March 2023}}
{{Infobox drug
| Verifiedfields = changed
| verifiedrevid = 459525440
| type = mab
| image =
| width =
| alt =
| caption =

<!-- Monoclonal antibody data -->
| mab_type = mab
| source = xi/o
| target = [[CD25]]

<!-- Clinical data -->
| pronounce =
| tradename = Simulect
| Drugs.com = {{drugs.com|monograph|basiliximab}}
| MedlinePlus = a612013
| licence_EU = yes
| DailyMedID = Basiliximab
| pregnancy_AU = D
| pregnancy_AU_comment =
| pregnancy_category =
| routes_of_administration = [[Intravenous]]
| class = [[Immunosuppressants]]
| ATCvet =
| ATC_prefix = L04
| ATC_suffix = AC02
| ATC_supplemental =
| biosimilars =

<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| 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 = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Simulect FDA label">{{cite web | title=Simulect- basiliximab injection, powder, for solution | website=DailyMed | date=6 October 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1af01887-b69d-444b-91ed-ebfe12784440 | access-date=27 February 2023 | archive-date=6 October 2022 | archive-url=https://web.archive.org/web/20221006113950/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1af01887-b69d-444b-91ed-ebfe12784440 | url-status=live }}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Simulect EPAR">{{cite web | title=Simulect EPAR | website=European Medicines Agency | date=31 October 2009 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/simulect | access-date=27 February 2023 | archive-date=11 January 2022 | archive-url=https://web.archive.org/web/20220111081038/https://www.ema.europa.eu/en/medicines/human/EPAR/simulect | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = Rx-only

<!-- Pharmacokinetic data -->
| bioavailability =
| protein_bound =
| metabolism =
| metabolites =
| onset =
| elimination_half-life = 7.2 days
| duration_of_action =
| excretion =

<!-- Identifiers -->
| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 179045-86-4
| CAS_supplemental =
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00074
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 9927MT646M
| KEGG = D03058
| ChEBI =
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201439
| NIAID_ChemDB =
| PDB_ligand =
| synonyms =

<!-- Chemical and physical data -->
| C=6378 | H=9844 | N=1698 | O=1997 | S=48
}}

'''Basiliximab''', sold under the brand name '''Simulect''', is a [[monoclonal antibody]] used to prevent [[Transplant rejection|rejection]] in [[kidney]] transplants.<ref name="Simulect FDA label" /><ref name="Simulect EPAR" /> It is a [[Chimera (genetics)|chimeric]] mouse-human monoclonal [[antibody]] to the α chain ([[CD25]]) of the [[IL-2 receptor]] of [[T cells]].<ref name="Simulect FDA label" /> It is used in combination with other medicines used to prevent organ rejection.<ref name="Simulect FDA label" /><ref name="Simulect EPAR" />

The most common side effects (seen in more than 20% of patients) include constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhea and upper respiratory tract infection (colds).<ref name="Simulect EPAR" />

Basiliximab was approved for medical use in the United States and in the European Union in 1998.<ref name="Simulect FDA label" /><ref name="Simulect EPAR" /><ref>{{cite web | title=Basiliximab Product Approval Information - Licensing Action | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=20 February 2009 | url=https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093359.htm | archive-url=https://web.archive.org/web/20170113111552/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093359.htm | archive-date=13 January 2017 | url-status=dead | access-date=27 February 2023}}</ref>

== Medical uses ==
Basiliximab is [[indicated]] for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation.<ref name="Simulect EPAR" /> It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in people with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.<ref name="Simulect EPAR" />

Basiliximab is an [[immunosuppressant]] agent used to prevent immediate [[transplant rejection]] in people who are receiving kidney transplants, in combination with other agents.<ref name=Medline>MedlinePlus. Last Revised - 15 June 2012 [https://www.nlm.nih.gov/medlineplus/druginfo/meds/a612013.html Basiliximab Injection] {{Webarchive|url=https://web.archive.org/web/20160705111853/https://www.nlm.nih.gov/medlineplus/druginfo/meds/a612013.html |date=5 July 2016 }}</ref> It has been reported that some cases of [[lichen planus]] have been successfully treated with basiliximab as an alternative therapy to [[cyclosporin]]. No short-term side effects have been reported.<ref>{{cite book | vauthors = Katsambas AD, Lotti TM | title = European handbook of dermatological treatments | edition = 2nd | date = 2003 | page = 291 | publisher = Springer | isbn = 3-540-00878-0 }}</ref>

==Mechanism of action==
Basiliximab competes with IL-2 to bind to the alpha chain subunit of the IL2 receptor on the surface of the activated T lymphocytes and thus prevents the receptor from signaling. This prevents T cells from replicating and also from activating B cells, which are responsible for the production of [[antibodies]], which would bind to the transplanted organ and stimulate an immune response against the transplant.<ref name=HardingerRev>{{cite journal | vauthors = Hardinger KL, Brennan DC, Klein CL | title = Selection of induction therapy in kidney transplantation | journal = Transplant International | volume = 26 | issue = 7 | pages = 662–72 | date = July 2013 | pmid = 23279211 | doi = 10.1111/tri.12043 | s2cid = 3296555 }}</ref><ref name=label>{{Cite web |url=https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113375.pdf |title=Basiliximab label |website=[[Food and Drug Administration]] |access-date=16 December 2019 |archive-date=22 February 2017 |archive-url=https://web.archive.org/web/20170222172506/https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113375.pdf |url-status=dead }}</ref>

==Chemistry==
It is a chimeric CD25 monoclonal antibody of the IgG1 isotype.<ref name=HardingerRev/><ref name=label/>

==History==
It is a [[Novartis]] product and was approved by the [[Food and Drug Administration]] (FDA) in 1998.<ref name="pmid12612576">{{cite journal | vauthors = Waldmann TA | title = Immunotherapy: past, present and future | journal = Nature Medicine | volume = 9 | issue = 3 | pages = 269–77 | date = March 2003 | pmid = 12612576 | doi = 10.1038/nm0303-269 | s2cid = 9745527 | url = https://zenodo.org/record/1233435 | access-date = 5 June 2020 | archive-date = 13 April 2021 | archive-url = https://web.archive.org/web/20210413201930/https://zenodo.org/record/1233435 | url-status = live | doi-access = free }}</ref>

== References ==
{{Reflist}}

{{Immunosuppressants}}
{{Monoclonals for immune system}}
{{Interleukin receptor modulators}}
{{Portal bar | Medicine}}

[[Category:Immunosuppressants]]
[[Category:Drugs developed by Novartis]]
[[Category:Monoclonal antibodies]]