Editing Botulinum toxin (section)

{{Short description|Neurotoxin produced by Clostridium botulinum}}
{{redirect|Botox|the film|Botox (film)}}
{{distinguish|Botoks}}
{{Use dmy dates|date=April 2024}}
{{cs1 config|name-list-style=vanc|display-authors=6}}
{{Infobox drug
| verifiedrevid = 480475821
| Verifiedfields = changed
| Watchedfields = changed
| drug_name = Botulinum toxin A
| image = Botulinum toxin 3BTA.png
| width =
| alt =
| caption = [[Ribbon diagram]] of tertiary structure of ''BotA'' ({{UniProt|P0DPI1}}). [[Protein Data Bank|PDB]] entry {{PDBe|3BTA}}.

<!-- Clinical data -->
| pronounce =
| tradename = Botox, Myobloc, Jeuveau,Dyston and others
| Drugs.com = {{ubl|
abobotulinumtoxinA {{drugs.com|monograph|abobotulinumtoxina}}|
daxibotulinumtoxinA {{drugs.com|monograph|daxibotulinumtoxina}}|
incobotulinumtoxinA {{drugs.com|monograph|incobotulinumtoxina}}|
onabotulinumtoxinA {{drugs.com|monograph|onabotulinumtoxina}}|
prabotulinumtoxinA {{drugs.com|monograph|prabotulinumtoxina-xvfs}}|
rimabotulinumtoxinB {{drugs.com|monograph|rimabotulinumtoxinb.html}}
}}
| MedlinePlus = a619021
| DailyMedID = Botulinum toxin
| pregnancy_AU = B3
| pregnancy_AU_comment = <ref name="Letybo APMDS" /><ref name="Nuceiva APMDS" /><ref name="Relfydess APMDS" />
| pregnancy_category =
| routes_of_administration = [[Intramuscular]], [[Subcutaneous administration|subcutaneous]], [[Intradermal injection|intradermal]]
| class =
| ATC_prefix = M03
| ATC_suffix = AX01
| ATC_supplemental =
| biosimilars = abobotulinumtoxinA, daxibotulinumtoxinA, daxibotulinumtoxinA-lanm, evabotulinumtoxinA, incobotulinumtoxinA, letibotulinumtoxinA, letibotulinumtoxinA-wlbg,<ref name="Letybo FDA label" /> onabotulinumtoxinA, prabotulinumtoxinA, relabotulinumtoxinA, rimabotulinumtoxinB

<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = <ref name="Letybo APMDS" /><ref name="Nuceiva APMDS">{{cite web |title=Nuceiva |website=Therapeutic Goods Administration (TGA) |date=10 February 2023 |url=https://www.tga.gov.au/resources/auspmd/nuceiva |access-date=8 April 2023}}</ref><ref>{{cite web |title=Nuceiva (PPD Australia Pty Ltd) |website=Therapeutic Goods Administration (TGA) |date=16 February 2023 |url=https://www.tga.gov.au/resources/prescription-medicines-registrations/nuceiva-ppd-australia-pty-ltd |access-date=8 April 2023 |archive-date=18 March 2023 |archive-url=https://web.archive.org/web/20230318023528/https://www.tga.gov.au/resources/prescription-medicines-registrations/nuceiva-ppd-australia-pty-ltd |url-status=live }}</ref><ref>{{cite web |title=Nuceiva prabotulinumtoxinA 100 Units Powder for Solution for Injection vial (381094) |website=Therapeutic Goods Administration (TGA) |date=26 January 2023 |url=https://www.tga.gov.au/resources/artg/381094 |access-date=8 April 2023 |archive-date=8 April 2023 |archive-url=https://web.archive.org/web/20230408041216/https://www.tga.gov.au/resources/artg/381094 |url-status=live }}</ref><ref>{{cite web |title=Prescription medicines: registration of new chemical entities in Australia, 2014 |website=Therapeutic Goods Administration (TGA) |date=21 June 2022 |url=https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 |access-date=10 April 2023 |archive-date=10 April 2023 |archive-url=https://web.archive.org/web/20230410065838/https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 |url-status=live }}</ref><ref>{{Cite web |url=https://www.tga.gov.au/resources/auspar/auspar-letybo |title=AusPAR: Letybo &#124; Therapeutic Goods Administration (TGA) |access-date=31 March 2024 |archive-date=31 March 2024 |archive-url=https://web.archive.org/web/20240331043040/https://www.tga.gov.au/resources/auspar/auspar-letybo |url-status=live }}</ref><ref name="Relfydess APMDS">{{cite web |title=Relfydess (relabotulinumtoxinA, purified Botulinum toxin type A) |website=Therapeutic Goods Administration (TGA) |date=30 July 2024 |url=https://www.tga.gov.au/resources/auspmd/relfydess-relabotulinumtoxina-purified-botulinum-toxin-type |access-date=12 October 2024}}</ref>
| 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=Regulatory Decision Summary - Botox |website=Health Canada |date=23 October 2014 |url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00792 |access-date=12 June 2022 |archive-date=12 June 2022 |archive-url=https://web.archive.org/web/20220612064147/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00792 |url-status=live }}</ref><ref>{{Cite web|url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00405|archive-url=https://web.archive.org/web/20220607080128/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00405|url-status=live|title=Regulatory Decision Summary - Nuceiva |date=23 October 2014|archive-date=7 June 2022|website=Health Canada|access-date=11 June 2022}}</ref><ref>{{cite web |title=Regulatory Decision Summary for Xeomin |website=Drug and Health Products Portal |date=15 March 2022 |url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709049767533 |access-date=1 April 2024}}</ref><ref>{{cite web |title=Regulatory Decision Summary for Botox |website=Drug and Health Products Portal |date=7 February 2024 |url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708464933703 |access-date=2 April 2024 |archive-date=2 April 2024 |archive-url=https://web.archive.org/web/20240402033454/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708464933703 |url-status=live }}</ref><ref>{{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 = <ref>{{cite web |title=Azzalure - Summary of Product Characteristics (SmPC) |website=(emc) |date=16 August 2022 |url=https://www.medicines.org.uk/emc/product/6584/smpc |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218024754/https://www.medicines.org.uk/emc/product/6584/smpc |url-status=live }}</ref><ref>{{cite web |title=Alluzience, 200 Speywood units/ml, solution for injection - Summary of Product Characteristics (SmPC) |website=(emc) |date=2 October 2022 |url=https://www.medicines.org.uk/emc/product/13798/smpc |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218024756/https://www.medicines.org.uk/emc/product/13798/smpc |url-status=live }}</ref><ref>{{cite web |title=Letybo 50 units powder for solution for injection - Summary of Product Characteristics (SmPC) |website=(emc) |date=10 May 2022 |url=https://www.medicines.org.uk/emc/product/13707/smpc |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218024749/https://www.medicines.org.uk/emc/product/13707/smpc |url-status=live }}</ref><ref>{{cite web |title=Xeomin 50 units powder for solution for injection - Summary of Product Characteristics (SmPC) |website=(emc) |date=28 July 2022 |url=https://www.medicines.org.uk/emc/product/4609/smpc |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218024747/https://www.medicines.org.uk/emc/product/4609/smpc |url-status=live }}</ref>
| legal_US = Rx-only
| legal_US_comment = <ref name="Botox FDA label">{{cite web |title=Botox- onabotulinumtoxina injection, powder, lyophilized, for solution |website=DailyMed |date=30 July 2021 |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33d066a9-34ff-4a1a-b38b-d10983df3300 |access-date=12 June 2022 |archive-date=2 June 2022 |archive-url=https://web.archive.org/web/20220602233512/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=33d066a9-34ff-4a1a-b38b-d10983df3300 |url-status=live }}</ref><ref>{{cite web |title=Botox Cosmetic- onabotulinumtoxina injection, powder, lyophilized, for solution |website=DailyMed |date=9 February 2021 |url=https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=485d9b71-6881-42c5-a620-a4360c7192ab |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218022735/https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=485d9b71-6881-42c5-a620-a4360c7192ab |url-status=live }}</ref><ref name="Myobloc FDA label">{{cite web |title=Myobloc- rimabotulinumtoxinb injection, solution |website=DailyMed |date=22 March 2021 |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=675cb354-9d13-482e-8ac2-22f709c58b4f |access-date=12 June 2022 |archive-date=2 June 2022 |archive-url=https://web.archive.org/web/20220602233512/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=675cb354-9d13-482e-8ac2-22f709c58b4f |url-status=live }}</ref><ref>{{cite web |title=Dysport- botulinum toxin type a injection, powder, lyophilized, for solution |website=DailyMed |date=28 February 2022 |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71313a04-1349-4c26-b840-a39e4a3ddaed |access-date=12 June 2022 |archive-date=2 June 2022 |archive-url=https://web.archive.org/web/20220602233513/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71313a04-1349-4c26-b840-a39e4a3ddaed |url-status=live }}</ref><ref name="Daxxify FDA label">{{cite web |title=Daxxify- botulinum toxin type a injection, powder, lyophilized, for solution |website=DailyMed |date=19 September 2022 |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f74 |access-date=27 September 2022 |archive-date=28 September 2022 |archive-url=https://web.archive.org/web/20220928041736/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f74 |url-status=live }}</ref><ref name="Letybo FDA label">{{cite web |title=Letybo- letibotulinumtoxina-wlbg injection, powder, lyophilized, for solution |website=DailyMed |date=5 August 2024 |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=910e5d0e-4d0b-4de8-8e2d-97879a044181 |access-date=5 September 2024}}</ref>
| legal_EU = Rx-only
| legal_EU_comment =
| 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 =
| protein_bound =
| metabolism =
| metabolites =
| onset =
| elimination_half-life =
| duration_of_action =
| excretion =

<!-- Identifiers -->
| index_label = Botulinum toxin A
| index2_label = Botulinum toxin B
| CAS_number_Ref = {{cascite|changed|CAS}}
| CAS_number = 93384-43-1
| CAS_number2 = 93384-43-2
| CAS_supplemental =
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|changed|drugbank}}
| DrugBank = DB00083
| DrugBank2 = DB00042
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = E211KPY694
| UNII2_Ref = {{fdacite|correct|FDA}}
| UNII2 = 0Y70779M1F
| KEGG = D00783
| KEGG2 = D08957
<!-- |KEGG3 = D00783 -->
| ChEBI =
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = BoNT, botox

<!-- Chemical and physical data -->
| C=6760 |H=10447 |N=1743 |O=2010 |S=32
}}

{{Infobox enzyme
| Name = Bontoxilysin
| EC_number = 3.4.24.69
| GO_code = 0006508
| width =
| caption =
}}

<!-- Definition and medical uses -->
'''Botulinum toxin''', or '''botulinum neurotoxin''' (commonly called '''botox'''), is a [[neurotoxin|neurotoxic]] [[protein]] produced by the [[bacteria|bacterium]] ''[[Clostridium botulinum]]'' and related species.<ref name="Montecucco2005">{{cite journal |vauthors = Montecucco C, Molgó J |title = Botulinal neurotoxins: revival of an old killer |journal = Current Opinion in Pharmacology |volume = 5 |issue = 3 |pages = 274–279 |date = June 2005 |pmid = 15907915 |doi = 10.1016/j.coph.2004.12.006 }}</ref> It prevents the release of the [[neurotransmitter]] [[acetylcholine]] from [[axon]] endings at the [[neuromuscular junction]], thus causing [[flaccid paralysis]].<ref>{{cite journal |vauthors = Figgitt DP, Noble S |title = Botulinum toxin B: a review of its therapeutic potential in the management of cervical dystonia |journal = Drugs |volume = 62 |issue = 4 |pages = 705–722 |date = 2002 |pmid = 11893235 |doi = 10.2165/00003495-200262040-00011 |s2cid = 46981635 }}</ref> The toxin causes the disease [[botulism]].<ref name=Shukla2004/> The toxin is also used commercially for medical and cosmetic purposes.<ref name="pmid33776040" /><ref name="Al-Ghamdi" /> Botulinum toxin is an acetylcholine release inhibitor and a neuromuscular blocking agent.<ref name="Letybo FDA label" /><ref name="Daxxify FDA label" />

The seven main types of botulinum toxin are named types A to G (A, B, C1, C2, D, E, F and G).<ref name="pmid33776040">{{cite journal |vauthors = Janes LE, Connor LM, Moradi A, Alghoul M |title = Current Use of Cosmetic Toxins to Improve Facial Aesthetics |journal = Plastic and Reconstructive Surgery |volume = 147 |issue = 4 |pages = 644e–657e |date = April 2021 |pmid = 33776040 |doi = 10.1097/PRS.0000000000007762 |s2cid = 232408799 }}</ref><ref name="pmid16417591">{{cite journal |vauthors = Rosales RL, Bigalke H, Dressler D |title = Pharmacology of botulinum toxin: differences between type A preparations |journal = European Journal of Neurology |volume = 13 |issue = Suppl 1 |pages = 2–10 |date = February 2006 |pmid = 16417591 |doi = 10.1111/j.1468-1331.2006.01438.x |s2cid = 32387953 }}</ref> New types are occasionally found.<ref name=BotX>{{cite web |title=Botulism toxin X: Time to update the textbooks, thanks to genomic sequencing |url=https://answers.childrenshospital.org/botulinum-toxin-x-discovered/ |publisher=Boston Children's Hospital |access-date=28 October 2019 |date=7 August 2017 |archive-date=14 September 2021 |archive-url=https://web.archive.org/web/20210914040619/https://answers.childrenshospital.org/botulinum-toxin-x-discovered/ |url-status=live }}</ref><ref name=BotH>{{cite web |title=Study: Novel botulinum toxin less dangerous than thought |url=https://www.cidrap.umn.edu/news-perspective/2015/06/study-novel-botulinum-toxin-less-dangerous-thought | work =  Center for Infectious Disease Research & Policy (CIDRAP) |publisher=University of Minnesota |access-date=28 October 2019 |date=17 June 2015 |archive-date=28 October 2019 |archive-url=https://web.archive.org/web/20191028181916/http://www.cidrap.umn.edu/news-perspective/2015/06/study-novel-botulinum-toxin-less-dangerous-thought |url-status=live }}</ref> Types A and B are capable of causing disease in humans, and are also used commercially and medically.<ref name=Farag2020>{{cite journal |vauthors = Farag SM, Mohammed MO, El-Sobky TA, ElKadery NA, ElZohiery AK |title = Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal = JBJS Reviews |volume = 8 |issue = 3 |pages = e0119 |date = March 2020 |pmid = 32224633 |pmc = 7161716 |doi = 10.2106/JBJS.RVW.19.00119 |doi-access = free |title-link = doi }}</ref><ref name=Blumetti2019>{{cite journal |vauthors = Blumetti FC, Belloti JC, Tamaoki MJ, Pinto JA |title = Botulinum toxin type A in the treatment of lower limb spasticity in children with cerebral palsy |journal = The Cochrane Database of Systematic Reviews |volume = 2019 |issue = 10 |pages = CD001408 |date = October 2019 |pmid = 31591703 |pmc = 6779591 |doi = 10.1002/14651858.CD001408.pub2 }}</ref><ref>{{cite web |author1=American Society of Health-System Pharmacists |title=OnabotulinumtoxinA (Botulinum Toxin Type A) Monograph for Professionals |url=https://www.drugs.com/monograph/onabotulinumtoxina.html |website=drugs.com |access-date=4 March 2015 |date=27 October 2011 |archive-date=6 September 2015 |archive-url=https://web.archive.org/web/20150906194001/http://www.drugs.com/monograph/onabotulinumtoxina.html |url-status=live }}</ref> Types C–G are less common; types E and F can cause disease in humans, while the other types cause disease in other animals.<ref name="WHO2018" />

<!-- Side effects -->
Botulinum toxins are among the most potent toxins known to science.<ref>{{cite journal |vauthors = Košenina S, Masuyer G, Zhang S, Dong M, Stenmark P |title = Crystal structure of the catalytic domain of the Weissella oryzae botulinum-like toxin |journal = FEBS Letters |volume = 593 |issue = 12 |pages = 1403–1410 |date = June 2019 |pmid = 31111466 |doi = 10.1002/1873-3468.13446 |doi-access = free |title-link = doi }}</ref><ref>{{Cite journal |date=November 2010 |title=Botulinum toxin: Bioweapon & magic drug  |journal=Indian Journal of Medical Research |pmc=3028942 |volume=132 |issue=5 |pages=489–503 |pmid=21149997 |vauthors = Dhaked RK, Singh MK, Singh P, Gupta P |doi=10.4103/IJMR.2010_132_05_489 |doi-access=free }}</ref> Intoxication can occur naturally as a result of either wound or intestinal infection or by ingesting formed toxin in food. The estimated human [[median lethal dose]] of type A toxin is 1.3–2.1{{nbsp}}[[nanogram|ng]]/kg [[intravenously]] or [[intramuscularly]], 10–13{{nbsp}}ng/kg when inhaled, or 1{{nbsp}}μg/kg when taken by mouth.<ref name="Arnon">{{cite journal |vauthors = Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Hauer J, Layton M, Lillibridge S, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Swerdlow DL, Tonat K |title = Botulinum toxin as a biological weapon: medical and public health management |journal = JAMA |volume = 285 |issue = 8 |pages = 1059–1070 |date = February 2001 |pmid = 11209178 |doi = 10.1001/jama.285.8.1059 }}</ref>