| Revision as of 18:46, 9 January 2012 editBeetstra (talk | contribs)Edit filter managers, Administrators172,084 edits Saving copy of the {{drugbox}} taken from revid 460517083 of page Technetium_(99mTc)_arcitumomab for the Chem/Drugbox validation project (updated: ''). |
Latest revision as of 18:09, 30 September 2024 edit Swinub (talk | contribs)Extended confirmed users69,443 editsmNo edit summary |
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{{Short description|Pharmaceutical drug}} |
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{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}} |
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{{DISPLAYTITLE:Technetium (<sup>99m</sup>Tc) arcitumomab}} |
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{{Drugbox |
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{{Drugbox |
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| verifiedrevid = 470478168 |
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| Verifiedfields = changed |
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| verifiedrevid = 447728109 |
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| drug_name = Technetium (<sup>99m</sup>Tc) arcitumomab |
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| drug_name = Technetium (<sup>99m</sup>Tc) arcitumomab |
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<!-- Monoclonal antibody data --> |
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<!--Monoclonal antibody data--> |
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| type = mab |
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| type = mab |
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| mab_type = Fab' |
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| mab_type = Fab' |
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| source = o |
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| source = o |
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| target = ] |
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| target = ] |
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<!--Clinical data --> |
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<!--Clinical data--> |
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| tradename = |
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| tradename = |
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| pregnancy_US = C |
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| legal_status = Rx |
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| legal_status = Rx |
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| routes_of_administration = ] |
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| routes_of_administration = ] |
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<!--Pharmacokinetic data --> |
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<!--Pharmacokinetic data--> |
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| bioavailability = N/A |
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| bioavailability = N/A |
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| protein_bound = |
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| protein_bound = |
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| metabolism = |
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| metabolism = |
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| elimination_half-life = 13 ± 4 hours |
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| elimination_half-life = 13 ± 4 hours |
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<!--Identifiers --> |
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| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} |
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<!--Identifiers--> |
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| ChemSpiderID = none |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| CAS_number_Ref = {{cascite|correct|CAS}} |
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| ChemSpiderID = NA |
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| CAS_number = 154361-49-6 |
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| CASNo_Ref = {{cascite}} |
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| CAS_number_Ref = {{cascite|correct|??}} |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII = 029JF1SCU8 |
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| CAS_number = 154361-48-5 |
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| CAS_supplemental = (arcitumomab) |
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| ATC_prefix = V09 |
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| ATC_prefix = V09 |
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| ATC_suffix = IA06 |
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| ATC_suffix = IA06 |
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| PubChem = |
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| PubChem = |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = |
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| DrugBank = DB00113 |
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<!--Chemical data --> |
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<!--Chemical data--> |
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| chemical_formula = |
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| chemical_formula = |
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| molecular_weight = 54 |
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| molecular_weight_comment = kDa{{cn|date=December 2023}} |
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| molecular_weight = ca. 50 ] |
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}} |
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}} |
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'''Technetium (<sup>99m</sup>Tc) arcitumomab''' was a drug used for the diagnostic imaging of ]s, marketed by ].<ref name="SPC">{{cite web|url=http://www.cea-scan.com/inserts/epckginst.htm|title=CEA-Scan Summary of Product Characteristics|publisher=Immunomedics|access-date=2009-10-28|archive-date=2016-03-13|archive-url=https://web.archive.org/web/20160313061725/http://cea-scan.com/inserts/epckginst.htm|url-status=dead}}</ref> It consisted of the ] of a ] (arcitumomab, trade name '''CEA-Scan''') and a ], ]. |
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CEA-Scan was approved by the European Medicine Association (EMA) on October of 1996 for imaging in the case of metastases and/or recurrence in patients that were suffering from colon or rectum cancer. Under the same decision, it was also approved to be used in patients that were suspected to have colon or rectal carcinoma recurrence and/or metastasis in association with rising blood CEA-levels. <ref>{{Cite web |date=2005-11-16 |title=CEA-Scan {{!}} European Medicines Agency (EMA) |url=https://www.ema.europa.eu/en/medicines/human/EPAR/cea-scan#more-information-on-cea-scan-1536 |access-date=2024-09-30 |website=www.ema.europa.eu |language=en}}</ref> |
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==Chemistry== |
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Technetium (<sup>99m</sup>Tc) arcitumomab is an ]. Arcitumomab is a Fab' fragment of IMMU-4, a ] ] monoclonal antibody extracted from the ] of mice. The enzyme ] cleaves the F(ab')<sub>2</sub> fragment off the antibody. From this, the Fab' fragment is prepared by mild ]. |
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Before application, arcitumomab is reconstituted with a solution of the radioactive agent sodium ] (<sup>99m</sup>Tc) from a ].<ref name="SPC" /> |
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==Mechanism of action== |
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Arcitumomab recognizes ] (CEA), an antigen over-] in 95% of colorectal cancers.<ref>{{cite journal | vauthors = Guadagni F, Kantor J, Aloe S, Carone MD, Spila A, D'Alessandro R, Abbolito MR, Cosimelli M, Graziano F, Carboni F, Carlini S, Perri P, Sciarretta F, Greiner JW, Kashmiri SV, Steinberg SM, Roselli M, Schlom J | display-authors = 6 | title = Detection of blood-borne cells in colorectal cancer patients by nested reverse transcription-polymerase chain reaction for carcinoembryonic antigen messenger RNA: longitudinal analyses and demonstration of its potential importance as an adjunct to multiple serum markers | journal = Cancer Research | volume = 61 | issue = 6 | pages = 2523–32 | date = March 2001 | pmid = 11289125 | url = http://cancerres.aacrjournals.org/cgi/content/abstract/61/6/2523 }}</ref> Consequently, the antibody accumulates in such tumours together with the radioisotope, which emits ]s. Via ] (SPECT), high-resolution images showing localisation, ] or progression, and ] of the tumour can be obtained.<ref name="SPC" /><ref>{{cite journal | vauthors = Behr T, Becker W, Hannappel E, Goldenberg DM, Wolf F | title = Targeting of liver metastases of colorectal cancer with IgG, F(ab')2, and Fab' anti-carcinoembryonic antigen antibodies labeled with 99mTc: the role of metabolism and kinetics | journal = Cancer Research | volume = 55 | issue = 23 Suppl | pages = 5777s–5785s | date = December 1995 | pmid = 7493346 }}</ref> |
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==Contraindications== |
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Technetium (<sup>99m</sup>Tc) arcitumomab is ] for patients with known allergies or hypersensitivity to mouse proteins, as well as during pregnancy. Women should pause breast feeding for 24 hours after application of the drug.<ref name="SPC" /> |
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==Adverse effects and overdose== |
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Only mild and transient side effects have been observed, mostly immunological reactions like ], itching and fever. Some patients develop ], so there is the theoretical possibility of ]. High doses of IMMU-4 (up to 20-fold diagnostic arcitumomab dose) have not led to any serious events. One patient has been reported to develop a ] after application.<ref name="SPC" /> |
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Radioactivity can lead to ]. Since the dose of an arcitumomab application is about 10 m],<ref name="SPC" /> such an overdose is unlikely. |
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== Removal from market == |
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In August 2005, the marketing company Immunodemics voluntarily decided to withdraw the product from the market. |
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In September 2005, EMA accepted the decision and CEA-Scan was removed from the market.<ref>{{Cite web |date=2005-11-16 |title=CEA-Scan {{!}} European Medicines Agency (EMA) |url=https://www.ema.europa.eu/en/medicines/human/EPAR/cea-scan#more-information-on-cea-scan-1536 |access-date=2024-09-30 |website=www.ema.europa.eu |language=en}}</ref> |
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== References == |
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{{reflist}} |
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== Further reading == |
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{{refbegin}} |
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* {{cite journal | vauthors = Primus FJ, Newell KD, Blue A, Goldenberg DM | title = Immunological heterogeneity of carcinoembryonic antigen: antigenic determinants on carcinoembryonic antigen distinguished by monoclonal antibodies | journal = Cancer Research | volume = 43 | issue = 2 | pages = 686–92 | date = February 1983 | pmid = 6184152 }} |
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* {{cite journal | vauthors = Hansen HJ, Jones AL, Sharkey RM, Grebenau R, Blazejewski N, Kunz A, Buckley MJ, Newman ES, Ostella F, Goldenberg DM | display-authors = 6 | title = Preclinical evaluation of an "instant" 99mTc-labeling kit for antibody imaging | journal = Cancer Research | volume = 50 | issue = 3 Suppl | pages = 794s–798s | date = February 1990 | pmid = 2297726 }} |
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* {{cite journal| vauthors = Hughes K |title=Use of radioimmunodetection with CEAScan in planning for resection of recurrent colorectal cancer|journal=Proc Amer Soc Clin Oncol|volume=14|year=1995|page=544}} |
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* {{cite journal | vauthors = Moffat FL, Pinsky CM, Hammershaimb L, Petrelli NJ, Patt YZ, Whaley FS, Goldenberg DM | title = Clinical utility of external immunoscintigraphy with the IMMU-4 technetium-99m Fab' antibody fragment in patients undergoing surgery for carcinoma of the colon and rectum: results of a pivotal, phase III trial. The Immunomedics Study Group | journal = Journal of Clinical Oncology | volume = 14 | issue = 8 | pages = 2295–305 | date = August 1996 | pmid = 8708720 | doi = 10.1200/JCO.1996.14.8.2295 }} |
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{{refend}} |
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{{Radiopharmaceuticals}} |
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{{Monoclonals for tumors}} |
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{{DEFAULTSORT:Technetium (99mtc) Arcitumomab}} |
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