Chemistry:Technetium (99mTc) fanolesomab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Mouse |
| Target | CD15 |
| Clinical data | |
| Trade names | NeutroSpec |
| Routes of administration | Intravenous |
| ATC code |
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| Identifiers | |
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Technetium (99mTc) fanolesomab (trade name NeutroSpec, manufactured by Palatin Technologies) is a mouse monoclonal antibody formerly used to aid in the diagnosis of appendicitis. It is labeled with a radioisotope, technetium-99m (99mTc).
History and use
NeutroSpec was approved by the U.S. Food and Drug Administration (FDA) in June 2004 for imaging of patients with symptoms of appendicitis. It consisted of an intact murine (mouse) IgM monoclonal antibody against human CD15, labeled with technetium-99m so as to be visible on a gamma camera image. Since anti-CD15 antibodies bind selectively to white blood cells such as neutrophils, it could be used to localize the site of an infection.
Deaths and associated recall
The FDA received reports from Palatin of 2 deaths and 15 life-threatening adverse events in patients who had received NeutroSpec.
These events occurred within minutes of administration of NeutroSpec and included shortness of breath, low blood pressure, and cardiopulmonary arrest. Affected patients required resuscitation with intravenous fluids, blood pressure support, and oxygen. Most, but not all, of the patients who experienced these events had existing cardiac and/or pulmonary conditions that may have placed them at higher risk for these adverse events. A review of all post-marketing reports showed an additional 46 patients who experienced adverse events that were similar but less severe. All of the reactions occurred immediately after NeutroSpec was administered.[1]
Marketing of the product was suspended in December 2005.
References
- ↑ "FDA Public Health Advisory: Suspended Marketing of NeutroSpec (Technetium (99m Tc) fanolesomab)" (Press release). U.S. Food and Drug Administration. December 19, 2005. Retrieved 2007-11-27.
Further reading
- "New imaging tools for the diagnosis of infection". Future Microbiology (Future Medicine Ltd) 2 (5): 527–554. October 2007. doi:10.2217/17460913.2.5.527. PMID 17927475.
- "Neutrophil-specific 99mTc-labeled anti-CD15 monoclonal antibody imaging for diagnosis of equivocal appendicitis". Journal of Nuclear Medicine 41 (3): 449–455. March 2000. PMID 10716317. https://jnm.snmjournals.org/content/41/3/449.
- "99m Tc anti-CD 15 monoclonal antibody (LeuTech) imaging improves diagnostic accuracy and clinical management in patients with equivocal presentation of appendicitis". Annals of Surgery 235 (2): 232–239. February 2002. doi:10.1097/00000658-200202000-00011. PMID 11807363.
- "Osteomyelitis: diagnosis with (99m)Tc-labeled antigranulocyte antibodies compared with diagnosis with (111)In-labeled leukocytes--initial experience". Radiology (Radiological Society of North America (RSNA)) 223 (3): 758–764. June 2002. doi:10.1148/radiol.2233011072. PMID 12034946.
- "Imaging of infection and inflammation with 99mTc-Fanolesomab". The Quarterly Journal of Nuclear Medicine and Molecular Imaging 50 (2): 113–120. June 2006. PMID 16770301. https://www.minervamedica.it/en/journals/nuclear-med-molecular-imaging/article.php?cod=R39Y2006N02A0113.
External links
- Technetium (99mTc) Fanolesomab from Micromedex
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