Technetium (99mTc) fanolesomab
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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.
Marketing of the product was suspended in December 2005.
- "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.
- Walker RC, Jones-Jackson LB, Martin W, Habibian MR, Delbeke D (October 2007). "New imaging tools for the diagnosis of infection". Future Microbiology. Future Medicine Ltd. 2 (5): 527–554. doi:10.2217/174609184.108.40.2067. PMID 17927475.
- Kipper SL, Rypins EB, Evans DG, Thakur ML, Smith TD, Rhodes B (March 2000). "Neutrophil-specific 99mTc-labeled anti-CD15 monoclonal antibody imaging for diagnosis of equivocal appendicitis". Journal of Nuclear Medicine. 41 (3): 449–455. PMID 10716317.
- Rypins EB, Kipper SL, Weiland F, Neal C, Line B, McDonald R, et al. (February 2002). "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. doi:10.1097/00000658-200202000-00011. PMC 1422419. PMID 11807363.
- Palestro CJ, Kipper SL, Weiland FL, Love C, Tomas MB (June 2002). "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. doi:10.1148/radiol.2233011072. PMID 12034946.
- Love C, Tronco GG, Palestro CJ (June 2006). "Imaging of infection and inflammation with 99mTc-Fanolesomab". The Quarterly Journal of Nuclear Medicine and Molecular Imaging. 50 (2): 113–120. PMID 16770301.
- Technetium (99mTc) Fanolesomab from Micromedex