Copper (64Cu) oxodotreotide
Names | |
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Trade names | Detectnet |
Other names | Copper Cu 64 dotatate |
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Clinical data | |
Drug class | Radioactive diagnostic agent[1] |
Main uses | Positron emission tomography (PET) of neuroendocrine tumors (NETs)[1] |
Side effects | Nausea, vomiting, flushing[1] |
Pregnancy category |
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Routes of use | Intravenous |
Legal | |
License data | |
Legal status | |
Chemical and physical data | |
Formula | C65H88CuN14O19S2 |
Molar mass | 1497.16 g·mol−1 |
3D model (JSmol) | |
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Copper (64Cu) oxodotreotide, sold under the brand name Detectnet, is a radioactive diagnostic agent used in positron emission tomography (PET) of neuroendocrine tumors (NETs).[1] Specifically it is used in adults with somatostatin receptor positive disease.[1] It is given by injection into a vein.[1]
Common side effects include nausea, vomiting, and flushing.[1] Other side effects include radiation exposure and allergic reactions.[1] It interacts with somatostatin analogs.[1] Use during pregnancy may harm the baby.[1] It works by binding to somatostatin receptor, particularly subtype 2 receptors.[1]
Copper (64Cu) oxodotreotide was approved for medical use in the United States in 2020.[1] In the United States it costs about 3,900 USD for a vial as of 2022.[2]
Medical uses
Dosage
It is typically used at a dose of 148 MBq (4 mCi).[1]
History
The U.S. Food and Drug Administration (FDA) approved copper 64Cu dotatate based on data from two trials that evaluated 175 adults.[3]
Trial 1 evaluated adults, some of whom had known or suspected NETs and some of whom were healthy volunteers.[3] The trial was conducted at one site in the United States (Houston, TX).[3] Both groups received copper 64Cu dotatate and underwent PET scan imaging.[3]
Trial 2 data came from the literature-reported trial of 112 adults, all of whom had history of NETs and underwent PET scan imaging with copper 64Cu dotatate.[3] The trial was conducted at one site in Denmark.[3] In both trials, copper 64Cu dotatate images were compared to either biopsy results or other images taken by different techniques to detect the sites of a tumor.[3] The images were read as either positive or negative for presence of NETs by three independent image readers who did not know participant clinical information.[3]
See also
References
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 "Detectnet- copper cu 64 dotatate injection, solution". DailyMed. 14 September 2020. Archived from the original on 1 November 2022. Retrieved 24 September 2020.
- ↑ "Detectnet Prices, Coupons, Copay & Patient Assistance". Drugs.com. Archived from the original on 22 May 2022. Retrieved 3 November 2022.
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 "Drug Trials Snapshots: Detectnet". U.S. Food and Drug Administration (FDA). 3 September 2020. Archived from the original on 21 September 2020. Retrieved 10 September 2020. This article incorporates text from this source, which is in the public domain.
External links
Identifiers: |
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- "Copper dotatate Cu-64". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2022-05-21. Retrieved 2022-10-20.
- "copper Cu 64 dotatate injection safety data sheet" (PDF). Curium US LLC. 15 March 2020. Archived (PDF) from the original on 27 October 2020. Retrieved 20 October 2022.
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