Medically reviewed by Drugs.com. Last updated on Sep 7, 2021.
Generic name: COPPER OXODOTREOTIDE CU-64 1.0mCi in 1mL
Dosage form: injection, solution
Radiation Safety – Drug Handling
Handle Detectnet with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1)]. Use waterproof gloves, effective radiation shielding and appropriate safety measures when preparing and handling Detectnet.
Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
Recommended Dosage and Administration Instructions
In adults, the recommended amount of radioactivity to be administered for PET imaging is 148 MBq (4 mCi) administered as an intravenous injection over a period of approximately 1 minute.
- Use Detectnet within 2 hours after calibration time.
- Use aseptic technique and radiation shielding when withdrawing and administering Detectnet.
- Inspect Detectnet visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
- Calculate the necessary volume to administer based on measured activity, volume, calibration time, and date.
- Use a dose calibrator to measure the patient dose immediately prior to administration of Detectnet.
- After injection of Detectnet, administer an intravenous flush of 0.9% sodium chloride injection, USP.
- Dispose of any unused drug in a safe manner in compliance with applicable regulations.
2.3 Patient Preparation
Image patients just prior to dosing with somatostatin analogs.
For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging.
For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging [see Drug Interactions (7.1)].
Instruct patients to drink water to ensure adequate hydration prior to administration of Detectnet and to continue to drink and void frequently during the first hours following administration to reduce radiation exposure [see Warnings and Precautions (5.1)].
Assessment of pregnancy status is recommended in females of reproductive potential before administering Detectnet.
2.4 Image Acquisition
For Detectnet PET imaging, a whole-body acquisition from the skull vertex to mid-thigh is recommended. Image acquisition can begin between 45 to 90 minutes after the intravenous administration of Detectnet. Adapt Detectnet uptake time and scan duration according to the equipment used and the patient and tumor characteristics, to obtain the optimal image quality.
Copper Cu 64 dotatate binds to somatostatin receptors. Based upon the intensity of the signals, PET images obtained using copper Cu 64 dotatate injection indicate the presence and density of somatostatin receptors in tissues. Uptake can also be seen in a variety of non-NET tumors that contain somatostatin receptors or as a normal physiologic variant [see Warnings and Precautions (5.2)]. NET tumors that do not bear somatostatin receptors will not be visualized.
Estimated radiation absorbed doses per injected activity for organs and tissues of adult patients following an intravenous administration of copper Cu 64 dotatate injection are shown in Table 1.
|Target Organ||Mean* absorbed dose (mGy/MBq)|
|Lower large intestine wall||0.043|
|Upper large intestine wall||0.022|
|Urinary bladder wall||0.037|
|Effective dose (mSv/MBq)||0.032|
The effective radiation dose resulting from the administration of 148 MBq (4 mCi) to an adult is about 4.7 mSv. For an administered activity of 148 MBq (4 mCi) the typical radiation dose to the critical organs, which are the liver, the kidneys/adrenals, and the spleen, are about 24 mGy, 21 mGy and 17 mGy, respectively. Because the spleen has one of the highest physiological uptakes, higher uptake and radiation dose to other organs or pathologic tissues may occur in patients with splenectomy.
More about Detectnet (copper Cu 64 dotatate)
- Side Effects
- Drug Interactions
- Pricing & Coupons
- Drug class: diagnostic radiopharmaceuticals
- FDA Approval History
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