DETECTNET Solution for injection Ref.[10056] Active ingredients:

2.1 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.

2.2 Recommended Dosage and Administration Instructions

Recommended Dosage

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.

Administration

• 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

Somatostatin Analogs

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)].

Patient Hydration

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)].

Pregnancy Status

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.

2.5 Image Interpretation

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.

2.6 Radiation Dosimetry

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.

Table 1. Estimated radiation absorbed dose per injected activity in selected organs with copper Cu 64 dotatate injection:

* Mean of 5 patients.

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.

In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding. A diuretic might also be considered. If possible, estimation of the radioactive dose given to the patient should be performed.

Store Detectnet in an upright position within the lead shielding to protect handlers from exposure to radiation.

Store Detectnet at controlled room temperature 20°C to 25°C (68°F to 77°F). Do not use and discard Detectnet 2 hours after the calibration date and time.

This radiopharmaceutical is for distribution and use by persons under license by the U.S. Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State. Store and dispose of Detectnet in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.