Detectnet (copper Cu 64 dotatate)

Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

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.

NET tumors that do not bear somatostatin receptors will not be visualized.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In safety and efficacy trials, 71 subjects received a single dose of Detectnet. Of these 71 subjects, 21 were healthy volunteers and the remainder were patients with known or suspected NET.

The following adverse reactions occurred at a rate of < 2%:

• Gastrointestinal Disorders: nausea, vomiting
• Vascular Disorders: flushing

In published clinical experience, 126 patients with known history of NET received a single dose of copper Cu 64 dotatate injection. Four patients were reported to have experienced nausea immediately after injection.

Handle Detectnet with appropriate safety measures to minimize radiation exposure. 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

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.

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.

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.

Pregnancy Status

Assessment of pregnancy status is recommended in females of reproductive potential before administering Detectnet.

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.

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.

NET tumors that do not bear somatostatin receptors will not be visualized.

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

Somatostatin Analogs

Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2). 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.

Advise a pregnant woman of the potential risks of fetal exposure to radiation doses with Detectnet.

Lactation

Advise a lactating woman to interrupt breastfeeding for 12 hours after Detectnet administration in order to minimize radiation exposure to a breastfed infant.