Detectnet (copper Cu 64 dotatate)

Detectnet is indicated for use with positron emission tomography (PET) to locate somatostatin receptor positive neuroendocrine tumors (NETs) in adults.

Copper Cu 64 dotatate binds to somatostatin receptors. 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 non-NET tumors that contain somatostatin receptors or as a normal physiologic variant.

NET tumors without somatostatin receptors will not be visualized.

Side effects of Detectnet

Clinical Trials

Clinical trials of a drug cannot be directly compared to other drug trials and may not reflect practice.

In safety and efficacy trials, 71 subjects received a single dose of Detectnet. Of these, 21 were healthy volunteers and the rest 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 a known history of NET received a single dose of copper Cu 64 dotatate injection. Four patients experienced nausea after injection.

Dosage for Detectnet

Handle Detectnet with appropriate safety measures. 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 in the safe use and handling of radionuclides, with approved experience and training.

Recommended Dosage And Administration Instructions

Recommended Dosage

For PET imaging in adults, the recommended dose is 148 MBq (4 mCi) administered intravenously over approximately 1 minute.

Administration

• Use Detectnet within 2 hours after calibration.
• Use aseptic technique and radiation shielding when withdrawing and administering Detectnet.
• Visually inspect Detectnet for particulate matter and discoloration before administration. Do not use if the solution contains particulate matter or is discolored.
• Calculate the necessary volume based on measured activity, volume, calibration time, and date.
• Use a dose calibrator to measure the patient dose immediately prior to Detectnet administration.
• After injection, administer an intravenous flush of 0.9% sodium chloride injection, USP.
• Dispose of any unused drug 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 Detectnet administration and 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. Adapt Detectnet uptake time and scan duration according to equipment, patient, and tumor characteristics to achieve optimal image quality.

Image Interpretation

Copper Cu 64 dotatate binds to somatostatin receptors. PET images indicate the presence and density of somatostatin receptors in tissues. Uptake can also be seen in non-NET tumors that contain somatostatin receptors or as a normal physiologic variant.

NET tumors without 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

Drug interactions with Detectnet

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.

Is Detectnet safe during pregnancy or breastfeeding?

Advise pregnant women of potential fetal exposure risks with Detectnet.

Lactating

Interrupt breastfeeding for 12 hours after Detectnet administration to minimize radiation exposure to a breastfed infant.

Summary

Detectnet (copper Cu 64 dotatate) binds to somatostatin receptors that are characteristic of neuroendocrine tumors (NETs). Detectnet settles in tissues and is absorbed by tumor receptors. Copper acts as a radioactive beacon visible on a PET scan image. PET images obtained using copper Cu 64 dotatate injection indicate the presence and density of somatostatin receptors, revealing neuroendocrine tumors in the body.