Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established. However, an injection site reaction (i.e., pain and burning sensation) has been reported during postmarketing use of the drug. No serious adverse reactions were observed following use of gallium Ga 68 dotatate during clinical trials. However, nausea and vomiting have been reported during postmarketing use of the drug. If case of extravasation, stop the injection, change the injection site, and irrigate the affected area with sodium chloride solution. Initiate the positron emission tomography (PET) scan 40 to 90 minutes after administration. Assay the dose in a suitable dose calibrator. Using aseptic technique and radiation shielding, withdraw the appropriate dose immediately prior to administration. Storage: After addition of gallium Ga 68 chloride to the reaction vial, use Ga 68 dotatate injection within 4 hours. Consult product information for detailed instructions regarding preparation of the radionuclide. Dispose of any unused drug in a safe manner in compliance with applicable regulations. Use waterproof gloves during the entire handling and administration process. To minimize radiation exposure, maintain adequate shielding during the life of the product. The solution is clear and colorless discard if the vial contains particulate matter or if the solution is discolored. Visually inspect parenteral products for particulate matter and discoloration.
#Netspot kit license
NOTE: Storage and disposal should be controlled in compliance with appropriate regulations of the governmental agency authorized to license the use of radiopharmaceuticals. Radiopharmaceuticals should only be used by nuclear physicians and/or radiopharmacists who are qualified by specific training and experienced in the safe use and handling of radioactive material, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. To minimize radiation exposure to occupational workers and patients, observe appropriate precautions that are consistent with proper patient management. Before reconstitution and radiolabeling with gallium Ga 68, the contents of the kit are not radioactive. NOTE: The radionuclide is not part of the kit. Patients should drink and void frequently during the first hours after administration to reduce radiation exposure. NOTE: Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to the administration of gallium Ga 68 dotatate. Gallium Ga 68 dotatate was FDA-approved in June 2016.įor storage information, see the specific product information within the How Supplied section. The uptake of gallium Ga 68 dotatate may need to be confirmed by histopathology or other assessments. This uptake can also be seen in a variety of other tumor types or other pathologic conditions, or might occur as a normal variant. The uptake of gallium Ga 68 dotatate reflects the level of somatostatin receptor density in NETs. NETs have receptors for somatostatin, a hormone that regulates the endocrine system.
NETs are rare benign or malignant tumors that develop in the hormone-producing cells of the body's neuroendocrine system, which are found in the stomach, intestines, pancreas, lungs, and other locations. Gallium Ga 68 dotatate is a radioactive diagnostic agent for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adults and pediatric patients.
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