68ga-dotatate

NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

Gallium Ga 68 dotatate binds to somatostatin receptors, with highest affinity for subtype 2 receptors (SSTR2). It binds to cells that express somatostatin receptors, including malignant cells, which overexpress SSTR2. Gallium-68 is a β+ emitting radionuclide with an emission yield that allows PET imaging.

After radiolabeling, handle gallium Ga 68 dotatate injection with appropriate safety measures to minimize radiation exposure. Instruct patients to drink a sufficient amount of water before administration, during the first hours following administration and to void frequently. Recommended dose is 2 MBq/kg (0.054 mCi/kg) of body weight up to 200 MBq (5.4 mCi) administered as intravenous bolus injection. See the Full Prescribing Information for detailed instructions on how to prepare gallium Ga 68 dotatate injection (e.g., radiolabeling).

None. None.

Radiation Risk: Gallium Ga 68 dotatate contributes to a patient’s overall long-term cumulative radiation exposure. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Restrict close contact with infants and pregnant women during the first 12 hours after administration of gallium Ga 68 dotatate. Hypersensitivity Reactions: Most reported reactions were rash and pruritus and reversible either spontaneously or with routine symptomatic management. Risk for Image Misinterpretation: The uptake of gallium Ga 68 dotatate can be seen in a variety of tumor types other than NETs (e.g., those derived from neural crest tissue), in sites of splenosis or other pathologic conditions, and as a normal physiologic variant (e.g., uncinate process of the pancreas).

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions Nausea, vomiting, and injection site pain and burning sensation were all reported during post-approval use.

Somatostatin Analogs: Somatostatin analogs competitively bind to the same somatostatin receptors as gallium Ga 68 dotatate and may affect imaging – image just prior to dosing with long-acting somatostatin analogs. Glucocorticoids: Repeated administration of high doses of glucocorticoids prior to gallium Ga 68 dotatate administration may affect imaging.

For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (77°F) (do not freeze). After radiolabeling with activities of up to 1,110 MBq (30 mCi), keep gallium Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25°C (77°F) (do not freeze), and use within 4 hours. The storage of the radiolabeled product must comply with regulatory requirements for radioactive materials.