Version November 2024
Diagnostic imaging: IV: 111 to 185 MBq (3 to 5 mCi). Begin positron emission tomography scanning 55 to 90 minutes after completion of gallium Ga 68 dotatoc administration.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
1% to 10%: Gastrointestinal: Nausea (<2%)
<1%: Flushing, pruritus
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity reactions: Hypersensitivity, including rash and pruritus and rarely, anaphylaxis-related reaction and angioedema, have occurred; cases usually resolved without intervention or with symptomatic management.
• Radiation accumulation: Gallium Ga 68 dotatoc administration contributes to the patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Risk for misinterpretation: Uptake of gallium Ga 68 dotatoc reflects the level of somatostatin receptor density in neuroendocrine tumors (NETs). Uptake may also be seen in other tumor types (eg, tumors that express somatostatin receptors), other pathologic conditions (eg, thyroid disease, subacute inflammation), or normal physiologic variants (eg, uncinated pancreatic process). Interpret positron emission tomography images visually, and the uptake may require confirmation by histopathology or other assessments. A negative scan in patients without a history of NETs, as well as patients suspected of ectopic ACTH-secreting tumors, does not rule out presence of NETs.
Availability may be limited to certain institutions.
IV: Administer as an IV bolus at ~10 seconds per mL. Flush with NS after administration to ensure full delivery of the dose.
Immediately prior to administration, measure and verify the radioactivity in the syringe with a dose calibrator.
Imaging should include whole body acquisition from skull to mid-thigh. Begin positron emission tomography scanning 55 to 90 minutes after administration of gallium Ga 68 dotatoc.
Patients should drink a sufficient amount of water to ensure adequate hydration prior to administration and in the first hours following administration and void frequently following administration to reduce radiation exposure.
For patients receiving a somatostatin analog, the manufacturer's labeling recommends to image patients with gallium Ga 68 dotatoc just prior to administration of a long-acting somatostatin analog. Short-acting somatostatin analogs can be used up to 24 hours before imaging with gallium Ga 68 dotatoc.
Radiopharmaceutical; use appropriate precautions for handling and disposal. When handling and administering, follow appropriate safety measures to minimize radiation exposure during administration; use waterproof gloves and effective shielding, including syringe shields.
Diagnostic imaging: Use with positron emission tomography for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients.
Gallium Ga 68 dotatoc may be confused with gallium citrate Ga-67, gallium Ga 68 dotatate, gallium Ga 68 PSMA-11.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and health care personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Somatostatin Analogs: May diminish the diagnostic effect of Gallium Ga 68 Dotatoc. Management: Imaging with gallium Ga 68 dotatoc positron emission tomography (PET) should be performed just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hours before imaging with gallium Ga 68 dotatoc. Risk D: Consider therapy modification
Animal reproduction studies have not been conducted.
In general, the potential for a radiopharmaceutical to cause fetal harm depends on the dose and stage of pregnancy.
It is not known if gallium Ga 68 dotatoc is present in breast milk.
According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Patients may express and discard milk for 8 hours after administration to decrease exposure to the breastfed infant.
Gallium Ga 68 dotatoc is a radioactive diagnostic agent. Ga 68 dotatoc binds to cells that express somatostatin receptors including malignant cells, which overexpress somatostatin type 2 (sstr2) receptors. Gallium 68 (68Ga) is a beta+ emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging. Tumors that do not express somatostatin receptors will not be visualized by imaging.
Distribution: Extensive to all somatostatin type 2 (sstr2)-expressing organs (including pituitary, thyroid, spleen, adrenals, kidney, pancreas, prostate, liver, and salivary glands).
Excretion: Urine (~16% in first 2 to 4 hours).
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