Version July 2025
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.
(For additional information see "Gallium Ga-68 dotatoc (United States: Availability limited to University of Iowa Health Care Imaging): Pediatric drug information")
Dosage guidance:
Safety: Administer in a health care setting that includes cardiopulmonary monitoring and can provide resuscitation if necessary.
Positron emission tomography (PET) imaging (somatostatin receptor positive neuroendocrine tumors): Children and Adolescents: IV: 1.59 MBq/kg (0.043 mCi/kg). Perform imaging 55 to 90 minutes after administration; see manufacturer's labeling.
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.
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 reactions, including rash and pruritus, have occurred; cases usually resolved without intervention or with symptomatic management. Reactions involving angioedema or anaphylaxis have been reported infrequently; cardiopulmonary resuscitation personnel and equipment should be readily available.
• 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Dotatoc Ga 68: 18.5 - 148 MBq/mL (0.5 - 4 mCi/mL) (1 ea) [contains alcohol, usp]
No
Solution (Dotatoc Ga 68 Intravenous)
0.5-4 mci/mL (per each): $3,637.92
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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.
Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.
Parenteral: 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 administered up to 24 hours before imaging with gallium Ga 68 dotatoc.
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: Coadministration of Somatostatin Analogs and Gallium Ga 68 Dotatoc may alter diagnostic results. 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).
