Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 30mL, multidose vial
- Contains 18.5-148 MBq/mL (0.5-4 mCi/mL) of Ga 68 dotatoc injection at calibration date and time
Neuroendocrine Tumors
Indicated for use with positron emission tomography (PET) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs)
4 mCi (148 MBq); range of 3-5 mCi (111-185 MBq) administered as an IV bolus injection
Dosing Considerations
Somatostatin analogs
- Somatostatin analogs (eg, lanreotide, octreotide, pasireotide) bind to the same somatostatin receptors as Ga 68 dotatoc
- Discontinue short-acting somatostatin analogs 24 hr before imaging
- Image with Ga 68 dotatoc just before dosing with long-acting analogs of somatostatin
Dosage Forms & Strengths
injectable solution
- 30mL, multidose vial
- Contains 18.5-148 MBq/mL (0.5-4 mCi/mL) of Ga 68 dotatoc injection at calibration date and time
Neuroendocrine Tumors
Indicated for use with positron emission tomography (PET) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs)
0.043 mCi/kg of body weight (1.59 MBq/kg); range of 0.3-3 mCi (11.1-111 MBq) as an IV bolus injection
Dosing Considerations
Somatostatin analogs
- Somatostatin analogs (eg, octreotide) bind to the same somatostatin receptors as Ga 68 dotatoc
- Discontinue short-acting somatostatin analogs 24 hr before imaging
- Image with Ga 68 dotatoc just before dosing with long-acting somatostatin analogs
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (3)
- lanreotide
lanreotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.
- octreotide
octreotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.
- pasireotide
pasireotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.
Minor (0)
Adverse Effects
1-10%
Nausea (<2%)
<1%
Pruritus
Flushing
Postmarketing Reports
Immune system disorders: Hypersensitivity reactions, predominantly rash, pruritus, less frequently angioedema or features of anaphylaxis
Warnings
Contraindications
None
Cautions
Hypersensitivity reactions consisting of cutaneous reactions such as rash and pruritus reported; reactions reversed either spontaneously or with routine symptomatic management; less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis
Radiation risk
- Contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure associated with increased cancer risk
- Ensure safe handling and preparation procedures to protect patients and healthcare workers from unintentional radiation exposure
Risk for image misinterpretation
- Uptake of Ga 68 dotatoc reflects somatostatin receptor density level in NETs
- Uptake can also be seen in other tumors that express somatostatin receptors
- Increased uptake might also be seen in other pathologic conditions (eg, thyroid disease, subacute inflammation) or might occur as a normal physiologic variant (eg, uncinate process of the pancreas)
- Negative scan after administration in patients without history of NET disease does not rule out disease
Drug interaction overview
- Nonradioactive somatostatin analogs (eg, lanreotide, octreotide, pasireotide) competitively bind to the same somatostatin receptors as Ga 68 dotatoc
Pregnancy & Lactation
Pregnancy
No data available on use in pregnant women to identify a risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
- Animal reproduction studies have not been conducted
- All radiopharmaceuticals may cause fetal harm depending on fetal stage of development and radiation dose magnitude
- If considering administration to a pregnant woman, inform of potential for adverse pregnancy outcomes based on the radiation dose from Ga 68 dotatoc and the gestational timing of exposure
Lactation
There is no information on the presence of Ga 68 dotatoc in human milk, the effect on the breastfed infant, or the effect on milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child from injection or from the underlying maternal condition
Clinical considerations
- Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hr after administration
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Ga 68 dotatoc binds to somatostatin receptors, with highest affinity for subtype 2 receptors (sstr2)
Drug binds to cells that express somatostatin receptors including malignant neuroendocrine cells, which overexpress sstr2 receptors
Gallium 68 is a beta-emitting radionuclide with associated 511 keV annihilation photons that allow PET imaging
Distribution
Distributed to all sstr2-expressing organs such as pituitary, thyroid, spleen, adrenals, kidney, pancreas, prostate, liver, and salivary glands
Uptake in the lung and lymph nodes is lower compared with other sstr-2 expressing organs
Elimination
Excretion: Exclusively via urine (~16%)
Administration
IV Preparation
Drug handling
- Handle injection with appropriate safety measures to minimize radiation exposure
Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling injection
Use radiopharmaceuticals under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides
Patient hydration
- Instruct patients to drink water to ensure adequate hydration before administration and to continue to drink and void frequently during first hours following administration to reduce radiation exposure
IV Administration
Use injection within 3 hr of calibration time
Visually inspect injection for particulate matter and discoloration before administration; do not use if solution contains particulate matter or is discolored
Calculate the necessary volume to administer based on measured activity, volume, calibration time, and date
Measure dose immediately before administration in a dose calibrator; refer to prescribing information for dose and estimated radiation absorbed
Inject IV bolus at ~ 10 sec/mL
After administration, flush IV with 0.9% NaCl to ensure dose is fully delivered
Dispose of any unused drug in a safe manner in compliance with applicable regulations
Image Acquisition
For Ga 68 dotatoc PET imaging, acquisition must include a whole body acquisition from skull to mid-thigh
Image can be acquired at 60 min (range 55-90 min) after IV bolus
Adapt injection uptake time and scan duration according to the equipment used, the patient, and tumor characteristics, to obtain optimal image quality
Image Interpretation
Drug binds to somatostatin receptors
Based upon the intensity of the signals, PET images obtained indicate presence and density of somatostatin receptors in tissues
Storage
Store upright in a lead shielded container at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Store and dispose of injection in accordance with the regulations and a general license, or its equivalent, of an agreement state or a licensing state
Images
Formulary
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