Version May 2024
Diagnostic imaging: IV: 148 MBq (4 mCi); begin positron emission tomography (PET) scanning 45 to 90 minutes after completion of copper Cu 64 dotatate 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; use caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Flushing (<2%)
Gastrointestinal: Nausea (<2%), vomiting (<2%)
Postmarketing: Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity reactions: Cutaneous hypersensitivity reactions (eg, pruritus, rash) have been reported; usually reverse spontaneously or with symptomatic management. Rarely, angioedema and anaphylaxis have occurred.
• Radiation accumulation: Copper Cu 64 dotatate 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 copper Cu 64 dotatate reflects the level of somatostatin receptor density in neuroendocrine tumors (NETs). Uptake may also be seen in other tumor types that express somatostatin receptors, other pathologic conditions (eg, thyroid disease, subacute inflammation), or normal physiologic variants (eg, uncinated pancreatic process). Uptake may require confirmation by histopathology or other assessments. The presence of NET tumors does not mean somatostatin receptors will not be visualized.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Detectnet: 1 mCi/mL (1 ea) [contains alcohol, usp]
No
Solution (Detectnet Intravenous)
1 mci/mL (per each): $4,620.00
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.
IV: Administer as an IV bolus over ~1 minute, followed by a saline flush. Immediately prior to administration use a dose calibrator to measure patient dose; use within 2 hours of calibration.
Begin imaging prior to dosing with somatostatin analogs. For patients on a long-acting somatostatin, a 28-day wash-out period is recommended prior to imaging. For patients on a short-acting somatostatin, a 2-day wash-out period is recommended prior to imaging.
Imaging should include whole body acquisition from skull vertex to midthigh. Begin positron emission tomography (PET) scanning 45 to 90 minutes after completion of copper Cu 64 dotatate administration.
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.
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 (PET) for localization of somatostatin receptor positive neuroendocrine tumors in adults.
Copper Cu 64 dotatate may be confused with Gallium Ga 68 dotatate.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Somatostatin Analogs: May diminish the diagnostic effect of Copper Cu 64 Dotatate. Management: Imaging with copper Cu 64 dotatate positron emission tomography (PET) should be performed just prior to dosing with somatostatin analogs. If on somatostatin analogs, stop long-acting agents 28 days before, and short-acting agents 2 days before, imaging. Risk D: Consider therapy modification
Evaluate pregnancy status prior to use in females of reproductive potential.
Animal reproduction studies have not been conducted. In general, the potential for a radiopharmaceutical to cause fetal harm depends on the dose absorbed by the fetus and the stage of pregnancy. Elective diagnostic procedures should be delayed until after delivery (ACR-SPR 2018; SNM 2010).
It is not known if copper Cu 64 dotatate is present in breast milk.
The manufacturer recommends that breastfeeding be interrupted for 12 hours after administration to decrease potential radiation exposure to the breastfed infant. Elective diagnostic procedures should be delayed until breastfeeding has stopped (SNM 2010). Women who are breastfeeding and caring for individuals undergoing nuclear medicine procedures do not need any additional precautions (ABM [Mitchell 2019]).
Copper Cu 64 dotatate is a radioactive diagnostic agent. Cu 64 dotatate binds to cells that express somatostatin receptors, including malignant neuroendocrine cells, which overexpress somatostatin type 2 (sstr2) receptors. Copper Cu 64 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 adrenal glands, kidney, liver, pituitary glands, and spleen).
Half-life elimination: Copper Cu 64 dotatate decays with a half-life of 12.7 hours.
Excretion: Urine (16% to 40% over 6 hours).
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