Version May 2024
Diagnostic imaging: IV: 2 MBq/kg (0.054 mCi/kg); maximum dose 200 MBq (5.4 mCi). Begin PET scanning 40 to 90 minutes after completion of gallium Ga 68 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.
(For additional information see "Gallium Ga-68 DOTATATE: Pediatric drug information")
Diagnostic imaging: Infants, Children, and Adolescents: IV: 2 MBq/kg (0.054 mCi/kg); maximum dose: 200 MBq/dose (5.4 mCi/dose). Begin positron emission tomography (PET) scanning 40 to 90 minutes after completion of gallium Ga 68 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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Postmarketing:
Gastrointestinal: Nausea, vomiting
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Local: Burning sensation at injection site, pain at injection site
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Extravasation: May be an irritant; extravasation may result in local irritation. Avoid extravasation. If extravasation occurs, stop infusion and restart in a different injection site. Irrigate extravasation site with sodium chloride solution.
• 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 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 healthcare 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:
• Appropriate use: Patients should avoid close contact with infants and pregnant patients during the first 12 hours following administration.
• Risk for misinterpretation: Uptake of gallium Ga 68 dotatate reflects the level of somatostatin receptor density in neuroendocrine tumors (NETs). Uptake may also be seen in other tumor types (eg, tumors derived from neural crest tissue), sites of splenosis, or other pathologic conditions (eg, thyroid disease, subacute inflammation), or normal physiologic variants (eg, uncinated pancreatic process). Interpret PET 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.
Kit, Intravenous:
Netspot: Lyophilized dotatate mixture and reaction buffer solution [to be combined with Ga 68 (not included)]
No
Solution (Dotatoc Ga 68 Intravenous)
0.5-4mCi/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.
IV: Administer as an IV bolus. Immediately prior to administration, measure and verify the radioactivity in the syringe with a dose calibrator to ensure radioactivity administered is within ±10% of the recommended dose.
Imaging should include whole body acquisition from skull to mid-thigh. Begin PET scanning 40 to 90 minutes after administration of gallium Ga 68 dotatate.
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 dotatate 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 dotatate.
May be an irritant; extravasation may result in local irritation. Avoid extravasation. If extravasation occurs, stop infusion and restart in a different injection site. Irrigate extravasation site with sodium chloride solution.
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.
Administer as an IV bolus. Immediately prior to administration, measure and verify the radioactivity in the syringe with a dose calibrator to ensure radioactivity administered is within 10% of the recommended dose.
Imaging should include whole body acquisition from skull to mid-thigh. Begin PET scanning 40 to 90 minutes after administration of gallium Ga 68 dotatate.
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 dotatate within 24 hours of administration of a short-acting somatostatin analog or just prior to administration of a long-acting somatostatin analog.
May be an irritant; extravasation may result in local irritation. Avoid extravasation. If extravasation occurs, stop infusion and restart in a different injection site. Irrigate extravasation site with sodium chloride solution.
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) (after radiolabeling with Ga 68) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Gallium Ga 68 dotatate may be confused with copper Cu 64 dotatate, gallium citrate Ga-67, gallium Ga 68 PSMA-11.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare 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.
Corticosteroids (Systemic): May diminish the diagnostic effect of Gallium Ga 68 Dotatate. Risk C: Monitor therapy
Somatostatin Analogs: May diminish the diagnostic effect of Gallium Ga 68 Dotatate. Specifically, a false negative PET scan may occur if Gallium GA 68 Dotatate is used during treatment with somatostatin analogs. Management: It is recommended to image with gallium Ga 68 dotatate positron emission tomography (PET) 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 dotatate. Risk D: Consider therapy modification
Animal reproduction studies have not been conducted.
It is not known if gallium ga 68 dotatate is present in breast milk. The manufacturer recommends breastfeeding be interrupted and breast milk discarded for 12 hours after administration.
Gallium Ga 68 dotatate is a radioactive diagnostic agent. Ga 68 dotatate 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 which 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, liver, and salivary glands).
Half-life elimination: Gallium Ga 68 dotatate decays with a half-life of 68 minutes to stable zinc ZN 68.
Excretion: Urine (12% in first 4 hours).
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