NETSPOT

Radiodiagnostic Agents

 
NOTE: Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to the administration of gallium Ga 68 dotatate. Patients should drink and void frequently during the first hours after administration to reduce radiation exposure.
NOTE: The radionuclide is not part of the kit. Before reconstitution and radiolabeling with gallium Ga 68, the contents of the kit are not radioactive. To minimize radiation exposure to occupational workers and patients, observe appropriate precautions that are consistent with proper patient management. Radiopharmaceuticals should only be used by nuclear physicians and/or radiopharmacists who are qualified by specific training and experienced in the safe use and handling of radioactive material, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.
NOTE: Storage and disposal should be controlled in compliance with appropriate regulations of the governmental agency authorized to license the use of radiopharmaceuticals.

Visually inspect parenteral products for particulate matter and discoloration. The solution is clear and colorless; discard if the vial contains particulate matter or if the solution is discolored.
To minimize radiation exposure, maintain adequate shielding during the life of the product.
Use waterproof gloves during the entire handling and administration process.
Dispose of any unused drug in a safe manner in compliance with applicable regulations.

Preparation
Consult product information for detailed instructions regarding preparation of the radionuclide.
Storage: After addition of gallium Ga 68 chloride to the reaction vial, use Ga 68 dotatate injection within 4 hours.
 
Administration
Using aseptic technique and radiation shielding, withdraw the appropriate dose immediately prior to administration.
Assay the dose in a suitable dose calibrator.
Administer via IV bolus injection.
Initiate the positron emission tomography (PET) scan 40 to 90 minutes after administration.
If case of extravasation, stop the injection, change the injection site, and irrigate the affected area with sodium chloride solution.

anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

nausea / Early / Incidence not known
vomiting / Early / Incidence not known
injection site reaction / Rapid / Incidence not known
rash / Early / Incidence not known
pruritus / Rapid / Incidence not known

NETSPOT

Rx

Radioactive diagnostic agent
For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adults and pediatric patients
Confirmation by histopathology or other assessments may be needed

2 MBq/kg (0.054 mCi/kg) by a single IV bolus; do not exceed 200 MBq (5.4 mCi). Images can be acquired 40 to 90 minutes after the bolus injection and must include a whole body acquisition from skull to mid-thigh. Adapt imaging acquisition delay and duration according to the equipment used and the patient and tumor characteristics to obtain the best possible image quality.

2 MBq/kg (0.054 mCi/kg) by a single IV bolus; do not exceed 200 MBq (5.4 mCi). Images can be acquired 40 to 90 minutes after the bolus injection and must include a whole body acquisition from skull to mid-thigh. Adapt imaging acquisition delay and duration according to the equipment used and the patient and tumor characteristics to obtain the best possible image quality.

2 MBq/kg (0.054 mCi/kg) by a single IV bolus; do not exceed 200 MBq (5.4 mCi). Images can be acquired 40 to 90 minutes after the bolus injection and must include a whole body acquisition from skull to mid-thigh. Adapt imaging acquisition delay and duration according to the equipment used and the patient and tumor characteristics to obtain the best possible image quality.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Albuterol; Budesonide: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Betamethasone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Budesonide: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Budesonide; Formoterol: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Corticosteroids (systemic): (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Cortisone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Deflazacort: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Dexamethasone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Fludrocortisone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Hydrocortisone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Lanreotide: (Moderate) Image patients with gallium Ga 68 dotatate just prior to dosing with non-radioactive, long-acting somatostatin analogs. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with gallium Ga 68 dotatate. These drugs may competitively bind to the same somatostatin receptors.
Methylprednisolone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Octreotide: (Moderate) Image patients with gallium Ga 68 dotatate just prior to dosing with non-radioactive, long-acting somatostatin analogs. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with gallium Ga 68 dotatate. These drugs may competitively bind to the same somatostatin receptors.
Pasireotide: (Moderate) Image patients with gallium Ga 68 dotatate just prior to dosing with non-radioactive, long-acting somatostatin analogs. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with gallium Ga 68 dotatate. These drugs may competitively bind to the same somatostatin receptors.
Prednisolone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Prednisone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.
Somatostatin analogs: (Moderate) Image patients with gallium Ga 68 dotatate just prior to dosing with non-radioactive, long-acting somatostatin analogs. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with gallium Ga 68 dotatate. These drugs may competitively bind to the same somatostatin receptors.
Triamcinolone: (Moderate) Repeated administration of high corticosteroid doses prior to gallium Ga 68 dotatate may result in false negative imaging. High-dose corticosteroid therapy is generally defined as at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. Corticosteroids can down-regulate somatostatin subtype 2 receptors: thereby, interfering with binding of gallium Ga 68 dotatate to malignant cells that overexpress these receptors.

NETSPOT Intravenous Inj Pwd F/Sol: 40mcg

2 MBq/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi) IV per procedure.

2 MBq/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi) IV per procedure.

2 MBq/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi) IV per procedure.

2 MBq/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi) IV per procedure.

2 MBq/kg (0.054 mCi/kg) IV per procedure.

2 MBq/kg (0.054 mCi/kg) IV per procedure.

Gallium Ga 68 dotatate binds to somatostatin receptors, with greatest affinity for subtype 2 receptors (sstr2). It binds to cells that express somatostatin receptors, including malignant cells, which over express sstr2 receptors. Gallium 68 is a beta positive emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging. The uptake of gallium Ga 68 dotatate reflects the level of somatostatin receptor density in neuroendocrine tumors (NETs). This uptake can also be seen in a variety of other tumor types or other pathologic conditions, or might occur as a normal variant. The uptake of gallium Ga 68 dotatate may need to be confirmed by histopathology or other assessments.

Gallium Ga 68 dotatate is administered intravenously. Once administered, the drug distributes to all subtype 2 receptor (sstr2) expressing organs such as pituitary, thyroid, spleen, adrenals, kidney, pancreas, prostate, liver, and salivary glands. There is no uptake in the cerebral cortex or in the heart; thymus and lung uptakes are usually low. A total of 12% of the injected dose is eliminated in the urine in the first 4 hours after administration.
 
Affected cytochrome P450 isoenzymes and drug transporters: none

The amount of radiation absorbed following administration of 150 MBq (4.05 mCi) of gallium Ga 68 dotatate to an adult weighing 75 kg is approximately 3.15 mSv (0.021 mSv/MBq). Gallium Ga 68 dotatate decays with a half-life of 68 minutes.

There are no studies with gallium Ga 68 dotatate in women or animals during pregnancy, and its ability to cause fetal harm or affect the reproductive capacity is unknown. However, all radiopharmaceuticals have the potential to cause fetal toxicity, with the likelihood of harm depending on the stage of fetal development and the radiopharmaceutical dose.

There are no data available regarding the presence of gallium Ga 68 dotatate in human milk, the effect on the breastfed infant, or the effect on milk production. However, because of the potential for radiation exposure in a nursing infant, lactating mothers should temporarily interrupt breast-feeding and pump and discard breast milk for 12 hours after gallium Ga 68 dotatate administration.