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68Ga-DOTATATE
Overview
What is NETSPOT?
NETSPOT is supplied as a sterile, single-dose kit for preparation of Ga 68 dotatate injection for intravenous use.
Dotatate, also known as
, is a cyclic 8 amino acid peptide with a covalently bound chelator (dota). The peptide has the amino acid sequence: H-D-Phe-Cys-Tyr-D-Trp-Lys-Thr-Cys-Thr-OH, and contains one disulfide bond. Dotatate has a molecular weight of 1435.6 Daltons and its chemical structure is shown in Figure 2 .
Figure 2 Chemical Structure of dotatate
[(4,7,10-Tricarboxymethyl-1,4,7,10-tetrazacyclododec-1-yl)acetyl]-(D)-Phenylalanyl-(L)Cysteinyl-(L)-Tyrosyl-(D)-Tryptophanyl-(L)-Lysyl-(L)-Threoninyl-(L)-Cysteinyl-(L)-Threonine-cyclic(2-7) disulfide
NETSPOT is a Kit with the following components:
After reconstitution and radiolabeling, [see
], Ga 68 dotatate injection also contains hydrochloric acid as an excipient derived from the generator eluate. The prepared Ga 68 dotatate injection for intravenous use, is a sterile, pyrogen free, clear, colorless, buffered solution, with a pH -between 3.2 - 3.8. Table 4, Table 5, and Table 6 display the principle radiation emission data, radiation attenuation by lead shielding, and physical decay of Ga 68.
What does NETSPOT look like?
What are the available doses of NETSPOT?
NETSPOT is supplied as a single dose kit containing:
After reconstitution with Ga68 and pH adjustment with Reaction Buffer, Vial 1 contains a sterile solution of Ga68 dotatate at a strength of 79.3 – 201.8 MBq/mL (2.1 – 5.45 mCi/mL).
What should I talk to my health care provider before I take NETSPOT?
Lactation:
8.2
How should I use NETSPOT?
NETSPOT, after radiolabeling with Ga 68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
Drug Handling
Radiopharmaceuticals should be used by or 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 Preparation
What interacts with NETSPOT?
Sorry No Records found
What are the warnings of NETSPOT?
Sorry No Records found
What are the precautions of NETSPOT?
Sorry No Records found
What are the side effects of NETSPOT?
Sorry No records found
What should I look out for while using NETSPOT?
None
What might happen if I take too much NETSPOT?
In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radioactive dose given to the patient should be performed.
How should I store and handle NETSPOT?
Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] [].NETSPOT is supplied as a single-dose kit (NDC# 69488-001-40) for preparing a single-dose of gallium 68 (Ga 68) radiolabeled dotatate injection.The kit contains:The radionuclide is not part of the kit. Before reconstitution and radiolabelling with Ga 68, the contents of this kit are not radioactive.Expiry date is indicated on the original outer packaging, and on the vials. This medicinal product must not be used beyond the date indicated on the packaging.For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (do not freeze). After reconstitution and radiolabeling [see ] with activities of up to 1110 MBq (30 mCi), keep Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25 °C (do not freeze), and for a maximum of 4 hours. The storage of the radiolabelled product must comply with regulatory requirements for radioactive materials. NETSPOT is supplied as a single-dose kit (NDC# 69488-001-40) for preparing a single-dose of gallium 68 (Ga 68) radiolabeled dotatate injection.The kit contains:The radionuclide is not part of the kit. Before reconstitution and radiolabelling with Ga 68, the contents of this kit are not radioactive.Expiry date is indicated on the original outer packaging, and on the vials. This medicinal product must not be used beyond the date indicated on the packaging.For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (do not freeze). After reconstitution and radiolabeling [see ] with activities of up to 1110 MBq (30 mCi), keep Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25 °C (do not freeze), and for a maximum of 4 hours. The storage of the radiolabelled product must comply with regulatory requirements for radioactive materials. NETSPOT is supplied as a single-dose kit (NDC# 69488-001-40) for preparing a single-dose of gallium 68 (Ga 68) radiolabeled dotatate injection.The kit contains:The radionuclide is not part of the kit. Before reconstitution and radiolabelling with Ga 68, the contents of this kit are not radioactive.Expiry date is indicated on the original outer packaging, and on the vials. This medicinal product must not be used beyond the date indicated on the packaging.For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (do not freeze). After reconstitution and radiolabeling [see ] with activities of up to 1110 MBq (30 mCi), keep Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25 °C (do not freeze), and for a maximum of 4 hours. The storage of the radiolabelled product must comply with regulatory requirements for radioactive materials. NETSPOT is supplied as a single-dose kit (NDC# 69488-001-40) for preparing a single-dose of gallium 68 (Ga 68) radiolabeled dotatate injection.The kit contains:The radionuclide is not part of the kit. Before reconstitution and radiolabelling with Ga 68, the contents of this kit are not radioactive.Expiry date is indicated on the original outer packaging, and on the vials. This medicinal product must not be used beyond the date indicated on the packaging.For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (do not freeze). After reconstitution and radiolabeling [see ] with activities of up to 1110 MBq (30 mCi), keep Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25 °C (do not freeze), and for a maximum of 4 hours. The storage of the radiolabelled product must comply with regulatory requirements for radioactive materials. NETSPOT is supplied as a single-dose kit (NDC# 69488-001-40) for preparing a single-dose of gallium 68 (Ga 68) radiolabeled dotatate injection.The kit contains:The radionuclide is not part of the kit. Before reconstitution and radiolabelling with Ga 68, the contents of this kit are not radioactive.Expiry date is indicated on the original outer packaging, and on the vials. This medicinal product must not be used beyond the date indicated on the packaging.For prolonged storage, store NETSPOT in its original packaging at room temperature below 25°C (do not freeze). After reconstitution and radiolabeling [see ] with activities of up to 1110 MBq (30 mCi), keep Ga 68 dotatate injection upright with an appropriate shielding to protect from radiation, at a temperature below 25 °C (do not freeze), and for a maximum of 4 hours. The storage of the radiolabelled product must comply with regulatory requirements for radioactive materials.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ga 68 dotatate binds to somatostatin receptors, with highest affinity for subtype 2 receptors (sstr2).
It binds to cells that express somatostatin receptors including malignant cells, which overexpress sstr2 receptors. Gallium 68 (
Ga) is a β+ emitting radionuclide with an emission yield that allows positron emission tomography (PET) imaging.
Non-Clinical Toxicology
NoneThe concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
The benzodiazepines, including lorazepam, produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.
Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.
Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate.
Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.
The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation.
Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.
Ga 68 dotatate contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure [ ]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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