gallium ga 68 gozetotide
Gallium Ga 68 Gozetotide (Gallium Ga-68 Gozetotide) is a radioactive diagnostic agent.
Gallium Ga-68 Gozetotide · by Univ Ca Los Angeles
Key facts
- Active ingredient
- Gallium Ga-68 Gozetotide
- Drug class
- Radioactive Diagnostic Agent
- Form
- Injectable
- Strength
- Gallium GA-68 Gozetotide 0.5-5mCi/mL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Univ Ca Los Angeles
- FDA application
- NDA212642
What is Gallium Ga 68 Gozetotide?
From the FDA label:11.1 Chemical Characteristics Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent for intravenous administration. It contains 5 mcg gozetotide, 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of gallium Ga 68 gozetotide at calibration time, 1 mL ethanol, 1 mL water for injection, and 10 mL of 0.9% sodium chloride solution (approximately 12 mL total volume). Gallium Ga 68 Gozetotide Injection is provided as a sterile, pyrogen free, clear, colorless solution for intravenous use, with a pH between 4.0 and 7.0. Gozetotide is also known as PSMA-11. Gallium Ga 68 gozetotide is a urea based peptidomimetic that has a covalently bound chelator (HBED-CC). The peptide has the amino acid sequence Glu-NH-CO-NH-Lys(Ahx)-HBED-CC. Gallium Ga 68 gozetotide has a molecular weight of 1011.91 g/mol and its chemical structure is shown in Figure 1. Figure 1: Chemical Structure of Gallium Ga 68 Gozetotide Chemical Structure 11.2 Physical Characteristics Gallium-68 (Ga 68) decays with a half-life of 68 minutes to stable zinc-68. Table 2 and Table 3 display the principal radiation emission data and physical decay of Ga 68. Table 2: Principal Radiation Emission Data (>1%) for Gallium Ga 68 Radiation/ Emission % Disintegration Mean Energy (MeV) beta+ 88% 0.8360 beta+ 1.1% 0.3526 gamma 178% 0.5110 gamma 3.0% 1.0770 X-ray 2.8% 0.0086 X-ray 1.4% 0.0086 Table 3: Physical Decay Chart for…
How to use
Use appropriate aseptic technique and radiation safety handling measures to maintain sterility during all operations involved in the manipulation and administration of Gallium Ga 68 Gozetotide Injection. ( 2.1 ) The recommended adult dose is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection. ( 2.2 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. ( 2.2 ) Initiate imaging 50 to 100 minutes after administration. The patient should void immediately prior to initiation of imaging. Scan should begin caudally and proceed cranially. ( 2.4 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety – Drug Handling Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection. 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…
Side effects
The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact UCLA Nuclear Medicine at 1-844-963-1855 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Gallium Ga 68 Gozetotide Injection was evaluated in 960 patients, each receiving one dose of Gallium Ga 68 Gozetotide Injection. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.
Warnings
Important safety information
Risk for misdiagnosis: Gallium Ga 68 gozetotide uptake can be seen in a variety of tumor types and in non-malignant processes. Image interpretation errors can occur with gallium Ga 68 gozetotide PET. ( 5.1 ) Radiation risk: Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. ( 2.1 , 5.2 ) 5.1 Risk for Misdiagnosis Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of Gallium Ga 68 Gozetotide Injection for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease [See Clinical Studies (14) ] . The performance of Gallium Ga 68 Gozetotide Injection for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score [See Clinical Studies (14) ] . Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. 5.2 Radiation Risks Gallium Ga 68 Gozetotide Injection contributes to a 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 workers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1 , 2.3) ] .
Who should not take Gallium Ga 68 Gozetotide
None None ( 4 )
Overdose — what happens if you take too much
In the event of an overdose of Gallium Ga 68 Gozetotide Injection, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.
Drug class
How this class works, per Radionuclide Imaging in Cancer Medicine - Holland-Frei Cancer Medicine, NCBI Bookshelf.
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- How does Gallium Ga 68 Gozetotide work?
- Gallium Ga 68 Gozetotide is a radioactive diagnostic agent. A radioactive diagnostic agent is a small dose of a radioactive substance attached to a molecule that travels to a specific organ or tissue. Once there it gives off radiation that a scanner outside the body detects, producing images that show where that tissue is or how it is working.
- Is there a coupon or discount for Gallium Ga 68 Gozetotide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Gallium Ga 68 Gozetotide. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Gallium Ga 68 Gozetotide?
- Gallium Ga 68 Gozetotide is marketed by Univ Ca Los Angeles. You can see Univ Ca Los Angeles's full profile, rating, and other products on pharmaranks.
- Is Gallium Ga 68 Gozetotide a brand-name or generic drug?
- Gallium Ga 68 Gozetotide is a brand-name product with the active ingredient Gallium Ga-68 Gozetotide.
- Is Gallium Ga 68 Gozetotide available over the counter?
- No. Gallium Ga 68 Gozetotide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Gallium Ga 68 Gozetotide come in?
- Gallium Ga 68 Gozetotide is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Gallium Ga 68 Gozetotide?
- Gallium Ga 68 Gozetotide is classified as radioactive diagnostic agent, per the FDA's Established Pharmacologic Class.
- Is Gallium Ga 68 Gozetotide FDA-registered?
- Gallium Ga 68 Gozetotide is on record with the U.S. FDA under application number NDA212642. You can verify this on its official FDA label.
- Is Gallium Ga 68 Gozetotide safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Gallium Ga 68 Gozetotide. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Gallium Ga 68 Gozetotide?
- Gallium Ga 68 Gozetotide's side effects are taken directly from its FDA label. From the label: The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact UCLA Nuclear Medicine at 1-844-963-1855 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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