locametz
Pharmaranks rates Locametz 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Locametz (Gallium Ga-68 Gozetotide) is a radioactive diagnostic agent.
Gallium Ga-68 Gozetotide · by Novartis
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Gallium Ga-68 Gozetotide
- Drug class
- Radioactive Diagnostic Agent
- Form
- Injectable
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Novartis
- FDA application
- NDA215841
What is Locametz?
From the FDA label:11.1 Chemical Characteristics LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection) is a sterile, radioactive diagnostic agent for intravenous administration after radiolabeling. Each vial contains 25 micrograms of gozetotide, 1 mg gentisic acid, 78 mg of sodium acetate trihydrate, and 40 mg sodium chloride. Gozetotide is also known as PSMA-11. After reconstitution and radiolabeling of LOCAMETZ, the vial contains gallium Ga 68 gozetotide injection at a radioactivity of up to 2,590 MBq (70 mCi) in up to 10 mL at calibration date and time. The vial also contains hydrochloric acid derived from the gallium-68 chloride solution. Gallium Ga 68 gozetotide injection has a pH between 3.2 to 6.5. Gallium Ga 68 gozetotide is a urea based peptidomimetic that has a covalently bound chelator (HBED-CC). The peptide has amino acid sequence OH-Glu-CO-Lys(Ahx-CC-HBED)-OH. Gallium Ga 68 gozetotide has a molecular weight of 1011.91 g/mol. The chemical structure is shown in Figure 3. Figure 3. Chemical Structure of Gallium Ga 68 Gozetotide 11.2 Physical Characteristics Gallium-68 decays with a half-life of 68 minutes to stable zinc-68. Table 4 and Table 5 display the principle radiation emission data, and physical decay of gallium-68. Table 4. Principal Radiation Emission Data (> 1%) for Gallium-68 Radiation/Emission % Disintegration Mean energy (MeV) beta+ 88% 0.8360 beta+ 1.1%…
How to use
Use appropriate radiation safety measures and aseptic precautions while handling and administering gallium Ga 68 gozetotide injection. ( 2.1 ) The recommended amount of radioactivity is 111 MBq to 259 MBq (3 mCi to 7 mCi). Administered as slow intravenous injection. ( 2.2 ) Advise patients to be well hydrated prior to the administration and to void immediately prior to and frequently after image acquisition. ( 2.3 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. ( 2.6 ) Acquire PET whole body images 50 minutes to 100 minutes after administration. ( 2.7 ) See the full prescribing information for detailed instructions on preparation, administration, imaging, and radiation dosimetry. ( 2 ) 2.1 Radiation Safety – Drug Handling After reconstitution and radiolabeling of LOCAMETZ, the vial contains gallium Ga 68 gozetotide injection. Handle the 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 health care providers who are qualified by specific training and experience in the safe use and handling of radionuclides,…
Side effects
The adverse reactions (incidence ≥ 0.5%) are fatigue, nausea, constipation, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 LOCAMETZ has been established based on three prospective studies of gallium Ga 68 gozetotide in patients with prostate cancer (i.e., Studies 1, 2, and 3). Adverse reactions from these studies are reported below. In Studies 1 and 2 using another formulation of gallium Ga 68 gozetotide injection, 960 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount (mean ± SD) of radioactivity 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi) [see Clinical Studies (14.1, 14.2)] . The most commonly reported adverse reactions were nausea, diarrhea and dizziness, occurring at a rate of < 1%. In a randomized, multicenter, open-label clinical study (NCT03511664, referred to as Study 3) in which gallium Ga 68 gozetotide was used to identify PSMA-positive patients on PET imaging to determine eligibility for PSMA-directed therapy,…
Warnings
Important safety information
Risk for Misinterpretation: Gallium Ga 68 gozetotide uptake may occur in other tumor types and in non-malignant processes. Interpretation of LOCAMETZ PET imaging with histopathology and/or other diagnostic procedures is recommended. ( 5.1 ) Radiation Risk: Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. ( 5.2 ) 5.1 Risk for Misinterpretation Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and positive imaging does not confirm the presence of prostate cancer. 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. The performance of LOCAMETZ for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of LOCAMETZ for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score [see Clinical Studies (14.1, 14.2)] . 5.2 Radiation Risk Gallium Ga 68 gozetotide contributes to the patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to be well hydrated prior to gallium Ga 68 gozetotide injection administration and to void immediately prior to and frequently during the first hours after image acquisition to reduce radiation exposure [see Dosage and Administration (2.1, 2.3)] .
Who should not take Locametz
None. None. ( 4 )
Overdose — what happens if you take too much
In the event of an overdose of gallium Ga 68 gozetotide, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the radioactivity from the body by hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the effective radiation dose exposure 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 LOCAMETZ 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
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- How does Locametz work?
- Locametz 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.
- How is Locametz rated?
- pharmaranks gives Locametz a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Locametz?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Locametz. 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 Locametz?
- Locametz is marketed by Novartis. You can see Novartis's full profile, rating, and other products on pharmaranks.
- Is Locametz a brand-name or generic drug?
- Locametz is a brand-name product with the active ingredient Gallium Ga-68 Gozetotide.
- Is Locametz available over the counter?
- No. Locametz 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 Locametz come in?
- Locametz is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Locametz?
- Locametz is classified as radioactive diagnostic agent, per the FDA's Established Pharmacologic Class.
- Is Locametz FDA-registered?
- Locametz is on record with the U.S. FDA under application number NDA215841. You can verify this on its official FDA label.
- Has Locametz been recalled by the FDA?
- Locametz has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Locametz safe?
- There's no single safe-or-not verdict. pharmaranks gives Locametz a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Locametz?
- Locametz's side effects are taken directly from its FDA label. From the label: The adverse reactions (incidence ≥ 0.5%) are fatigue, nausea, constipation, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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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locametz
70/100