fludeoxyglucose f18
Fludeoxyglucose F18 (Fludeoxyglucose F-18) is a radioactive diagnostic agent.
Fludeoxyglucose F-18 · by Sofie
Key facts
- Active ingredient
- Fludeoxyglucose F-18
- Drug class
- Radioactive Diagnostic Agent
- Form
- Injectable, Solution
- Strength
- Fludeoxyglucose F-18 20-300mCi/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Sofie
- FDA application
- ANDA204463
What is Fludeoxyglucose F18?
From the FDA label:11.1 Chemical Characteristics Fludeoxyglucose F18 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18 F]fluoro-D-glucose has the molecular formula of C 6 H 11 18 FO 5 with a molecular weight of 181.26, and has the following chemical structure: Fludeoxyglucose F 18 Injection, USP is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 GBq—11.1 GBq (20.0 mCi—300 mCi) of 2-deoxy-2-[ 18 F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative. Molecule 11.2 Physical Characteristics Fluorine F18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons that are produced and emitted simultaneously in opposite directions when the positron interacts with an electron ( Table 2 ). Table 2. Principal Radiation Emission Data for Fluorine F18 *Produced by positron annihilation From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981) Radiation/Emission % Per Disintegration Mean…
How to use
Fludeoxyglucose F18 is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application ANDA204463 — follow the label that came with the product you were actually prescribed.
Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description ( 11.2 )] . Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities. In the oncology and neurology settings, instruct patients to fast for 4 – 6 hours prior to the drug’s injection. Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug’s administration ( 5.2 ). In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50–75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia ( 2.3 ). Aseptically withdraw Fludeoxyglucose F 18 Injection from its container and administer by intravenous injection ( 2 ).The recommended dose: For adults is 5 mCi–10 mCi (185 MBq–370 MBq), in all indicated clinical settings ( 2.1 ). For pediatric patients is 2.6 mCi (96.2 MBq) in the neurology setting ( 2.2 ). Initiate imaging within 40 minutes following drug injection; acquire static emission images 30–100 minutes from time of injection ( 2 ). 2.1 Recommended Dose for Adults Within the oncology,…
Side effects
Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available. Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact SOFIE Co. at 800-207-1865 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Radiation risks: use smallest dose necessary for imaging ( 5.1 ). Blood glucose abnormalities: may cause suboptimal imaging ( 5.2 ). 5.1 Radiation Risks Radiation-emitting products, including Fludeoxyglucose F18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.5 )] . 5.2 Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F18 Injection administration.
Who should not take Fludeoxyglucose F18
None. None ( 4 ).
Interactions
The interaction of Fludeoxyglucose F18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
Drug class
How this class works, per Radionuclide Imaging in Cancer Medicine - Holland-Frei Cancer Medicine, NCBI Bookshelf.
Dosage forms
Injectable and Solution
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 Fludeoxyglucose F18 work?
- Fludeoxyglucose F18 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 Fludeoxyglucose F18?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Fludeoxyglucose F18. To pay less, Fludeoxyglucose F18 is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Fludeoxyglucose F18?
- Fludeoxyglucose F18 is marketed by Sofie. You can see Sofie's full profile, rating, and other products on pharmaranks.
- Is Fludeoxyglucose F18 a brand-name or generic drug?
- Fludeoxyglucose F18 is a generic medication; its active ingredient is Fludeoxyglucose F-18. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Fludeoxyglucose F18 available over the counter?
- No. Fludeoxyglucose F18 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 Fludeoxyglucose F18 come in?
- Fludeoxyglucose F18 is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- What class of drug is Fludeoxyglucose F18?
- Fludeoxyglucose F18 is classified as radioactive diagnostic agent, per the FDA's Established Pharmacologic Class.
- Is Fludeoxyglucose F18 FDA-registered?
- Fludeoxyglucose F18 is on record with the U.S. FDA under application number ANDA204463. You can verify this on its official FDA label.
- Is Fludeoxyglucose F18 safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Fludeoxyglucose F18. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Fludeoxyglucose F18?
- Fludeoxyglucose F18's side effects are taken directly from its FDA label. From the label: Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available. Hypersensitivity reactions have occurred;… 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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