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Fludeoxyglucose F 18 240 mCi/mL Injection, 30 mL — NDC 52670-0551-30 package photo
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Fludeoxyglucose F 18 240 mCi/mL Injection, 30 mL — NDC 52670-551-30 (Billing 52670-0551-30)

by Mayo Clinic · 30 mL in 1 VIAL, MULTI-DOSE

This is a package of 30 mL of Fludeoxyglucose F 18 240 mCi/mL Injection from Mayo Clinic, marketed since Aug 2013 and currently FDA-listed. It is this product's only package size.

NDC 52670-0551-30
🏷️ FDA NDC (as labeled) 52670-551-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52670-551-30
Product NDC 52670-551
11-digit billing NDC 52670055130
UNII 0Z5B2CJX4D
Application # ANDA203612
SPL Set ID 153b650d-7b69-4880-a72a-a5f13059d248
Established class (EPC) Radioactive Diagnostic Agent
Mechanism of action Radiopharmaceutical Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-08-05
Route INTRAVENOUS
Dosage form INJECTION
Substance FLUDEOXYGLUCOSE F-18
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 52670-551-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 52670-0551-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52670-0551-30 You're viewing this Main listing 30 mL in 1 VIAL, MULTI-DOSE 2013-08-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fludeoxyglucose F 18 240 mCi/mLthis 52670-0551-30 Mayo 30 ml — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2013
On the market since
Aug 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 4.5 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMayo Clinic
Application holderMAYO CLINIC PET RADIOCHEMISTRY FACILITY
FDA applicationANDA203612 (ANDA)
Labeler code52670
First marketedAug 2013
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 216 words ▾

1 INDICATIONS AND USAGE Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures ( 1 ).

1.1Oncology For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

1.2Cardiology For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

1.3Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Fludeoxyglucose F 18 Injection USP 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 F 18 Injection USP 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 USP from its container and administer by intravenous injection (2). The recommended dose: for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated clinical settings ( 2.1 ). for pediatric patients is 2.6 mCi 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 ).

2.1Recommended Dose for Adults Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.

2.2Recommended Dose for Pediatric Patients Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [ see Use in Special Populations (8.4) ].

2.3Patient Preparation To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour.

Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [ see Warnings and Precautions (5.2) ]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug’s injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to Fludeoxyglucose F 18 Injection USP facilitates localization of cardiac ischemia.

2.4Radiation Dosimetry The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection USP are shown in Table 1. These estimates were calculated based on human 2 data and using the data published by the International Commission on Radiological Protection 4 for Fludeoxyglucose 18 F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups.

These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs. Table 1.

Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injection USP a Organ Newborn (3.4 kg) 1-year old (9.8 kg) 5-year old (19 kg) 10-year old (32 kg) 15-year old (57 kg) Adult (70 kg) Bladder wall b 4.3 1.7 0.93 0.60 0.40

0.32Heart wall 2.4 1.2 0.70 0.44 0.29

0.22Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19

0.14Lungs… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 124 words ▾

3 DOSAGE FORMS AND STRENGTHS Multiple-dose glass vial containing 0.74 –

8.88GBq (20 - 240 mCi/mL) of Fludeoxyglucose F 18 Injection USP and 4.5 mg of sodium chloride in citrate buffer (approximately 29 mL volume) for intravenous administration. Ethanol (3 mg/mL) is used as an antioxidant in Fludeoxyglucose F 18 Injection USP. The pH of the solution is between 4.5 and 7.5. Multiple-dose glass vial containing 20 - 240 mCi/mL (0.74 –

8.88GBq) of Fludeoxyglucose F 18 Injection USP and 4.5 mg of sodium chloride in citrate buffer (approximately 29 mL volume), for intravenous administration ( 3 ). Ethanol (3 mg/mL) is used as an antioxidant in Fludeoxyglucose F 18 Injection USP. The pH of the solution is between 4.5 and 7.5.

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None None

⚠️ Warnings and Cautions 119 words ▾

5 WARNINGS AND PRECAUTIONS Radiation risks: use smallest dose necessary for imaging ( 5.1 ). Blood glucose abnormalities: may cause suboptimal imaging ( 5.2 ).

5.1Radiation Risks Radiation-emitting products, including Fludeoxyglucose F 18 Injection USP, 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) ].

5.2Blood 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 F 18 Injection USP administration.

🤒 Adverse Reactions 60 words ▾

6 ADVERSE REACTIONS 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 The Feinstein Institute for Medical Research at 516-562-1042 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 26 words ▾

7 DRUG INTERACTIONS The possibility of interactions of Fludeoxyglucose F 18 Injection USP with other drugs taken by patients undergoing PET imaging has not been studied.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIAL POPULATIONS Pregnancy Category C: No human or animal data. Consider alternative diagnostics; use only if clearly needed ( 8.1 ). Nursing mothers: Use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if Fludeoxyglucose F 18 Injection USP is administered to a woman who is breast-feeding ( 8.3 ).

Pediatric Use: Safety and effectiveness in pediatric patients have not been established in the oncology and cardiology settings ( 8.4 ).

8.1Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection USP. It is also not known whether Fludeoxyglucose F 18 Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in a pregnant woman; administer Fludeoxyglucose F 18 Injection USP only if clearly needed.

8.3Nursing Mothers It is not known whether Fludeoxyglucose F 18 Injection USP is excreted in human milk. Consider alternative diagnostic tests in women who are breast-feeding. Use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if Fludeoxyglucose F 18 Injection USP is administered to a woman who is breast-feeding.

8.4Pediatric Use The safety and effectiveness of Fludeoxyglucose F 18 Injection USP in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.

In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F 18 Injection USP have not been established in pediatric patients.

🤰 Pregnancy 62 words ▾

8.1Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection USP. It is also not known whether Fludeoxyglucose F 18 Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in a pregnant woman; administer Fludeoxyglucose F 18 Injection USP only if clearly needed.

🧒 Pediatric Use 80 words ▾

8.4Pediatric Use The safety and effectiveness of Fludeoxyglucose F 18 Injection USP in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.

In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F 18 Injection USP have not been established in pediatric patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fludeoxyglucose F 18 is a glucose analog that concentrates in cells that rely upon glucose as an energy source, or in cells whose dependence on glucose increases under pathophysiological conditions. Fludeoxyglucose F 18 is transported through the cell membrane by facilitative glucose transporter proteins and is phosphorylated within the cell to [ 18 F] FDG-6-phosphate by the enzyme hexokinase. Once phosphorylated it cannot exit until it is dephosphorylated by glucose-6-phosphatase.

Therefore, within a given tissue or pathophysiological process, the retention and clearance of Fludeoxyglucose F 18 reflect a balance involving glucose transporter, hexokinase and glucose-6-phosphatase activities. When allowance is made for the kinetic differences between glucose and Fludeoxyglucose F 18 transport and phosphorylation (expressed as the ''lumped constant'' ratio), Fludeoxyglucose F 18 is used to assess glucose metabolism. In comparison to background activity of the specific organ or tissue type, regions of decreased or absent uptake of Fludeoxyglucose F 18 reflect the decrease or absence of glucose metabolism.

Regions of increased uptake of Fludeoxyglucose F 18 reflect greater than normal rates of glucose metabolism.

12.2Pharmacodynamics Fludeoxyglucose F 18 Injection USP is rapidly distributed to all organs of the body after intravenous administration. After background clearance of Fludeoxyglucose F 18 Injection USP, optimal PET imaging is generally achieved between 30 to 40 minutes after administration. In cancer, the cells are generally characterized by enhanced glucose metabolism partially due to (1) an increase in activity of glucose transporters, (2) an increased rate of phosphorylation activity, (3) a reduction of phosphatase activity or, (4) a dynamic alteration in the balance among all these processes.

However, glucose metabolism of cancer as reflected by Fludeoxyglucose F 18 accumulation shows considerable variability. Depending on tumor type, stage, and location, Fludeoxyglucose F 18 accumulation may be increased, normal, or decreased. Also, inflammatory cells can have the same variability of uptake of Fludeoxyglucose F 18.

In the heart, under normal aerobic conditions, the myocardium meets the bulk of its energy requirements by oxidizing free fatty acids. Most of the exogenous glucose taken up by the myocyte is converted into glycogen. However, under ischemic conditions, the oxidation of free fatty acids decreases, exogenous glucose becomes the preferred myocardial substrate, glycolysis is stimulated, and glucose taken up by the myocyte is metabolized immediately instead of being converted into glycogen.

Under these conditions, phosphorylated Fludeoxyglucose F 18 accumulates in the myocyte and can be detected with PET imaging. In the brain, cells normally rely on aerobic metabolism. In epilepsy, the glucose metabolism varies.

Generally, during a seizure, glucose metabolism increases. Interictally, the seizure focus tends to be hypometabolic.

12.3Pharmacokinetics Distrib u tio n : In four healthy male volunteers, receiving an intravenous administration of 30 seconds in duration, the arterial blood level profile for Fludeoxyglucose F 18 decayed triexponentially. The effective half-life ranges of the three phases were 0.2-0.3 minutes, 10-13 minutes with a mean and standard deviation (STD) of 11.6 (±) 1.1 min, and 80-95 minutes with a mean and STD of 88 (±) 4 min. Plasma protein binding of Fludeoxyglucose F 18 has not been studied.

Metab o lism: Fludeoxyglucose F 18 is transported into cells and phosphorylated to [ 1 8 F]­ FDG-6- phosphate at a rate proportional to the rate of glucose utilization within that tissue. [F 18]-FDG-6-phosphate presumably is metabolized to 2-deoxy-2-[F 18]fluoro-6­ phospho-D-mannose([F 18]FDM-6-phosphate). Fludeoxyglucose F 18 Injection USP may contain several impurities (e.g., 2-deoxy-2-chloro­D-glucose (ClDG)). Biodistribution and metabolism of C… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 178 words ▾

12.1Mechanism of Action Fludeoxyglucose F 18 is a glucose analog that concentrates in cells that rely upon glucose as an energy source, or in cells whose dependence on glucose increases under pathophysiological conditions. Fludeoxyglucose F 18 is transported through the cell membrane by facilitative glucose transporter proteins and is phosphorylated within the cell to [ 18 F] FDG-6-phosphate by the enzyme hexokinase. Once phosphorylated it cannot exit until it is dephosphorylated by glucose-6-phosphatase.

Therefore, within a given tissue or pathophysiological process, the retention and clearance of Fludeoxyglucose F 18 reflect a balance involving glucose transporter, hexokinase and glucose-6-phosphatase activities. When allowance is made for the kinetic differences between glucose and Fludeoxyglucose F 18 transport and phosphorylation (expressed as the ''lumped constant'' ratio), Fludeoxyglucose F 18 is used to assess glucose metabolism. In comparison to background activity of the specific organ or tissue type, regions of decreased or absent uptake of Fludeoxyglucose F 18 reflect the decrease or absence of glucose metabolism.

Regions of increased uptake of Fludeoxyglucose F 18 reflect greater than normal rates of glucose metabolism.

📋 Description ~2 min read ▾

11 DESCRIPTION

11.1Chemical Characteristics Fludeoxyglucose F 18 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 to

8.88GBq (20.0­240 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.

Ethanol (3 mg/mL) is used as an antioxidant in Fludeoxyglucose F 18 Injection USP. 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 to

8.88GBq (20.0­240 mCi) of 2-deox

11.2Physical Characteristics Fluorine F 18 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 F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±)* 193.46 511.0 keV *Produced by positron annihilation From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981) The specific gamma ray constant (point source air kerma coefficient) for fluorine F 18 is

5.7R/hr/mCi (1.35 x 10 - 6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3.

For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%. Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding Shield thickness (Pb) mm Coefficient of attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.

Table 4. Physical Decay Chart for Fluorine F 18 Minutes Fraction Remaining 0* 1.000 15 0.909 30 0.826 60 0.683 110 0.500 220 0.250 *calibration time

💬 Information for Patients 106 words ▾

17 PATIENT COUNSELING INFORMATION Instruct patients in procedures that increase renal clearance of radioactivity. Encourage patients to: drink water or other fluids (as tolerated) in the 4 hours before their PET study. void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. Manufactured by: Mayo Clinic PET Radiochemistry Facility 200 1 st St SW Rochester, MN 55905 Mayo Clinic PET Radiochemistry Facility 5861 E Mayo Blvd Phoenix, AZ 85054 Distributed by: Mayo Clinic PET Radiochemistry Facility 200 1 st St SW Rochester, MN 55905 Mayo Clinic PET Radiochemistry Facility 5861 E Mayo Blvd Phoenix, AZ 85054

🍼 Nursing Mothers 61 words ▾

8.3Nursing Mothers It is not known whether Fludeoxyglucose F 18 Injection USP is excreted in human milk. Consider alternative diagnostic tests in women who are breast-feeding. Use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if Fludeoxyglucose F 18 Injection USP is administered to a woman who is breast-feeding.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Distrib u tio n : In four healthy male volunteers, receiving an intravenous administration of 30 seconds in duration, the arterial blood level profile for Fludeoxyglucose F 18 decayed triexponentially. The effective half-life ranges of the three phases were 0.2-0.3 minutes, 10-13 minutes with a mean and standard deviation (STD) of 11.6 (±) 1.1 min, and 80-95 minutes with a mean and STD of 88 (±) 4 min. Plasma protein binding of Fludeoxyglucose F 18 has not been studied.

Metab o lism: Fludeoxyglucose F 18 is transported into cells and phosphorylated to [ 1 8 F]­ FDG-6- phosphate at a rate proportional to the rate of glucose utilization within that tissue. [F 18]-FDG-6-phosphate presumably is metabolized to 2-deoxy-2-[F 18]fluoro-6­ phospho-D-mannose([F 18]FDM-6-phosphate). Fludeoxyglucose F 18 Injection USP may contain several impurities (e.g., 2-deoxy-2-chloro­D-glucose (ClDG)). Biodistribution and metabolism of ClDG are presumed to be similar to Fludeoxyglucose F 18 and would be expected to result in intracellular formation of 2­ deoxy-2-chloro-6-phospho-D-glucose (ClDG-6-phosphate) and 2-deoxy-2-chloro-6­phospho-D-mannose (ClDM-6-phosphate).

The phosphorylated deoxyglucose compounds are dephosphorylated and the resulting compounds (FDG, FDM, ClDG, and ClDM) presumably leave cells by passive diffusion. Fludeoxyglucose F 18 and related compounds are cleared from non-cardiac tissues within 3 to 24 hours after administration. Clearance from the cardiac tissue may require more than 96 hours.

Fludeoxyglucose F 18 that is not involved in glucose metabolism in any tissue is then excreted in the urine. Elimination: Fludeoxyglucose F 18 is cleared from most tissues within 24 hours and can be eliminated from the body unchanged in the urine. Three elimination phases have been identified in the reviewed literature.

Within 33 minutes, a mean of 3.9% of the administrated radioactive dose was measured in the urine. The amount of radiation exposure of the urinary bladder at two hours post-administration suggests that 20.6% (mean) of the radioactive dose was present in the bladder. Special Populations: The pharmacokinetics of Fludeoxyglucose F 18 Injection USP have not been studied in renally-impaired, hepatically impaired or pediatric patients.

Fludeoxyglucose F 18 is eliminated through the renal system. Avoid excessive radiation exposure to this organ system and adjacent tissues. The effects of fasting, varying blood sugar levels, conditions of glucose intolerance, and diabetes mellitus on Fludeoxyglucose F 18 distribution in humans have not been ascertained [ see Warnings and Precautions (5.2) ].

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Fludeoxyglucose F 18 Injection USP is rapidly distributed to all organs of the body after intravenous administration. After background clearance of Fludeoxyglucose F 18 Injection USP, optimal PET imaging is generally achieved between 30 to 40 minutes after administration. In cancer, the cells are generally characterized by enhanced glucose metabolism partially due to (1) an increase in activity of glucose transporters, (2) an increased rate of phosphorylation activity, (3) a reduction of phosphatase activity or, (4) a dynamic alteration in the balance among all these processes.

However, glucose metabolism of cancer as reflected by Fludeoxyglucose F 18 accumulation shows considerable variability. Depending on tumor type, stage, and location, Fludeoxyglucose F 18 accumulation may be increased, normal, or decreased. Also, inflammatory cells can have the same variability of uptake of Fludeoxyglucose F 18.

In the heart, under normal aerobic conditions, the myocardium meets the bulk of its energy requirements by oxidizing free fatty acids. Most of the exogenous glucose taken up by the myocyte is converted into glycogen. However, under ischemic conditions, the oxidation of free fatty acids decreases, exogenous glucose becomes the preferred myocardial substrate, glycolysis is stimulated, and glucose taken up by the myocyte is metabolized immediately instead of being converted into glycogen.

Under these conditions, phosphorylated Fludeoxyglucose F 18 accumulates in the myocyte and can be detected with PET imaging. In the brain, cells normally rely on aerobic metabolism. In epilepsy, the glucose metabolism varies.

Generally, during a seizure, glucose metabolism increases. Interictally, the seizure focus tends to be hypometabolic.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Oncology The efficacy of Fludeoxyglucose F 18 Injection USP in positron emission tomography cancer imaging was demonstrated in 16 independent studies. These studies prospectively evaluated the use of Fludeoxyglucose F 18 in patients with suspected or known malignancies, including non-small cell lung cancer, colo-rectal, pancreatic, breast, thyroid, melanoma, Hodgkin's and non-Hodgkin's lymphoma, and various types of metastatic cancers to lung, liver, bone, and axillary nodes. All these studies had at least 50 patients and used pathology as a standard of truth.

The Fludeoxyglucose F 18 Injection USP doses in the studies ranged from 200 MBq to 740 MBq with a median and mean dose of 370 MBq. In the studies, the diagnostic performance of Fludeoxyglucose F 18 Injection USP varied with the type of cancer, size of cancer, and other clinical conditions. False negative and false positive scans were observed.

Negative Fludeoxyglucose F 18 Injection USP PET scans do not exclude the diagnosis of cancer. Positive Fludeoxyglucose F 18 Injection USP PET scans can not replace pathology to establish a diagnosis of cancer. Non-malignant conditions such as fungal infections, inflammatory processes and benign tumors have patterns of increased glucose metabolism that may give rise to false-positive scans.

The efficacy of Fludeoxyglucose F 18 Injection USP PET imaging in cancer screening was not studied.

14.2Cardiology The efficacy of Fludeoxyglucose F 18 Injection USP for cardiac use was demonstrated in ten independent, prospective studies of patients with coronary artery disease and chronic left ventricular systolic dysfunction who were scheduled to undergo coronary revascularization. Before revascularization, patients underwent PET imaging with Fludeoxyglucose F 18 Injection USP (74 – 370 MBq, 2 – 10 mCi) and perfusion imaging with other diagnostic radiopharmaceuticals. Doses of Fludeoxyglucose F 18 Injection USP ranged from 74-370 MBq (2-10 mCi).

Segmental, left ventricular, wall-motion assessments of asynergic areas made before revascularization were compared in a blinded manner to assessments made after successful revascularization to identify myocardial segments with functional recovery. Left ventricular myocardial segments were predicted to have reversible loss of systolic function if they showed Fludeoxyglucose F 18 accumulation and reduced perfusion (i.e., flow-metabolism mismatch). Conversely, myocardial segments were predicted to have irreversible loss of systolic function if they showed reductions in both Fludeoxyglucose F 18 accumulation and perfusion (i.e., matched defects).

Findings of flow-metabolism mismatch in a myocardial segment may suggest that successful revascularization will restore myocardial function in that segment. However, false-positive tests occur regularly, and the decision to have a patient undergo revascularization should not be based on PET findings alone. Similarly, findings of a matched defect in a myocardial segment may suggest that myocardial function will not recover in that segment, even if it is successfully revascularized.

However, false- negative tests occur regularly, and the decision to recommend against coronary revascularization, or to recommend a cardiac transplant, should not be based on PET findings alone. The reversibility of segmental dysfunction as predicted with Fludeoxyglucose F 18 PET imaging depends on successful coronary revascularization. Therefore, in patients with a low likelihood of successful revascularization, the diagnostic usefulness of PET imaging with Fludeoxyglucose F 18 Injection USP is more limited.

14.3Neurology In a prospective, open label trial, Fludeoxyglucose F 18 Injection USP was evaluated in 86 patients with epilepsy. Each patient received a dose of Fludeoxyglucose F 18 Injection USP in the range of 185-370 MBq (5-10 mCi). The mean age was 16.4 years (range: 4 months - 58 years; of these, 42 patients were less than 12 years and 16 patients we… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 31 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been performed to evaluate the Fludeoxyglucose F 18 Injection USP carcinogenic potential, mutagenic potential or effects on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 28 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been performed to evaluate the Fludeoxyglucose F 18 Injection USP carcinogenic potential, mutagenic potential or effects on fertility.

📚 References 119 words ▾

15 REFERENCES Gallagher B.M., Ansari A., Atkins H., Casella V., Christman D.R., Fowler J.S., Ido T., MacGregor R.R., Som P., Wan C.N., Wolf A.P., Kuhl D.E., and Reivich M. “Radiopharmaceuticals XXVII. 18F-labeled 2-deoxy-2-fluoro-d-glucose as a radiopharmaceutical for measuring regional myocardial glucose metabolism in vivo: tissue distribution and imaging studies in animals,” J Nucl Med , 1977; 18, 990-6. Jones S.C., Alavi, A., Christman D., Montanez, I., Wolf, A.P., and Reivich M. “The radiation dosimetry of 2 [F-18] fluoro-2-deoxy-D-glucose in man,” J Nucl Med , 1982; 23, 613-617.

Kocher, D.C. “Radioactive Decay Tables: A handbook of decay data for application to radiation dosimetry and radiological assessments,” 1981, DOE/TIC-I 1026, 89. ICRP Publication 53, Volume 18, No. l-4, 1987, pages 75-76.

📄 Recent Major Changes 15 words ▾

Warnings and Precautions: ( 5.1 , 5.2 ) 7/2010 Adverse Reactions ( 6 ) 7/2010

📄 Package Label / Principal Display Panel 28 words ▾

PRINCIPAL DISPLAY PANEL NDC 52670-551-30 Fludeoxyglucose F 18 Injection, USP Intravenous Use Rx Only PRINCIPAL DISPLAY PANEL NDC 52670-551-30 Fludeoxyglucose F 18 Injection, USP Intravenous Use Rx Only

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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← 52670-0550-30 · Mayo 52670-0552-30 · Mayo →
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