INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. Fludeoxyglucose F18 Injection is indicated for positronemission tomography (PET) imaging in the following settings:. Fludeoxyglucose F18 Injection is indicated forpositron emission tomography (PET) imaging in the following settings:Oncology: For assessment of abnormal glucosemetabolism to assist in the evaluation of malignancy in patients with known orsuspected abnormalities found by other testing modalities, or in patients withan existing diagnosis of cancer.Cardiology: For the identification of left ventricularmyocardium with residual glucose metabolism and reversible loss of systolicfunction in patients with coronary artery disease and left ventriculardysfunction, when used together with myocardial perfusion imaging.Neurology: For the identification of regions of abnormal glucose metabolism associated withfoci of epileptic seizures (1). Oncology: For assessment of abnormal glucosemetabolism to assist in the evaluation of malignancy in patients with known orsuspected abnormalities found by other testing modalities, or in patients withan existing diagnosis of cancer.. Cardiology: For the identification of left ventricularmyocardium with residual glucose metabolism and reversible loss of systolicfunction in patients with coronary artery disease and left ventriculardysfunction, when used together with myocardial perfusion imaging.. Neurology: For the identification of regions of abnormal glucose metabolism associated withfoci of epileptic seizures (1). 1.1 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. 1.2 Cardiology. For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function inpatients with coronary artery disease and left ventricular dysfunction, when used together withmyocardial perfusion imaging.. 1.3 Neurology. For the identification of regions of abnormalglucose metabolism associated with foci of epileptic seizures.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Fludeoxyglucose 18 is glucose analog thatconcentrates in cells that rely upon glucose as an energy source, or in cellswhose dependence on glucose increases under pathophysiological conditions.Fludeoxyglucose 18 is transported through the cell membrane by facilitativeglucose transporter proteins and is phosphorylated within the cell to [18F] FDG-6-phosphate by the enzyme hexokinase. Oncephosphorylated it cannot exit until it is dephosphorylated byglucose-6-phosphatase. Therefore, within given tissue or pathophysiologicalprocess, the retention and clearance of Fludeoxyglucose 18 reflect balanceinvolving glucose transporter, hexokinase and glucose-6-phosphatase activities.When allowance is made for the kinetic differences between glucose andFludeoxyglucose 18 transport and phosphorylation (expressed as the lumpedconstant ratio), Fludeoxyglucose 18 is used to assess glucose metabolism. In comparison to background activity of thespecific organ or tissue type, regions of decreased or absent uptake ofFludeoxyglucose 18 reflect the decrease or absence of glucose metabolism.Regions of increased uptake of Fludeoxyglucose 18 reflect greater than normalrates of glucose metabolism.. 12.2 Pharmacodynamics. Fludeoxyglucose 18 Injection is rapidlydistributed to all organs of the body after intravenous administration. Afterbackground clearance of Fludeoxyglucose 18 Injection, optimal PET imaging isgenerally achieved between 30 to 40 minutes after administration.In cancer, the cells are generally characterizedby enhanced glucose metabolism partially due to (1) an increase in activity ofglucose transporters, (2) an increased rate of phosphorylation activity, (3) areduction of phosphatase activity or, (4) dynamic alteration in the balanceamong all these processes. However, glucose metabolism of cancer as reflectedby Fludeoxyglucose 18 accumulation shows considerable variability. Dependingon tumor type, stage, and location, Fludeoxyglucose 18 accumulation may beincreased, normal, or decreased. Also, inflammatory cells can have the samevariability of uptake of Fludeoxyglucose 18. In the heart, under normal aerobic conditions,the myocardium meets the bulk of its energy requirements by oxidizing freefatty acids. Most of the exogenous glucose taken up by the myocyte is convertedinto glycogen. However, under ischemic conditions, the oxidation of free fattyacids decreases, exogenous glucose becomes the preferred myocardial substrate,glycolysis is stimulated, and glucose taken up by the myocyte is metabolizedimmediately instead of being converted into glycogen. Under these conditions,phosphorylated Fludeoxyglucose 18 accumulates in the myocyte and can bedetected with PET imaging. In the brain, cells normally rely on aerobicmetabolism. In epilepsy, the glucose metabolism varies. Generally, during aseizure, glucose metabolism increases. Interictally, the seizure focus tends tobe hypometabolic.. 12.3 Pharmacokinetics. Distribution: In four healthy male volunteers, receiving anintravenous administration of 30 seconds in duration, the arterial blood levelprofile for Fludeoxyglucose 18 decayed triexponentially. The effectivehalf-life ranges of the three phases were 0.2-0.3 minutes, 10-13 minutes with amean and standard deviation (STD) of 11.6 (+-) 1.1 min, and 80-95 minutes with amean and STD of 88 (+-) min.Plasma protein binding of Fludeoxyglucose 18has not been studied. Metabolism: FludeoxyglucoseF 18 is transported into cells and phosphorylated to [18F]-FDG-6-phosphate at rate proportional to the rate of glucose utilization within thattissue. [F 18]-FDG-6-phosphate presumably is metabolized to 2-deoxy-2-[F18]fluoro-6-phospho-D-mannose([F 18]FDM-6-phosphate). Fludeoxyglucose 18 Injection may containseveral impurities (e.g., 2-deoxy-2-chloro-D-glucose (ClDG)). Biodistribution andmetabolism of ClDG are presumed to be similar to Fludeoxyglucose 18 and wouldbe expected to result in intracellular formation of2-deoxy-2-chloro-6-phospho-D-glucose (ClDG-6-phosphate) and2-deoxy-2-chloro-6-phospho-D-mannose (ClDM-6-phosphate). The phosphorylateddeoxyglucose compounds are dephosphorylated and the resulting compounds (FDG,FDM, ClDG, and ClDM) presumably leave cells by passive diffusion.Fludeoxyglucose 18 and related compounds are cleared from non-cardiac tissueswithin to 24 hours after administration. Clearance from the cardiac tissuemay require more than 96 hours. Fludeoxyglucose 18 that is not involved inglucose metabolism in any tissue is then excreted in the urine. Elimination: FludeoxyglucoseF 18 is cleared from most tissues within 24 hours and can be eliminated fromthe body unchanged in the urine. Three elimination phases have been identifiedin the reviewed literature. Within 33 minutes, mean of 3.9% of theadministrated radioactive dose was measured in the urine. The amount ofradiation exposure of the urinary bladder at two hours post-administrationsuggests that 20.6% (mean) of the radioactive dose was present in the bladder.Special Populations: The pharmacokinetics of Fludeoxyglucose 18Injection have not been studied in renally-impaired, hepatically impaired orpediatric patients. Fludeoxyglucose 18 is eliminated through the renalsystem. Avoid excessive radiation exposure to this organ system and adjacenttissues. The effects of fasting, varying blood sugarlevels, conditions of glucose intolerance, and diabetes mellitus onFludeoxyglucose 18 distribution in humans have not been ascertained see Warnings and Precautions (5.2)].

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES. 14.1 Oncology. The efficacy of Fludeoxyglucose 18 Injectionin positron emission tomography cancer imaging was demonstrated in16 independent studies. These studies prospectively evaluated the use ofFludeoxyglucose 18 in patients with suspected or known malignancies,including non-small cell lung cancer, colo-rectal, pancreatic, breast, thyroid,melanoma, Hodgkins and non-Hodgkins lymphoma, and various types of metastaticcancers to lung, liver, bone, and axillary nodes. All these studies had at least 50 patients andused pathology as standard of truth. The Fludeoxyglucose 18 Injection dosesin the studies ranged from 200 MBq to 740 MBq with median and mean dose of370 MBq.In the studies, the diagnostic performance ofFludeoxyglucose 18 Injection varied with the type of cancer, size of cancer,and other clinical conditions. Falsenegative and false positive scans were observed. Negative Fludeoxyglucose 18Injection PET scans do not exclude the diagnosis of cancer. Positive Fludeoxyglucose 18 Injection PETscans can not replace pathology to establish diagnosis of cancer. Non-malignant conditions such as fungalinfections, inflammatory processes and benign tumors have patterns of increasedglucose metabolism that may give rise to false-positive scans. The efficacy of Fludeoxyglucose 18Injection PET imaging in cancer screening was not studied.. 14.2 Cardiology. The efficacy of Fludeoxyglucose 18 Injectionfor cardiac use was demonstrated in ten independent, prospective studies ofpatients with coronary artery disease and chronic left ventricular systolicdysfunction who were scheduled to undergo coronary revascularization. Before revascularization, patients underwentPET imaging with Fludeoxyglucose 18 Injection (74 370 MBq, - 10 mCi) and perfusionimaging with other diagnostic radiopharmaceuticals. Doses of Fludeoxyglucose F18 Injection ranged from 74-370 MBq (2-10 mCi). Segmental, left ventricular, wall-motion assessments of asynergic areasmade before revascularization were compared in blinded manner to assessmentsmade after successful revascularization to identify myocardial segments withfunctional recovery. Left ventricular myocardial segments werepredicted to have reversible loss of systolic function if they showedFludeoxyglucose 18 accumulation and reduced perfusion (i.e., flow-metabolismmismatch). Conversely, myocardial segments were predicted to have irreversibleloss of systolic function if they showed reductions in both Fludeoxyglucose F18 accumulation and perfusion (i.e., matched defects). Findings of flow-metabolism mismatch in amyocardial segment may suggest that successful revascularization will restoremyocardial function in that segment. However, false-positive tests occur regularly, and the decision to havea patient undergo revascularization should not be based on PET findingsalone. Similarly, findings of matcheddefect in myocardial segment may suggest that myocardial function will notrecover in that segment, even if it is successfully revascularized. However, false-negative tests occur regularly,and the decision to recommend against coronary revascularization, or torecommend cardiac transplant, should not be based on PET findings alone. The reversibility of segmental dysfunction aspredicted with Fludeoxyglucose 18 PET imaging depends on successful coronaryrevascularization. Therefore, in patients with low likelihood of successfulrevascularization, the diagnostic usefulness of PET imaging withFludeoxyglucose 18 Injection is more limited.. 14.3 Neurology. In prospective, open label trial,Fludeoxyglucose 18 Injection was evaluated in 86 patients with epilepsy. Each patient received dose ofFludeoxyglucose 18 Injection in the range of 185-370 MBq (5-10 mCi). The mean age was 16.4 years (range: months- 58 years; of these, 42 patients were less than 12 years and 16 patients wereless than years old). Patients had known diagnosis of complex partialepilepsy and were under evaluation for surgical treatment of their seizuredisorder. Seizure foci had beenpreviously identified on ictal EEGs and sphenoidal EEGs. Fludeoxyglucose 18 Injection PET imagingconfirmed previous diagnostic findings in 16% (14/87) of the patients; in 34%(30/87) of the patients, Fludeoxyglucose 18 Injection PET images provided newfindings. In 32% (27/87), imaging withFludeoxyglucose 18 Injection was inconclusive. The impact of these imagingfindings on clinical outcomes is not known.Several other studies comparing imaging withFludeoxyglucose 18 Injection results to subsphenoidal EEG, MRI and/orsurgical findings supported the concept that the degree of hypometabolismcorresponds to areas of confirmed epileptogenic foci. The safety and effectiveness ofFludeoxyglucose 18 Injection to distinguish idiopathic epileptogenic focifrom tumors or other brain lesions that may cause seizures have not beenestablished.

DESCRIPTION SECTION.

11 DESCRIPTION. 11.1 Chemical Characteristics. Fludeoxyglucose 18 Injection is positronemitting radiopharmaceutical that is used for diagnostic purposes inconjunction with positron emission tomography (PET) imaging. The activeingredient 2-deoxy-2-[18F]fluoro-D-glucosehas the molecular formula of C6H11 18FO5 with molecular weight of 181.26, and has thefollowing chemical structure: Fludeoxyglucose 18 Injection is provided as aready to use sterile, pyrogen free, clear, colorless citrate buffered solution.Each mL contains between 0.740 to 11.1GBq (20.0-300 mCi) of 2-deoxy-2-[18F]fluoro-D-glucose at the EOS, 4.5 mg of sodiumchloride in citrate buffer. The pH of the solution isbetween 4.5 and 7.5. The solution is packaged in multiple-dose glass vial anddoes not contain any preservative.. image of FDG. 11.2 Physical Characteristics. Fluorine 18 has physical half-life of 109.7 minutes and decays to Oxygen 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 18Radiation/Emission%Per DisintegrationMeanEnergyPositron(+)96.73249.8 keVGamma(+-)193.46511.0 keVProduced by positron annihilation From: Kocher, D.C. Radioactive Decay TablesDOE/TIC-I 1026, 89 (1981)The specific gamma ray constant (point sourceair kerma coefficient) for fluorine 18 is 5.7 R/hr/mCi (1.35 10 -6Gy/hr/kBq) at cm. The half-value layer (HVL) for the 511 keV photons is mmlead (Pb). The range of attenuation coefficients for this radionuclide as afunction of lead shield thickness is shown in Table 3. For example, the interpositionof an mm thickness of Pb, with coefficient of attenuation of 0.25, willdecrease the external radiation by 75%. Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shieldingShieldthickness (Pb) mmCoefficientof attenuation0 0.00 0.50 0.25 13 0.10 26 0.01 39 0.001 52 0.0001For use in correcting for physical decay of thisradionuclide, the fractions remaining at selected intervals after calibrationare shown in Table 4.Table 4. Physical Decay Chart for Fluorine 18MinutesFraction Remaining0 1.000 15 0.909 30 0.826 60 0.683 110 0.500 220 0.250calibration time.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. Fludeoxyglucose F18 Injection emitsradiation. Use procedures to minimizeradiation exposure. Calculate the finaldose from the end of synthesis (EOS) time using proper radioactive decayfactors. Assay the final dose in aproperly calibrated dose calibrator before administration to the patient see Description (11.2)].. Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiationexposure. Screenfor blood glucose abnormalities. Inthe oncology and neurology settings, instruct patients to fast for - hoursprior to the drugs injection. Consider medical therapy and laboratorytesting to assure at least two days of normoglycemia prior to the drugsadministration (5.2). Inthe cardiology setting, administration of glucose-containing food or liquids(e.g., 50 75 grams) prior to thedrugs injection facilitates localization of cardiac ischemia (2.3).Aseptically withdraw Fludeoxyglucose F18 Injectionfrom its container and administer by intravenous injection (2). The recommended dose:for adults is - 10 mCi (185 370 MBq), in allindicated clinical settings (2.1).for pediatric patients is 2.6 mCi in the neurologysetting (2.2).Initiateimaging within 40 minutes following drug injection; acquire static emissionimages 30 100 minutes from time of injection (2). Inthe oncology and neurology settings, instruct patients to fast for - hoursprior to the drugs injection. Consider medical therapy and laboratorytesting to assure at least two days of normoglycemia prior to the drugsadministration (5.2). Inthe cardiology setting, administration of glucose-containing food or liquids(e.g., 50 75 grams) prior to thedrugs injection facilitates localization of cardiac ischemia (2.3).. for adults is - 10 mCi (185 370 MBq), in allindicated clinical settings (2.1).. for pediatric patients is 2.6 mCi in the neurologysetting (2.2).. 2.1 Recommended Dose for Adults. Withinthe oncology, cardiology and neurology settings, the recommended dose foradults is - 10 mCi (185 370 MBq) as an intravenous injection.. 2.2 Recommended Dose for Pediatric Patients. Withinthe neurology setting, the recommended dose for pediatric patients is 2.6 mCi,as an intravenous injection. The optimaldose adjustment on the basis of body size or weight has not been determined see Use in Special Populations (8.4)].. 2.3 Patient Preparation. Tominimize the radiation absorbed dose to the bladder, encourage adequatehydration.Encourage the patient to drink water or other fluids (as tolerated) in the 4hours before their PET study. Encourage the patient to void as soon as theimaging study is completed and as often as possible thereafter for at least onehour.Screenpatients for clinically significant blood glucose abnormalities by obtaining ahistory and/or laboratory tests see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose 18 PET imaging in the oncology and neurologysettings, instruct patient to fast for - hours prior to the drugsinjection.Inthe cardiology setting, administration of glucose-containing food or liquids(e.g., 50 75 grams) prior to Fludeoxyglucose 18 Injection facilitateslocalization of cardiac ischemia.. Tominimize the radiation absorbed dose to the bladder, encourage adequatehydration.Encourage the patient to drink water or other fluids (as tolerated) in the 4hours before their PET study. Encourage the patient to void as soon as theimaging study is completed and as often as possible thereafter for at least onehour.. Screenpatients for clinically significant blood glucose abnormalities by obtaining ahistory and/or laboratory tests see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose 18 PET imaging in the oncology and neurologysettings, instruct patient to fast for - hours prior to the drugsinjection.. Inthe cardiology setting, administration of glucose-containing food or liquids(e.g., 50 75 grams) prior to Fludeoxyglucose 18 Injection facilitateslocalization of cardiac ischemia.. 2.4 Radiation Dosimetry. The estimated human absorbed radiation doses(rem/mCi) to 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 intravenousadministration of Fludeoxyglucose 18 Injection are shown in Table 1. Theseestimates were calculated based on human2data and using the data published by the International Commission onRadiological Protection4 for Fludeoxyglucose 18F.The dosimetry data show that there are slight variations in absorbed radiationdose for various organs in each of the age groups. These dissimilarities inabsorbed radiation dose are due to developmental age variations (e.g., organsize, location, and overall metabolic rate for each age group). The identifiedcritical organs (in descending order) across all age groups evaluated are theurinary bladder, heart, pancreas, spleen, and lungs.Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose 18 Injectiona Organ Newborn(3.4kg) 1-year old(9.8kg) 5-year old(19kg)10-year old(32kg)15-year old(57kg)Adult(70kg) Bladder wallb 4.3 1.7 0.93 0.60 0.40 0.32 Heart wall 2.4 1.2 0.70 0.44 0.29 0.22 Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19 0.14 Lungs 0.96 0.38 0.20 0.13 0.092 0.064 Kidneys 0.81 0.34 0.19 0.13 0.089 0.074 Ovaries 0.80 0.8 0.19 0.11 0.058 0.053 Uterus 0.79 0.35 0.19 0.12 0.076 0.062 LLI wall 0.69 0.28 0.15 0.097 0.060 0.051 Liver 0.69 0.31 0.17 0.11 0.076 0.058 Gallbladder wall 0.69 0.26 0.14 0.093 0.059 0.049 Small intestine 0.68 0.29 0.15 0.096 0.060 0.047 ULI wall 0.67 0.27 0.15 0.090 0.057 0.046 Stomach wall 0.65 0.27 0.14 0.089 0.057 0.047 Adrenals 0.65 0.28 0.15 0.095 0.061 0.048 Testes 0.64 0.27 0.14 0.085 0.052 0.041 Red marrow 0.62 0.26 0.14 0.089 0.057 0.047 Thymus 0.61 0.26 0.14 0.086 0.056 0.044 Thyroid 0.61 0.26 0.13 0.080 0.049 0.039 Muscle0.058 0.25 0.13 0.078 0.049 0.039 Bone surface0.57 0.24 0.12 0.079 0.052 0.041 Breast0.54 0.22 0.11 0.068 0.043 0.034 Skin0.49 0.20 0.10 0.060 0.037 0.030 Brain0.29 0.13 0.09 0.078 0.072 0.070 Other tissues0.59 0.25 0.13 0.083 0.052 0.042 aMIRDOSE software was used to calculate the radiationabsorbed dose. Assumptions on the biodistribution based on data from Gallagheret al.1 and Jones et al.2 bThe dynamic bladder model with uniform voidingfrequency of 1.5 hours was used.LLI lower large intestine; ULI upper largeintestine. 2.5 Radiation Safety Drug Handling. Use waterproof gloves, effective radiationshielding, and appropriate safety measures when handling Fludeoxyglucose F18Injection to avoid unnecessary radiation exposure to the patient, occupationalworkers, clinical personnel and other persons.Radiopharmaceuticals should be used by or underthe control of physicians who are qualified by specific training and experiencein the safe use and handling of radionuclides, and whose experience andtraining have been approved by the appropriate governmental agency authorizedto license the use of radionuclides.Calculatethe final dose from the end of synthesis (EOS) time using proper radioactivedecay factors. Assay the final dose in aproperly calibrated dose calibrator before administration to the patient see Description (11.2)].The dose of Fludeoxyglucose F18 used in givenpatient should be minimized consistent with the objectives of the procedure,and the nature of the radiation detection devices employed.. Use waterproof gloves, effective radiationshielding, and appropriate safety measures when handling Fludeoxyglucose F18Injection to avoid unnecessary radiation exposure to the patient, occupationalworkers, clinical personnel and other persons.. Radiopharmaceuticals should be used by or underthe control of physicians who are qualified by specific training and experiencein the safe use and handling of radionuclides, and whose experience andtraining have been approved by the appropriate governmental agency authorizedto license the use of radionuclides.. Calculatethe final dose from the end of synthesis (EOS) time using proper radioactivedecay factors. Assay the final dose in aproperly calibrated dose calibrator before administration to the patient see Description (11.2)].. The dose of Fludeoxyglucose F18 used in givenpatient should be minimized consistent with the objectives of the procedure,and the nature of the radiation detection devices employed.. 2.6 Drug Preparation and Administration. Calculate the necessary volume to administerbased on calibration time and dose.Aseptically withdraw Fludeoxyglucose F18Injection from its container.Inspect Fludeoxyglucose F18 Injection visuallyfor particulate matter and discoloration before administration, wheneversolution and container permit.Do not administer the drug if it containsparticulate matter or discoloration; dispose of these unacceptable or unusedpreparations in safe manner, in compliance with applicable regulations.Use Fludeoxyglucose 18 Injection within 12hours from the EOS.. Calculate the necessary volume to administerbased on calibration time and dose.. Aseptically withdraw Fludeoxyglucose F18Injection from its container.. Inspect Fludeoxyglucose F18 Injection visuallyfor particulate matter and discoloration before administration, wheneversolution and container permit.. Do not administer the drug if it containsparticulate matter or discoloration; dispose of these unacceptable or unusedpreparations in safe manner, in compliance with applicable regulations.. Use Fludeoxyglucose 18 Injection within 12hours from the EOS.. 2.7 Imaging Guidelines. Initiateimaging within 40 minutes following Fludeoxyglucose 18 Injectionadministration.Acquirestatic emission images 30 100 minutes from the time of injection.. Initiateimaging within 40 minutes following Fludeoxyglucose 18 Injectionadministration.. Acquirestatic emission images 30 100 minutes from the time of injection.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIAL POPULATIONS. Pregnancy Category C: Nohuman or animal data. Consider alternative diagnostics; use only if clearlyneeded (8.1). Nursing mothers: Use alternatives to breast feeding (e.g., storedbreast milk or infant formula) for at least 10 half-lives of radioactive decay,if Fludeoxyglucose 18 Injection is administered to woman who isbreast-feeding (8.3). Pediatric Use: Safety andeffectiveness in pediatric patients have not been established in the oncologyand cardiology settings (8.4).. Pregnancy Category C: Nohuman or animal data. Consider alternative diagnostics; use only if clearlyneeded (8.1). Nursing mothers: Use alternatives to breast feeding (e.g., storedbreast milk or infant formula) for at least 10 half-lives of radioactive decay,if Fludeoxyglucose 18 Injection is administered to woman who isbreast-feeding (8.3). Pediatric Use: Safety andeffectiveness in pediatric patients have not been established in the oncologyand cardiology settings (8.4).. 8.1 Pregnancy. Pregnancy Category CAnimal reproduction studies have not beenconducted with Fludeoxyglucose 18 Injection. It is also not known whetherFludeoxyglucose 18 Injection can cause fetal harm when administered to apregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in pregnantwoman; administer Fludeoxyglucose 18 Injection only if clearly needed.. 8.3 Nursing Mothers. It is not known whether Fludeoxyglucose 18Injection is excreted in human milk. Consider alternative diagnostic tests inwomen who are breast-feeding. Usealternatives to breast feeding (e.g., stored breast milk or infant formula) forat least 10 half-lives of radioactive decay, if Fludeoxyglucose 18 Injectionis administered to woman who is breast-feeding.. 8.4 Pediatric Use. The safety and effectiveness of FludeoxyglucoseF 18 Injection in pediatric patients with epilepsy is established on the basisof studies in adult and pediatric patients. In pediatric patients withepilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basisof body size or weight has not been determined. In the oncology or cardiology settings, thesafety and effectiveness of Fludeoxyglucose 18 Injection have not beenestablished in pediatric patients.