Fludeoxyglucose F18

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 2.
• DOSAGE AND ADMINISTRATION 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 F18 Injection 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 (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, cardiology and neurology settings, the recommended dose for
• adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.
• 2.2 Recommended 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) ].
• 2.3 Patient 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 [s ee 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 facilitates localization of cardiac ischemia.
• 2.4 Radiation 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 are shown in Table 1.
• These estimates were calculated based on human 1 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.
• Organ Newborn (3.4kg) 1-year old (9.8kg) 5-year old (19kg) 10-year old (32kg) 15-year old (57kg) Adult (70kg) Bladder wall b 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 Muscle 0.058 0.25 0.13 0.078 0.049
• 0.039 Bone Surface 0.57 0.24 0.12 0.079 0.052
• 0.041 Breast 0.54 0.22 0.11 0.068 0.043
• 0.034 Skin 0.49 0.20 0.10 0.060 0.037
• 0.030 Brain 0.29 0.13 0.09 0.078 0.072
• 0.070 Other Tissues 0.59 0.25 0.13 0.083 0.052 0.042 a MIRDOSE 2 software was used to calculate the radiation absorbed dose.
• Assumptions on the biodistribution based on data from Gallagher et al. 1 and Jones et al. 2b The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used. *LLI = lower large intestine; **ULI = upper large intestine
• 2.5 Radiation Safety – Drug Handling Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F18 Injection to
• avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons.
• 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 radionuclides.
• 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) ].
• The dose of Fludeoxyglucose F18 used in a given patient 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 administer based on calibration time and dose.
• Aseptically withdraw Fludeoxyglucose F18 Injection from its container.
• Inspect Fludeoxyglucose F18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.
• Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
• Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS.
• 2.7 Imaging Guidelines Initiate imaging within 40 minutes following Fludeoxyglucose F 18 Injection administration.
• Acquire static emission images 30 – 100 minutes from the time of injection.
• 2.1 ​Recommended 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.
• 2.2 Recommended 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) ].
• 2.3 Patient 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 [s ee 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 facilitates localization of cardiac ischemia.
• 2.4 Radiation 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 are shown in Table 1.
• These estimates were calculated based on human 1 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.
• Organ Newborn (3.4kg) 1-year old (9.8kg) 5-year old (19kg) 10-year old (32kg) 15-year old (57kg) Adult (70kg) Bladder wall b 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 Muscle 0.058 0.25 0.13 0.078 0.049
• 0.039 Bone Surface 0.57 0.24 0.12 0.079 0.052
• 0.041 Breast 0.54 0.22 0.11 0.068 0.043
• 0.034 Skin 0.49 0.20 0.10 0.060 0.037
• 0.030 Brain 0.29 0.13 0.09 0.078 0.072
• 0.070 Other Tissues 0.59 0.25 0.13 0.083 0.052 0.042 a MIRDOSE 2 software was used to calculate the radiation absorbed dose.
• Assumptions on the biodistribution based on data from Gallagher et al. 1 and Jones et al. 2b The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used. *LLI = lower large intestine; **ULI = upper large intestine
• 2.5 Radiation Safety – Drug Handling Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F18 Injection to
• avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons.
• 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 radionuclides.
• 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) ].
• The dose of Fludeoxyglucose F18 used in a given patient 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 administer based on calibration time and dose.
• Aseptically withdraw Fludeoxyglucose F18 Injection from its container.
• Inspect Fludeoxyglucose F18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.
• Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
• Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS.
• 2.7 Imaging Guidelines Initiate imaging within 40 minutes following Fludeoxyglucose F 18 Injection administration. Acquire static emission images 30 – 100 minutes from the time of injection.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Side effects

• 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 UT MDACC, Cyclotron Radiochemistry Facility at 713-563-5455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

• 3.
• DOSAGE FORMS AND STRENGTHS Multiple-dose vial containing: 0.74 -
• 11.1 GBq/mL (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection and a 4.5 mg of sodium chloride in citrate buffer (approximately 27 mL volume), for intravenous administration.
• Multiple-dose vial containing: 0.74 -
• 11.1 GBq/mL (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection and a 4.5 mg of sodium chloride in citrate buffer (approximately 27 mL volume), for intravenous administration.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.
• HOW SUPPLIED/STORAGE AND HANDLING Fludeoxyglucose F 18 Injection is supplied in a multi-dose, 30 mL glass vial containing:
• between 0.740 -
• 11.1 GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 27 mL.
• The contents of each vial are sterile, pyrogen-free and preservative free.
• NDC 60215-411-30
• 16.1 Storage Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container at 10 - 25°C (50 - 77°F), excursions permitted to 15 - 30°C (59 - 86°F) [ See USP Controlled Room Temperature ].
• 16.2 Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S.
• Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.
• Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container at 10 - 25°C (50 - 77°F), excursions permitted to 15 - 30°C (59 - 86°F) [ See USP Controlled Room Temperature ].
• 16.2 Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.

Quoted from the official label, section “How Supplied”.

What is in it

• 11.2 Physical 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).
• (*) 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
• 5.7 R/hr/mCi (1.35 x 10 Gy/hr/kBq) at 1 cm.
• The half-value layer (HVL) for the 511keV 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%.
• For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.
• (*) Calibration time Table 2 Radiation Emission Data Table 3 Radiation Attenuation Table 4:
• Physical Decay Chart
• 11.1 Chemical Characteristics Fludeoxyglucose F 18 Injection 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 is provided as a ready to use sterile, pyrogen free, clear, colorless solution.
• Each mL contains between 0.740 to
• 11.1 GBq (20.0 - 300 mCi) of 2-deoxy-2-[ 18 F]fluoro-Dglucose 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.
• FDG Chemical Structure
• 11.2 Physical 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).
• (*) 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
• 5.7 R/hr/mCi (1.35 x 10 Gy/hr/kBq) at 1 cm.
• The half-value layer (HVL) for the 511keV 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%.
• For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.
• (*) Calibration time Table 2 Radiation Emission Data Table 3 Radiation Attenuation Table 4:
• Physical Decay Chart
• 11.1 Chemical Characteristics Fludeoxyglucose F 18 Injection 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 is provided as a ready to use sterile, pyrogen free, clear, colorless solution.
• Each mL contains between 0.740 to
• 11.1 GBq (20.0 - 300 mCi) of 2-deoxy-2-[ 18 F]fluoro-Dglucose 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.
• FDG Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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