Fludeoxyglucose f-18

FDA label, THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH, intravenous, effective 2019-07-11. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Radioactive Diagnostic Agent

Dosing in kidney impairment

Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injectiona
OrganNewborn (3.4kg)1-year old (9.8kg)5-year old (19kg)10-year old (32kg)15-year old (57kg)Adult (70kg)
Bladder wallb4.31.70.930.600.400.32
Heart wall2.41.20.700.440.290.22
Pancreas2.20.680.330.250.130.096
Spleen2.20.840.460.290.190.14
Lungs0.960.380.200.130.0920.064
Kidneys0.810.340.190.130.0890.074
Ovaries0.800.80.190.110.0580.053
Uterus0.790.350.190.120.0760.062
LLI wall*0.690.280.150.0970.0600.051
Liver0.690.310.170.110.0760.058
Gallbladder wall0.690.260.140.0930.0590.049
Small intestine0.680.290.150.0960.0600.047
ULI wall**0.670.270.150.0900.0570.046
Stomach wall0.650.270.140.0890.0570.047
Adrenals0.650.280.150.0950.0610.048
Testes0.640.270.140.0850.0520.041
Red marrow0.620.260.140.0890.0570.047
Thymus0.610.260.140.0860.0560.044
Thyroid0.610.260.130.0800.0490.039
Muscle0.580.250.130.0780.0490.039
Bone surface0.570.240.120.0790.0520.041
Breast0.540.220.110.0680.0430.034
Skin0.490.200.100.0600.0370.030
Brain0.290.130.090.0780.0720.070
Other tissues0.590.250.130.0830.0520.042
Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injectiona
OrganNewborn (3.4kg)1-year old (9.8kg)5-year old (19kg)10-year old (32kg)15-year old (57kg)Adult (70kg)
Bladder wallb4.31.70.930.600.400.32
Heart wall2.41.20.700.440.290.22
Pancreas2.20.680.330.250.130.096
Spleen2.20.840.460.290.190.14
Lungs0.960.380.200.130.0920.064
Kidneys0.810.340.190.130.0890.074
Ovaries0.800.80.190.110.0580.053
Uterus0.790.350.190.120.0760.062
LLI wall*0.690.280.150.0970.0600.051
Liver0.690.310.170.110.0760.058
Gallbladder wall0.690.260.140.0930.0590.049
Small intestine0.680.290.150.0960.0600.047
ULI wall**0.670.270.150.0900.0570.046
Stomach wall0.650.270.140.0890.0570.047
Adrenals0.650.280.150.0950.0610.048
Testes0.640.270.140.0850.0520.041
Red marrow0.620.260.140.0890.0570.047
Thymus0.610.260.140.0860.0560.044
Thyroid0.610.260.130.0800.0490.039
Muscle0.580.250.130.0780.0490.039
Bone surface0.570.240.120.0790.0520.041
Breast0.540.220.110.0680.0430.034
Skin0.490.200.100.0600.0370.030
Brain0.290.130.090.0780.0720.070
Other tissues0.590.250.130.0830.0520.042

Preparation and administration

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Your numbers for fludeoxyglucose f-18. Take vial strength, diluent, and limits from the label below.

Basis

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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 [ see Warnings and Precautions ]. 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.

Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Aseptically withdraw Fludeoxyglucose F 18 Injection from its container. Inspect Fludeoxyglucose F 18 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.

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.

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 [ see Warnings and Precautions ]. 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.

Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Aseptically withdraw Fludeoxyglucose F 18 Injection from its container. Inspect Fludeoxyglucose F 18 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.

Drug interactions

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Label text (1 paragraph)

The interaction of Fludeoxyglucose F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

Contraindications

None None

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for fludeoxyglucose f-18. Check the label's hepatic warnings.

Supply and cost

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Therapeutic equivalence (Orange Book)

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