Fludeoxyglucose F 18 Injection

INDICATIONS

Fludeoxyglucose F 18 Injection (fdg) is indicated in positron emission tomography (PET) imaging 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 diagnoses of cancer.

Fludeoxyglucose F 18 Injection (fdg) is indicated in positron emission tomography (PET) imaging in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function.

Fludeoxyglucose F 18 Injection (fdg) is indicated in positron emission tomography (PET) imaging in patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

DOSAGE AND ADMINISTRATION

The recommended dose of Fludeoxyglucose F 18 Injection (fdg) for an adult (70 kg) is 185-370 MBq (5-10 mCi), as an intravenous injection for studies of malignancy, cardiology, and epilepsy.

In general, Fludeoxyglucose F 18 Injection (fdg) should be administered after patients have fasted for 4-6 hours. For cardiac use, Fludeoxyglucose F 18 Injection (fdg) may be administered either to patients who have fasted or to patients who have received a glucose load (See Patient Preparation section).

The optimum rates of administration and upper safe dose for Fludeoxyglucose F 18 Injection (fdg) have not been established. The time interval between doses of Fludeoxyglucose F 18 Injection (fdg) should be long enough to allow substantial decay (physical and biological) of previous administrations.

The final dose for the patient should be calculated using proper decay factors from the time of the end of synthesis (EOS), and measured by a suitable radioactivity calibration system before administration. See decay factors in Table 3.

Patient Preparation: Blood glucose levels should be stabilized before Fludeoxyglucose F 18 Injection (fdg) is administered. In non-diabetic patients this may be accomplished by fasting 4-6 hours before Fludeoxyglucose F 18 Injection (fdg) . Diabetic patients may need stabilization of blood glucose on the day preceding and on the day of administration of Fludeoxyglucose F 18 Injection (fdg) .

For cardiac imaging, administration of Fludeoxyglucose F 18 Injection (fdg) to fasting patients limits the accumulation of Fludeoxyglucose F 18 to ischemic myocardium. This may make localization of the ischemic region difficult because the surrounding myocardium will not be well visualized. Conversely, administration of Fludeoxyglucose F 18 Injection (fdg) to patients who have received a glucose load (e.g., 50-75 grams, 1-2 hours before administration of Fludeoxyglucose F 18 Injection (fdg) ) allows the surrounding, non-ischemic myocardium to be seen and facilitates localization of ischemic areas.

Imaging: Optimally, it is recommended that positron emission tomography (PET) imaging be initiated within 40 minutes of administration of Fludeoxyglucose F 18 Injection.

Static emission scans are acquired 30-100 minutes from time of injection.

Drug Handling

Fludeoxyglucose F 18 Injection (fdg) , like other parenteral drugs, should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit. Fludeoxyglucose F 18 Injection (fdg) preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with applicable regulations.

Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves and effective shielding should be worn when handling the product.

The contents of each vial are sterile and non-pyrogenic. To maintain sterility, aseptic technique must be used during all operations involved in the manipulation and administration of Fludeoxyglucose F 18 Injection (fdg) .

Fludeoxyglucose F 18 Injection (fdg) should be used within 12 hours of the end of synthesis (EOS).

As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other persons. Fludeoxyglucose F 18 Injection (fdg) , like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should be taken to minimize exposure to the patient consistent with proper patient management. 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.

Radiation Dosimetry

The estimated human absorbed radiation doses (rem/mCi) to a 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 (fdg) are shown in Table 4. These estimates were calculated based on human4 data and using the data published by the International Commission on Radiological Protection5 for Fludeoxyglucose F 18. The dosimetry data obtained and presented in this table 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 understood to be 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 (i.e., newborn, 1, 5, 10, 15 year(s) and adults) are the urinary bladder, heart, pancreas, spleen, and lungs. The absolute values for absorbed radiation in each of these organs vary in each of the age groups.

Table 4. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18

Organ Newborn1
(3.4 kg)
1-year old1
(9.8 kg)
5-year old1
(19 kg)
10-year old1
(32 kg)
15-year old1
(57 kg)
Adult1
(70 kg)
Bladder wall2 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 0.80 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
Sm 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 0.58 0.25 0.13 0.078 0.049 0.039
Bone Surfaces 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 0.13 0.078 0.072 0.070
Other tissues 0.59 0.25 0.25 0.083 0.052 0.042
1MIRDOSE 2 software was used to calculate the radiation absorbed dose. Assumptions on the biodistribution based on data from Gallager et al. (J. Nucl. Med. 18: 990-996) and Jones et al., (J. Nucl. Med, 23: 613-617).
2The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used.

HOW SUPPLIED

Fludeoxyglucose F 18 Injection (fdg) is supplied in a multi-dose septum capped 25 mL glass vial containing between 0.37 - 3.7 GBq/mL( 10 - 100 mCi/mL), of no carrier added 2-deoxy-2-[18F]fluoro-D-glucose, at end of synthesis, in approximately 16 mL.

NDC _ _ _ _ _ - _ _ _ - _ _ *

This radiopharmaceutical is licensed by the City of New York, Bureau of Radiological Health, Radioactive Materials Division for distribution to persons licensed pursuant to the City of New York's Section Regulatory Code for Radioactive material specified in Section of New York City Charter and Article 175 of the New York City health Code, as appropriate, or under the equivalent licenses of an Agreement State or Licensing State.

Storage

Store Fludeoxyglucose F 18 Injection (fdg) at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Store Fludeoxyglucose F 18 Injection (fdg) multiple-dose vial upright in a lead shielded container.

Store and dispose of Fludeoxyglucose F 18 Injection (fdg) in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.

Expiration Date and Time

The expiration date and time are provided on the container label. Fludeoxyglucose F 18 Injection (fdg) should be used within 12 hours from the time of the end of synthesis (EOS).

Caution: Federal Law Prohibits Dispensing Without Prescription

REFERENCE

4 Jones, S. C., A. Alavi, Christman, D., Montanez, I., Wolf, A.P. and Reivich, M. (1982)."The Radiation Dosimetry of 2- F-18 fluoro-2-deoxyglucose in Man&". J. Nucl. Med. 23, 613-617.

5 ICRP Publication 53,Volume 18, No. l, 1987, page 76

Manufactured and Distributed by: Citigroup Biomedical Imaging Center, Weill Medical College of Cornell University, 516 East 72nd Street, New York, NY 10021. FDA rev date: 8/5/2004

 

 

NDC # ------------ Sterile

Multiple-Dose Vial Non-pyrogenic

Fludeoxyglucose F 18 Injection (fdg)
10-100 mCi / mL (@ EOS*)

Calibration Date _________ Lot#_________________

Calibration Time________(@EOS*)

Exp. Date / Time ______ (Expires 12 hours after EOS*)

Activity @ EOS*: Total _____________mCi Volume_________mL

Concentration__________________mCi/mL

Contains:

0.37-3.70 GBq (10-100 mCi) of no-carrier added Fludeoxyglucose F 18 (2-deoxy-2-[18F]fluoro-D- glucose) @ EOS*; 4.5 mg of sodium chloride; and 7.2 mg of citrate.

For Intravenous Use Only. Do not use if cloudy or if it contains particulate matter. * EOS = End of Synthesis

Store at 25°C (77°F) (see insert). Store upright in a shielded container. Aseptically withdraw and handle doses.

18F Half-Life = 109.7 min Calculate correct dosage from date and time of calibration.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

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