FLUDEOXYGLUCOSE F18 Solution for injection Ref.[11029] Active ingredients: Fludeoxyglucose ¹⁸F

Fludeoxyglucose F18 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)].

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 [see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F18 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 F18 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 F18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the International Commission on Radiological Protection for Fludeoxyglucose F18.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 F18 Injection USP^a:

^a MIRDOSE 2 software was used to calculate the radiation absorbed dose.
^b 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 USP 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 Injection USP 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 USP from its container.
• Inspect Fludeoxyglucose F18 Injection USP 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 F18 Injection within 12 hours from the EOS.

2.7 Imaging Guidelines

• Initiate imaging within 40 minutes following Fludeoxyglucose F18 Injection administration.
• Acquire static emission images 30–100 minutes from the time of injection.

Store the Fludeoxyglucose F18 Injection USP vial upright in a lead shielded container at 20°-25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F).

Store and dispose of Fludeoxyglucose F18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.

The expiration date and time are provided on the container label. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS time.