Fludeoxyglucose F-18

FLUDEOXYGLUCOSE F-18- fludeoxyglucose f-18 injection
Cardinal Health 414, LLC

1 INDICATIONS AND USAGE

Fludeoxyglucose F-18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

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 in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

1.3 Neurology

For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

2 DOSAGE AND ADMINISTRATION

Fludeoxyglucose F-18 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) ].

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 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 human² data and using the data published by the International Commission on Radiological Protection⁴ 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.

Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F-18 Injection^a

Organ	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)	Adult (70 kg)
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.2 b The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used.* LLI = lower large intestine; ** ULI = upper large intestine
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
Muscle	0.58	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