Fludeoxyglucose F 18 Drug Information

    Generic name: FLUDEOXYGLUCOSE F-18

    Radioactive Diagnostic Agent [EPC]

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    Uses of Fludeoxyglucose F 18

    • Fludeoxyglucose F-18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F-18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
    • 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 ).
    • 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 ).
    • Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures ( 1 ). 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.

    Dosage & Administration of Fludeoxyglucose F 18

    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 wallb4.3
    Heart wall2.4
    Pancreas2.2
    Spleen2.2
    Lungs0.96
    Kidneys0.81
    Ovaries0.80
    Uterus0.79
    LLI wall*0.69
    Liver0.69
    Gallbladder wall0.69
    Small intestine0.68
    ULI wall**0.67
    Stomach wall0.65
    Adrenals0.65
    Testes0.64
    Red marrow0.62
    Thymus0.61
    Thyroid0.61
    Muscle0.58
    Bone surface0.57
    Breast0.54
    Skin0.49
    Brain0.29
    Other tissues0.59

    Side Effects of Fludeoxyglucose F 18

    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.

    To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Warnings & Cautions for Fludeoxyglucose F 18

    • Radiation risks: use smallest dose necessary for imaging ( 5.1 ).
    • Blood glucose abnormalities: may cause suboptimal imaging ( 5.2 ). 5.1 Radiation Risks Radiation-emitting products, including Fludeoxyglucose F-18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [ see Dosage and Administration ( 2.5 ) ]. 5.2 Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F-18 Injection administration.

    Drug Interactions with Fludeoxyglucose F 18

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

    Pregnancy Safety for Fludeoxyglucose F 18

    Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F-18 Injection. It is also not known whether Fludeoxyglucose F-18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in a pregnant woman; administer Fludeoxyglucose F-18 Injection only if clearly needed.

    Pediatric Use of Fludeoxyglucose F 18

    Pediatric Use The safety and effectiveness of Fludeoxyglucose F-18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.

    In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F-18 Injection have not been established in pediatric patients.

    Clinical Studies of Fludeoxyglucose F 18

    Oncology

    The efficacy of Fludeoxyglucose F-18 Injection in positron emission tomography cancer imaging was demonstrated in 16 independent studies. These studies prospectively evaluated the use of Fludeoxyglucose F-18 in patients with suspected or known malignancies, including non-small cell lung cancer, colo-rectal, pancreatic, breast, thyroid, melanoma, Hodgkin's and non-Hodgkin's lymphoma, and various types of metastatic cancers to lung, liver, bone, and axillary nodes. All these studies had at least 50 patients and used pathology as a standard of truth.

    The Fludeoxyglucose F-18 Injection doses in the studies ranged from 200 MBq to 740 MBq with a median and mean dose of 370 MBq. In the studies, the diagnostic performance of Fludeoxyglucose F-18 Injection varied with the type of cancer, size of cancer, and other clinical conditions. False negative and false positive scans were observed.

    Negative Fludeoxyglucose F-18 Injection PET scans do not exclude the diagnosis of cancer. Positive Fludeoxyglucose F-18 Injection PET scans cannot replace pathology to establish a diagnosis of cancer. Non-malignant conditions such as fungal infections, inflammatory processes and benign tumors have patterns of increased glucose metabolism that may give rise to false-positive scans.

    The efficacy of Fludeoxyglucose F-18 Injection PET imaging in cancer screening was not studied.

    Cardiology

    The efficacy of Fludeoxyglucose F-18 Injection for cardiac use was demonstrated in ten independent, prospective studies of patients with coronary artery disease and chronic left ventricular systolic dysfunction who were scheduled to undergo coronary revascularization. Before revascularization, patients underwent PET imaging with Fludeoxyglucose F-18 Injection (74 - 370 MBq, 2 - 10 mCi) and perfusion imaging with other diagnostic radiopharmaceuticals. Doses of Fludeoxyglucose F-18 Injection ranged from 74 - 370 MBq (2 - 10 mCi). Segmental, left ventricular, wall-motion assessments of asynergic areas made before revascularization were compared in a blinded manner to assessments made after successful revascularization to identify myocardial segments with functional recovery.

    Left ventricular myocardial segments were predicted to have reversible loss of systolic function if they showed Fludeoxyglucose F-18 accumulation and reduced perfusion (i.e., flow-metabolism mismatch). Conversely, myocardial segments were predicted to have irreversible loss of systolic function if they showed reductions in both Fludeoxyglucose F-18 accumulation and perfusion (i.e., matched defects). Findings of flow-metabolism mismatch in a myocardial segment may suggest that successful revascularization will restore myocardial function in that segment. However, false-positive tests occur regularly, and the decision to have a patient undergo revascularization should not be based on PET findings alone. Similarly, findings of a matched defect in a myocardial segment may suggest that myocardial function will not recover in that segment, even if it is successfully revascularized.

    However, false-negative tests occur regularly, and the decision to recommend against coronary revascularization, or to recommend a cardiac transplant, should not be based on PET findings alone. The reversibility of segmental dysfunction as predicted with Fludeoxyglucose F-18 PET imaging depends on successful coronary revascularization. Therefore, in patients with a low likelihood of successful revascularization, the diagnostic usefulness of PET imaging with Fludeoxyglucose F-18 Injection is more limited.

    Neurology

    In a prospective, open label trial, Fludeoxyglucose F-18 Injection was evaluated in 86 patients with epilepsy. Each patient received a dose of Fludeoxyglucose F-18 Injection in the range of 185-370 MBq (5-10 mCi). The mean age was 16.4 years (range: 4 months - 58 years; of these, 42 patients were less than 12 years and 16 patients were less than 2 years old). Patients had a known diagnosis of complex partial epilepsy and were under evaluation for surgical treatment of their seizure disorder. Seizure foci had been previously identified on ictal EEGs and sphenoidal EEGs.

    Fludeoxyglucose F-18 Injection PET imaging confirmed previous diagnostic findings in 16% (14/87) of the patients; in 34% (30/87) of the patients, Fludeoxyglucose F-18 Injection PET images provided new findings. In 32% (27/87), imaging with Fludeoxyglucose F-18 Injection was inconclusive. The impact of these imaging findings on clinical outcomes is not known.

    Several other studies comparing imaging with Fludeoxyglucose F-18 Injection results to subsphenoidal EEG, MRI and/or surgical findings supported the concept that the degree of hypometabolism corresponds to areas of confirmed epileptogenic foci. The safety and effectiveness of Fludeoxyglucose F-18 Injection to distinguish idiopathic epileptogenic foci from tumors or other brain lesions that may cause seizures have not been established.

    Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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