FLUDEOXYGLUCOSE F18- fludeoxyglucose f-18 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)

Available from:

Wisconsin Medical Radiopharmacy, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: 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. 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. For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. None Risk Summary Data from published case series and case reports describe Fludeoxyglucose F 18 Injection crossing the placenta with uptake by the fetus (see Data ). All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose

Product summary:

Fludeoxyglucose F 18 Injection USP is supplied in a multi-dose, capped, 30 mL glass vial containing between 0.74 GBq/mL to 18.5 GBq/mL (20 mCi/mL to 500 mCi/mL), of no carrier added 2-deoxy-2-[F 18]fluoro-D-glucose, at end of synthesis, in approximately 13 to 30 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 81365-001-30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 to 30°C (59 to 86°) [see USP Controlled Room Temperature ]. Store in adequately shielded containers and dispose of Fludeoxyglucose F 18 Injection USP 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 USP within 12 hours from the EOS time.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F18- FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION
WISCONSIN MEDICAL RADIOPHARMACY, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F 18
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUDEOXYGLUCOSE F
18 INJECTION.
FLUDEOXYGLUCOSE F 18 INJECTION USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
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.
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.
Neurology: For the identification of regions of abnormal glucose
metabolism associated with foci of
epileptic seizures (1).
DOSAGE AND ADMINISTRATION
Fludeoxyglucose F 18 Injection emits radiation. Use procedures to
minimize radiation exposure. Screen for
blood glucose abnormalities.
In the oncology and neurology settings, instruct patients to fast for
4 to 6 hours prior to the drug's
injection. Consider medical therapy and laboratory testing to assure
at least two days of
normoglycemia prior to the drug's administration (5.2).
In the cardiology setting, administration of glucose-containing food
or liquids (e.g., 50 to 75 grams)
prior to the drug's injection facilitates localization of cardiac
ischemia (2.3).
Aseptically withdraw Fludeoxyglucose F 18 Injection, from its
container and administer by intravenous
injection (2). The recommended dose:
for adults is 5 to 10 mCi (185 to 370 MBq), in all indicated clinical
settings (2.1).
for pediatric patients is 2.6 mCi (96.