FLUDEOXYGLUCOSE F 18 injection

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:

The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute

INN (International Name):

FLUDEOXYGLUCOSE F-18

Composition:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludeoxyglucose F-18 Injection, USP 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

Product summary:

Fludeoxyglucose F-18 Injection, USP is supplied in a multi-dose, capped 50 mL glass vial containing between 0.740 – 11.1 GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[18F] fluoro-D-glucose, at end of synthesis, in approximately 35 mL or 50 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 67939-010-50 Store the Fludeoxyglucose F-18 Injection, USP vial upright in a lead shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Store 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 F18 Injection, USP within 12 hours from the EOS time.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F 18 INJECTION
THE UNIVERSITY OF UTAH DBA CYCLOTRON RADIOCHEMISTRY LAB / HUNTSMAN
CANCER
INSTITUTE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18
INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR FLUDEOXYGLUCOSE
F18 INJECTION, USP.
FLUDEOXYGLUCOSE F18 INJECTION, USP
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection, USP is indicated for positron emission
tomography (PET) imaging in the
following settings: (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)
• 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)
DOSAGE AND ADMINISTRATION
Fludeoxyglucose F18 Injection emits radiation. Use procedures to
minimize radiation exposure. Screen for
blood glucose abnormalities. (2)
• In the oncology and neurology settings, instruct patients to fast
for 4 – 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). (2)
• In the cardiology setting, administration of glucose-containing
food or liquids (e.g., 50 – 75 grams) prior
to the drug’s injection facilitates localization of cardiac ischemia
(2.3). (2)
to the drug’s injection facilitates localization of cardiac ischemia
(2.3). (2)
Aseptically withdraw Fludeoxyglucose F18 Injection from its container
and ad