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:

BRIGHAM AND WOMEN`S HOSPITAL, INC., THE

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 F18 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 8.1 Pregnancy 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

Product summary:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 11.1GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 25 - 30 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. Store the Fludeoxyglucose F 18 Injection 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 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F-18- FLUDEOXYGLUCOSE F-18 INJECTION
BRIGHAM AND WOMEN`S HOSPITAL, INC., THE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUDEOXYGLUCOSE F18
INJECTION.
FLUDEOXYGLUCOSE F18 INJECTION
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Warnings and Precautions: (5.1,5.2) 7/2010
Adverse Reactions (6)7/2010
INDICATIONS AND USAGE
Fludeoxyglucose F18 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 F18 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 – 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 – 75 grams) prior
to the drug’s injection facilitates localization of cardiac ischemia
(2.3).
Aseptically withdraw Fludeoxyglucose F18 Injection from its container
and administer by intravenous
injection (2). The recommended dose:
for adults is 5 – 10 mCi (185 – 370 MBq), in all indicate