FLUDEOXYGLUCOSE F18 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:

The Methodist Hospital Research Institute

INN (International Name):

FLUDEOXYGLUCOSE F-18

Composition:

FLUDEOXYGLUCOSE F-18 0.3 Ci in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludeoxyglucose F18 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 USP 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 radiatio

Product summary:

Fludeoxyglucose F18 Injection USP 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 F18 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 F18 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 F18- FLUDEOXYGLUCOSE F18 INJECTION, SOLUTION
THE METHODIST HOSPITAL RESEARCH 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
RECENT MAJOR CHANGES
Warnings and Precautions: ( 5.1, 5.2) 7/2010
Adverse Reactions ( 6) 7/2010
Pregnancy ( 8.1) 8/2021
Lactation ( 8.2) 8/2021
INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection USP 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 USP 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 USP
from its container and administer by i