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:

Lantheus Medical Imaging, Inc.

INN (International Name):

Fludeoxyglucose F-18

Composition:

Fludeoxyglucose F-18 200 mCi in 1 mL

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 is supplied in a multi-dose, capped 30 mL glass vial containing between 0.74 – 7.40 GBq/mL (20 – 200 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 25 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. This radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to the Code of Federal Regulations (CFR) for radioactive material specified in 10 CFR 35, as appropriate, or under equivalent regulations of an Agreement State or a Licensing State. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. 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
LANTHEUS MEDICAL IMAGING, INC.
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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 (1.1): 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
cance r.
Cardiology (1.2): 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 (1.3): For the identification of regions of abnormal glucose
metabolism associated with foci of epileptic
se izure s.
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 – 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 F 18 Injection from its container
and administer by intravenous injection (2). The
recommended dose:
for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated
clinical settings (2.1).
for pediatric patients is 2.6 m