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:

Centre for Probe Development and Commercialization

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 multi-dose, capped 10 mL or 30 mL glass vials and 1 mL, 3 mL, or 5 mL syringes containing between 0.740 GBq/mL – 11.1 GBq/mL (20 mCi/mL - 300 mCi/mL), of no carrier added 2-deoxy-2-[F18] fluoro-D-glucose, at end of synthesis. The contents of each vial and syringe are sterile, pyrogen-free and preservative-free. NDC: 21731-647-01 Syringe 1 mL (approximate net contents 0.1 mL to 0.8 mL). NDC: 21731-647-03 Syringe 3 mL (approximate net contents 0.5 mL to 2.5 mL). NDC: 21731-647-05 Syringe 5 mL (approximate net contents 1.5 mL to 3.5 mL). NDC: 21731-647-10 Vial 10 mL (approximate net contents 0.5 mL to 10 mL). NDC: 21731-647-30 Vial 30 mL (approximate net contents 0.5 mL to 30 mL). Store the Fludeoxyglucose F 18 Injection USP syringes and vials 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. Use Fludeoxyglucose F 18 Injection USP within 19 hours from EOS time as reflected by the expiration date and time provided on the container label.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F 18 INJECTION
CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION
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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 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 F 18 Injection emits radiation. Use procedures to
minimize radiation exposure. Screen for blood glucose
abnormalitie s.
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 mCi – 10 mCi (185 MBq – 370 MBq), in all indicated
clinical settings (2.1).
for pediat