FLUDEOXYGLUCOSE F-18 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:

Trustees of the University of Pennsylvania

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 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. Pregnancy Category C. Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection. It is also not known whether Fludeoxyglucose F 18 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Consider alternative diagnostic tests in

Product summary:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 25 mL glass vial containing between 0.740 – 7.4 GBq/mL (20 -200 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, 4.5 mg/mL of sodium chloride in citrate buffer, in an approximate volume of up to 22 mL for intravenous administration. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 40098-101-19 The State of Pennsylvania laws and regulations apply for this radiopharmaceutical, Pennsylvania Code for Radioactive material specified in Chapter 217, 129.34 and 27.101 as appropriate, or under equivalent licenses of an Agreement State or Licensing State. Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container (lead, tungsten or similar) 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, SOLUTION
TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
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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.
INITIAL U.S. APPROVAL 10/2014
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 indicated
clinical settings ( 2.1).
for pediatric patients is 2.6 mCi in the neurology setting ( 2.2).
Initiate imagi