fludeoxyglucose F-18 [IV]

Adult Dosing

PET imaging in oncology, cardiology and neurology settings

Recommended dose: 5-10 mCi (185-370 MBq) IV

Notes:

Start imaging within 40 minutes following fludeoxyglucose F-18 administration
Obtain static emission images 30-100 minutes from the time of injection
Use the product within 12 hours from the end of synthesis (EOS)
Calculate the final dose from the EOS time using proper radioactive decay factors
Encourage adequate hydration to minimize the radiation absorbed dose to the bladder
Encourage patients to drink water or other fluids as tolerated in the 4 hours prior to PET imaging
Encourage patients to void soon after the imaging study is completed and as often as possible thereafter for at least one hour
Screen patients for blood glucose abnormalities by obtaining a history and/or laboratory tests
Prior to PET imaging in the oncology and neurology settings, instruct patients to fast for 4-6 hours prior to the injection
In the cardiology setting, intake of glucose-containing food or liquids prior to the injection facilitates localization of cardiac ischemia
To avoid unnecessary radiation exposure, use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling this injection

Pediatric Dosing

PET imaging in neurology settings

Recommended dose: 2.6 mCi IV

Notes:

Start imaging within 40 minutes following fludeoxyglucose F-18 administration
Obtain static emission images 30-100 minutes from the time of injection
Use the product within 12 hours from the end of synthesis (EOS)
Calculate the final dose from the EOS time using proper radioactive decay factors
Encourage adequate hydration to minimize the radiation absorbed dose to the bladder
Encourage patients to drink water or other fluids as tolerated in the 4 hours prior to PET imaging
Encourage patients to void soon after the imaging study is completed and as often as possible thereafter for at least one hour
Screen patients for blood glucose abnormalities by obtaining a history and/or laboratory tests
Prior to PET imaging in the neurology setting, instruct patients to fast for 4-6 hours prior to the injection
To avoid unnecessary radiation exposure, use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling this injection

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Indicated for positron emission tomography (PET) imaging in:

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 those with an existing diagnosis of cancer
Identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with CAD and left ventricular dysfunction, when used with myocardial perfusion imaging
Identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of product

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Therapy may increase the risk for cancer, especially in pediatric patients. Consider the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker
In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. Consider medical therapy and laboratory testing in such patients to assure at least two days of normoglycemia before injection administration
Monitor blood glucose levels and hypersensitivity reactions; have emergency resuscitation equipment and personnel immediately available
Radiopharmaceuticals should be used by or under the supervision of physicians who are well trained and experienced in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides

Supplemental Patient Information

Encourage patients to drink water or other fluids as tolerated in the 4 hours prior to PET imaging
Encourage patients to void immediately after the imaging study is completed and frequently thereafter for at least one hour

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Elective diagnostic nuclear medicine procedures should be delayed until the patient is no longer breastfeeding. However, the use of therapy in PET scans may be preferable to other types of scans during breastfeeding because of the low levels and rapid disappearance of radiation. The amounts of drug excreted in breastmilk after a PET scan are below the level of concern for the breastfed infant. However, because of extensive uptake by lactating breasts and the consequent external radiation, nursing mothers should refrain from close contact with their infants for a short time. Some authors suggest that the infant be bottle fed with expressed breastmilk by a third person for 1 feeding or 4 to 6 hours, depending on the dose, after a PET scan with 18F-FDG in a nursing mother, while the Society of Nuclear Medicine states that no interruption is necessary. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 Jan 2012). It is unknown whether this injection is excreted in human milk. As per manufacturer's data, alternative diagnostic tests should be considered in women who are breast-feeding. Use alternatives to breast feeding for at least 10 half-lives of radioactive decay, if therapy is administered to a nursing woman.

Adverse Reactions ⬆ ⬇

HYPERSENSITIVITY: Hypersensitivity reactions such as pruritus, edema, rash

Clinical Pharmacology ⬆ ⬇

Radiopharmaceutical agent; it is a glucose analog that concentrates in high-glucose-using cells or in cells whose dependence on glucose increases under pathophysiological conditions
Metabolism: Phosphorylation to [18F]-FDG-6-phosphate, which is metabolized to 2-deoxy-2-[F 18]fluoro-6-phospho-D-mannose (metabolites)
Eliminated unchanged in the urine
Half-life: 109.7 minutes

Brands and Availability ⬆ ⬇