Adult Dosing

Radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging

• Administer 370 to 740 MBq (10 to 20 mCi) as a bolus IV injection
• The radioactivity dose is chosen based on patient body dimensions and the characteristics of the image acquisition system
• Initiate imaging immediately after administration of Choline C 11 Injection and acquire static emission images 0 to 15 minutes from the time of injection

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available
• Imaging errors have been reported with C-choline PET and PET/CT imaging
• Negative imaging results does not rule out the presence of recurrent prostate cancer and positive imaging results does not confirm the presence of recurrent cancer
• Clinical and histopathological evaluation of the suspected recurrence site is essential for proper use of the PET imaging information
• C-choline PE imaging has been associated with blood PSA levels < 2 ng/mL
• Tissue inflammation and prostatic hyperplasia have been associated with false positive C -choline PET images
• Concomitant use of colchicine or androgen-deprivation therapeutic drugs such as luteinizing hormonereleasing analogs and anti-androgen drugs may interfere with C-choline PET imaging
• Choline C 11 injection may lead to a patient’s overall long-term cumulative radiation exposure which may be associated with an increased risk for cancer. Ensure safe handling should to minimize radiation exposure to the patient and health care workers

Pregnancy Category:C

Breastfeeding: It is not known whether choline C-11 is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants, nursing mothers should use alternative infant nutrition sources

• HYPERSENSITIVITY: Mild injection site reaction

• Radioactive diagnostic choline analog; involved in synthesis of the structural components of cell membranes, as well as modulation of trans-membrane signaling
• Absorption: Unknown
• Metabolism: Undergoes metabolism resulting in the detection of C-betaine as the major metabolite
• Excretion: Urinary excretion < 2% of the injected radioactivity at 1.5 hours after injection of the drug
• Half-life: Unknown

US Trade Name(s)

• Choline C-11

US Availability

Choline C-11

• INJ: 4-33.1 mCi/mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Radiologic

Diagnostic Agents