Note: Total injection volume per patient will vary based on patient body dimensions and the characteristics of the image acquisition system.
Prostate imaging: IV: 10 to 20 mCi (370 to 740 MBq)
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution: 148 to 1225 megabecquerels (4 to 33.1 mCi) per 1 mL (10 mL)
Yes
Radiopharmaceutical; use appropriate precautions for handling and disposal. Use waterproof gloves and effective radiation shielding when handling.
IV: Administer as bolus through a peripheral venous catheter; obtain static emission images within 0 to 15 minutes after injection. Patient should be fasting (at least 6 hours) prior to administration to minimize the potential for dietary choline interference with radioactivity uptake in tissue. Patients should be adequately hydrated 4 hours prior to imaging; instruct patients to void after each image session and frequently for 1 hour following completion of PET/CT scan.
Prostate imaging: Radiopharmaceutical imaging agent used in conjunction with positron emission tomography (PET) for patients with suspected prostate cancer recurrence and noninformative bone scintigraphy, computerized tomography (CT), or magnetic resonance imaging (MRI).
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Local: Injection site reaction (mild)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Allergic reactions, including anaphylaxis, can occur. Treatment of hypersensitivity reactions should be available for immediate use.
• Malignancy: Radiation-emitting products may increase the risk for cancer, particularly in children. Use the smallest dose necessary and ensure safe handling to protect patients and healthcare workers.
Concomitant drug therapy:
• Androgen-deprivation therapy: Concomitant use with androgen-deprivation therapy (eg, luteinizing hormone releasing analogs, antiandrogen drugs) may interfere with imaging.
• Colchicine: Concomitant colchicine use may interfere with imaging; consider discontinuation of colchicine for 2 weeks prior to imaging.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Not a replacement for histologic verification of recurrent prostate cancer. Patient should be fasting (at least 6 hours) prior to administration. Patients should be adequately hydrated 4 hours prior to imaging; instruct patients to void after each image session and frequently for 1 hour following completion of PET/CT scan.
• Risk for misinterpretation: Due to the high rate of false-positive or false-negative image interpretations, other appropriate tests should be done for confirmation of results. Tissue inflammation as well as prostatic hyperplasia have been associated with false-positive images; PSA levels <2 ng/mL have been associated with poorer imaging results. Choline C 11 uptake is not specific for the prostate and may occur with other cancers (eg, lung, brain tumors).
None known.
Antiandrogens: May diminish the therapeutic effect of Choline C 11. Risk C: Monitor therapy
Colchicine: May diminish the therapeutic effect of Choline C 11. Risk C: Monitor therapy
Luteinizing Hormone-Releasing Hormone Analogs: May diminish the therapeutic effect of Choline C 11. Risk C: Monitor therapy
Animal reproduction studies have not been conducted. Not indicated for use in women.
It is not known if choline C 11 is present in breast milk. Not indicated for use in women.
Monitor for signs/symptoms of hypersensitivity.
Radiolabeled analog of choline, a precursor molecule essential for the biosynthesis of cell membrane phospholipids. Increased uptake of choline has been associated with cell proliferation and the transformation process that occurs in tumor cells.
Onset of action: Within 5 minutes
Duration: Activity retained >30 minutes
Distribution: Radioactivity also distributes to the pancreas, kidneys, liver, spleen, and colon
Excretion: Urine: <2% (1.5 hours postadministration)