Choline c-11

FDA label, Mayo Clinic, intravenous, effective 2025-12-26. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Radioactive Diagnostic Agent

Dosing in kidney impairment

Imaging is typically performed from the base of the pelvis to the base of the skull. Acquire static emission images 0 – 15 minutes from the time of injection. Localized uptake of 11 C-choline in a site suspicious for prostate cancer recurrence (a positive image) is determined by comparison of the anatomical relationship of concentrated radioactivity to the neighboring tissue background, exclusive of the radioactivity physiologically accumulated within the pancreas, liver, spleen, kidney and colon.

Table 1: Estimated Radiation Absorbed Dose Per Unit Activity for Adults, Choline C 11 Injection
Organ/TissueMean Absorbed Dose Per Unit Administered Activity (μ Gy/MBq)b
Adrenals 3.59
Bone - Osteogenic Cells 4.81
Bone - Red Marrow 1.90
Brain 1.16
Breast 1.39
Gallbladder Wall4.54
GI a – Lower Large Intestine Wall 1.81
GI a - Small Intestine 2.35
GI a - Stomach Wall 6.00
GI a – Upper Large Intestine Wall 6.41
Heart wall3.43
Kidneys 20.62
Liver 20.11
Lungs 4.59
Muscle2.54
Ovaries 2.02
Pancreas 29.19
Skin1.22
Spleen 9.16
Testes 1.36
Thymus1.69
Thyroid 1.49
Urinary Bladder Wall 3.41
Uterus 1.96
Total body 2.97
Effective Dose (μSv/MBq) c4.35

Preparation and administration

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Basis

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Recommended Dose and Administration Instructions The recommended dose is 370 – 740 MBq (10 – 20 mCi) administered as a bolus intravenous injection. The radioactivity dose (370 – 740 MBq, 10 – 20 mCi) is chosen based on patient body dimensions and the characteristics of the image acquisition system Inspect Choline C 11 Injection visually for particulate matter and discoloration before administration.

Do not use the drug if the solution contains particulate matter or is discolored. Aseptically withdraw Choline C 11 Injection from its container and administer the drug as a bolus through a peripheral venous catheter. Dispose of any unused drug in a safe manner, in compliance with applicable regulations.

Patient Preparation Prior to administration of Choline C 11 Injection: Fasting for at least six hours is recommended to minimize the potential for dietary choline interference with radioactivity uptake in tissue. Ensure that the patient is well hydrated and encourage voiding when imaging is completed.

Imaging Guidelines Initiate image acquisition immediately after administration of Choline C 11 Injection. Imaging is typically performed from the base of the pelvis to the base of the skull. Acquire static emission images 0 – 15 minutes from the time of injection. Localized uptake of 11 C-choline in a site suspicious for prostate cancer recurrence (a positive image) is determined by comparison of the anatomical relationship of concentrated radioactivity to the neighboring tissue background, exclusive of the radioactivity physiologically accumulated within the pancreas, liver, spleen, kidney and colon.

Drug interactions

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Label text (2 paragraphs)

Colchicine and androgen-deprivation therapeutic drugs have been reported to interfere with choline-based PET imaging [ see Warnings and Precautions (5.1) ]. The impact of androgen-deprivation therapeutic drugs upon 11 C-choline PET imaging may depend upon the hormonal responsiveness of a patient’s recurrent prostate cancer. Clinical studies have not established this relationship but published reports suggest 11 C-choline PET imaging may be productive in patients with “hormone resistant” recurrent prostate cancer even if the patients are receiving anti-androgen therapy.

Imaging may prove unproductive or misleading due to failed or insufficient 11 C-choline uptake in patients with hormone-responsive cancer if the patients are receiving androgen-deprivation therapy. Colchicine and androgen-deprivation therapeutic drugs may interfere with 11 C-choline PET/CT imaging performance ( 5.1 ).

Contraindications

None. None ( 4 ).

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for choline c-11. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Pregnancy Category C. There are no adequate and well controlled studies with Choline C 11 Injection in pregnant women and the fetal radiation dose from a 11 C-choline PET imaging study is unknown. It is not known whether Choline C 11 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with 11 C-choline. All radiopharmaceuticals, including Choline C 11 Injection, have a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development and the magnitude of the radiopharmaceutical dose.

Assess pregnancy status before administering Choline C 11 Injection to a female of child bearing potential. Choline C 11 Injection should be given to a pregnant woman only if clearly needed.

Lactation

8.3 Nursing Mothers Choline C 11 Injection is not indicated for use in women. It is not known whether Choline C 11 Injection is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from Choline C 11 Injection, nursing mothers should use alternative infant nutrition sources (e.g., stored breast milk or infant formula) and pump and discard breast milk for 8 hours (>10 half lives of radioactive decay for 11 C isotope) after administration of the drug or avoid use of the drug, taking into account the importance of the drug to the mother.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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