Choline C-11
Generic Name: choline c-11
Brand Names:
Choline C 11
11 DESCRIPTION 11.1 Chemical Characteristics Choline C 11 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with PET imaging. The active ingredient, 11 C-choline, has the molecular formula of C 4 11 CH 14 NOCl with a molecular weight of 138.63 g and has the following chemical structure: Choline C 11 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution.
Overview
11 DESCRIPTION 11.1 Chemical Characteristics Choline C 11 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with PET imaging. The active ingredient, 11 C-choline, has the molecular formula of C 4 11 CH 14 NOCl with a molecular weight of 138.63 g and has the following chemical structure: Choline C 11 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution.
Uses
1 INDICATIONS AND USAGE Choline C 11 Injection is indicated 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 (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer.
Dosage
2 DOSAGE AND ADMINISTRATION Aseptically withdraw Choline C 11 Injection from its container and administer 370 – 740 MBq (10 – 20 mCi) 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 ( 2.1 ). Initiate imaging immediately after administration of Choline C 11 Injection and acquire static emission images 0 – 15 minutes from the time of injection ( 2.5 ). The effective radiation absorbed dose from 740 MBq (20 mCi) dose of Choline C 11 Injection is approximately 3.22 mSv (0.32 rem) in an adult ( 2.4 ). Image interpretation: Refer to full prescribing information ( 2.5 ).
Side Effects
6 ADVERSE REACTIONS Exclusive of an uncommon, mild injection site reaction, no adverse reactions to 11 C-choline have been reported. Exclusive of an uncommon, mild injection site reaction, no other adverse reactions have been reported ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Division of Nuclear Medicine, Department of Radiology, Mayo Clinic at 507-284-2511 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS Imaging errors have been reported; blood PSA levels < 2 ng/mL have been associated with poor imaging performance ( 5.1 ). Allergic reactions: have emergency resuscitation equipment and personnel readily available ( 5.2 ). Radiation risk: Choline C 11 Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect the patient and health care worker ( 5.3 ). 5.1 Imaging Errors Imaging errors have been reported with 11 C-choline PET and PET/CT imaging. A negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent cancer. 4 CONTRAINDICATIONS None. None ( 4 ).
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.
Storage
16.2 Storage and Handling Store Choline C 11 Injection at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) (see USP Controlled Room Temperature). Use the solution within 120 minutes of EOS calibration.
Frequently Asked Questions
What is Choline C-11 used for?▼
1 INDICATIONS AND USAGE Choline C 11 Injection is indicated 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 (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of U se: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer.
What are the side effects of Choline C-11?▼
6 ADVERSE REACTIONS Exclusive of an uncommon, mild injection site reaction, no adverse reactions to 11 C-choline have been reported. Exclusive of an uncommon, mild injection site reaction, no other adverse reactions have been reported ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Division of Nuclear Medicine, Department of Radiology, Mayo Clinic at 507-284-2511 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Can I take Choline C-11 during 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.
What are the important warnings for Choline C-11?▼
5 WARNINGS AND PRECAUTIONS Imaging errors have been reported; blood PSA levels < 2 ng/mL have been associated with poor imaging performance ( 5.1 ). Allergic reactions: have emergency resuscitation equipment and personnel readily available ( 5.2 ). Radiation risk: Choline C 11 Injection contributes to a patient’s long-term cumulative radiation exposure. Ensure safe handling to protect the patient and health care worker ( 5.3 ). 5.1 Imaging Errors Imaging errors have been reported with 11 C-choline PET and PET/CT imaging. A negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent cancer. 4 CONTRAINDICATIONS None. None ( 4 ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.