Country: United States
Language: English
Source: NLM (National Library of Medicine)
CHOLINE C-11 (UNII: M4AS4XGD4Q) (CHOLINE C-11 - UNII:M4AS4XGD4Q)
Mayo Clinic
CHOLINE C-11
CHOLINE C-11 33.1 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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. None. 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. 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. The safety and effectiveness of Choline C 11 Injection have not been established in pediatric patients.
Choline C 11 Injection is packaged in a single dose glass vial containing between 148 MBq to 1,225 MBq (4 mCi to 33.1 mCi) per milliliter of 11 C-choline at EOS calibration time in aqueous 0.9% sodium chloride solution. 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.
New Drug Application
CHOLINE C 11- CHOLINE C-11 INJECTION MAYO CLINIC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CHOLINE C 11 INJECTIONSAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FORCHOLINE C 11 INJECTION. CHOLINEC 11 INJECTION,FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2012 INDICATIONS AND USAGE Choline C 11 Injection is a 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. In these patients, 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 Use: C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer ( 1). 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). DOSAGE FORMS AND STRENGTHS Choline C 11 Injection contains 148 – 1,225 MBq (4 – 33.1 mCi) per milliliter of C-choline at end of synthesis calibration time in aqueous 0.9% sodium chloride solution ( 3). CONTRAINDICATIONS None ( 4). WARNINGS AND PREC Read the complete document