CHOLINE C 11- choline c11 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLINE C-11 (UNII: M4AS4XGD4Q) (CHOLINE C-11 - UNII:M4AS4XGD4Q)

Available from:

Global Isotopes, LLC d/b/a Zevacor Molecular

INN (International Name):

CHOLINE C-11

Composition:

CHOLINE C-11 4 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Choline C11 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 Use : 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer. None. There are no adequate and well controlled studies with Choline C11 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 C11 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capa

Product summary:

Choline C 11 Injection is packaged in a multi-dose glass vial containing between 148 MBq to 1225 MBq (4 mCi to 33.1 mCi) of 11 C- choline at EOS calibration time in aqueous 0.9% sodium chloride solution (approximately 10 mL volume). Store Choline C 11 Injection at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) (see USP Controlled Room Temperature). Use the solution within 120 minutes of EOS calibration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHOLINE C 11- CHOLINE C11 INJECTION
GLOBAL ISOTOPES, LLC D/B/A ZEVACOR MOLECULAR
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CHOLINE C11 INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR CHOLINE C11 INJECTION. CHOLINE
C11 INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
These highlights do not include all the information needed to use
Choline C11 Injection safely and effectively. See full
prescribing information for Choline C11 Injection. CHOLINE C11
Injection for intravenous use
Initial U.S. Approval: 2012
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 to 740 MBq (10 to 20 mCi) as a bolus
intravenous injection. The radioactivity dose (370 to 740 MBq, 10 to
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 to 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 inf