Brand Name
Cerianna
Generic Name
Fluoroestradiol
View Brand Information FDA approval date: May 20, 2020
Classification: Radioactive Diagnostic Agent
Form: Injection
What is Cerianna (Fluoroestradiol)?
CERIANNA is indicated for use with positron emission tomography for characterization of estrogen receptor status of known or suspected metastatic lesions in patients with confirmed ER-positive breast cancer. Limitations of Use Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaigng other receptors, such as human epidermal growth factor receptor 2 and the progesterone receptor CERIANNA is a radioactive diagnostic agent indicated for positron emission tomography imaging. Fluoroestradiol F 18 is indicated for characterization of estrogen receptor status of known or suspected metastatic lesions in patients with confirmed ER-positive breast cancer.
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Related Latest Advances
Brand Information
CERIANNA (FLUOROESTRADIOL F 18)
1INDICATIONS AND USAGE
CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
2DOSAGE FORMS AND STRENGTHS
Injection: clear, colorless solution in a multiple-dose vial containing 148 MBq/mL to 3,700 MBq/mL (4 mCi/mL to 100 mCi/mL) of fluoroestradiol F 18 at end of synthesis.
3CONTRAINDICATIONS
None
4DRUG INTERACTIONS
Drugs that bind to the estrogen receptor (ER) may compete with the binding of fluoroestradiol F 18 and may reduce the detection of ER-positive lesions with CERIANNA.
Before administering CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives (e.g., elacestrant for 11 days, tamoxifen for 8 weeks, and fulvestrant for 28 weeks)
5CLINICAL STUDIES
The effectiveness of CERIANNA for detecting ER-positive non-primary breast cancer lesions was evaluated based on published study reports of fluoroestradiol F 18. Study 1 (NCT01986569) enrolled 90 women (median age 55 years, 39% premenopausal) with histologically confirmed invasive breast cancer. The patients had first known or suspected recurrence of treated breast cancer or stage IV metastatic breast cancer. Recent biopsy of lesions outside of bone and areas with high physiologic fluoroestradiol F 18 uptake was also required
Image reader performance for distinguishing between ER-positive and ER-negative fluoroestradiol F 18 uptake was compared to biopsy in 85 patients. Of the 47 patients with positive biopsy (Allred score ≥ 3), 36 were positive on imaging (majority reader score = 3). Ten of 11 patients with false negative imaging had Allred scores between 3 and 6
Study 2 (NCT00602043) in 13 patients showed similar results.
6PRINCIPAL DISPLAY PANEL - 50 mL Vial Label
CERIANNA™ (fluoroestradiol F 18) Injection
Multiple-Dose Vial
Date of manufacture:
Expiration date & time:__________; ______hr:min
Lot# _______________________________________
Volume: ________ mL
Contains: 148 MBq/mL to 3,700 MBq/mL
Usual dosage: See prescribing information
CAUTION: RADIOACTIVE
Dist.by: GE Healthcare, Inc., Arlington Heights, IL 60004 USA
100112-0B
7PRINCIPAL DISPLAY PANEL - 50 mL Vial Shield Label
NDC 72874-001-01
Multiple-Dose Vial
CERIANNA™ (fluoroestradiol F 18) Injection
Sterile, Non-pyrogenic
Date/time of calibration: _____________; ________hr:min
Expiration date & time: _____________; ________hr:min
Volume: _______________________ mL
Lot # ________________________
Concentration: ___________mCi/mL
Total Activity: ____________mCi at
Contains: 148 MBq/mL to 3,700 MBq/mL (4 mCi/mL to 100
Usual dosage: See prescribing information
*EOS = End of Synthesis
CAUTION: RADIOACTIVE MATERIAL
Expires 12 hours after EOS*
Store upright in a shielded container
[18F] Half-Life = 109.8 minutes
Calculate correct dosage from date
Dist. by: GE Healthcare, Inc.
GE is a trademark of General Electric
100113-0B
Rx ONLY
