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Cerianna (fluoroestradiol F 18) injection is the only imaging agent that detects whole-body ER+ lesions in recurrent or metastatic breast cancer patients that may inform clinical decisions.
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About Cerianna™
Cerianna PET reveals whole-body ER+ lesion status in patients with recurrent or metastatic breast cancer that may help guide clinical decisions.
INDICATIONS 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.
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 imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
CONTRAINDICATIONS
None.
ADVERSE REACTIONS
In clinical trials evaluating the safety of CERIANNA in patients with breast cancer (n=1207), the following adverse reactions occurred at a rate < 1%: injection-site pain and dysgeusia.
To report SUSPECTED ADVERSE REACTIONS, contact Zionexa US Corp, a GE HealthCare Company at +1.800.654.0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For full Prescribing Information, click here.
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Cerianna is a trademark of GE HealthCare.
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September 2023 | JB07297US