Additional information to better understand Cerianna and how it can help patients
Important Safety Information
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 (n=1207) the most common adverse reactions seen occurred at a rate
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.
Please see full Prescribing Information
here, for additional important safety information.