CERIANNA INDICATION AND IMPORTANT SAFETY INFORMATION FOR NON-HEALTHCARE PROFESSIONALS
CERIANNATM (fluoroestradiol F18) injection is a diagnostic imaging agent (sometimes called a
radiopharmaceutical or tracer). CERIANNA is used as part of a Positron Emission Tomography (PET) scan to detect a specific protein called the estrogen receptor on breast cancer tumors that have recurred or spread from their original site (metastasized). CERIANNA is used as an adjunct to biopsy.
Adverse Reactions: The most common side effects seen with CERIANNA were pain at the site of injection and temporary altered taste sensation.
Radiation Risks: CERIANNA is radioactive and exposure to radiation has a dose dependent increased risk of cancer. Please discuss with your doctor about ways to help minimize this risk.
Risk of Misdiagnosis: CERIANNA imaging results can have false negatives and false positives. Please discuss any concerns with your doctor.
Use in Specific Populations: Tell your doctor if you are or may be pregnant; if you plan on becoming pregnant; or you are currently breastfeeding.
Additionally, CERIANNA has not been studied in patients under the age of 18.
CERIANNA is expected to behave similarly in adult patients, regardless of age.
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