FLUOROESTRADIOL F 18
Drug Details
- Generic Name
- FLUOROESTRADIOL F 18
- Brand Names
- CERIANNA
- Application Number
- NDA212155
- Sponsor
- GE Healthcare Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- FLUOROESTRADIOL F-18
Indications and Usage
1 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. CERIANNA is a radioactive diagnostic agent 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. ( 1 ) 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). ( 1 , 5.1 ) 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).