CERIANNA
Generic: FLUOROESTRADIOL F 18
Basic Information
Manufacturer
GE Healthcare Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
b2c2a2df-cf3e-4a29-a033-231ed5a94b58
Indications & 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).
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).
Adverse Reactions
6 ADVERSE REACTIONS Reported adverse reactions include: injection-site pain and dysgeusia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of CERIANNA was evaluated from published clinical studies of 1,207 patients with breast cancer receiving at least one fluoroestradiol F 18 administration.
The following adverse reactions occurred at a rate < 1%: General disorders : injection-site pain Neurological and gastrointestinal disorders : dysgeusia
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of CERIANNA was evaluated from published clinical studies of 1,207 patients with breast cancer receiving at least one fluoroestradiol F 18 administration.
The following adverse reactions occurred at a rate < 1%: General disorders : injection-site pain Neurological and gastrointestinal disorders : dysgeusia