Cerianna™ (fluoroestradiol F18) injection
At a glance
ER discordance in MBC
Detecting ER+ lesions
Unique mechanism of action
Concordance with biopsy
The only imaging agent that detects whole-body ER+ lesion status
Unique mechanism of action that detects ER+ lesions*†5
Verified concordance with biopsy for determining ER status in MBC* 1
Distinct mode of action that may help inform clinical decisions
F18 fluoroestradiol and FDG PET images in a MBC treatment responder and non-responder*†15
Patient 1 (anterior/superior) responded to treatment with an AI and a CDK 4/6 inhibitor*15
Patient 2 (anterior/superior) did not respond to treatment with an AI and a CDK 4/6 inhibitor*15
Potential clinical applications
Determine ER+ status in recurrent or metastatic lesions, as an adjunct to biopsy
Assess ER+ status in difficult-to-biopsy lesions
Evaluate extent of ER expression in indolent tumors
May resolve clinical dilemmas after inconclusive results from conventional assessment
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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).
WARNINGS AND PRECAUTIONS
Risk of Misdiagnosis
Inadequate Tumor Characterization and Other ER-Positive Pathology
• Breast cancer may be heterogeneous within patients and across time. CERIANNA images ER and is not useful for imaging other receptors such as HER2 and PR. The uptake of fluoroestradiol F 18 is not specific for breast cancer and may occur in a variety of ER-positive tumors that arise outside of the breast, including from the uterus and ovaries. Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.
False Negative CERIANNA Scan
• A negative CERIANNA scan does not rule out ER-positive breast cancer. Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative CERIANNA scan.
• Diagnostic radiopharmaceuticals, including CERIANNA, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe drug handling and patient preparation procedures (including adequate hydration and voiding) to protect patients and health care providers from unintentional radiation exposure.
• Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA.
•In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate <1%: were injection-site pain and dysgeusia.
USE IN SPECIFIC POPULATIONS
Pregnancy Risk Summary
• All radiopharmaceuticals, including CERIANNA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of CERIANNA.
• There are no available data on CERIANNA use in pregnant women. No animal reproduction studies using fluoroestradiol F 18 have been conducted to evaluate its effect on female reproduction and embryo-fetal development.
• The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Lactation Risk Summary
• There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration in order to minimize radiation exposure to a breastfed infant.
• The safety and effectiveness of CERIANNA in pediatric patients have not been established.
• Clinical studies of fluoroestradiol F 18 injection did not reveal any difference in pharmacokinetics or biodistribution in patients aged 65 and over.
Systemic Endocrine Therapies that Target Estrogen Receptors
• Certain classes of systemic endocrine therapies, including ER modulators and ER down-regulators, block ER, reduce the uptake of fluoroestradiol F 18, and may reduce detection of ER-positive lesions after administration of CERIANNA. Drugs from these classes such as tamoxifen and fulvestrant may block ER for up to 8 and 28 weeks, respectively. Do not delay indicated therapy in order to administer CERIANNA. Administer CERIANNA prior to starting systemic endocrine therapies that block ER.
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