Fluoroestradiol F 18

Fluoroestradiol F 18 is an imaging agent indicated for use with positron emission tomography (PET) to detect estrogen receptor–positive (ER+) lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

• Fluoroestradiol F 18 is available under the following different brand names: Cerianna

Common side effects of Fluoroestradiol F 18 include:

• injection-site pain and
• changes in taste

Serious side effects of Fluoroestradiol F 18 include:

• not available

Rare side effects of Fluoroestradiol F 18 include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 148-3,700 MBq/mL (4-100 mCi/mL) per vial at the end of synthesis

Breast cancer PET imaging

Adult dosage

• 222 MBq (6 mCi), range of 111-222 MBq (3-6 mCi), administered as a single IV injection of 10 mL and lower over 1-2 minutes.

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fluoroestradiol F 18 has severe interactions with no other drugs.
• Fluoroestradiol F 18 has serious interactions with no other drugs.
• Fluoroestradiol F 18 has moderate interactions with no other drugs.
• Fluoroestradiol F 18 has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Fluoroestradiol F 18?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fluoroestradiol F 18?”

Cautions

• Radiation risks
  • Diagnostic radiopharmaceuticals expose patients to radiation
  • Radiation exposure is associated with a dose-dependent increased risk for cancer
  • Ensure safe drug handling and patient preparation procedures to protect patients and healthcare providers from unintentional radiation exposure
• Misdiagnosis risks
  • Inadequate tumor characterization and other estrogen receptor–positive (ER+) pathology
  • Breast cancer may be heterogeneous within patients and across time
  • Fluoroestradiol F 18 images ER and is not useful for imaging other receptors (eg, human epidermal growth factor receptor 2, progesterone receptor)
  • Uptake is not specific to breast cancer and may occur in various ER+ tumors that arise outside of the breast, including the uterus and ovaries
  • Do not use instead of biopsy when a biopsy is indicated in patients with recurrent or metastatic breast cancer
• False-negative scan
  • A negative scan does not rule out ER+ breast cancer
  • Pathology or clinical characteristics that suggest a patient may benefit from systemic hormone therapy should take precedence over a discordant negative scan
• Drug interaction overview
  • 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 the detection of ER+ lesions after administration
  • Drugs from these classes (eg, tamoxifen, fulvestrant) may block ER for up to 8-28 weeks, respectively
  • Do not delay indicated therapy to administer fluoroestradiol F 18
  • Administer fluoroestradiol F 18 before starting systemic endocrine therapies that block ER

Pregnancy and Lactation

• All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose
• Advise pregnant women of the potential risks for fetal exposure to radiation from the administration
• There are no available data on use during pregnancy
• No animal reproduction studies have been conducted
• Lactation
  • There are no data on the presence of fluoroestradiol F 18 in human milk or its effects on breastfed infants or milk production
  • Lactation studies have not been conducted on animals
  • Advise breastfeeding women to avoid breastfeeding for 4 hours after administration