Fluoroestradiol F-18

What is Fluoroestradiol F-18?[edit | edit source]

Fluoroestradiol F-18 (CERIANNA) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging.

This medicine is indicated for use with positron emission tomography (PET imaging) for characterization of estrogen receptor (ER) status of known or suspected metastatic lesions in patients with confirmed ER-positive breast cancer.

Fluoroestradiol F 18 binds ER.
The following binding affinity: Kd = 0.13 ± 0.02 nM, Bmax = 1901 ± 89 fmol/mg, and IC50 = 0.085 nM, was determined in an ER-positive human breast cancer cell line (MCF-7).

Limitation 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 imaigng other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).

Drugs such as tamoxifen and fulvestrant that block the estrogen receptor reduce the uptake of fluoroestradiol F 18.
Administer CERIANNA prior to starting systemic endocrine therapies that block ER.

CERIANNA is a radioactive drug.
Only authorized persons qualified by training and experience should receive, use, and administer CERIANNA.
Handle CERIANNA with appropriate safety measures to minimize radiation exposure during administration .
Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling CERIANNA.

Recommended Dosage

The recommended amount of radioactivity to be administered for PET imaging is 222 MBq (6 mCi), with a range of 111 MBq to 222 MBq (3 mCi to 6 mCi), administered as a single intravenous injection of 10 mL or less over 1 to 2 minutes.
The recommended dose for an adult weighing 70 Kg is 222 MBq with an allowable range from 111 to 222 MBq (3 – 6 mCi).
This activity injected can be adapted to the body weight of the patient, the type of camera used and the acquisition mode.
Recommended imaging start time is 80 minutes (range 20 minutes to 80 minutes) after drug administration.

Administration

Use aseptic technique and radiation shielding when withdrawing and administering CERIANNA.
Visually inspect the radiopharmaceutical solution.
Do not use if it contains particulate matter or if it is cloudy or discolored (CERIANNA is a clear, colorless solution).
CERIANNA may be diluted with 0.9% Sodium Chloride Injection, USP.
Assay the dose in a suitable dose calibrator prior to administration.

This medicine is available in fallowing doasage form:

As Injection: 148 MBq/mL to 3,700 MBq/mL (4 mCi/mL to 100 mCi/mL) of fluoroestradiol F 18 in a multiple-dose vial.

This medicine is available in fallowing brand namesː

Common possible side effects of this medicine include:

Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.
Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure.

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Overdose related information is also available online at poisonhelp.org/help.
In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

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.

The safety and effectiveness of CERIANNA in pediatric patients have not been established.

Storage

Store CERIANNA at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F).
Store CERIANNA upright in the original container with radiation shielding.
The expiration date and time are provided on the container label.
Use CERIANNA within 10 hours from the time of the end of synthesis.

Handling

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Fluoroestradiol F-18 Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.