Fluoroestradiol F-18

What is Fluoroestradiol F-18?

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

What are the uses of this medicine?

• 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.

How does this medicine work?

• 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).

Who Should Not Use this medicine ?

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).

What drug interactions can this medicine cause?

• 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.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• 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.

What are the dosage forms and brand names of this medicine?

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

• CERIANNA

What side effects can this medication cause?

Common possible side effects of this medicine include:

• injection-site pain
• dysgeusia

What special precautions should I follow?

• 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.

What to do in case of emergency/overdose?

• 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.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

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

What should I know about storage and disposal of this medication?

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.

• Dailymed label info on Fluoroestradiol F-18
• FDA Fluoroestradiol F-18