CERIANNA Solution for injection Ref.[10084] Active ingredients: Fluoroestradiol ¹⁸F

2.1 Radiation Safety – Drug Handling

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 [see Warnings and Precautions (5.2)]. Use waterproof gloves and effective radiation shielding, including syringe shields, when preparing and handling CERIANNA.

2.2 Recommended Dose and Administration Instructions

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.

Preparation and Administration

• For patient preparation instructions, see (2.3).
• 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.

Post-Administration Instructions

• Follow the CERIANNA injection with an intravenous flush of 0.9% Sodium Chloride injection, USP.
• Dispose of any unused CERIANNA in compliance with applicable regulations

2.3 Patient Preparation

Assessment for Drug Interactions

Image patients with CERIANNA prior to starting systemic endocrine therapies that target ER (e.g., ER modulators and ER down-regulators) [see Drug Interactions (7.1)].

Patient Hydration and Voiding

Instruct patients to drink water to ensure adequate hydration prior to administration of CERIANNA and to continue drinking and voiding frequently during the first hours following administration to reduce radiation exposure.

Pregnancy Status

Assessment of pregnancy status is recommended in females of reproductive potential before administering CERIANNA.

2.4 Image Acquisition

Position the patient supine with arms above the head, if possible. The recommended start time for image acquisition is 80 minutes after the intravenous administration of CERIANNA. Scan duration adapted from the range of 20 minutes to 30 minutes and imaging start times adapted within the range of 20 minutes to 80 minutes may be customized according to the equipment used and patient and tumor characteristics for optimal image quality.

2.5 Image Interpretation

Uptake of fluoroestradiol F 18 depends on ER density and function in tumors and physiologic tissue, including in liver, ovary, and uterus. Detection of ER-positive tumors should be based on comparison with tissue background outside of organs with high physiologic uptake and regions with high activity due to hepatobiliary and urinary excretion.

2.6 Radiation Dosimetry

Radiation absorbed dose estimates are shown in Table 1 for organs and tissues of adults from intravenous administration of CERIANNA. The radiation effective dose resulting from administration of 222 MBq (6 mCi) of CERIANNA to an adult weighing 70 kg is estimated to be 4.9 mSv. Critical organs include the liver, gallbladder, and uterus. When PET/CT is performed, exposure to radiation will increase by an amount dependent on the settings used for the CT acquisition.

Table 1. Estimated Radiation Absorbed Doses in Various Organs/Tissues in Adults who Received FLUOROESTRADIOL F 18:

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.