Fluoroestradiol f-18

FDA label, GE Healthcare Inc., intravenous, effective 2026-01-12. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Radioactive Diagnostic Agent

Dosing in kidney impairment

Table 1. Estimated Radiation Absorbed Doses in Various Organs/Tissues in Adults Who Received FLUOROESTRADIOL F 18
OrganMean Absorbed Dose Per Unit of Activity Administered (mGy/MBq)
Adrenals0.023
Brain0.01
Breasts0.009
Gallbladder0.102
Lower large intestine0.012
Small intestine0.027
Stomach0.014
Upper large intestine0.03
Heart wall0.026
Kidney0.035
Liver0.126
Lungs0.017
Muscle0.021
Ovaries0.018
Pancreas0.023
Red Marrow0.013
Bone surface0.014
Skin0.005
Spleen0.015
Testes0.012
Thymus0.014
Thyroid0.012
Urinary bladder0.05
Uterus0.039
Lens0.009
Effective dose = 0.022 mSv/MBq

Preparation and administration

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Basis

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Recommended Dosage 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 Dosage and Administration 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.

Patient Preparation Assessment for Drug Interactions Before administering CERIANNA, discontinue drugs that bind to ER (e.g., selective estrogen receptor modulators (SERMs) and selective estrogen receptor down-regulators (SERDs)) [see Drug Interactions ] . 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.

Drug interactions

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Label text (1 paragraph)

Drugs that bind to the estrogen receptor (ER) may compete with the binding of fluoroestradiol F 18 and may reduce the detection of ER-positive lesions with CERIANNA. Before administering CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives (e.g., elacestrant for 11 days, tamoxifen for 8 weeks, and fulvestrant for 28 weeks) [see Dosage and Administration (2.3) ] . Before administering CERIANNA, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives (e.g., elacestrant for 11 days, tamoxifen for 8 weeks, and fulvestrant for 28 weeks). ( 2.3 , 7 )

Contraindications

None . None. ( 4 )

Pregnancy and lactation

Pregnancy

8.1 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% to 4% and 15% to 20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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