Chemical formula: C₁₈H₂₃FO₂ Molecular mass: 289.381 g/mol
All radiopharmaceuticals, including fluoroestradiol F 18, 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 fluoroestradiol F 18.
There are no available data on fluoroestradiol F 18 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 2-4% and 15-20%, respectively.
There are no data on the presence of fluoroestradiol F 18 in human milk, or its effects on the breastfed infant or milk production. Lactation studies have not been conducted in animals. Advise a lactating woman to avoid breastfeeding for 4 hours after fluoroestradiol F 18 administration in order to minimize radiation exposure to a breastfed infant.
No long-term studies in animals were performed to evaluate the carcinogenic potential of fluoroestradiol F 18.
Fluoroestradiol was evaluated by in vitro bacterial reverse mutation assay (Ames test) and in vitro L5178Y/TK+/- mouse lymphoma mutagenesis assay. Fluoroestradiol was negative for genotoxicity by Ames test at up to 1.25 μg per plate for 5 tester strains (Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia Coli tester strain WP2 uvrA) in the presence or absence of S9 metabolic activation. Fluoroestradiol was negative for genotoxicity by L5178Y/TK+/- mouse lymphoma mutagenesis assay at up to 8 ng/mL in the absence or presence of S9 metabolic activation.
Potential in vivo genotoxicity of fluoroestradiol was evaluated in a rat micronucleus assay. In this assay, fluoroestradiol did not increase the number of micronucleated polychromatic erythrocytes (MN-PCEs) at 51 μg/kg/day, when given for 14 consecutive days. However, fluoroestradiol F 18 has the potential to be mutagenic because of the F 18 radioisotope.
No studies in animals have been performed to evaluate potential impairment of fertility in males or females.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of fluoroestradiol F 18 was evaluated from published clinical studies of 1207 patients with breast cancer receiving at least one fluoroestradiol F 18 administration.
The following adverse reactions occurred at a rate <1%:
General disorders: injection-site pain
Neurological and gastrointestinal disorders: dysgeusia
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