Chemical formula: C₅H₈FNO₂ Molecular mass: 132.125 g/mol PubChem compound: 450601
Fluciclovine F 18 is not indicated for use in females and there is no information on the risk of adverse development outcomes in pregnant women or animals with the use of fluciclovine F 18.
Fluciclovine F 18 is not indicated for use in females and there is no information of the presence of fluciclovine F 18 in human milk.
No long term studies in animals have been performed to evaluate the carcinogenic potential of fluciclovine.
Fluciclovine was not mutagenic in vitro in reverse mutation assay in bacterial cells and in chromosome aberration test in cultured mammalian cells, and was negative in an in vivo clastogenicity assay in rats after intravenous injection of doses up to 43 mcg/kg. However, fluciclovine 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 clinical trial database for fluciclovine F 18 includes data from 877 subjects including 797 males diagnosed with prostate cancer. Most patients received a single administration of fluciclovine F 18, a small number of subjects (n=50) received up to five administrations of the drug. The mean administered activity was 370 MBq (range, 163 to 485 MBq).
Adverse reactions were reported in ≤1% of subjects during clinical studies with fluciclovine F 18. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
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