Chemical formula: C₉H₁₀FNO₄ Molecular mass: 214.183 g/mol
There are no available data on fluorodopa F18 injection use in pregnant women. Additionally, animal reproductive and developmental toxicity studies have not been conducted with fluorodopa F18 injection. However, all radiopharmaceuticals, including fluorodopa F18 injection, have a potential to cause fetal harm depending on the stage of fetal development, and the magnitude of the radiation dose. If considering fluorodopa F18 injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively, regardless of drug exposure.
No data are available regarding the presence of fluorodopa F18 injection in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Exposure of fluorodopa F18 injection to a breast fed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fluorodopa F18 injection and any potential adverse effects on the breastfed child from fluorodopa F18 injection or from the underlying maternal condition.
The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours.
To decrease radiation exposure to a nursing infant, advise a lactating woman to pump and discard breastmilk for at least 24 hours (12 half-lives) after administration of fluorodopa F18 injection.
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. No adverse reactions have been reported for fluorodopa F18 injection based on an open-label clinical trial in 68 patients and additional clinical experience in 53 patients.
The following adverse reactions have been identified during post approval of use of fluorodopa F18 injection outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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