Florbetaben ¹⁸F Other names: Florbetaben F-18

Risk Summary

There are no available data on florbetaben F18 use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with florbetaben F18. All radiopharmaceuticals, including florbetaben F18, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering florbetaben F18 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Risk Summary

There are no data on the presence of florbetaben F18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F18 injection on milk production. Exposure of florbetaben F18 to a breastfed 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 florbetaben F18 and any potential adverse effects on the breastfed child from florbetaben F18 or from the underlying maternal condition.

Clinical Considerations

To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of florbetaben F18.

Animal studies have not been performed to evaluate the carcinogenic potential of florbetaben.

Florbetaben did not demonstrate mutagenic potential in an in vitro bacterial mutation assay (Ames test) using five strains of Salmonella typhimurium and one strain of Escherichia coli or in an in vitro chromosomal aberration assay using human peripheral lymphocytes in the absence and presence of a metabolic activator.

No study on impairment of male or female fertility and reproductive performance was conducted in animals.

Clinical Trials Experience

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 rate observed in clinical practice.

The overall safety profile of florbetaben F18 is based on data from 1090 administrations of florbetaben F18 to 872 subjects. No serious adverse reactions related to florbetaben F18 administration have been reported. The most frequently observed adverse drug reactions in subjects receiving florbetaben F18 were injection site reactions consisting of erythema, irritation and pain. All adverse reactions were mild to moderate in severity and of short duration. The most commonly reported adverse reactions (occurring in at least 1% of subjects) during florbetaben F18 clinical trials are shown in the following table.

Adverse Reactions with a Frequency ≥1% Reported in Clinical Trials (n=1090 Administrations in 872 Subjects):