Florbetapir ¹⁸F Other names: Florbetapir fluorine 18 Florbetapir (18F) Florbetapir F-18

Risk Summary

There are no available data on florbetapir F 18 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 florbetapir F 18 to evaluate its effect on female reproduction and embryo-fetal development. All radiopharmaceuticals, including florbetapir F 18, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering florbetapir F 18 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 background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of adverse outcomes. The background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Risk Summary

There are no data on the presence of florbetapir F 18 Injection in human milk, the effects on the breastfed infant, or the effects of florbetapir F 18 Injection on milk production. Lactation studies have not been conducted in animals. Exposure of florbetapir F 18 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 florbetapir F 18 and any potential adverse effects on the breastfed child from florbetapir F 18 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 (>10 half-lives of radioactive decay for the F 18 isotope) following administration of florbetapir F 18.

Animal studies to assess the carcinogenicity or reproductive toxicity potentials of florbetapir F 18 have not been conducted.

In an in vitro bacterial reverse mutation assay (Ames test), increases in the number of revertant colonies were observed in 2 of the 5 strains exposed to ¹⁹F-AV-45, the non-radioactive form of florbetapir F 18. In a chromosomal aberration in vitro study with cultured human peripheral lymphocytes, ¹⁹F-AV-45 did not increase the percentage of cells with structural aberrations with 3-hour exposure with or without activation; however, 22-hour exposure produced a statistically significant increase in structural aberrations at all tested concentrations. Potential in vivo genotoxicity of ¹⁹F-AV-45 was evaluated in a rat micronucleus study. In this assay, ¹⁹F-AV-45 did not increase the number of micronucleated polychromatic erythrocytes at the highest achievable dose level, 372 μg/kg/day, when given twice daily for 3 consecutive days.

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 rates observed in clinical practice.

In clinical studies, 555 patients were exposed to florbetapir F 18. Florbetapir F 18 caused no serious adverse reactions in the studies and the reported adverse reactions were predominantly mild to moderate in severity. The adverse reactions reported in more than one subject within the studies are shown in the following list.

Adverse Reactions Reported in Clinical Trials (N=555 patients):

^a Includes the terms blood pressure increased and hypertension.
^b Includes the terms injection site haemorrhage, injection site irritation, and injection site pain.
^c Includes the terms feeling cold and chills.

Other adverse reactions occurred at lower frequencies and included infusion site rash, dysgeusia, pruritus, urticaria, and flushing.