Gallium ⁶⁸Ga edotreotide Other names: Edotreotide gallium Ga-68

Risk Summary

There are no available data on the use of gallium ⁶⁸Ga edotreotide injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with gallium ⁶⁸Ga edotreotide. However, all radiopharmaceuticals, including gallium ⁶⁸Ga edotreotide injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering gallium ⁶⁸Ga edotreotide injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from gallium ⁶⁸Ga edotreotide injection 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 2-4% and 15-20%, respectively.

Risk Summary

There is no information on the presence of gallium ⁶⁸Ga edotreotide in human milk, the effect on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gallium ⁶⁸Ga edotreotide injection and any potential adverse effects on the breastfed child from gallium ⁶⁸Ga edotreotide injection or from the underlying maternal condition.

Clinical Considerations

To decrease exposure to the breastfed infant, advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hours after gallium ⁶⁸Ga edotreotide injection administration.