Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Limited available data with Technetium Tc 99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Sestamibi. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technetium Tc 99m Sestamibi administration to a pregnant woman, inform the patient about the potential for adverse pregancy outcomes based on the radiation dose from Technetium Tc 99m Sestamibi and the gestational timing of exposure. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregancies is 2 % to 4 % and 15 % to 20 %, respectively.