Technetium ⁹⁹ᵐTc pertechnetate Other names: Technetium TC-99M pertechnetate

Risk Summary

There are no available data with sodium pertechnetate Tc-99m use in pregnant women to inform any drug-associated risks of developmental outcomes. Animal reproductive studies have not been conducted with sodium pertechnetate Tc-99m. All radiopharmaceuticals, including sodium pertechnetate Tc-99m, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering sodium pertechnetate Tc-99m administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from sodium pertechnetate Tc-99m 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 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 pregnancies is 2-4% and 15-20%, respectively.

Risk Summary

There are limited data available in the published literature on the presence of technetium Tc-99m in human milk. There are no data available on the effects of sodium pertechnetate Tc-99m on the breast fed infant or the effects on milk production. Exposure of sodium pertechnetate Tc-99m to a breastfed infant can be minimized by temporary discontinuation of breast feeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium pertechnetate Tc-99m, any potential adverse effects on the breastfed child from sodium pertechnetate Tc-99m or from the underlying maternal condition.

Clinical Considerations

To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breastmilk after the administration of Sodium Pertechnetate Tc-99m for 12 to 24 hours, where the duration corresponds to the typical range of administrated activity, 259 MBq to 925 MBq (7 mCi to 25 mCi).

No long-term studies have been performed to evaluate carcinogenic potential, mutagenicity potential, or to determine whether sodium pertechnetate Tc-99m injection may affect fertility in males or females.

• Radiation Exposure Risk
• Unintended Mo-99 Exposure

Postmarketing Experience

The following adverse reactions associated with the use of sodium pertechnetate Tc 99m injection have been identified in postmarketing experience. 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.

Allergic reactions (skin rash, hives, or itching) including anaphylaxis has been reported following the administration of sodium pertechnetate Tc-99m.