Limited available data with technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta (see Data). No animal reproductive studies have been conducted with technetium Tc 99m pentetate. 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 pentetate administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m pentetate and the gestational timing of exposure.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S., general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
Limited published literature describes technetium Tc 99m pentetate crossing the placental barrier. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses.
There are limited data available in scientific literature on the presence of technetium Tc 99m pentetate in human milk. There are no data available on the effects of technetium Tc 99m pentetate on the breastfed infant or the effects on milk production. Based on the United States Nuclear Regulatory Commission guidelines for breast feeding interruption after exposure to radiopharmaceuticals, breastfeeding interruption is not recommended for technetium Tc 99m pentetate at levels less than 1000 MBq (30 mCi). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for technetium Tc 99m pentetate, any potential adverse effects on the breastfed child from technetium Tc 99m pentetate or from the underlying maternal condition.
The following adverse reactions have been identified post-approval. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their exact frequency or establish a causal relationship to technetium Tc 99m pentetate exposure.
Adverse reactions are presented in decreasing order of reported frequency:
Immune system disorders: allergic reaction, anaphylactic reaction, angioedema.
Skin and subcutaneous tissue disorders: rash, itching, hives, erythema.
Respiratory, thoracic and mediastinal disorders: throat irritation, wheezing.
Vascular disorders: hypotension, hypertension.
Nervous system disorders: headache, fainting, dizziness.
General disorders and administration site conditions: chills.
Gastrointestinal disorders: nausea, vomiting.
Cardiac disorders: cyanosis, tachycardia.
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